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Tina-quant Lp(a) RxDx Phase III Trial Sample Measurement

The objective of this study is to support the pharma partner*s Phase III trial using Tina-quant Lipoprotein (a) RxDx assay for subject selection and optional batch testing of follow-up samples. This study is carried out to evaluate the performance…

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…

A Phase 3 Multicenter, Open-label Study to Evaluate the Efficacy, Pharmacokinetics, Safety, and Immunogenicity of Subcutaneously Administered Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis

This study has been transitioned to CTIS with ID 2023-507144-36-00 check the CTIS register for the current data. Primary:Evaluate PK and efficacy of ustekinumab and guselkumab in jPsA. Secondary:Evaluate safety of ustekinumab and guselkumab in…

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…

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…

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)…

Can molecular imaging predict outcome to firstline endocrine treatment ± CDK 4/6 inhibition in
advanced ER+ breast cancer?

Based on the data as described above, we hypothesize that the FES-PET heterogeneity score can predict progression free survival (PFS) in individual patients prior to start of 1st line endocrine treatment and CDK 4/6 inhibition in ER+ advanced breast…

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.

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…

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 multicentre randomised open-label phase III study of stereotactic radiosurgery, in addition to standard systemic therapy for patients with metastatic melanoma or newly diagnosed metastatic NSCLC and asymptomatic or oligosymptomatic brain metastases.

The primary objective of the study is to assess the efficacy in terms of CNS-specific PFS ofthe combination of standard systemic treatment plus SRS versus standard systemictreatment alone in patients with newly diagnosed and untreated (except for…

Glucose control through a bihormonal artificial pancreas in patients after total pancreatectomy for cancer (PANORAMA): multicenter randomized controlled cross-over trial - Dutch Pancreatic Cancer Group (DPCG)

To assess the efficacy of the BIHAP (AP® 5, Inreda Diabetic BV) using glucagon and insulin during a three-months period. It is hypothesized that treatment with BIHAP provides better glucose control than current diabetes treatment. Main parameter to…

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…

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…

Phase III study assessing the *best of* radiotherapy compared to the *best of* surgery (trans-oral surgery (TOS)) in patients with T1-T2, N0-N1 oropharyngeal, supraglottic carcinoma and with T1, N0 hypopharyngeal carcinoma

The main objective of the study is to assess and compare the patient-reported swallowing function over the first year after randomization to either IMRT or TOS among patients with early stage OPSCC, SGSCC and HPSCC.

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…