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PRODEO: PROfylactic Haloperidol in patients defined as high risk for DElirium with delirium risk mOdel

Research questionWill prophylactic administration of haloperidol to patients with a high risk of developing a delirium according to DEMO, reduce the incidence of a delirium? HypothesesProphylactic administration of haloperidol in post-operative…

Preservation of ovarian cortex tissue in girls with Turner syndrome:
A multicenter exploratory intervention study

To investigate the occurrence of live birth in women with TS after ovarian tissue cryopreservation in childhood followed by auto transplantation in adulthood.

Sentix: A prospective observational trial on sentinel lymph node biopsy in patients
with early stage cervical cancer

To evaluate whether a less radical surgical approach with sentinel lymph node biopsy is non-inferior to treatment with systematic pelvic lymphadenectomy.The null hypothesis is that the recurrence rate after SLN biopsy is non-inferior to the…

Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication

Primary objective* To evaluate the efficacy in terms of overall survival (OS) of erlotinib, everolimus and dasatinib in combination with radiation therapy, in patients with a DIPG both: - compared to the other experimental treatments by comparisons…

A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy of Axicabtagene Ciloleucel versus Standard of Care Therapy in Subjects with Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)

Primary Objective- To determine if axicabtagene ciloleucel is superior to SOC as measured by event-free survival (EFS), as determined by blinded central reviewSecondary Objectives- To evaluate the effect of axicabtagene ciloleucel compared to SOC on…

Magnetic resonance imaging in early arthritis:
The use of a hand and foot MR scanner in early diagnosis of rheumatoid arthritis

To validate the findings on the diagnostic value of hand and foot MRI for early detection of RA in an independent sample set.

A RCT of direct- versus indirect bilateral- sacrospinous ligament fixation for surgical correction of apical prolapse stage 2 or more.

1. To asses non-inferiority of BSC mesh in surgical success (= anatomic cure, subjective improvement and no re-treatment necessary) in the treatment of apical prolapse compared to unilateral SSLF at 12 months;2. Improvement of quality of life…

A Randomized Phase III study of pembrolizumab given concomitantly with chemoradiation and as maintenance therapy versus chemoradiation alone in subjects with locally advanced head and neck squamous cell carcinoma (KEYNOTE-412)

Primary: To compare Event-free survival (EFS) per RECIST in subjects treated with pembrolizumab in combination with CRT and subjects treated with placebo in combination with CRT.Secondary:(1) To compare Overall Survival (OS) in subjects treated with…

Neural correlates of suicidal behaviour: a longitudinal study

The objectives of this study are threefold. First, we aim to understand the underlying neural mechanisms of suicidality. Therefore, we will investigate brain activation during resting state and three psychological processes that have been suggested…

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTINATIONAL, MULTICENTER STUDY WITH OPEN-LABEL TREATMENT EXTENSION TO ASSESS THE EFFECT OF MIN-102 ON THE PROGRESSION OF ADRENOMYELONEUROPATHY IN MALE PATIENTS WITH X-LINKED ADRENOLEUKODYSTROPHY

Main StudyPrimary efficacy objective: To evaluate the efficacy of MIN-102 on the progression ofadrenomyeloneuropathy (AMN) in male patients as determined by the change from baseline in Six-Minute Walk Test (6MWT) compared with placebo after 96 weeks…

Back2Action: Physiotherapy enriched with an eHealth psychological intervention for patients at risk of developing persistent low back pain or neck pain

To study the effectiveness of physiotherapy plus an eHealth psychological intervention targeted at psychosocial risk factors compared to usual physiotherapy care on disability, for patients at risk of developing persistent low back pain and neck…

Organoids to Predict Treatment response In mCRC (OPTIC)

Primary objectives:To validate the concept that ex vivo organoid response correlates to in vivo response to standard treatment in mCRC patients on a metastasis level.Secondary objectives:• Relate organoid results to response to treatment on a…

Dipeptidylpeptidase IV (CD26) on Philadelphia-positive leukemic stem cells (LSC) as marker and novel therapeutic target in chronic myeloid leukemia (CML).

The purpose of this study is to determine the safety and efficacy of Nilotinib and Vildagliptin as combination therapy in optimal dosage. In addition, it is investigated whether the addition of Vildagliptin to Nilotinib treatment causes the…

A Phase IIb, prospective, intra-patient randomised controlled, multicentre study to evaluate the safety and efficacy of an autologous bio-engineered dermo-epidermal skin substitute (EHSG-KF) for the treatment of partial deep dermal and full thickness burns in adults and adolescents in comparison to autologous split-thickness skin grafts (STSG)

This study has been transitioned to CTIS with ID 2024-512188-29-00 check the CTIS register for the current data. To evaluate the efficacy and safety of EHSG-KF in comparison to meshed STSG in adults and adolescents with partial deep dermal and full…