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Pharmacokinetic Interaction between Antiretroviral and Cytotoxic therapy in HIV-infected patients - a pilot study

1º Is there a significant difference of more than 10% in the pharmacokinetic parameter AUC of the investigated antineoplastic drugs (as a surrogate parameter for the efficacy) in the presence and absence of NNRTIs and/or PIs?2º Are there clinically…

Surgical excision versus Mohs*micrographic surgery for cutaneous Squamous Cell Carcinoma

There's alack of randomized controlled trials for the treatment of primary squamous cell carcinoma of the skin and randomized comparative studies are recommended. With this pilot study, we want to study the effectiveness of Mohs'…

DISCOVER: Dutch Iliac Stent trial: COVERed balloon-expandable versus uncovered balloon-expandable stents. A prospective, randomized, controlled, triple-blind, multi-center trial comparing PTFE-covered balloon-expandable stents versus uncovered balloon-expandable stents in patients with advanced occlusive disease of the common iliac artery in terms of morphologic, clinical, and hemodynamic outcome after a 2-year follow-up.

Our primary objective is to assess the absence of binary restenosis rate, the reocclusion rate and target-lesion revascularization rate of endovascular treatment of advanced atherosclerotic lesions of the common iliac artery with a balloon…

Evaluation of microsampling systems for bloodanalysis in the follow-up of patients

Effect of capillary blood collected in Hem-Col and kept at roomtemperature for 72 hrs on several routine laboratory parameters. The results of the tests are compared with the outcome of these tests when blood is collected by venapuncture and…

Catch the cancer;
towards a cfDNA-based test for colorectal cancer screening

The primary objective of the CATCA-study is to develop a cfDNA based screening/surveillance tool for colorectal adenoma and cancer, both in the setting of the national CRC screening program and in the surveillance of LS carriers. Additionally, we…

Early implicit promotion of vitality in breast cancer patients during neo-adjuvant treatment.

The objective of this study is to test the CBM eHealth app, with regard to the influence of the app on implicit fatigue self-concept and on explicitly experienced fatigue and vitality, both immediately after finishing the two-weekly training.…

Electrolytes and small organic molecules in blood and sweat during an incremental cycling protocol

Possible correlations between blood and sweat composition will be investigated. If these correlations exist, sweat composition can be related to phenomena like dehydration. In this way, invasive measurements may become unnecessary in elite sport and…

Magnetic Resonance Direct Thrombus Imaging for diagnostic management of suspected pelvic vein thrombosis during pregnancy -

Zie protocol, hoofdstuk 3 (Objectives)

Time-effectiveness of Mini-C-arm FLuoroscopy ASsisted Closed Reduction of Distal Radius Fractures versus Standard RadiograpH: The FLASH-trial, a randomized controlled trial

The aim of the current study is to assess the potential time- and cost-savings of fluoroscopically aided reductions of dislocated DRFs in adult patients.

Pragmatic randomised controlled study to assess the effectiveness of two patient management
strategies in mild-to-moderate Ulcerative Colitis

The purpose of this pragmatic randomised controlled study is to compare two patient management strategies in mild-to-moderate UC disease. The goal of the study is to propose a new patient management strategy to both physicians and patients, as an…

Cost-effectiveness of a transmural integrated care program for knee arthroplasty patients in the working population

In this study we will assess the (cost)effectiveness of a transmural integrated care programme supporting return to daily activities (including work)after knee arthroplasty compared to usual care. We hypothesize our transmural integrated care…

Open Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegunigalsidase Alfa (PRX-102) in Patients with Fabry Disease

To evaluate the ongoing safety, tolerability, and efficacy parameters of pegunigalsidase alfa in adult Fabry patients who have successfully completed studies PB-102-F20 and PB-102-F30, or completed at least 48 months in study PB-102-F03.

Phase 3 Study of Sacituzumab Govitecan (IMMU-132) Versus Treatment of Physician's Choice (TPC) in subjects with Hormonal Receptor-Positive (HR+) Human Epidermal Growth Factor Receptor 2 (HER2) Negative Metastatic Breast Cancer (MBC) who have failed at least two prior chemotherapy regimens

Primary Objective:• To assess and compare efficacy of sacituzumab govitecan to TPC as measured by progression free survival (PFS) as determined by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors Version 1…

Virtual Reality cognitive behavioral therapy for paranoid delusions - a randomized effect study

To investigate if VRcbt is more (cost-)effective than standard CBT for treatment of paranoid delusions and improving daily life social functioning of patients with schizophrenia and related psychotic disorders.

Identifying motivational alterations associated with cancer-related fatigue: a longitudinal study in testicular cancer patients

Objectives: - To identify and compare motivational behaviour in patients during different phases of cancer treatment. - To test its associations with self-reported fatigue/depression. - To determine to what extent treatment regimen, inflammation,…

Deventilation dyspnoea in patients with Chronic Obstructive Pulmonary Disease after switching off from non-invasive ventilation.

1) To investigate what mechanisms underlie the phenomenon of deventilation dyspnoea in COPD patients. 2) To investigate how the change in electrical impedance, measured with electrical impedance tomography (EIT), is related to the change in…

The vasoactive role of TRPV1, TRPA1 and TRPM3 in human dermal arteries

In this study the primary objective is to investigate whether activation of TRPV1, TRPA1 and TRPM3 by selective channel agonists induces vasodilation in human dermal arteries. If the primary objective is achieved, the secondary objective is to…

Laparoscopic Peritoneal Dialysis Catheter Placement: with or without omental and catheter fixation

Comparison of functional outcome of PD catheters in the two placement techniques.Describing 30 day mortality and short and middle term complications.

Maternal and fetal/neonatal pharmacokinetics and - dynamics of corticosteroids during pregnancy as treatment for fetal lung maturation

To examine the pharmacokinetics in maternal blood of standard regimen at the Erasmus MC of two doses of 12 mg betamethasone intramuscular with a 24 hours interval for pregnant women suspected of preterm birth with a gestational age between 23+5…

Phase 1/2, Open-Label, Multi-Center Trial to Assess Safety, Tolerability, Pharmacokinetics , Pharmacodynamics, and Efficacy of CLN-081 in Patients with Locally-Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations Who Have Previously Received Platinum-Based Systemic Chemotherapy

Phase 1Primary ObjectivesTo assess the safety and tolerability of orally administered CLN-081 monotherapy.To define the maximum tolerated dose (MTD) of orally administered CLN-081 monotherapy.Secondary ObjectivesTo assess the anti-tumor activity.To…