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Technical validation of quantitative methods for 3 'deoxy-3-[18F] fluorothymidine ([18F] FLT) PET in liver metastases of colorectal cancer patients

To investigate lesion detection in patients with liver metastases of colorectal cancer with [18F] FLT-PET compared to CT at baseline (= gold standard). This investigation will be done based on a qualitative assessment of the scans ([18F] FLT-PET and…

A Randomized Phase 3 Open Label Study of Nivolumab versus Bevacizumab and a Safety Study
of Nivolumab or Nivolumab in Combination with Ipilimumab in Adult Subjects with Recurrent
Glioblastoma (GBM)

This study will investigate whether treatment with Nivolumab is comparable to Bevacizumab in patients with Glioblastoma. We will measure this by comparing how many patients arestill alive after a certain period of time once they have started…

Effect of IVF culture medium on health of IVF children

The primary objective is to elucidate whether there is a difference in the outcome of health parameters between IVF children who as an embryo were cultured in two different culture media. As secondary objectives we will investigate how the health…

Phase II study with oral fibroblast growth factor-1 inhibitor BIBF1120 as treatment in lung carcinoma patients harboring fibroblast growth factor receptor-1 gene amplification (NVALT-15 study)

Primary: To assess PFS of lung cancer patients with an FGFR1 gene amplified in their tumor cells upon treatment with BIBF1120.Secondary: To assess response rate, duration of response, overall survival and safety.

A Phase 1 Dose Escalation and Phase 2 Randomized Double-Blind Study of Veliparib in Combination with Carboplatin and Etoposide as a Therapy of Treatment-Naïve Extensive Stage Disease Small Cell Lung Cancer.

The objectives of the Phase 1 dose escalation are:Primary Objectives:* To establish the Maximum Tolerated Dose (MTD) and to establish the Recommended Phase 2 Dose (RPTD) for veliparib in combination withcarboplatin and etoposide.* To evaluate the…

Randomized, Double-Blind, Multicenter, Phase 3 Study Comparing Veliparib Plus Carboplatin and
Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Advanced or
Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)

The primary objective of the study is to assess whether the addition of oral veliparib to carboplatin and paclitaxel will improve overall survival (OS) in current smokers when compared to the addition of placebo to carboplatin and paclitaxel, in…

A Phase III Randomized, Placebo-Controlled Trial of Carboplatin and Paclitaxel with or without the PARP Inhibitor Veliparib (ABT-888) in Her-2 Negative Metastatic or Locally Advanced Unresectable BRCA-Associated Breast Cancer

The primary endpoint is to assess the progression-free survival (PFS) of veliparib in combination with carboplatin (C) and paclitaxel (P) compared to placebo with C/P in subjects with a BRCA1 and/or BRCA2 Mutation and HER2-Negative Metastatic or…

Cortrak bedside Or Regular Endoscopic placement of nasoenteral feeding tubes in surgical patients (CORE): a randomized controlled multicenter non-inferiority trial

To determine the (cost-)effectiveness and budget impact EM-guided bedside placement as compared to endoscopic placement of a nasoenteral feeding tube in surgical patients.

Adrenaline use in local infiltration analgesia during TKA;Randomized, double blind, controlled study

The goal of the pilot study is to compare LIA with or without adrenaline infiltration by means of post operative pain (VAS) scores, PONV, early mobilisation and early discharge criteria.

Human thermoregulatory behavior and thermo-physiology before and after mild heat acclimation in healthy lean and obese subjects

1. To study thermoregulatory behavior and thermo-physiology of healthy lean and obese subjects before and after mild heat acclimation. 2. To define categories of *temperature preference* based on thermoregulatory behavior and thermo-physiology of…

A randomized controlled trial comparing no compression therapy versus 4 hours of compressive therapy with a TED class II stocking after radiofrequency ablation for primary great saphenous vein incompetence

To evaluate whether no utilization of compressive stockings is as effective as wearing a Class II Thrombo Embolic Deterrent (TED) stocking for 4 hours. Primary outcome is leg volume on post-operative day 14.The secondary objective is to study the…

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 EMDR and CBT on low self-esteem, a randomized controlled trial

The aim of the present study is to investigate whether EMDR is an effective method to treat low self-esteem and if this is more effective than CBT. Hypothesis:1. Participants will improve on measures of self-esteem, psychological symptoms and social…

Multi-joint coordination and adaptation of ankle and hip strategy in healthy young and healthy elderly

The aim of the study is to investigate the differences in multi-joint coordination between healthy young and healthy elderly. Secondly, we want to study adaptation of ankle and hip strategy with the application of whole-body force fields and…

Safety, toxicity and immunogenicity of HPV16 E7 DNA vaccination in HPV16+ vulvar intraepithelial neoplasia grade III: a phase I study.

To study the safety, toxicity and immunogenicity of a naked DNA vaccine encoding the shuffled HPV16 E7 gene product (TTFC-E7SH) in patients with HPV16+ VINIII lesions.

Deal-iD Study: Dealing with daily challenges in Dementia - Effectiveness of an ESM-based intervention for spousal caregivers of people with dementia

The primary objective of this study is to evaluate the effectiveness of an ESM-based intervention, called *Partner in Zicht* to increase spousal caregiver competence and feelings of control in managing daily challenges. Increased caregiver…

ProtEUs: Effects of an infant formula with an optimized amino acid composition on growth and body composition in infants

To assess the effect of an infant formula with an optimized amino acid composition and a lower total protein content during the first four months of life on infant growth. Amendment follow-up study: To assess the long term effect of the intake of an…

HCMR - Novel Predictors of Outcome in Hypertrophic Cardiomyopathy.

Primary:To understand the relationship between novel risk markers (based on the following) and clinical outcome. Secondary:Developing a score from the predictive model that can be used to assess risk given a patient*s combination of risk factors.

Long term, multicenter, single-arm, open-label extension study of the MERIT-1 study, to assess the safety, tolerability and efficacy of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH)

Safety objective:• To evaluate the long-term safety and tolerability of macitentan 10 mg in subjects withinoperable CTEPH.Efficacy objectives:• To evaluate the long term effects of macitentan 10 mg on exercise capacity andfunctional class (FC).

A Phase III, randomized, double-blind, placebo-controlled, parallel-group, multicenter efficacy and safety study of Gantenerumab in patients with Mild Alzheimer*s disease; part II: open-label extension for participating patients

The primary efficacy objective for this study was to evaluate the efficacy of gantenerumab compared with placebo administered to patients by subcutaneous (SC) injection over 100 weeks as measured by the following co-primary endpoints (final outcome…