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Use of mechanical left ventricular unloading in acute decompensated systolic heart failure complicated by cardiogenic shock

To assess the efficacy of early mechanical left ventricular unloading and standard of care (inotropes/vasopressors) versus inotropes/vasopressors alone (standard-of-care) in patients with ADHF and signs of cardiogenic shock.

DRAGON 2 - An international multicenter randomized controlled trial to compare combined Portal and Hepatic Vein Embolization (PVE/HVE) with PVE alone in patients with Colorectal Liver Cancer Metastases (CRLM) and a small Future Liver Remnant (FLR).

The primary objective of DRAGON 2 is to demonstrate the superiority of combined PVE/HVE over PVE alone in either the resectability of the patients within 3 weeks after intervention defined as FLR sufficient for resection on week 3 and the 5-year…

First-in-human, open-label, multicenter, Phase I/IIa, dose escalation trial with expansion cohorts to evaluate safety and preliminary efficacy of BNT142 in patients with CLDN6-positive advanced solid tumors

This study has been transitioned to CTIS with ID 2024-512639-58-00 check the CTIS register for the current data. ____________________PRIMARY OBJECTIVESFor Parts 1 and 2: To assess the safety and tolerability of BNT142 at all dose …

Comparison of different transfusion strategies for red blood cell transfusion dependent MDS and MPN patients - a cross-over study with remote patient monitoring

Compare the effect of three different RBC transfusion strategies* (Standard of care (SoC), SoC+1 and SoC+2**) on heart rate in a population of chronically transfused patients (with on average at least 1 RBC transfusion each 8 weeks as personal…

PROTECT: on-line adaptive proton therapy for cervical cancer to reduce the impact on morbidity and the immune system

Primary objective:- To determine the difference in mean dose (Gy) to pelvic bones (whole pelvic contour), and the difference in the mean V15Gy-bowelbag volume in cc (according to EMBRACE bowel bag definition) between photon and proton therapy in…

Minitub: Prospective registry of Sentinel Node (SN) positive melanoma patients with minimal SN tumor burden who undergo Completion Lymph Node Dissection (CLND) or Nodal Observation

With this prospective registry we aim to evaluate the outcome of patients with a T2-T3 primary melanoma and minimal SN tumor burden, treated by CLND or nodal observation:* The main objective is to determine if T2-T3 melanoma patients with minimal SN…

Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks - A Prospective Multicenter Study.

To evaluate the safety of IMPEDE-FX Embolization Plug and/or IMPEDE-FX RapidFill to fill a AAA sac outside of an EVAR stent graft, and the efficacy of the IMPEDE-FX Embolization Plugs to reduce the volume and/or diameter of the AAA sac and/or the…

Frailty in uremia: A survey on the effects of CKD 3-5 on physical functioning and -activity, quality of life and nutritional state

The primary objective of the study is to assess the longitudinal effects of differences and changes in renal function at CKD stage 3-5 on physical functioning. The secondary objectives of the study are to assess the longitudinal effects of…

The (cost-)effectiveness of generalist (GIT-PD) versus specialist treatment (MBT/ST) for severe personality disorders (the P-DAET study): a pragmatic randomized controlled non-inferiority trial

To compare the effectiveness of a generalist approach (GIT-PD) to specialized psychotherapy for personality disorders (PD) and to predict for which individual patient generalist treatment is not inferior to specialist treatment.

The haemostatic effect of thawed deep-frozen platelets resuspended in thawed plasma versus room temperature stored platelets in platelet additive solution in the treatment of surgical bleeding; a randomized controlled non-inferiority trial

the primary aim is to determine the effect of thawed deep-frozen platelets re-suspended in thawed deep-frozen plasma versus room temperature stored platelets in platelet additive solution for transfusion on the percentage of patients with surgical…

A 24-week with possible extension, prospective, multicenter, randomized, double blind, placebo-controlled, 2-parallel group with a randomization 1:1, phase III study to compare efficacy and safety of oral masitinib to placebo in treatment of patients with Smouldering or Indolent Severe Systemic mastocytosis with handicap, unresponsive to optimal symptomatic treatment

To evaluate the efficacy and safety of oral masitinib versus placebo in the treatment of patients suffering from Smouldering or Indolent SevereSystemic mastocytosis with handicap unresponsive to optimal symptomatic treatment.

How does pneumatic tube transportation of thrombocyteconcentrates for transfusion purposes influence the thrombocyte in vivo function?

Aim of the study is to show the feasibility of pneumatic tube transport of thrombocyte concentrates. The efficacy will be measured by thrombocyte increment (CCI) and thrombocyte funtion analysis. This shall lead to routine transportation of TC*s to…

Safety and Performance Study for Venous Large Hole Vascular Closure Device - ELITE study

The objective of this study is to evaluate the safety and effectiveness of the PerQseal Elite vascular closure system when used to achieve haemostasis of common femoral venotomies created by 14 to 22F sheaths (venotomy up to 26F) in patients…

The RECOGNISE Study: Neuropsychological Rehabilitation for Emotional and Cognitive consequences After Neurovascular Diseases

Primary objective: To assess whether a psychoeducational and peer-support-based intervention improves self-efficacy in individuals with neurovascular conditions. Secondary objectives: To examine the intervention’s effects on quality of life (QoL),…

Accelerated Pacing for Improved Quality of Life in Symptomatic Atrial Fibrillation Patients undergoing Pace-and-Abate Strategy with Left Bundle Branch Area Pacing: a Randomized Controlled Pilot Trial: PACE-AF

To determine the effect of accelerated pacing (lower programmed rate of 80 bpm) compared to pacing at the standard programmed rate of 60 bpm on HRQoL in symptomatic AF patients undergo-ing pace-and-ablate strategy with LBBAP.Secondary objectives: -…

Treatment of diverticulitis in patients with weakend immune systems

To evaluate the disease course of diverticulitis in immunocompromised patients to determine a safe and effective treatment strategy. 

Deliver mOre aPplications for more durable Pulmonary vein IsOlation with the Pentaspline Pulsed Field Ablation catheter, the DOPPIO trial

to determine if freedom of AF may be improved by delivering more, and targeted PFA applications while avoiding side-effects of higher PFA dosing.

A comparison of pericapsular nerve group block, fascia-iliaca compartment block and femoral nerve block for pain management in patients with hip fracture in the emergency department - A randomized controlled trial

The aim of this study is to compare the efficacy and safety of preoperatively placed Pericapsular Nerve Group block (PENG), Fascia-Iliaca Compartment Block (FICB) and Femoral Nerve Block (FNB) for patients with hip fractures in the ED.

Physiotherapist Overseen Whole-body Exercises for Residents with Dementia: a non-randomized pilot study

To assess the adherence to the intervention regarding successfully followed exercise sessions, adverse events related to the intervention and experiences of intervention supervisors and participants. Secondly, we will evaluate intervention effects…

Detection of upper GI tumour depth and demarcation by quantified fluorescence molecular endoscopy using systemic administration of ICG during endoscopic submucosal dissection

The primary objective is to evaluate the feasibility of ICG-enhanced near-infrared qFME to determine tumour demarcation and tumour depth in upper GI tumours (e.g. HGD or superficial oesophageal and/or gastric adenocarcinoma (T1)) during ESD.