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A randomized, double-blind, phase 3 study of tucatinib or placebo in combination with trastuzumab and pertuzumab as maintenance therapy for metastatic HER2+ breast cancer

This study has been transitioned to CTIS with ID 2023-503826-37-00 check the CTIS register for the current data. To evaluate the efficacy and safety of tucatinib in combination with trastuzumab and pertuzumab as maintenance therapy in subjects with…

Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation

This study has been transitioned to CTIS with ID 2023-510384-36-00 check the CTIS register for the current data. The primary objective of this study is to compare the efficacy of teclistamab in combination with lenalidomide (Tec-Len) with that of…

StoMakker: Improving the quality of life of children receiving an ileostomy, colostomy or continent urostomy by offering access to a peer support platform, age dependent information provision and games in a smartphone application

The main objective of this study is to investigate whether access to a peer support platform, age-dependent information provision and games in a smartphone application increases self-reported quality of life, for children receiving a stoma.

Phase II randomised controlled trial of patient-specific adaptive versus continuous Abiraterone or eNZalutamide in metastatic castration-resistant prostate cancer: the ANZadapt study

The primary objective is to investigate whether the patient-specific adaptive treatment with AA/ENZ leads to a superior time to time to treatment failure (TTTF) while on treatment compared to continuous treatment with AA/ENZ. Secondary/tertiary…

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose, Multicenter Study to Examine the Efficacy and Safety of ZX008 in Subjects with CDKL5 Deficiency Disorder Followed by an Open-Label Extension

This study has been transitioned to CTIS with ID 2023-506269-78-00 check the CTIS register for the current data. Objectives for Part 1: Primary (Efficacy): To demonstrate that the efficacy of fenfluramine (ZX008) 0.8 mg/kg/day is superior to placebo…

A Phase 3 Randomized Study Comparing Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Ciltacabtagene Autoleucel versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Autologous Stem Cell Transplant (ASCT) in Participants with Newly Diagnosed Multiple Myeloma who are Transplant Eligible

This study has been transitioned to CTIS with ID 2023-507632-20-00 check the CTIS register for the current data. The primary objective is to compare the efficacy of DVRd followed by cilta-cel and lenalidomide therapy versus DVRd followed by ASCT,…

A phase 3 randomized, double-blind study of ianalumab (VAY736) versus placebo in addition to eltrombopag in patients with primary immune thrombocytopenia (ITP) who had an insufficient response or relapsed after first line steroid treatment (VAYHIT2)

This study has been transitioned to CTIS with ID 2024-512890-28-00 check the CTIS register for the current data. The purpose of this study is to assess the efficacy and safety of ianalumab (VAY736) compared to placebo in addition to second-line…

Repeated corticosteroid injections around the Greater Occipital Nerve (GON) as prophylactic treatment in chronic cluster headache

This study has been transitioned to CTIS with ID 2024-514311-10-00 check the CTIS register for the current data. The primary objective is to determine if repeated GON-injection result in effective control of cluster headache attacks for more months…

HERTHENA-Lung02: A Phase 3, Randomized, Open-label Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced Epidermal Growth Factor Receptor-mutated (EGFRm) Non-small Cell Lung Cancer (NSCLC) After Failure of Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) Therapy

This study has been transitioned to CTIS with ID 2023-507964-38-00 check the CTIS register for the current data. To compare the efficacy of patritumab deruxtecan versus platinumbased chemotherapy, as measured by progression-free survival (PFS),…

Effect of an immune-supportive diet on gut permeability and allergic symptoms in children with peanut and/or nut allergy.

Therefore, the purpose of our study is to study, in peanut and nut allergic children:1. the relationship between gut permeability and threshold levels to peanut or nuts;2. the effect of an immune-supportive diet on gut permeability, coexisting…

Clinical Outcome and Cost-effectiveness of Reduced Noradrenaline by Using a Lower Blood Pressure Target in Patients with Cardiogenic Shock from Acute Myocardial Infarction: A Multicenter Randomized Trial

This study has been transitioned to CTIS with ID 2024-510892-40-00 check the CTIS register for the current data. The objective of this study is to evaluate the (cost-)effectiveness of reduced noradrenaline in patients with CS by using a lower MAP…

Anticoagulation for Stroke Prevention In patients with Recent Episodes of perioperative Atrial Fibrillation after noncardiac surgery

This study has been transitioned to CTIS with ID 2023-509142-35-00 check the CTIS register for the current data. Primary objective: To assess the effects of non-vitamin K oral anticoagulants (NOACs) versus no anticoagulation on the co-primary…

A New Intervention for Implementation of Pharmacogenetics in Psychiatry.

PSY-PGx is the first initiative to propose a large-scale non-industry sponsored clinical study that aims to demonstrate the clinical benefits and potential of the implementation of pharmacogenetics for psychiatric patients in existing medical…

Platelet inhibition versus direct oral anticoagulation in patients undergoing percutaneous closure of patent foramen ovale or atrial septal defect

This study has been transitioned to CTIS with ID 2024-517115-70-00 check the CTIS register for the current data. Primary Objective: The goal of the study is to evaluate hemostasis, such as coagulation activation/thrombin generation and platelet…

DUALITY - a Register-based, Randomised Controlled Trial to Investigate Dual Mobility
Cups in Hip Fracture Patients

The primary objective is to assess whether dual mobility cups reduce the risk of dislocations in patients with a femoral neck fracture treated with a THA by 50% within one year, as suggested by observational data.