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Effectiveness of Somatostatin Analogues in patients with Gastric antral
vascular ectasia and symptomatic gastrointestinal bleeding: SAGAVE-trial

Primary Objective: To investigate the efficacy and safety of octreotide treatment (a somatostatin analogue) in decreasing the transfusion requirements (IV iron infusions and / or red blood cell transfusions) in patients with GI bleeding caused by…

Mental Health Promotion and Intervention in Occupational Settings: A Pilot Study

The project aims to improve mental health and wellbeing in the workplace by developing, implementing and evaluating an intervention targeting both clinical (depressive, anxiety disorders) and non-clinical (stress, burnout, depressive symptoms)…

Sentinel lymph node detection in early-stage ORal Cavity squamous cell carcinoma using Magnetic Resonance (MR) lymphogrAphy

The primary objective of this feasibility study is to investigate the detection rate of SLNs using MR lymphography.

Adjuvant hepatic arterial infusion pump chemotherapy after repeat hepatectomy for patients with recurrent colorectal liver metastases without a history of extrahepatic disease - a phase II study

Primary Objective: The first objective of this study is to evaluate efficacy of adjuvant HAIP chemotherapy after repeat hepatectomy for recurrent CRLM in the Erasmus MC.Secondary Objective(s): The second objective is to determine treatment related…

Pilot study eHealth CF-CBT

Objective: To investigate the feasibility and acceptability of the online cognitive behavioral therapy program (eHealth CF-CGT), so that the program can be tailored to the needs of the patient

A Phase I/II study of Brigatinib in pediatric and young adult patients with ALK+ Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumors or other solid tumors

This study has been transitioned to CTIS with ID 2024-513412-10-00 check the CTIS register for the current data. Phase 1: • To determine the MTD/RP2D regimen of brigatinib monotherapy when administered in pediatric and AYA patients with ALK+ ALCL or…

A Phase II Trial of Personalized Tumor Neoantigen Based Vaccine FRAME-001 for Advanced Non-Small Cell Lung Cancer

To determine FRAME-001-specific immune responses in peripheral blood after administration of FRAME-001 to patients with advanced NSCLC.Secondary objectives- To assess safety and tolerability of FRAME-001.- To evaluate clinical anti-tumor response to…

Phase 1/2 Study to Investigate the Safety, Pharmacokinetics and Efficacy of Tinostamustine, a First-in-Class Alkylating Histone Deacetylase Inhibition (HDACi) Fusion Molecule, in Patients with Advanced Solid Tumors

The ability to fuse discrete small molecules with different types of pharmacologic activity has created remarkable opportunities in drug discovery and development. Bendamustine itself is a fusion molecule of the nitrogen mustard mechlorethamine and…

TEMOkids study (ORP-TMZ-I- b): A Population pharmacokinetic, acceptability and safety study for KIMOZO, a paediatric oral suspension of temozolomide

Primary objective:• Evaluate PK parameters of the oral suspension of temozolomide in the paediatric population aged 1 year and over.Secondary objectives:• Evaluate the safety of the oral suspension of temozolomide,• Evaluate the acceptability of the…

A Phase 2a open label, non-comparative, single dose escalation study to evaluate the dynamics of viral clearance, pharmacokinetics and tolerability of ensovibep in patients with symptomatic COVID-19 disease

Primary* To characterize the dynamics of viral clearance (incl. viral cultures, qPCR, antigen clearance) following ensovibep administration * To characterize the serum pharmacokinetics of two single i.v. flat dose levels of ensovibep in patients…

A Phase 2, Adaptive, Open-Label, Multiple-Dose, Dose-Escalation Study to Evaluate the Efficacy, Safety,Tolerability, and Pharmacokinetics of Intravenous AMB-05X in Subjects with Tenosynovial Giant Cell Tumor

The objectives of this study are to evaluate the safety, efficacy, and pharmacokinetics (PK) of AMB-05X in the treatment of tenosynovial giant cell tumor (TGCT)

An Open-Label, Multi-Centre Phase I/IIa Study Evaluating the Safety and Clinical Activity of Neoantigen Reactive T cells in Patients with Advanced Non-Small Cell Lung Cancer

The objectives and relevant endpoints of the study are as follows:Primary: To assess the safety and tolerability of ATL001 as amonotherapy and in combination with pembrolizumabSecondary: To evaluate the clinical efficacy of ATL001treatment as a…

A Phase 2a, Open-label, Multicenter Study to Evaluate Biomarkers and Safety of Repeated Administration of NurOwn® (Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors; MSC-NTF cells) in Participants with Prodromal to Mild Alzheimer*s Disease

Primary:• To evaluate AD-specific, neuroinflammatory, neurotrophic and neurodegenerative biomarkers and safety of 3 intrathecal (IT) administrations of NurOwn® (MSC-NTF cells) given at two monthly intervals to participants with prodromal to mild…

[18F]mFBG PET-CT imaging of pheochromocytoma

This study has been transitioned to CTIS with ID 2024-513622-35-00 check the CTIS register for the current data. The primary objective of this study is to assess the number of detected pheochromocytoma lesions, proved by histology, with [18F]mFBG…

Virtual Reality to Assess How Boys with Mild to Borderline Intellectual Disabilities Behave in Social Situations

The first aim is to investigate whether SIP indicators measured with VR are better predictors of aggression in real-life than SIP indicators measured with hypothetical vignettes in youth with MID-BIF. The second aim is to explore whether we can…

Single-Arm, Phase 2 Study of Valemetostat Tosylate Monotherapy in Subjects with Relapsed/Refractory Peripheral T-Cell Lymphoma

Valemetostat tosylate may modify epigenetic changes, which plays an important role in the pathogenesis of PTCL. In the ongoing open-label Phase 1 study (DS3201-A-J101, 25 Dec 2019 data cut-off), valemetostat tosylate monotherapy demonstrated…

A phase II, open label, multicenter study to investigate the efficacy and safety of domatinostat in combination with avelumab in patients with treatment-naïve metastatic Merkel Cell Carcinoma - the MERKLIN 1 Study

Primary Objective: to evaluate clinical efficacy of domatinostat in combination with avelumab in treatment-naïve metastatic or distally recurrent MCC patients as determined by the Objective Response Rate (ORR) according to Response Evaluation…

Superparamagnetic iron oxide-enhanced magnetic resonance imaging for sentinel lymph node identification in oral cancer: a feasibility study

To explore the feasibility of sentinel lymph node identification by SPIO injection followed by MRI in head-and-neck cancer patients.

A Phase 2a, Proof-of-Concept, Open-Label Study to Evaluate the Pharmacodynamics, Pharmacokinetics, and Safety of Obicetrapib in Patients with Early Alzheimer*s Disease (Hetero/Homozygote APOE4 Carriers)

The primary objective of this study is to evaluate the pharmacodynamics (PD) (apolipoproteins/lipid particles and cholesterol efflux) of obicetrapib in cerebrospinal fluid (CSF) and plasma (apolipoproteins/lipid particles) in patients with early…

An Adaptive, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Intra-articular AMB-05X Injections in Subjects with Tenosynovial Giant Cell Tumor of the Knee

Obtain safety and efficacy data for the investigational drug AMB-05X in the treatment of tenosynovial giant cell tumor (TGCT)