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Sedation with propofol TCI during ERCP: Is the combination with esketamine more effective and safer than with alfentanil (SPEKA): A randomized controlled multicentre trial

The aim of this study is to demonstrate that procedural sedation with propofol and esketamine is more effective and will result in less cardiopulmonary depression than sedation with propofol and the opioid alfentanil. Less side effects should also…

Glycocalyx assessment in temporal lobe epilepsy

Primary objective of this study: To establish glycocalyx properties of temporal lobe epilepsy (TLE) patients. Secondary objectives of this study:- To establish differences in glycocalyx properties of glycocalyx between TLE patients and controls.- To…

APIXABAN FOR THE REDUCTION OF THROMBO-EMBOLISM IN PATIENTS
WITH DEVICE-DETECTED SUB-CLINICAL ATRIAL FIBRILLATION

To determine if the use of apixaban in patients with SCAF will reduce the incidence of stroke and systemic embolism compared to aspirin.

Functional Outcome of Vanguard XP vs CR: a single centre randomized controlled trial using three dimensional fluoroscopic analysis

The primary objective is to compare the Vanguard XP with a CR TKA in terms of kinematics during functional tests using 3D fluoroscopy. The secondary objective is to compare both TKAs in terms of 3D migration of the prosthesis up until 2 years post-…

International Randomised Controlled Trial for the Treatment of Newly Diagnosed Ewing's Sarcoma Family of Tumours

The objective of the induction/consolidation chemotherapy randomisation (R1) is to compare: - VIDE strategy: vincristine, ifosfamide, doxorubicin and etoposide (VIDE) as induction chemotherapy and vincristine, actinomycin D and ifosfamide (VAI),…

Detection of circulating tumour cells in cerebrospinal fluid (CSFCTs) to diagnose leptomeningeal metastases (LM) among breast cancer patients

In this pilot, we aim to improve the detection rate of LM by using the CellSearch technique quantifying circulating tumor cells (CTCs) in cerebrospinal fluid (CSF, i.e. CSFCTs) and compare this with the current standard of care; namely cytological…

An Open-Label, Randomized Phase 3 Trial of Nivolumab, or Nivolumab plus Ipilimumab, or Nivolumab plus platinum doublet chemotherapy versus platinum doublet chemotherapy in Subjects with Chemotherapy-Naïve Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)

The study will look at patients with chemotherapy-naive Stage IV or recurrent Non-Small Cell Lung Cancer (NSCLC). The research aims to compare a new drug called nivolumab OR nivolumab with ipilimumab (another cancer drug) OR nivolumab combined with…

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Ramucirumab plus Docetaxel versus Placebo plus Docetaxel in Patients with Locally Advanced or Unresectable or Metastatic Urothelial Carcinoma Who Progressed on or after Platinum-Based Therapy.

The primary objective of this study is to compare the progression-free survival (PFS) of ramucirumab in combination with docetaxel with the PFS of placebo in combination with docetaxel, in patients with locally advanced or unresectable or metastatic…

DDAVP treatment combined with FVIII clotting factor concentrates in patients with mild hemophilia A.

Primary objectives:To assess the proportion of non-severe hemophilia A patients within FVIII target levels with the DDAVP and FVIII concentrate combination treatment in the first 72 hours after the start of combination treatment, without adding off-…

INTELLANCE 2: ABT-414 alone or ABT-414 plus temozolomide versus lomustine or temozolomide for recurrent glioblastoma: a randomized phase II study of the EORTC Brain Tumor Group

The objectives of the trial are to assess whether ABT-414 alone or in combination with TMZ improves overall survival (OS), PFS, tumor response, quality of life, NDFS and steroid use compared to standard treatment with lomustine single agent or TMZ…

Non Invasive Cancer Test (NICT) : a pilot study

To test if the NIPT approach is capable of detecting ctDNA in patients diagnosed with four different types of cancer.

INtegratioN of trastuzumab, with or without pertuzumab, into periOperatiVe chemotherApy of HER-2 posiTIve stOmach caNcer: the INNOVATION-TRIAL

To increase the major pathological response rate (< 10% vital tumor cells) to neoadjuvant treatment by integrating both trastuzumab and pertuzumab into perioperative chemotherapy for HER-2 positive, resectable gastric cancer.

CHAMP: Children with Arthritis: Monotherapy or Polytherapy. A multicentre, single-blinded, randomized treat to target, one-year follow-up clinical trial in patients with recent onset Juvenile Idiopathic Arthritis (JIA).

To study whether polytherapy (methotrexate plus sulfasalazine plus hydroxychloroquine) results in more patients with inactive disease and therefore less patients who need treatment with a TNF inhibitor after 6 months of treatment compared to primary…

Micronutrient status and executive functions in eating disorders

The current study aims to investigate whether vitamin and mineral status is associated with executive functioning in patients with an eating disorder. Key objectives: 1.To investigate the micronutrient status in patients with an eating disorder…

Clinically node negative breast cancer patients undergoing breast conserving therapy: Sentinel lymph node procedure versus follow-up. A Dutch randomized controlled multicentre trial.

The objective of this study is to decrease the number of breast cancer patients receiving overtreatment of the axilla, in order to positively influence the axillary morbidity rate and quality of life. Therefore, we investigate whether the sentinel…

A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis

To evaluate the long-term safety and efficacy of RPC1063 for the treatment of all patients with moderate to severe UCTo evaluate the long-term efficacy of RPC1063 for the treatment of adult patients with moderate to severe UC.

Compare Absorb
ABSORB bioresorbable scaffold vs. Xience metallic stent for prevention of restenosis following percutaneous coronary intervention in patients at high risk of restenosis. ;Annex study of in-stent restenosis
COMPARE ABSORB ISR study: A single-arm, annex study of patients with in-DES restenotic lesions requiring PCI and treated with Absorb BVS

The purpose of the current investigation is therefore to prove the short-term equivalence and long-term benefit of the ABSORB scaffold over a Xience in patients at high risk of restenosis or with complex lesion(s).Diabetic substudyTo assess the…

A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy with Nivolumab
versus Ipilimumab after Complete Resection of Stage IIIb/c or Stage IV Melanoma in Subjects who are at High Risk for Recurrence.

The purpose of this study is to find out if treatment with Nivolumab monotherapy will improve recurrence-free survival (RFS) when compared to Ipilimumab monotherapy in subjects with high risk for recurrence, completely resected Stage III and Stage…

Study of brain areas involved in the sensation of bladder filling in healthy females and untreated females with Overactive Bladder (OAB) using fMRI and water pressure urodynamics

Main objectives are to identify brain areas involved in sensation of bladder filling through fMRI during urodynamic measurements. Secondary goals are to assess the correlation between bladder filling and subjects* bladder sensations in combination…

Uterine artery embolization versus hysterectomy for symptomatic adenomyosis: a case-control study

This study aims to evaluate the impact of UAE on Quality of life (QOL) in comparison to hysterectomy in adenomyosis patients. A cost-effectiveness study will be part of the trial as well as a cohort hysterectomy group to clearify imaging and…