There are about 13332 clinical studies being (or have been) conducted in Netherlands. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The objective of this investigator-initiated phase II single-arm open-label clinical trial is to investigate neurological response rate, safety and tolerability of Zanubrutinib 320 mg daily in combination with Rituximab 375 mg/m2 (standard therapy) for the treatment of immunoglobulin M monoclonal gammopathy of unknown significance (IgM MGUS) related polyneuropathy with Myelin Associated Glycoprotein antibodies (anti-MAG). 42 adult patients will be included in two Dutch hospitals (University Medical Center Utrecht and Amsterdam University Medical Center). This trial consists of a 6-month treatment period, after which the hematological response will be evaluated. Adequately responding participants (at least partial response) will be treated for an additional 6 months, after which hematological response will be re-evaluated. Participants with at least a very good partial response will remain on treatment. Non-responding participants will be followed for clinical outcomes only. The total study period per participant will be 36 months.
Chronic dyspnea is the most characteristic symptom of patients with Chronic Obstructive Pulmonary Disease (COPD), with intermittent increases during exercise and other events.Despite optimal standard therapy, episodic dyspnea is a common occurrence in COPD. Recently, the PEP buddy was developed which is an easy-to use, hands-free device that generates positive expiratory pressure (PEP). Although currently the available evidence is limited, it indicates that utilizing the PEP-buddy can result in enhancements in dyspnea during exertion, exertional desaturation and overall quality of life. More research is needed to evaluate the effectiveness of this device and the long term usability, as well as getting more insight in the mechanism of action. Therefore, the aim of our study is to explore the potential of this device for patients with COPD and episodic breathlessness.
This study is an open-label, first-in-human, dose-escalation study of CV09050101 mRNA vaccine (CVGBM) in patients with newly diagnosed "MGMT-unmethylated" Glioblastoma (GBM). Patients with isocitrate dehydrogenase (IDH)-wildtype astrocytoma with a molecular signature of "unmethylated" GBM are also eligible. After surgical resection and completion of radiotherapy for GBM with or without chemotherapy, patients will receive CVGBM i.e. as monotherapy after radiotherapy with or without chemotherapy. The study consists of a dose-escalation part (Part A) which completes enrollment in February 2024 and a dose-expansion part (Part B) which is anticipated to begin enrolling in June/July 2024. Patients will receive a total of 7 administrations of CVGBM on Days 1, 8, 15, 29, 43, 57, and 71. At the discretion of the Investigator in alignment with the Sponsor's medical monitor the vaccinations may continue beyond Day 71 every 6 weeks until one year after the first CVGBM vaccination or upon disease progression or undue toxicity.
A Study to Investigate the Biological Effects of Saruparib (AZD5305) Alone, Darolutamide Alone, and in Combination Given Prior to Radical Prostatectomy in Men with Newly Diagnosed Prostate Cancer (ASCERTAIN)
The goal of this observational study is to explore the effectiveness and side effects of a high dose daily adapted SBRT (stereotactic body radiotherapy) boost delivered with MRLinac in patients with gynaecological cancers that cannot receive a brachytherapy boost to the primary tumour for different reasons (medical conditions, tumour extensions, etc). Current alternative for brachytherapy in these situations is often a non-adaptive conebeam- CT guided boost. Conebeam-CT guided non-adaptive high dose SBRT in under these circumstances is described being quite toxic. The main questions this study aims to answer are: - In how many cases could local control (i.e. total disappearance of the tumor) is be achieved with this treatment? - Which side effects are observed in patients receiving this treatment? Participants will be asked to fill out questionnaires (e.g. regarding side effects). Furthermore, participants are asked if their clinical data may be used for study purposes.
Background: The choice whether or not to preserve the posterior cruciate ligament (PCL) in total knee arthroplasty (TKA) is coupled to the us of a PCL-retaining (CR) or a condylar (CS) insert. The CS insert is anterior-lipped (AL) to prevent anterior translation of the femur on the tibia with flexion and compensate the function of the PCL. Currently both the CR and CS insert are made of highly cross-linked polyethylene (HXPLE) to theoretically reduce wear related osteolysis. However, this also might diminish the fracture toughness and crack propagation of the insert. The investigators expect that due to the high contact forces on the anterior lip of the CS insert during flexion, especially in younger and more active patients, and the lower fracture toughness of HXPLE, the CS insert insert might show more migration, wear or other damage compared to the CR insert in the long-term, which might lead to more revisions in the CS insert compared to the CR insert. To measure the migration and wear, during surgery tantalum markers will be inserted in the host bone using a marker inserter. The displacement of the prosthesis with reference to the host bone will be measured using model-based RSA. Both tantalum markers ande the inserter are already used for study purposes. However, the safety and usability are not registered before. Objective: The primary objective is to compare the migration of both the femoral and tibial component by the use of a CS insert or CR insert both made of HXPLE using model-based roentgen stereophotogrammetric analysis (mRSA). Furthermore, the safety and usability of the tantalum markers and the marker inserter will be determined. The secondary objective is to determine the influence of the type of insert on the wear, inducible displacement, survival and clinical outcomes. Study design: A randomized controlled trial Study population: Forty-four patients scheduled to undergo primary total knee replacement, aged below 70 years with an ASA-score of 1 or 2 will be needed in total, divided in two groups of 22 patients each. Intervention: One group receives an uncemented TKP with a CS insert, while the other group receives an uncemented TKP with a CR insert. Both will be placed using the MAKO-robotic arm using a kinematic balancing technique. Outcomes: Main study parameters are migration of the femoral and tibial components measured with model-based RSA software till 10 years postoperatively. Furthermore, the stability of the markers will be determined and the complications due to the markers and/or the marker inserter will be registered. The secondary parameters are wear, inducible displacement, survival, clinical outcomes and complications up to 10 years postoperatively.
This is a prospective exploratory multicentre pilot study designed to study the safety and efficacy of mitapivat in RBC membranopathies and CDAII
The primary objective of the study is to determine the effect of seralutinib on improving exercise capacity in subjects with WHO Group 1 PAH who are FC II or III. The secondary objective for this trial is to determine time to clinical worsening.
This is a randomised, double-blind, placebo-controlled, multicentre study to evaluate the efficacy, safety, and tolerability of givinostat in non-ambulant male paediatric (aged 9 to <18 years) patients with DMD. 138 patients will be randomised 2:1 to givinostat or placebo and will be treated for 18 months. - Planned screening duration: approximately 4 weeks (±14 days) - Planned treatment duration: 18 months (approximately 72 weeks) - Planned follow-up duration: 4 weeks (±7 days) (for patients not participating in the long-term safety study) - Total duration of study participation: up to 83 weeks (ie, 20-21 months)
Rationale: Gestational diabetes is currently treated by the one-size-fits-all-approach. Treatment efficacy is poorly defined and inconsiderate of patients clinical presentation Objective: To characterize the efficacy of pharmacological treatment of gestational diabetes mellitus between patients with distinct metabolic phenotypes Study design: Prospective observational study, in metformin-treatment efficacy is compared between patients with GDM caused by insulin resistance and patients with GDM caused by low insulin secretion. Study population: A prospective cohort of 103 women with diagnosed gestational diabetes mellitus treated by metformin. Main study parameters/endpoints: Primary outcomes is the glucose-disposition-index in late pregnancy (35-37 weeks gestation) and requirement for supplemental insulin-treatment. Secondary outcomes include insulin sensitivity (Matsuda-index), insulin secretion (Stumvoll-index), HbA1c, gestational weight gain, body composition, physical activity, eating behavior, plasma biomarkers, glucose control, and maternal and infant pregnancy outcomes.