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Screening and treatment of psychological distress in colorectal cancer with metastasized disease: the TES-trial

We have developed the TES program, which involves Targeted selection and Enhanced care, delivered on the basis of Stepped care (TES). The primary study aim is to evaluate the effectiveness of the TES-program compared to usual care in reducing…

Prospective Open label study of Parenteral vs Enteral iron in Young IBD patients and Effect on physical fitness

To examine if intravenous administration of iron ismore efficacious than oral iron in improvement offitness scores, iron status and reduction of fatigue

A double blind, randomized, placebo controlled, cross-over study to validate the predictive power of the demarcation formula for Lybrido and Lybridos efficacy in women with female sexual interest/arousal disorder, in the domestic situation.

Primary Objective• To validate the existing demarcation formula (consisting of psychometric and biological markers) which predicts the sensitivity to Lybrido or Lybridos in women with female sexual interest/arousal disorder (FSIAD with or without…

Computer based cognitive flexibility training after stroke

In this study the effectiveness of online cognitive flexibility training on cognitive functioning in stroke patients will be investigated. The aim of this study is to improve executive functions: both trained executive functions as well as untrained…

The effects of body weight support, guidance, and gait speed on the patterning of muscle activity in the Lokomat

a. To establish the effects of (1) body weight support (2) treadmill speed, and (3) level of movement guidance provided by the exoskeleton on the neuromuscular control of the lower extremities.b. To establish the interactions between the above…

Transcranial Doppler (TCD) versus Computed Tomography Angiography (CTA) for the detection of cerebral vasospasm after subarachnoid hemorrhage

Assessment of the diagnostic accuracy of CTA for the detection of vasospasm after SAH in comparison to TCD.

Stereotactic body radiotherapy for cT1c - cT3a prostate cancer with a low risk of nodal metastases (<= 20%, Roach index): a Novalis Circle Phase II prospective randomized Trial*

Aim of this study is to investigate the tolerance and the outcome of extreme hypofractionated RT for prostate cancer by delivering a high dose using two alternative time schedules, a short and long treatment interval.

Ablation of slow conducting anatomical isthmuses in patients with repaired Tetralogy of Fallot, who undergo reoperation for pulmonary valve replacement and who are at risk for isthmus related ventricular arrhythmias.

1) To evaluate the feasibility and the acute effect of intra-operative cryoablation of the slow conducting anatomical isthmuses (endpoint bidirectional conduction block) and on the re-inducibility of monomorphic isthmus dependent VT. 2) To study the…

Hysteropexy in treatment of uterine prolapse stage >= 2: laparoscopic sacrohysteropexy versus vaginal sacrospinous hysteropexy (LAVA-trial)

To investigate the hypothesis that women with uterine prolapse stage 2 or more treated by laparoscopic sacrohysteropexy will have equal or lower recurrence rate of prolapse compared to women treated by vaginal sacrospinous hysteropexy.

Cognitive behaviour therapy by internet for chronic fatigue in type 1 Diabetes: a randomized controlled trial.

The main objective of this study is to test whether cognitive behaviour therapy delivered by internet has a significant effect on fatigue in patients with type 1 diabetes en whether this effect is sustained during a follow-up period of six months.…

Measurement of nociceptive index during general anesthesia in ASA 1-3 patients undergoing elective surgery using the Nociception Level (NoL) index

Measurement of the pain index, NoL, during laryngoscopy, intubation and skin incission during variations in de level of propofol and remifentanil.

Duplex-guided PTA (DuPTA) versus conventional PTA utilizing contrast in peripheral artery disease: Randomised control trial

The aim of the research is to demonstrate a possible significant difference in procedural success and / or clinical success of duplex-guided PTAs compared with conventional PTA in an RCT.The study describes the above hypothesis and has led to the…

A feasibility study investigating the safety, performance and gastrointestinal transit of the DV3395 device concept in healthy participants.

We will investigate how safe the study device DV3395-C1 is when it is taken in by healthy participants. We will also look at the passage (i.e., gastrointestinal transit time) and activation of the study device. For this, we will see if the device…

Artificial Intelligence driven synthetic CT to substitute CT scans of the head and neck region

(1) to create and train an algorithm to generate synthetic CT images of the craniofacial area(2) to evaluate the resulting synthetic CT images in terms of geometrical accurate visualization of the craniofacial osseous structures compared to the…

A phase 1, open-label, single-center study of absorption, metabolism and excretion and absolute bioavailability in humans of leriglitazone (MIN-102) in 2 parallel cohorts of male healthy subjects

In this study we will investigate how safe the compound leriglitazone is and how well it is tolerated when it is used by healthy participants.Apart from extensive laboratory and animal testing, leriglitazone has been used in the past both in healthy…

T&T trial: adding Testosterone to Tamoxifen in male breast cancer patients

Primary Objective: To assess the safety profile (AEs, SAEs) on combined treatment with tamoxifen and testosterone.Secondary Objectives:• AR to ER ratio on baseline FES- and FDHT-PET imaging (assessed per lesion and per patient by quantitative…

The immunomodulatory effect of sugammadex after total hip replacement surgery under neuraxial anaesthesia: a pilot study

The overall objective of this study is to investigate the potential immunomodulatory effect of sugammadex as seen in previous ex vivo experiments. Specified, the main objective is to investigate the effect of administration of sugammadex without…

Adrenal vein sampling as a tool to identify biomarkers that aid the diagnosis of adrenocortical carcinoma

To detect differences between ACC patients and controls without ACC, and between the diseased and healthy adrenal gland of ACC patients, in microRNA (miRNA), circulating cell-free tumor DNA (ctDNA), circulating tumor cells (CTCs), and steroid…

Two-groups, open label, fixed-sequence study to evaluate the effect of CYP3A4/P-gp inhibition (Itraconazole) or CYP1A2/3A4 inhibition (Fluvoxamine) on the single-dose PK of MEN1611 in healthy subjects.

In this study we will look at how quickly and to what extent the study compound MEN1611 is absorbed, transported, and eliminated from the body (this is called pharmacokinetics) and how this is influenced by the approved drug itraconazole fluvoxamine…

A two-part, single dose, randomized, single-blinded, placebo controlled, phase I study to assess the safety and pharmacokinetics of oral MT1980 in healthy volunteers when dosed in the fasted state

In this study we will investigate how safe the new compound MT1980 is and how well it is tolerated when it is used by healthy participants. We also investigate how quickly and to what extent MT1980 is absorbed, transported, and eliminated from the…