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DIRECT-2: Fasting mimicking Diet Program to ImpRovE ChemoTherapy in HR+, HER2- breast cancer

To improve the pathological response rate according to Miller and PayneTo improve quality of life including cognitionTo determine the effect of FMD on local tumor immunity

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study with an Open-Label Extension to Evaluate the Efficacy and Safety of Oral Rilzabrutinib (PRN1008) in Adults and Adolescents with Persistent or Chronic Immune Thrombocytopenia (ITP)

Primary Efficacy Objective (Blinded Treatment Period)• To demonstrate the efficacy of rilzabrutinib versus placebo in participants with refractory/relapsed ITP, based on the durability of platelet response during the last12 weeks of the 24-week…

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 (…

Hollands-midden Acute Regional Triage - cardiology (HART-c): point-of-care high-sensitivity cardiac Troponin I study

To determine the effectiveness of the HEART (History, Electrocardiogram (ECG), Age, Risk factors, Troponin) score with POC hs-cTnI testing by ambulance nurses in safely ruling out ACS and increasing the number of patients left at home after…

Dupuytren*s disease Evaluation of Preventative or Adjuvant Radiation Therapy

Primary objective: To show a meaningful reduction in progression of DD with the application of radiotherapy both in the early stages as well as following local treatment in the later stages.Secondary objectives: 1. Report physician graded toxicity…

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.

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.…

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…

A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Study to Assess the Efficacy and Safety of ELGN-2112 on Intestinal Malabsorption in Preterm Infants

Primary objective: To assess the efficacy of treatment with ELGN-2112 as compared to placebo on intestinal malabsorption in preterm infants as measured by the time to full enteral feeding. Defined as first day of reaching three consecutive days of…

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Upifitamab Rilsodotin (XMT-1536) as Post-Platinum Maintenance Therapy for Participants with Recurrent, Platinum-Sensitive Ovarian Cancer (UP-NEXT)

In this study, we look at how safe the new medicinal product XMT-1536 is for the treatment of ovarian cancer and how well it works. We compare the effect of XMT-1536 with the effect of a placebo. A placebo is a product without the active ingredient…

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)…

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…

Peroperative Administration of Tranexamic acid in Roux-en-Y and one-anastomosis gastric bypass to reduce hemorrhage rates (PATRY study): a randomized controlled trial

This study has been transitioned to CTIS with ID 2024-513570-22-00 check the CTIS register for the current data. This trial aims to investigate whether peroperative administration of TXA reduces haemorrhage rates in patients who undergo metabolic…

Phase 3, Multicenter, Randomized, Double-Masked, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Tinlarebant in the Treatment ofStargardt Disease in Adolescent Subjects

This study has been transitioned to CTIS with ID 2024-513483-26-00 check the CTIS register for the current data. To assesses the efficacy of Tinlarebant in slowing the rate of growth of atrophic lesion(s) in adolescent subjects with STGD1.

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…

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…