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.
Background of the study: The accurate assessment of local cervical cancer spread (i.e. invasion) is of clinical importance for staging and treatment considerations. For example, if parametrial invasion is absent, radical surgery is the treatment of choice for tumors less than 4cm in diameter. However, if such invasion is present, the patient has become inoperable and (chemo)radiotherapy is warranted. Unfortunately, regular 1.5T MRI as a part of staging work-up has a limited accuracy for detecting loco-regional tumor invasion. Due to relatively frequent false-negative findings a risk of understaging and under-treatment occurs. For such cases adjuvant treatments with (chemo)radiotherapy are indicated after the initial surgery, causing increased morbidity and treatment associated risks. For higher stages, with primary (chemo)radiotherapy, a more reliable MRI based delineation of local tumor spread could enable individualized dose(volume) and field modifications. Hypothesis/aim of the study: To develop and in vivo optimize T2w ultra high field (7T) MRI sequences, which use a combination of an endorectal and external coil, to image the (para)cervical area for assessment of the loco-regional tumor status in cervical cancer. Study design: The proposed study is an investigator initiated, single center, prospective pilotstudy. Study population: 20 patients with histological proven cervical cancer stage IB1, IB2, IIA of IIB will be included. Primary study parameters/outcome of the study: Optimized T2w ultra high field (7T) MRI sequences of the (para)cervical area which allow qualitative assessment of the loco-regional invasion of cervical cancer.
Irreversible electroporation (IRE) is a new, minimal-invasive image-guided treatment method for tumors not amenable for surgical resection or thermal ablation, due to vicinity near vital structures such as vessels and bile ducts. With IRE, multiple electrical pulses are applied to tumorous tissue. These pulses alter the existing transmembrane potential of the cell membranes, and create 'nanopores', after which the cell dies through loss of homeastasis. The purpose of this study is to investigate the efficacy of percutaneous and open IRE in the treatment of patients with colorectal liver metastases (CRLM) that are unsuitable for resection or thermal ablation due to vicinity to vulnerable structures such as vessels and bile ducts. Other objectives are safety, feasibility (technical success) and imaging characteristics on follow-up (PET-)CT and PET-MRI and the value of these imaging modalities in dianosing local site recurrence (LSR) or residual disease (RD). 29 patients with histologically confirmed colorectal carcinoma who present with unresectable and not thermally ablative CRLM< 3.5cm suitable for IRE will undergo percutaneous or open irreversible electroporation of the tumor using CT and ultrasound guidance. All (serious) adverse events are registered. One day post-IRE MRI is performed to assess technical success. Follow-up will consist of frequent (PET-)CT and (PET-)MRI scanning to localize residual or recurrent disease. Overall technique effectiveness is determined 1 year after treatment. The investigators hypothesize that IRE for central CRLM will lead to good tumor control without causing severe complications.
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of IV migalastat HCl alone and to determine absolute bioavailability for oral migalastat HCl as compared to IV administered migalastat HCl in healthy volunteers. The data from this study will help us understand how migalastat works in the body and will help us determine what would be an effective dose in future studies with migalastat hydrochloride.
The design of a phase I, open label, dose finding study was chosen in order to establish a safe and tolerated dose of single agent ABL001 in Chronic myeloid leukemia (CML) and Philadelphia chromosome positive Acute lymphoblastic leukemia (Ph+ ALL) patients who are relapsed or refractory to or are intolerant of Tyrosine kinase inhibitors (TKIs), and of ABL001+Nilotinib, ABL001+Imatinib and ABL001+Dasatinib in Ph positive CML patients who are relapsed or refractory to TKIs.
Malaria, a disease caused by the parasite Plasmodium, is one of the world's major infectious diseases. With approximately 627.000 deaths a year, there is desperate need for an effective vaccine. Though a number of vaccine-candidates have been developed, they have yet to achieve the level of efficacy necessary to eliminate malaria. It has been shown previously that healthy human volunteers bitten by malaria-infected mosquitoes while taking chloroquine, medicine that prevents malaria, are fully protected against a subsequent malaria challenge. This is called CPS-immunization. The unprecedented effectiveness of CPS-immunization makes it a good model to identify what immune responses protect against malaria, to further guide vaccine development. In this study we will use CPS-immunization to induce protection against malaria in healthy subjects and then analyse their immune response to a malaria challenge infection.
This study will assess the safety and preliminary efficacy of escalating doses of LGH447 monotherapy in AML and MDS and LGH447 in combination with midostaurin in AML.
Dose escalation part: to determine the highest dose of alpelisib administered on a daily basis when given in combination with daily everolimus or in combination with daily everolimus and exemestane. Dose expansion part: To describe safety and tolerability of the alpelisib and everolimus or alpelisib, everolimus and exemestane combinations.
Rationale and background: Predictive factors are needed to discriminate chemoradiotherapy responders from non-responders and to individualize the treatment regime. Various cytokines play a role in processes affecting tumour growth and metastasis. Furthermore, cytokines might influence treatment response. Various cytokines are abnormally expressed in colorectal cancer patients, are associated with colorectal cancer or determine response to chemoradiotherapy. Therefore the investigators want to investigate whether levels of circulating cytokines could predict response to preoperative chemoradiotherapy in patients with rectal cancer. Hypothesis: The investigators hypothesis is that the varying levels of circulating cytokines in the blood of rectal cancer patients may predict the response to preoperative chemoradiotherapy. Study design: This study is an explorative clinical pilot study in which the investigators will collect 4 ml of blood from a selection of rectal cancer patients during a regular venipuncture before, during and after preoperative chemoradiotherapy and before and after surgery. Cytokines will be measured in blood plasma and in tumour and healthy tissue from the resection specimen using multiplex immunoassays. Plasma cytokine measurements will be linked to pathological response to identify which cytokines and corresponding levels can predict response to preoperative chemoradiotherapy for patients with locally advanced rectal cancer. Furthermore, blood plasma cytokine measurements before and after surgery will be compared to evaluate the effect of tumour resection on the immune response. In addition, preoperative blood plasma cytokine levels will be compared with cytokine levels in normal and tumour tissue to test whether circulating cytokine levels are representative for tissue cytokine levels. Study population: Thirty patients (≥18 years) with locally advanced rectal adenocarcinoma eligible for preoperative chemoradiotherapy (oral capecitabine and 45-50 gray (Gy) in total; fractions of 1.8-2 Gy) and surgery. Country of recruitment: The Netherlands
The primary objective of this study was to assess the long term safety of fostamatinib in subjects with persistent/chronic ITP
The purpose of this study is to determine whether fostamatinib is safe and effective in the treatment of persistent/chronic Immune Thrombocytopenic Purpura (ITP).