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.
A phase II, multi-center study to compare the feasibility, and clinical efficacy of local manufacturing of CD19-directed CAR T-cells (ARI-0001 CAR T-cells) with commercial produced CAR T-cells (for example axicabtagene ciloleucel, a CD19 targeting commercially available CAR T-cell) in patients with relapsed or refractory (R/R) DLBCL.
The FIBROPANC-1 investigates the feasibility and safety of preoperative stereotactic radiotherapy of 4cm pancreas in patients undergoing pancreatoduodenectomy at high risk (>25%) of developing post operative pancreatic fistula (POPF). A single course of 12Gy preoperative radiotherapy may lead to sufficient fibrosis in a small (4cm) targeted area, thereby reducing the risk of grade B and C POPF.
This protocol tests de-escalated adjuvant treatment in patients with POLE-mutated or p53wt/NSMP (p53 wildtype/no specific molecular profile) early-stage endometrial cancer (EC). Patients may be enrolled in one of two sub-studies - EN10.A/RAINBO BLUE: POLE-mutated EC - EN10.B/TAPER: p53 wildtype / NSMP EC
Previous studies with fMRI-neurofeedback in depression have demonstrated a good safety profile and considerable symptom reduction. The goal of this clinical trial is to compare fMRI-neurofeedback plus standard care with standard care in patients with depression. Participants will either receive standard care, or standard care plus a fMRI neurofeedback training, consisting of 5 neurofeedback training sessions. Symptom severity will be assessed before, immediately after and 6 months after the intervention.
This is a Phase 1 dose-escalation study of PRT3789, a SMARCA2 degrader, in participants with advanced or metastatic solid tumors with loss of SMARCA4 due to truncating mutation and/or deletion. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of PRT3789 monotherapy and in combination with docetaxel, describe any dose limiting toxicities (DLTs), define the dosing schedule, and to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) to be used in subsequent development of PRT3789.
Rationale: An adrenal crisis is an acute life-threatening event which may occur in patients with adrenal insufficiency. The initial emergency treatment consists of an intramuscular injection with 100 mg hydrocortisone administered by the patient or a bystander. The injection should be administered immediately. Although it is considered life-saving, it is not very patient-friendly, because of the several steps required for reconstitution, the intramuscular injection, the frequent presence of needle phobia, and pain at the injection site. Inhalation of predniso(lo)ne could be a more patient-friendly alternative. Objective: This study investigates the pharmacokinetics of nebulized prednisolone in two different dosages. Study design: Single-center, open-label study Study population: Healthy participants aged 18-75 years. Intervention (if applicable): Healthy volunteers receive a lower dose of nebulized prednisolone (46.75 mg).After a wash-out period of at least one week, each volunteer receives a higher dose of nebulized prednisolone (93.5 mg). Main study parameters/endpoints: To establish the time from nebulizing to maximum prednisolone concentration in serum and the area under the curve of prednisolone. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participants are exposed to a single supraphysiological dose of glucocorticoids on two separate occasions. The risk of SAE is very limited. There is a small risk of an AE during blood sampling. If it is demonstrated that therapeutic plasma concentrations of prednisolone can be reached by nebulizing prednisolone, we intend to use the pharmacokinetic data to design and perform a clinical study with a dry-powder micronized prednisone inhalation. This would represent a novel and promising alternative treatment for an adrenal crisis. Patients with adrenal insufficiency could then be offered a much more patient-friendly and reliable alternative for intramuscular hydrocortisone injection.
The purpose of this study is to assess the whole-body biodistribution and tumour uptake of 89Zr-S095012 in participants with solid tumours treated with S095012 (PD-L1x4-1BB bispecific antibody)
In this study we aim to develop an automatic pelvic artery segmentation algorithm, which is required for future clinical implementation of US registration for surgical navigation. Various registration methods will be evaluated with the data of this study to obtain most optimal results. If automatic segmentation and registration is successful, the final accuracy of the developed US registration method for tumor tracking should be evaluated in future studies in patients eligible for surgical navigation. Eventually, we aim to replace the CBCT-scan with an automatic tracked US registration pipeline for a more efficient and accurate registration procedure, which could improve the applicability and accuracy of surgical navigation and patient outcomes.
Management of the neck in Wang cT1-T2N0 nasal vestibule carcinoma (NVC) has been an ongoing point of discussion. As the disease is rare publications are scarce and published regional recurrence rates vary widely between 0% up to 23%. In general, literature recommends adequate radiological neck staging followed by a watchful waiting policy, as overall regional recurrence rates are low (5-10%). However, according to recent findings, a subset of patients with large or voluminous cT1-T2N0 NVC is deemed at high risk of nodal involvement (20-40% regional recurrence) but receive no elective treatment, although it is well known that presence of nodal metastases impacts the prognosis of head and neck cancer (HNC) dramatically. Whereas elective neck dissection may be too aggressive, sentinel node biopsy (SNB) has been proven a reliable and safe alternative to bridge the gap between imaging and neck dissection. SNB is currently routinely employed in most HNC centres in the Netherlands and is considered state of the art care, but its application in HNC is limited to oral cavity carcinoma and squamous cell carcinoma of the skin. Following the observation of increased risk of (occult) nodal metastases and regional recurrence in bulky tumors, the sentinel node procedure seems ideally suited for cT1-T2N0 NVC patients. Its superficial tumor localization is easily accessible for peritumoral Tc-99m-nanocolloid-ICG tracer injection. The purpose of this prospective registration study is to document the clinical introduction of the sentinel node procedure for bulky nasal vestibule carcinoma in our centre by protocol, and to identify and address possible unexpected difficulties specific for this tumor site. Ultimately, the goal will be routine and wide implementation of SNB in the NVC subgroup known to be at risk of nodal involvement, as a means to improve regional disease staging and control. Objective: To prospectively document the introduction of the sentinel node procedure for bulky cT1-T2N0 nasal vestibule carcinoma in patients at risk of nodal involvement. Study design: Single centre prospective registration study. To be extended with a second centre. Study population: Patients with Wang cT1-T2N0 squamous cell carcinoma of the nasal vestibule, with tumor diameter ≥1.5 cm and/or tumor volume ≥1.5 cm3, with a WHO performance score of 2 or lower and no history of previous surgery or radiotherapy of the neck. Interventions: 1. Subcutaneous peritumoral radioactive tracer injection followed by lymphoscintigraphy and Single Photon Emission Computed Tomography (SPECT) imaging for sentinel lymph node visualization. 2. Surgical sentinel node biopsy and histopathological examination of harvested nodes following the abovementioned imaging. Main study parameters/endpoints: The primary endpoint of this study will be successful identification of sentinel nodes on lymphoscintigraphy and SPECT imaging. The procedure will be considered feasible when one or more sentinel nodes can be identified and localized in at least 7 out of the 10 patients..
The Value of Repeated BIOMarker Measurements During an SBT to Predict EXtubation Failure in Mechanically Ventilated ICU Patients