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Wireless Laser Speckle Contrast Imaging Device for the visualisation of the microcirculatory during DIEP flap breast reconstruction.

This study aims to demonstrate that the new generation of the HAPI, the Wireless Perfusion Imager (WIPI) is able to visualise the microcirculation of the abdominal flap and the newly reconstructed breast during DIEP flap breast reconstruction. The…

Evaluation of ablation lesions using cardiovascular magnetic resonance imaging

Primary Objective: 1. To evaluate the ablation lesion characteristics of different ablation modalities and strategies Secondary Objectives: 2. To evaluate the ablation lesion characteristics of different ablation energy profiles; 3. To evaluate the…

COMPARISON OF CONVENTIONAL AND COOLED RADIOFREQUENCY TREATMENT OF THE GENICULAR NERVES VERSUS SHAM PROCEDURE FOR PATIENTS WITH CHRONIC KNEE PAIN: A MULTICENTRE, DOUBLE BLIND, RANDOMISED CONTROLLED TRIAL

The aim of the COGENIUS trial is to investigate the effect of the two types of RF treatment on individuals experiencing chronic knee pain that is resistant to conservative treatments. For this purpose, the efficacy and cost-effectiveness of cooled…

Oral versus intravenous iron in IBD patients with anti-inflammatory therapy

Regarding the current recommended once daily dosing of oral iron (with probably less side effects than with a 3 times daily dose), and the decrease of hepcidin in patients on immunosuppressive medication, we hypothesize that patients with mild to…

Tracer-Based Imaged Guided Surgery for Recurrent Prostate Cancer: A Prospective Randomized Controlled Trial - TRACE II

Evaluate the clinical progression free survival after randomization to either 6 months of androgen deprivation therapy (ADT) or 6 months of ADT plus a 99mTechnetium (99mTc)-based PSMA-radioguided salvage surgery.

A randomized, double-blind, placebo-controlled, 2-arm Phase III study to assess efficacy and safety of xevinapant and radiotherapy compared to placebo and radiotherapy for demonstrating improvement of disease-free survival in participants with resected squamous cell carcinoma of the head and neck, who are at high-risk for relapse and are ineligible for high-dose cisplatin

This study has been transitioned to CTIS with ID 2023-508528-36-00 check the CTIS register for the current data. The purpose of this study is to demonstrate improvement in Disease-Free Survival (DFS) with xevinapant compared to placebo when added to…

Programmed death ligand 1 (PD-L1) PET imaging in patients with (Diffuse) Large B-cell lymphoma who are treated with CD19-directed CAR T-cell therapy: a pilot study.

This study has been transitioned to CTIS with ID 2024-518422-32-01 check the CTIS register for the current data. Primary objectives: The first primary objective is to study the expression of PD-L1 in normal tissue and lymphoma lesions before CAR T-…

A phase 2/3 Adaptive, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of VX-147 in Adult and Pediatric Subjects With APOL1-mediated Proteinuric Kidney Disease

• To evaluate the efficacy of VX-147 to reduce proteinuria• To evaluate the efficacy of VX 147 on renal function as measured by eGFR slope

European First in Human Study of the NeoChord Transcatheter Mitral Repair System to Assess Safety and Performance in Patients with Mitral Regurgitation

The objective of this First-in-Human (FIH) evaluation is to assess the safety and performance of transcatheter based mitral repair in subjects with mitral regurgitation.

MASTER SCREENING STUDY TO DETERMINE BIOMARKER STATUS AND POTENTIAL TRIAL
ELIGIBILITY FOR PATIENTS WITH MALIGNANT TUMORS

Primary: The primary objective of this study is to determine the biomarker status of patients screened in this master screening study and their potential biomarker eligibility to participate in a linked Roche clinical trial.Exploratory:The…

Detection and Quantification of Atrial Fibrillation in High-Risk Patients Using a Smartwatch Wearable (Apple Watch) with a Photoplethysmographic sensor and ECG-functionality

The primary objective of this trial is to quantify the incidence of AF in patients at high risk for but without previously known AF using a smartwatch wearable with a photoplethysmographic sensor and to determine if the incidence is higher compared…

A Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of XB002 as Single-Agent and Combination Therapy in Subjects with Inoperable Locally Advanced or Metastatic Solid Tumors

This study has been transitioned to CTIS with ID 2023-508267-69-00 check the CTIS register for the current data. Cohort-Expansion Stage (Single-Agent and Combination Therapy Cohorts):Primary:• To evaluate the preliminary efficacy of XB002 when…

Clinical outcomes and cost-effectiveness of a diagnostic and treatment strategy of upfront CTCA plus selective non-invasive functional imaging compared with standard care in patients with chest pain and suspected coronary artery disease

This strategy will result in a reduction reduce the incidence of major adverse cardiovascular events (MACE) defined as death or non-fatal myocardial infarction and appear more efficient than care as usual.

Optimising surgical anastomosis in ileocolic resection for Crohn's disease to reduce recurrent disease: A Randomized controlled trial comparing hand-sewn (END-TO-END or Kono-S) to stapled anastomosis (END2END study)

To understand if handsewn (end to end and Kono S side to side) anastomoses is superior to side to side stapled anastomosis after ileocolic resection for Crohn's disease with respect to endoscopic recurrence, gastrointestinal function and costs.

A randomized placebo-controlled double-blind trial studying the effect of single antiplatelet therapy (clopidogrel) versus dual antiplatelet therapy (clopidogrel + aspirin) on the occurrence of atherothrombotic events following lower extremity peripheral transluminal angioplasty

To assess whether and to what extent dual therapy clopidogrel 75 mg/acetylsalicylic acid 80 mg daily is superior to monotherapy clopidogrel 75 mg daily, in reducing the combined endpoint all-cause death and cardiovascular adverse events after one-…

Preoperative CT-imaging with patient-specific computer simulation in transcatheter aortic valve replacement: a randomized controlled trial.

The objective of this randomized controlled trial (RCT) is to evaluate whether pre-operative CT-imaging with advanced computer modelling and simulation (FEops HEARTguide* (FHG)) adequately predicts procedural outcomes in TAVR procedures, whether it…

Precision psychiatry: Anti-inflammatory medication in Immuno-metabolic depression

This study has been transitioned to CTIS with ID 2024-513907-15-01 check the CTIS register for the current data. Among patients under treatment for depression, we will select 140 persons with IMD. In this specific group of patients, we will test…

Intraperitoneal irinotecan with concomitant FOLFOX and bevacizumab for patients with unresectable colorectal peritoneal metastases - a phase II study

This study has been transitioned to CTIS with ID 2024-517152-34-00 check the CTIS register for the current data. The primary objectives are to explore the overall survival for the addition of intraperitoneal irinotecan (75 mg) to palliative systemic…

Body surface area-based vs concentration-based dosing of cisplatin for hyperthermic intraperitoneal chemotherapy (HIPEC) in women with advanced ovarian cancer

This study has been transitioned to CTIS with ID 2024-514711-99-00 check the CTIS register for the current data. To evaluate BSA-based versus concentration-based OVHIPEC with cisplatin in patients with advanced-stage ovarian cancer.

A Randomized, Double-blind, Placebo-controlled, Multinational, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects with Idiopathic Pulmonary Fibrosis (TETON-2) // A Multinational, Uncontrolled, Usability Evaluation Study of the TD-300/A Tyvaso Inhalation Device Used in RIN-PF-303

This study has been transitioned to CTIS with ID 2024-514761-19-00 check the CTIS register for the current data. The primary objective of RIN-PF-303 is to evaluate superiority of inhaled treprostinil against placebo for the annual rate of change in…