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.
This will be the first trial investigating whether tumor targeted fluorescence is able to discriminate invasive T1 carcinoma / High grade dysplasia from Low grade dysplasia/normal tissue during endoscopic intraluminal resection. This will be done using the CEA-targeted fluorescent probe SGM-101.
The aim of this study is to increase understanding of the effectiveness and efficiency of psychological treatment for adult patients with posttraumatic stress disorder -PTSD- and to make it more personalized. Key questions: 1. Which predictors of treatment success influence treatment outcome of patients with PTSD who receive the three psychotherapeutic treatments investigated in this study? 2. Which specific moderators can be identified with regard to the different psychotherapies (Eye Movement Desensitization and Reprocessing -EMDR-; Prolonged Exposure -PE-; and Interpersonal Psychotherapy -IPT- in the second phase)? 3. In patients with PTSD, does offering another proven effective form of trauma-focused psychotherapy (PE after EMDR, or EMDR after PE) improve symptoms following insufficient response to a first trauma-focused treatment? 4. Is switching from a trauma-focused therapy to a non-trauma-focused treatment (IPT) a more effective strategy for dealing with non-response to a first proven effective psychotherapeutic treatment compared to switching to another trauma-focused therapy? 5. Are there differences in treatment tolerance and differences in dropout rates between PE, EMDR and IPT? Secondary goals: - Investigating the extent to which therapist allegiance to a specific therapy method affects outcomes; - Investigating whether the quality of therapy implementation or the treatment integrity ('adherence/ competence') affects treatment outcomes; - Investigating how much the quality of the therapeutic alliance influences outcomes. Participants receive treatment and will complete questionnaires. The study is conducted in two phases. Its aim is to compare two different trauma-focused treatments (EMDR and PE) for patients with PTSD to one another and with a nontrauma-focused psychotherapy (IPT) and to investigate possible predictors and moderators for treatment success. Patients will first be randomized to PE or EMDR in the first treatment phase. After this first phase, non-responders are re-randomized for a second phase of treatment. They receive either the alternative phase 1 trauma-focused psychotherapy or IPT as non-trauma-focused therapy. In phase 1 researchers will compare the PE and EMDR group to see which treatment is most effective for whom. In phase 2 researchers will compare the trauma-focused treatments (PE and EMDR group) with the nontrauma-focused treatment (IPT group) to see which treatment is most effective for whom.
In this study, the efficacy of botensilimab and balstilimab in mismatch repair deficient (dMMR) and mismatch repair proficient (pMMR) tumors will be assessed.
Moesin deficiency was initially described in 7 male participants aged 4 to 69 years and is characterized by lymphopenia of the 3 lineages and moderate neutropenia. Genetically, 6 out of 7 participants had the same missense mutation in the moesin gene located on the X chromosome. The 7th patient has a mutation leading to the premature introduction of a STOP codon into the protein.Clinically the 7 participants with X-linked moesin-associated immunodeficiency all presented with recurrent bacterial infections of the respiratory, gastrointestinal or urinary tracts, and some had severe varicella.Therapeutically, in the absence of a molecular diagnosis and due to his SCID-like phenotype, one patient was treated with geno-identical hematopoietic stem cell transplantation . The remaining are untreated or treated with immunoglobulin substitution and/or prophylactic antibiotics. Since this study, the moesin gene has been integrated into DNA chips used for the molecular diagnosis of immune deficiencies in several countries. Physicians in Canada, the United States, Japan, South Africa and Europe have contacted us with a total of 16 known participants to date. Because of their very low severe, uncontrolled CMV infection and the absence of treatment recommendations, two 2 American participants were treated with allogeneic transplantation with severe post-transplant complications (1), and one of the participants died as a result of the transplant. Management of XMAID participants therefore varies widely from country to country, depending on age at diagnosis and clinical picture. It ranges from no treatment treatment (associated with recurrent infections and skin manifestations), IgIv substitution and/or antibiotic prophylaxis antibiotic prophylaxis, with low toxicity and apparent efficacy, and allogeneic transplantation, with all the risks risks involved (graft-related toxicity, graft versus host, disease, rejection, risk of infection). The Investigators therefore feel it is important to review the diagnosis, clinical presentation and management of X-MAID participants. The study the investigator propose will enable to understand the presentation of X-MAID participants, establish guidelines and provide the best treatment for each patient according to his or her clinical picture
The goal of this phase III, open-label, non-inferiority randomized controlled clinical trial is compare upfront dose-reduced chemotherapy with the standard dose chemotherapy in older patients ( ≥70 years) with metastasized colorectal cancer, with regard to progression-free survival (PFS). The choice between monotherapy (a fluoropyrimidine) and doublet chemotherapy (a fluoropyrimidine with oxaliplatin) will be made for each individual patient based on expected risk of chemotherapy toxicity (according to the G8 screening). Patients classified as low risk of toxicity will be randomized between doublet chemotherapy in either full-dose, or with an upfront dose-reduction of 25%. Patients classified as high risk will be randomized between monotherapy in either full-dose or upfront dose-reduction. Primary outcome is PFS. Secondary endpoints include grade ≥3 toxicity, QoL, physical functioning, overall survival, number of treatment cycles, dose reductions, hospital admissions, cumulative received dosage and cost-effectiveness.
This prospective randomised trial will investigate the effect of four different suturing techniques (Monocryl, Vicryl Rapide with Indermil skin glue, Dermabond Prineo, and Stryker Zip) on the amount of aberrant wound recovery within 14 days after total hip arthroplasty at the RHOC in Zoetermeer, The Netherlands. This will be done by assessing photographs of the plaster and photographs of the operation wound with a self-developed classification model. The photographs of the plaster will be taken by the test subject at home at 3 days and 11 days postoperatively. The photographs of the operation wound will be taken by a member of the research team, and the doctor's assistant, respectively, during a visit to the outpatient clinic at 7 days and 14 days postoperatively. Hypothesis: Monocryl sutures give the highest amount of aberrant wound recovery within fourteen days after primary THA.
Background of the study: To measure blood clotting, blood is taken from a vein. This blood is processed in the laboratory and then tested. A new device has been developed that requires only a very small volume of blood (5-10 drops of blood) to perform the laboratory tests. The long-term goal is that this device can be used by a doctor or at home to quickly measure blood clotting. In this research we want to compare this new system with the standard methods - measurement in the laboratory - and evaluate whether the correct value is determined. Objective of the study: The primary objective of this study is to demonstrate that the EnzySystem HemA version A can record thrombin generation TG and quantify FVIII activity levels within a time frame of 60 min in fresh whole blood samples of healthy volunteers and patients with hemophilia A in the Enzyre laboratory (for healthy volunteers) and the Radboudumc (for patients with hemophilia A). Study design: This is a cross-sectional observational study. All participants are asked to fill a questionnaire prior to blood collection. The blood of healthy volunteers will be collected in an office of Enzyre BV, the blood of patients will be collected in the Radboudumc. Blood collection, by venepuncture, will be conducted by a Radboudumc research nurse or physician of the research team in both locations. In total, four blood tubes with citrate as anticoagulant will be drawn (a total of around 11 mL). Study population: The study population consists of 20 healthy volunteers: evenly distributed between male and female; ages spread over the range from 20 to 70 years old; recruited by Enzyre via advertisement. 20 Patients: 5 severe hemophilia A; 5 moderate hemophilia A; 10 mild hemophilia A; recruited from the Hemophilia Treatment Center (HTC) Nijmegen-Eindhoven-Maastricht (NEM) (location Radboudumc). Primary study parameters/outcome of the study: Demonstrate that the EnzySystem HemA version A can record TG and quantitative FVIII activity levels within a time frame of 60 min in fresh blood samples of healthy volunteers and patients with hemophilia A. Secondary study parameters/outcome of the study (if applicable): Secondary study parameters are composed whether the measured values comply with the desired assay specificity and accuracy. Outcomes are analysed for equivalence compared to one-stage FVIII assay, FVIII chromogenic assay, thrombin generation via the Nijmegen Hemostasis Assay, and possibly via the Technoclone assay. Is it possible to measure FVIII activity with the EnzySystem HemA version A in fresh blood samples of healthy volunteers and patients with hemophilia A, compared to the gold standard with; - Precision in the normal range (60-140%): min. 30% - Precision in the low range (3-10%): min. 50% - Limit of Detection range min. 100 % FVIII activity - Limit of Detection low range min. 3 % FVIII activity Is it possible to measure TG with the EnzySystem HemA version A in fresh blood samples of healthy volunteers and patients with hemophilia A, compared to the gold standard with; - Precision in the normal range (60-140%) of control samples: min. 30% - Precision in patient with hemophilia A: min. 50% - Limit of Detection, high range > 400 nM thrombin activity - Limit of Detection measured with Plasma, low range < 50 nM thrombin Other study parameters All samples will also be tested for other hemostasis specific parameters as these parameters may affect a proper measurement of both FVIII activity and Thrombin Generation. The following parameters will be measured in plasma obtained from the whole blood vacutainers. Moreover, left over samples (plasma) will eventually be used to develop other coagulation related parameters. - von Willebrand Factor antigen levels - von Willebrand Factor ristocetin activity levels - Prothrombin Fragment 1+2 levels - ADAMTS13 activity - FVIII antigen levels - blood group
This study is a prospective, multicenter study in which a serum sample will be collected at the day of starting neo adjuvant treatment in breast cancer patients
Resection of glioblastoma in or near functional brain tissue is challenging because of the proximity of important structures to the tumor site. To pursue maximal resection in a safe manner, mapping methods have been developed to test for motor and language function during the operation. Previous evidence suggests that these techniques are beneficial for maximum safe resection in newly diagnosed grade 2-4 astrocytoma, grade 2-3 oligodendroglioma, and recently, glioblastoma. However, their effects in recurrent glioblastoma are still poorly understood. The aim of this study, therefore, is to compare the effects of awake mapping and asleep mapping with no mapping in resections for recurrent glioblastoma. This study is an international, multicenter, prospective 3-arm cohort study of observational nature. Recurrent glioblastoma patients will be operated with mapping or no mapping techniques with a 1:1 ratio. Primary endpoints are: 1) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks, 3 months, and 6 months after surgery and 2) residual tumor volume of the contrast-enhancing and non-contrast-enhancing part as assessed by a neuroradiologist on postoperative contrast MRI scans. Secondary endpoints are: 1) overall survival (OS), 2) progression-free survival (PFS), 4) health-related quality of life (HRQoL) at 6 weeks, 3 months, and 6 months after surgery, and 4) frequency and severity of Serious Adverse Events (SAEs) in each arm. Estimated total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year. The study will be carried out by the centers affiliated with the European and North American Consortium and Registry for Intraoperative Mapping (ENCRAM).
The goal of this study is to explore the effect of protein quantity and quality in plant-based drinks. Healthy normal-weight males aged between 18 and 45 years will be included in the study. The main objectives are to examine the differences in postprandial amino acid profiles, and to examine differences in gastric behavior between cow's milk and plant based drinks. Participants will visit after an overnight fast three times and have blood draws before and after consumption one of the study drinks. There will be MRI scans of the stomach before and after consumption of the drink to assess gastric behavior.