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CHIP-AML22 Master protocol: An open label complex clinical trial in newly diagnosed pediatric de novo AML patients - a study by the NOPHO-DBSHIP consortium

This study has been transitioned to CTIS with ID 2023-504999-25-00 check the CTIS register for the current data. To investigate wether the treatment of children and adolescents with AML can be improvedby means of:1) improved risk-group adapted…

Randomized multi-centre open-label non-inferiority phase 3 clinical trial for patients with a stage IV childhood renal tumour comparing upfront Vincristine, Actinomycin-D and Doxorubicin (VAD, standard arm) with upfront Vincristine, Carboplatin and Etoposide (VCE, experimental arm)

This study has been transitioned to CTIS with ID 2023-508926-91-00 check the CTIS register for the current data. To determine non-inferiority of preoperative 6 weeks of VCE to VAD in the overall metastatic rapid response rate (MetRR) in newly…

International cooperative Phase III trial of the HIT-HGG study group for the treatment of high grade glioma, diffuse intrinsic pontine glioma, and gliomatosis cerebri in children and adolescents < 18 years.

Primary objective:-To confirm that the Event-Free Survival (EFS) in patients &gt;= 3 years of age with WHO grade IV/CNS WHO grade 4 and WHO grade III/CNS WHOgrade 3 diffuse high grade gliomas as well as diffuse high grade gliomas without a…

Sodium-oxybate as a potential new treatment for catatonia in patients with depression, bipolar disorder or a psychotic disorder, a randomized controlled trial. The Laborit study.

We aim to investigate whether sodium oxybate can be used as a novel treatment in psychiatric patients with catatonia. Our primary objective is: To determine if sodium oxybate is effective as a novel treatment in psychiatric patients with catatonia…

Discovery of biomarkers in cervical smears for diagnosis and prognosis of cervical lesions

To identify molecular biomarker profiles that are associated with cervical tumorigenesis, and that can be used for development of an algorithm for detection of low grade CIN1, CIN2, CIN3 and cervical cancer. The algorithm should provide advice for a…

A Global, Phase 3, Randomized, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Furmonertinib Compared to Platinum-Based Chemotherapy as First-Line Treatment for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer with Epidermal Growth Factor Receptor Exon 20 Insertion Mutations

This study has been transitioned to CTIS with ID 2022-502977-41-00 check the CTIS register for the current data. Primary ObjectiveTo assess the efficacy of furmonertinib compared to platinum-based chemotherapy using progression-free survival (PFS)…

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.

A Phase 3, Randomized, International Multicenter Trial of DAY101 Monotherapy Versus Standard of Care Chemotherapy in Patients with Pediatric Low-Grade Glioma Harboring an Activating RAF Alteration Requiring First-Line Systemic Therapy

This study has been transitioned to CTIS with ID 2024-510742-13-00 check the CTIS register for the current data. The primary objective is to compare the objective response rate (ORR) assessed per Response Assessment in Neuro Oncology for low-grade…

A Randomized, Multi-Center Phase III Trial comparing two conditioning regimens (CloFluBu and BuCyMel) in children with Acute Myeloid Leukemia undergoing allogeneic stem cell transplantation.

This study has been transitioned to CTIS with ID 2023-505512-37-00 check the CTIS register for the current data. The primary objective of the randomized part of the protocol is to investigate if a conditioning regimen containing one alkylator (Bu)…

COLLISION RELAPSE trial - Recurrent colorectal liver metastases: repeat local treatment +/- neoadjuvant systemic therapy - a phase III prospective randomized controlled trial

This study has been transitioned to CTIS with ID 2024-515341-41-01 check the CTIS register for the current data. The primary objective is to demonstrate superiority of neoadjuvant systemic therapy followed by repeat local treatment as compared to…

Randomized Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients who Present with Symptomatic Heart Failure with Reduced Ejection Fraction (HFrEF): The CORCINCH-HF
Study

The objective of this study is to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with symptomaticheart failure with reduced ejection fraction (HFrEF).

A Phase 3, Multicenter, Randomized, Platform Study of p19 Inhibition of the IL-23 Pathway to Establish Efficacy in Pediatric Crohn*s Disease;ISA title: A Phase 3, Multicenter, Randomized Clinical Study to Evaluate Mirikizumab in Pediatric Crohn*s Disease

This study has been transitioned to CTIS with ID 2024-511472-32-00 check the CTIS register for the current data. Primary for Platform-Level Exploratory Analysis1. To evaluate whether treatment with IL-23 inhibitors is superior to adult placebo in…

Phase 3 Randomized, Controlled Study of Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia With Safety Run-in (Golden Gate Study)

This study has been transitioned to CTIS with ID 2023-503640-14-00 check the CTIS register for the current data. Primary:• To compare event-free survival (EFS) of subjects receiving blinatumomab alternating with low-intensity chemotherapy to EFS of…

An Open-Label, 2-Arm, Multicenter, Randomized Phase 3 Study To Evaluate The Efficacy And Safety of Elranatamab (PF-06863135) + Daratumumab + Lenalidomide Versus Daratumumab + Lenalidomide + Dexamethasone in Transplant-Ineligible Participants With Newly-Diagnosed Multiple Myeloma

This study has been transitioned to CTIS with ID 2024-514139-50-00 check the CTIS register for the current data. Part 1PrimaryTo assess dose limiting toxicities (DLTs) of EDR to select an RP3D for the combination to be used in Part 2 of this study.…

Efficacy of Pectoral Nerve (PECS II) Block with Liposomal Bupivacaine versus Levobupivacaine for Patients undergoing a Mastectomy: A Prospective Randomized Controlled Trial.

This study has been transitioned to CTIS with ID 2024-515183-30-00 check the CTIS register for the current data. The aim of this prospective randomized, double blind study is to evaluate the analgesic effects of pre-operative PECS II-block with (…

A Phase 3, Multicenter, Randomized, Platform Study of p19 Inhibition of the IL-23
Pathway to Establish Efficacy in Pediatric Crohn*s Disease;ISA title: Efficacy, Safety, and Pharmacokinetics of Guselkumab in Pediatric Participants with
Moderately to Severely Active Crohn*s Disease

This study has been transitioned to CTIS with ID 2023-504735-41-00 check the CTIS register for the current data. Primary for Platform-Level Exploratory Analysis1. To evaluate whether treatment with IL-23 inhibitors is superior to adult placebo in…

Standard moderately hypofractionated radiotherapy vs. ultra-hypofractionated focal lesion ablative microboost in prostate cancer, Hypo-FLAME 3.0

To demonstrate superiority of whole gland SBRT with a simultaneous integrated focal boost 35/50 Gy in 5 fractions (Hypo-FLAME) regarding 5-year bDFS compared to the current standard moderately hypofractionated schedule of 62 Gy in 20 fractions of 3.…

MRI-BASED GRAFT MATURITY AFTER BLOOD FLOW RESTRICTION TRAINING IN BONE-PATELLAR TENDON-BONE ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION:
A RANDOMIZED CONTROLLED STUDY

Primary objective: The effect of LL-BFRT on MRI-based graft maturity after BPTB ACL reconstruction compared to HLRT.Secondary objectives: The effect of LL-BFRT on donor-site morbidity, range of motion, knee stability, PROMs, muscle strength, safe…

Effectiveness of focal therapy in men with prostate cancer (ENFORCE)

We hypothesize that a significant proportion of the patients will benefit more from focal therapy as compared to usual care in terms of morbidity and quality of life, without compromising oncological effectiveness. Primary objective: To study the…

Excitability Modeling And Correction of Hyperactive Brain Networks in Alzheimer*s disease

The overall objective is to perform simulations in a computer model of the human brain to map out the optimal parameters for non-invasive brain stimulation in AD. Simulations will be performed in both general and personalised models, the latter…