Search for a trial

Optimizing neoadjuvant systemic treatment in HER2 positive breast cancer - the TRAIN-2 study

To compare the efficacy of six cycles neoadjuvant PTC plus pertuzumab preceded by either three cycles of FEC-T plus pertuzumab or three cycles of PTC plus pertuzumab in HER2 positive breast cancerSecondary objectives• To describe the safety of the…

A randomized study with cisplatinum concomitant with standard or adaptive high dose radiotherapy for advanced head and neck cancer.

The most important questions of this phase III trial is:Can adaptive high dose radiotherapy improve loco-regional control without increase of toxicity?

The added value of couple-based interventions compared to individual treatment for patients with personality disorder and their partners

Studies examining the effect of couple therapy or couple-based interventions in treatment for personality disorder are very scarce and more research is required. Therefore, the present study examines the effect of couple-based interventions in…

A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating, Phase 2a Safety, Tolerability, and Pharmacodynamic Study of Two Doses of an Histone Deacetylase Inhibitor (FRM-0334) in Subjects with Prodromal to Moderate Frontotemporal Dementia with Granulin Mutation

2.1 Primary Objectives• Evaluate the safety and tolerability of 2 fixed doses of FRM-0334 (300 and 500 mg daily in 2 sequential periods) over 28 days in subjects with prodromal to moderate FTD-GRN• Assess the PD effects of FRM-0334 on the change…

The effect of exenatide compared to insulin glargine on cardiac function and metabolism in type 2 diabetic patients with congestive heart failure: a randomized-controlled trial

In this study we will assess the effects of exenatide on cardiac metabolism and function in patients with T2DM and CHF. We will address the following hypothesis: exenatide improves global cardiac function in CHF patients with T2DM, by favorable…

Effects of oral corticosteroids and DMSO on inflammatory signs and symptoms in Complex Regional Pain Syndrome type 1

In this trial we will study if treatment with oral corticosteroids or DMSO is effective in decreasing signs and symptoms of CRPS-1. Tolerance of the treatment options and effects on different subtypes of CRPS-1 patients will be evaluated as well.

Does the application of cryolijm SQ fibrin sealant, for abdominal closure after secondary DIEP flap surgery, leads to a quicker recovery with less complications? A randomized controlled study.

The aim of this study is to assess the efficacy of Cryolijm SQ (Sanquin blood supply foundation, Groningen, The Netherlands) fibrin sealant in reducing postoperative drainage at the abdominal donor site which could result in earlier drain removal,…

A randomized controlled trial on the effects of periconceptional and prenatal folic acid supplementation on congenital anomalies and preterm birth

In the proposed study, two main issues will be addressed: first, it will be studied whether a high dose (4.0 mg) of FA supplementation periconceptional has an added value over the now recommended low dose of 0.4 mg in the prevention of congenital…

Phase 2 Study Comparing Pembrolizumab with Intermittent/Short-term Dual MAPK Pathway Inhibition Plus Pembrolizumab in patients harboring the BRAFV600 mutation (IMPemBra)

Primary objectives: To explore the safety, feasibility, and the immune-activating capacity of different schemes of continuous/intermittent dabrafenib+trametinib during treatment with pembrolizumab as compared to pembrolizumab monotherapySecondary…

Drug-COated Balloon Coronary Angioplasty versus Stenting for Treatment of Disease Adjacent to a Chronic Total Occlusion - The Co-CTO Trial.

The aim of the study is to investigate the value of DCB treatment in the residual disease of the coronary artery after successful recanalization and stenting of the actual CTO body as compared with complete stenting in a randomized fashion.

A single-center, double-blind, randomized, phase I/II dose escalating study to assess the safety, tolerability and immunogenicity of three doses of the therapeutic synthetic long peptide (SLP) vaccine (ISA104) in patients with chronic hepatitis B (cHBV).

This study has been transitioned to CTIS with ID 2024-518355-36-00 check the CTIS register for the current data. Primary objective:- To determine the safety and optimal dose of three doses of a novel therapeutic vaccine (ISA104) consisting of 12…

SURGERY FOR ADENOCARCINOMA OF THE GASTROESOPHAGEAL JUNCTION (GEJ) TYPE II: TRANSTHORACIC ESOPHAGECTOMY VS. TRANSHIATAL EXTENDED GASTRECTOMY (CARDIA trial)

The aim of the study is to compare transthoracic esophagectomy versus transhiatal extended gastrectomy in patients with GEJ type II tumors. It is hypothesized that esophagectomy allows for a higher rate of radical resections and a more complete…

A PHASE III, RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED STUDY OF TIRAGOLUMAB, AN ANTI-TIGIT ANTIBODY, IN COMBINATION WITH ATEZOLIZUMAB COMPARED WITH PLACEBO IN COMBINATION WITH ATEZOLIZUMAB IN PATIENTS WITH PREVIOUSLY UNTREATED LOCALLY ADVANCED UNRESECTABLE OR METASTATIC PD-L1-SELECTED NON-SMALL CELL LUNG CANCER.

This study has been transitioned to CTIS with ID 2022-502482-17-00 check the CTIS register for the current data. This study will evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in patients…

Impact of peri-operative tEstosterone levels oN Functional and oncological Outcomes following RadiCal prostatEctomy (ENFORCE)

This study has been transitioned to CTIS with ID 2024-511340-29-00 check the CTIS register for the current data. Primary Objective: Evaluate if testosterone replacement therapy (TRT) in (a)symptomatic testosterone deficient men with prostate cancer…

Chronotherapy in Inflammatory Arthritis (ChronIA trial): a randomized controlled trial comparing the effectiveness of morning and evening dosing of tofacitinib extended-release

This study has been transitioned to CTIS with ID 2024-517865-17-00 check the CTIS register for the current data. We hypothesize that the timing of treatment in IA, also known as chronotherapy, matters and that the efficacy of tofacitinib XR depends…

A 3-Part, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate Safety and Efficacy of Avapritinib (BLU-285), a Selective KIT Mutation-Targeted Tyrosine Kinase Inhibitor, in Indolent and Smoldering Systemic Mastocytosis with Symptoms Inadequately Controlled with Standard Therapy

This study has been transitioned to CTIS with ID 2024-512585-34-00 check the CTIS register for the current data. Primary: Part 1 • To determine the RP2D of avapritinib in patients with ISM for use in Part 2 and Part 3 of the study.Part 2 • To…

DRAGON 2 - An international multicenter randomized controlled trial to compare combined Portal and Hepatic Vein Embolization (PVE/HVE) with PVE alone in patients with Colorectal Liver Cancer Metastases (CRLM) and a small Future Liver Remnant (FLR).

The primary objective of DRAGON 2 is to demonstrate the superiority of combined PVE/HVE over PVE alone in either the resectability of the patients within 3 weeks after intervention defined as FLR sufficient for resection on week 3 and the 5-year…

A PHASE 3, MULTINATIONAL, RANDOMIZED, OPEN-LABEL, PARALLEL-ARM
STUDY OF AVELUMAb (MSB0010718C) IN COMBINATION WITH AXITINIB
(INLYTA®) VERSUS SUNITINIB (SUTENT®) ) MONOTHERAPY IN THE
FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED RENAL CELL
CARCINOMA

Primary ObjectiveTo demonstrate that avelumab in combination with axitinib is superior to sunitinib monotherapy in prolonging PFS or OS in the first-line treatment of PD-L1 positive patients with aRCC.Secondary Objectives* To demonstrate that…

A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adolescent and Adult Subjects with Moderate to Severe Atopic Dermatitis

This study has been transitioned to CTIS with ID 2022-502936-38-00 check the CTIS register for the current data. The objective of the study is to assess the efficacy and safety of upadacitinib for the treatment of adolescent and adult subjects with…

A Phase III double-blind placebo-controlled Randomized Trial of Aspirin on Recurrence and Survival in Colon Cancer Patients

This study has been transitioned to CTIS with ID 2022-502324-48-00 check the CTIS register for the current data. To study the effect of 80mg aspirin (given orally once daily for five years) on fiveyear overall survival (OS) for stage II and III…