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 purpose of this study is to assess the efficacy, safety, and pharmacokinetics of niraparib in men with metastatic castration-resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies.
The primary objective of the present study is to evaluate the effect of tiotropium + olodaterol fixed dose combination (FDC) compared to tiotropium monotherapy on the intensity of breathlessness during the 3min constant speed shuttle test (CSST). A secondary objective is to explore the relationship between reductions in breathlessness during the 3min CSST and reductions in breathlessness during activities of everyday living as measured by the dyspnea domain of the Chronic Respiratory Questionnaire (CRQ) following bronchodilator therapy.
The hypo-FLAME study is a multicenter phase II study (n=100) to investigate whether a focal SBRT boost to the MRI-defined macroscopic tumor volume is feasible and associated with acceptable toxicity in addition to whole gland prostate SBRT.
Primary Objective The primary objective of the study was to establish the effects of givinostat versus placebo administered chronically over 18 months to slow disease progression in ambulant DMD subjects. Secondary Objectives The secondary objectives of this study were: - To assess the safety and tolerability of givinostat versus placebo administered chronically in DMD subjects - To evaluate the PK profile of givinostat administered chronically in DMD subjects - To evaluate the impact on quality of life (QoL) and activities of daily living of givinostat versus placebo administered chronically.
This is an open-label study to determine the pharmacokinetics of a new tablet formulation of GLPG1972 and to compare it with this of the liquid solution used during the First-in-Human study (GLPG1972-CL-101). The impact of food intake on the oral bioavailability of GLPG1972 administered as tablet will also be investigated in this study. A dose of 600 mg has been selected. The study is a phase I randomized open-label cross-over study with three single dose treatments: A) 600 mg GLPG1972 oral solution after overnight fast, B) 600 mg GLPG1972 oral tablet after overnight fast, C) 600 mg GLPG1972 oral tablet 30 minutes after high-fat high-calorie breakfast. A washout of at least 6 days between subsequent dosing days is respected so that no measurable plasma levels or biologically significant effects are remaining. There will be frequent assessment of adverse experiences post-dose. Twelve healthy male subjects will be selected according to the inclusion and exclusion criteria and 2 subjects each will be randomized to one of the 6 treatment sequences (ABC, ACB, BAC, BCA, CAB, CBA)
Rationale: Lymph node status is the most important factor in the selection of patients for adjuvant chemotherapy after surgical treatment of primary colorectal carcinoma. Up to 30% stage I/II patients with negative lymph node involvement will develop distant metastases and eventually die from colorectal carcinoma (CRC). Better detection and pathologic staging of the lymph nodes could contribute to a better survival of colon cancer patients. This sentinel lymph node (SLN) procedure aims to identify the first draining lymph node(s) from the primary tumour, which have the highest risk of harbouring metastases. These SLNs can be pathological analysed with several more sensitive histopathologic techniques like immunohistochemical staining (IHC). Objective: Aim of this study is to investigate if the combination of a radioactive and fluorescent tracer can increase the sensitivity and specificity of the sentinel lymph node mapping (SLNM) technique in colon cancer by utilizing the radioactive component for preoperative imaging (PET/CT) of the SLNs and the near infrared (NIR) fluorescence component for guidance to the SLNs during surgery. Study design: Single centre pilot study Study population: Ten patients with colon cancer (colon ascendens, colon transversum, colon descendens, sigmoid) stage Tis-T1-T2-T3, scheduled for laparoscopic surgical resection of the tumour. Intervention (if applicable): The present study will be performed with the radioactive tracer 89Zr-Nanocoll and fluorescent tracer Indocyanine Green (ICG). A colonoscopy will be performed to inject the radioactive tracer 48 hrs before surgery. After injection, patients will undergo the first PET/CT scan. A second PET/CT scan will be performed ± 24 hrs after tracer injection and a third scan just before the surgical procedure; ± 48 hrs after tracer administration. During the surgical procedure ICG diluted in saline and human albumin will be injected at the base of the tumour by colonoscopy. The PET/CT images will be compared with respect to the total number and location of foci and , if visible, lymphatic vessels. During surgery the fluorescent nodes will be marked with a suture in vivo. Thereafter the PET/CT images will be used as a roadmap, to detect SLNs which are not visible with the NIR laparoscope. These nodes will be marked with a suture too. When all radioactive and/ or fluorescent nodes are detected, the specimen will be resected like the conventional method. Ex vivo the specimen will be inspected for fluorescent and/or radioactive nodes not found in vivo. All the identified nodes will be taken out ex vivo and stored separately. The entire specimen will be submitted for pathologic examination. All identified SLNs will be stained with hematoxylin-eosin (H&E). If the fluorescent or radioactive SLNs are negative after routine H&E staining, they will be sliced in multiple parts and examined with H&E staining and immunohistochemistry with the specific marker CAM5.2. Finally, the pathologist uses palpation to identify the remaining non-fluorescent and/ or radioactive lymph nodes. Nodes found by palpation will be screened for fluorescent and/ or radioactive activity too. The amount of tumour tissue in positive nodes will be evaluated with the Q-prodit; an interactive video morphometry system (Leica, Cambridge, UK). Main study parameters/endpoints: Main study parameter is the identification rate of SLN mapping with preoperative PET/CT scans combined with intraoperative near-infrared (NIR) fluorescence imaging in patients with colon carcinoma. Thereby biodistribution and kinetics of 89Zr-Nanocoll have to be considered as primary study parameter. Secondary endpoints are the number and localization of the SLNs and optimal tracer volume. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: All participating patients will receive conventional resection of the tumour and follow-up according to normal standards in our hospital. The main goal of this study is to optimize the SLN mapping technique in colon cancer. If the investigators are able to identify the true SLN this could lead to better staging and survival of patients with this type of cancer. . Because of the colonoscopy ± 48 hrs before surgery, patients stay in the hospital will be prolonged with one day. The additional risks of exposure to radiation for participating patients are calculated and can be considered as negligible.
The purpose of this study is to assess the pharmacodynamics, safety and efficacy of omiganan in patients with external genital warts.
The Purpose of this study is to characterize the single and multiple-dose pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/ PD) profiles after oral rivaroxaban therapy administered to pediatric participants 2 to 8 years of age with single ventricle physiology who have completed the Fontan procedure within 4 months prior to enrollment (Part A) and to evaluate the safety and efficacy of rivaroxaban, administered twice daily (exposure matched to rivaroxaban 10 milligram [mg] once daily in adults) compared to acetylsalicylic acid (ASA), given once daily (approximately 5 milligram per kilogram [mg/kg]) for thromboprophylaxis in pediatric participants 2 to 8 years of age with single ventricle physiology who have completed the Fontan procedure within 4 months prior to enrollment.
In this study the investigators will assess (i) the effect of partial neuromuscular blockade (NMB; TOF ratio 0.8 and 0.6) induced by low-dose rocuronium on the ventilatory response to isocapnic hypoxia and (ii) the effect over time (from TOF 0.6 to TOF 1.0) of the reversal by sugammadex, neostigmine or placebo in healthy volunteers. Additionally the investigators will assess the effect of partial NMB (TOF ratio 0.6) induced by low-dose rocuronium on the ventilatory response to hypercapnia and effect over time (from TOF 0.6 to TOF 1.0) of the reversal by sugammadex, neostigmine or placebo in healthy volunteers.
This study is designed to observe the presence or absence of intrauterine adhesions at 6 weeks after treatment with the Sonata® System through hysteroscopic evaluation by third party readers.