Hoorn

This research aims to evaluate the long-term safety and explore the efficacy of astegolimab in adults aged 40 to 90 years with chronic obstructive pulmonary disease COPD. It focuses on participants who have completed a 52-week placebo-controlled treatment period in previous studies GB43311 or GB44332. The study is a phase 3, open-label extension to gather extended safety information on this drug in COPD patients. Participants from the parent studies who qualify will receive subcutaneous injections of astegolimab every two weeks throughout the study until it ends. This open-label extension allows all participants to receive the active drug without placebo comparison. The study continues treatment beyond the initial 52-week period to monitor long-term effects. During the study, participants will be monitored for adverse events up to 12 weeks after their last dose of astegolimab. Researchers will collect safety data to understand the incidence of any side effects. The study involves regular assessments and follow-ups to ensure participant well-being, with the total duration lasting until July 2034.

Researchers are investigating the best way to position implants in reverse shoulder arthroplasty by comparing a new technology called Exactech Guided Personalized Surgery GPS with traditional surgical methods. This study aims to see how the implant placement affects shoulder range of motion and patient-reported outcomes. The study includes long-term follow-up of up to 10 years, with at least 2 years of monitoring for each patient. Participants will undergo reverse shoulder arthroplasty using either the GPS technique or conventional tools. The study will compare these two methods to see which allows for better implant positioning. Patients will have a preoperative CT scan taken within three months before surgery to assist in planning. The study involves regular follow-up visits to monitor progress and outcomes. Throughout the study, participants will be evaluated using several shoulder function and pain assessments, including SST-12, SPADI, Constant, ASES, and UCLA scores, with an average of one assessment per year. These measures will help researchers understand the impact of implant positioning on shoulder function and patient satisfaction. Participants must commit to attending follow-up visits for a minimum of two years, with some followed for up to ten years to assess long-term results.

Researchers are studying whether adjuvant chemotherapy can prevent disease recurrence in adults with high-risk rectal cancer who have detectable circulating tumor DNA ctDNA after surgery. The study aims to determine if this chemotherapy improves disease-free survival compared to standard care. Rectal cancer remains a significant cause of mortality, and while current treatments reduce local recurrence, distant recurrence rates stay high. Identifying patients with residual disease through ctDNA may help target those who might benefit from additional chemotherapy. Participants with detectable ctDNA after surgery will be randomly assigned to receive either standard care or adjuvant chemotherapy consisting of 6 cycles of FOLFOX 5FUfolinic acid and oxaliplatin every 2 weeks or 4 cycles of CAPOX capecitabine and oxaliplatin within 8 to 12 weeks after surgery. The chemotherapy treatment lasts about 3 months. The study is conducted within a prospective colorectal cancer cohort using a randomized controlled design. During the study, participants will have blood samples taken and visits with their physicians before each chemotherapy cycle if assigned to treatment. Researchers will monitor disease-free survival, overall survival, and quality of life using questionnaires over several years. They will also assess the clearance of ctDNA after chemotherapy and study its presence at recurrence. The total follow-up includes up to 2 years for disease recurrence and up to 5 years for survival outcomes.

Researchers are evaluating the feasibility and safety of a ventilation strategy called permissive lung-protective ventilation in adult critically ill patients who require invasive mechanical ventilation due to acute hypoxemic respiratory failure. This pilot trial aims to inform the design of a future larger randomized clinical trial by comparing permissive lung-protective ventilation with conventional lung-protective ventilation. The study focuses on how lowering the respiratory rate may reduce ventilation intensity while managing carbon dioxide levels safely. Participants are randomly assigned to one of two groups one group receives permissive lung-protective ventilation where the respiratory rate is gradually reduced based on blood gas analysis and continuous monitoring, allowing mild increases in carbon dioxide levels within safe limits. The other group receives conventional lung-protective ventilation with standard respiratory rates targeting normal carbon dioxide and pH levels. Blood gas analyses are performed frequently to monitor patient status until ventilator weaning or extubation. Throughout the study, participants undergo regular assessments including arterial blood gas tests, continuous end-tidal CO2 monitoring, and data collection on ventilation parameters and outcomes. Researchers measure the feasibility of reducing respiratory rate, adherence to the protocol, safety indicators such as hypercapnia and hypoxemia, and ventilator-associated complications. Data collection continues up to 90 days for follow-up, with the primary evaluation lasting from ventilation start until first extubation, up to 28 days.

Researchers are investigating whether taking breaks from the standard combination therapy of daratumumab, lenalidomide, and dexamethasone Dara-Rd for newly diagnosed multiple myeloma patients affects survival and quality of life. This study aims to compare continuous treatment versus planned treatment-free intervals to see if stopping therapy temporarily may reduce side effects, allow recovery from toxicity, and improve overall well-being while controlling the disease. Participants who have completed 12 cycles of Dara-Rd with at least a partial response and no signs of disease progression will be randomly assigned to one of two groups. One group will continue Dara-Rd therapy without interruption until disease progression, while the other group will stop treatment temporarily and restart it at biochemical progression, continuing until disease progression. The trial is open-label and will follow patients for several years to assess outcomes. Throughout the study, researchers will monitor participants event-free survival and progression-free survival for up to about 57 and 69 months, respectively. Additional assessments include side effect burden, patient-reported quality of life, treatment costs, treatment-free interval length, response times, and survival after second-line therapy. Regular evaluations will help determine how treatment interruption affects toxicity, dose intensity, and overall treatment outcomes over the long term.

Researchers are comparing robot-assisted radical prostatectomy RARP and external beam radiotherapy EBRT, sometimes combined with androgen deprivation therapy ADT, for men with high-risk non-metastatic prostate cancer. The study aims to understand differences in quality of life, functional outcomes, cost-effectiveness, progression-free survival, and distant metastasis-free survival. There is currently no clear consensus on which treatment is better, leading to variation in hospital practices. Participants will receive either RARP, which may include pelvic lymph node dissection and possibly adjuvant radiotherapy or androgen deprivation therapy, or EBRT delivered at an effective radiation dose, possibly combined with a brachytherapy boost and pelvic lymph node dissection. Positive lymph node findings will not exclude participants and may be treated with lymph node irradiation. Treatment details vary based on clinical decisions. During the study, participants will be followed for up to five years, with key assessments at three years including health-related quality of life and functional outcomes. Cost-effectiveness will also be evaluated at three years, while progression-free and distant metastasis-free survival will be tracked up to five years. The study involves regular monitoring to gather these outcomes and support shared decision-making for future patients.

Pelvic fragility fractures in elderly patients often lead to serious health problems and high death rates. Currently, treatment approaches vary widely due to the lack of a standard protocol. This trial evaluates a new clinical pathway based on evidence and expert experience, aiming to improve outcomes for this vulnerable group who face multiple risks for poor recovery. The study compares the usual care with an evidence-based clinical pathway designed to guide diagnosis and treatment strategies. Patients will be randomly assigned to either continue with standard care or follow this best-practice clinical pathway. The pathway focuses on early diagnosis and minimally invasive treatments tailored for fragile patients. Participants will be monitored over time to assess their mobility, daily function, quality of life, pain levels, medication use, complication rates, and mortality. Assessments use tools like the Parker mobility score, Elderly mobility scale, Katz Index, EuroQol quality of life questionnaire, and pain rating scales. Follow-ups occur at multiple intervals up to two years, with careful tracking of recovery and any additional injuries or complications.

Breast cancer affects about one in seven women, and determining if cancer has spread to the lymph nodes is vital for treatment planning and predicting outcomes. This trial evaluates a new method using indocyanine green ICG fluorescence imaging to identify the sentinel lymph node during breast cancer surgery. The study aims to introduce ICG into regular hospital care in the Netherlands, comparing it to the current standard method using a radioactive tracer, technetium-labeled 99mTc-nanocolloid, which has logistical challenges and exposes patients to radiation. The trial is conducted in three phases first, using the standard 99mTc method second, a transition phase combining both 99mTc and ICG and third, fully implementing ICG alone. During surgery, ICG is injected after anesthesia and visualized with a special camera to locate lymph nodes, while 99mTc requires preoperative injection and imaging. The study takes place in several hospitals and involves gradually introducing ICG while monitoring and adjusting the process. Participants undergo sentinel lymph node biopsy during planned surgery with no extra hospital visits. After surgery, they complete a short questionnaire about their experience. Researchers collect data on how well ICG is adopted, patient satisfaction, procedure safety, costs, and surgical outcomes. The trial aims to create medical protocols and educational materials to support widespread, sustainable use of ICG in breast cancer care.

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 whether skipping the usual follow-up surgery called re-excision after removing primary cutaneous melanoma affects patient outcomes. This large, phase III trial involves 1,749 patients with melanoma stages pT1b to pT4b who have no signs of metastases. The study compares relapse-free survival between those who receive standard re-excision and those who do not, while also examining overall survival, recurrence rates, surgical side effects, quality of life, and economic impact. Participants are randomly assigned to either undergo re-excision surgery with margins of 1 to 2 centimeters according to local guidelines or to receive no further surgery after the initial tumor removal. Sentinel lymph node biopsy and additional systemic treatments are given as needed in both groups. Re-excision, if performed, occurs within 12 weeks of the first surgery and follows standardized procedures to ensure clear margins. Patients will be monitored for up to five years to track recurrence and other outcomes. During the study, patients will have regular follow-ups including assessments of cancer recurrence, surgical complications, and quality of life using validated questionnaires at various time points up to two years. Health economic data will also be collected to evaluate cost-effectiveness. The main measure is relapse-free survival over five years, with additional measures including overall survival and different types of melanoma recurrence. Safety and quality of life are carefully tracked, with management of recurrences left to treating physicians throughout the study period.