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An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease

The primary objective of this efficacy and safety study is to demonstrate that tight control of disease activity using stringent criteria based on CDAI, hs-CRP, fecal Calprotectin, and corticosteroid use improves the rate of mucosal healing 48 weeks…

The effectiveness of Parent-Child Interaction Therapy versus methylphenidate in preschool children with ADHD and disruptive behavior problems with insufficient improvement through Parent Management Training.

The primary aim of our study will be to investigate the effectiveness of PCIT in comparison with methylphenidate in children with ADHD and disruptive behavior problems aged 2;6 till 6 years who have not responded sufficiently to previously offered…

COLON-study
Colorectal cancer: Longitudinal, Observational study on Nutritional and lifestyle factors that influence colorectal tumour recurrence, survival and quality of life

We will start a Dutch prospective cohort study of colorectal cancer patients. In this cohort we will assess the intake of dietary supplements, dietary intake and life style factors of colorectal cancer patients. We will study if and how those…

Binocular visual function in glaucoma

We hypothesise that glaucoma patients with non-overlapping visual field defects have poorer binocular visual performance while performing complex visual tasks than would be predicted from their visual field. Knowledge on this topic is highly…

Can goal directed nutritional support reduce sarcopenia in surgical oesophagus patients?

This study investigates the impact of a goal directed nutritional support protocol on sarcopenia in oncological patients undergoing an esophagectomy and secondary the incidence of anastomotic leakage and pneumonia, surgical infection and lenght of…

Effectiveness of Somatostatin Analogues in Patients with hereditary hemorrhagic telangiectasia and symptomatic gastrointestinal bleeding, the SAIPAN-trial: a multicenter, randomized, open-label, parallelgroup, superiority trial.

To determine if SSA are effective in decreasing transfusion requirements and improving quality of life while being cost-effective.

Cardiac CT for therapeutic stratification in low gradient presumed severe aortic stenosis with preserved left ventricular ejection fraction

Primary objective: The primary objective of this non-randomized intervention trial is to investigate whether TAVR improves exercise capacity in patients with preserved LVEF and NF/LG or LF/LG severe AS reclassified based on hybrid CT/TTE-derived…

Understanding Neuromodulation of the Stroke Brain

The objective of this study is to determine whether contralesional cTBS treatment modulates the interhemispheric imbalance in excitability or local or transcallosal inhibitory processes in the motor network of a population of stroke patients…

Time to diagnosis of HCV re-infection with the use of a self-test. A feasibility study.

To assess the effectivity and feasibility of HCV RNA self-testing in reducing the time to diagnosis of HCV re-infection in MSM previously cured of an HCV infection, compared to the current diagnostic standard of care. To evaluate whether the uptake…

Track and treat in NSCLC (TATIN) - ctDNA guided treatment of early resistance to targeted treatment in patients with EGFR positive NSCLC

Primary objectives• To identify the percentage of patients in which a drug resistant clone can be detected with ctDNA before the emergence of radiological progression.• To determine the success rate of crizotinib and osimertinib combination…

A Phase 1 trial to Investigate the Safety, Pharmacokinetic Profiles and the Efficacy of Tinostamustine, a First-in-Class Alkylating Histone Deacetylase Inhibition (HDACi) Fusion Molecule, in Relapsed/Refractory Hematologic Malignancies.

Main objective:1. To estimate the Overall Response Rate (ORR) and the clinical benefit rate in selected cohorts of patients with hematologic malignancies,separately for each cohort2. To evaluate the safety of the selected dose regimes in an expanded…

Psychopathology and cognition in CNV disorders

The objective of this study is to describe cognitive profile and dimensions of psychopathology in subjects with CNV disorders.

Mindfulness versus Cognitive Behavioural Therapy in Tinnitus Patients - A Randomized Controlled, Non Inferiority Trial

Primary Objective: The primary objective is to determine whether MBCT is non inferior in the effectiveness on TFI reduction as CBT in adults with chronic tinnitus. Non inferioirty would be declared if the mean decrease in TFI score for MBCT is no…

Effects of discontinuation of levothyroxine treatment in older adults: a self-controlled study.

Primary aim1) To investigate what proportion of levothyroxine users aged 60 years and older can withdraw from levothyroxine treatment successfully, defined as having normal fT4 levels and TSH levels <10 mU/L at 52 weeks after start of the…

Leukapheresis of healthy volunteer donors for T cell study and TolDC production process validations

To obtain fresh mononuclear cells from healthy volunteer donors to be used for validation of procedures for the generation of GMP-grade T cell or tolerogenic dendritic cell products for clinical application.

Visual impairment in children with a brain tumor in the Netherlands: a prospective nationwide study using standard visual testing and optical coherence tomography

Primary objective:To study whether changes in OCT parameters lead to earlier detection of visual decline compared to standard ophthalmological testing (visual field, visual acuity) in children with a brain tumor. Secondary objective: To study the…

Treatment of metastatic vulvar carcinoma in a neoadjuvant setting with Carboplatin and Paclitaxel chemotherapy

Main objective: response rate and tumour size reduction by chemotherapy

Bidirectional treatment consisting of repetitive laparoscopic electrostatic pressurized intraperitoneal aerosol chemotherapy with oxaliplatin (ePIPAC-OX) and systemic intravenous chemotherapy for isolated unresectable colorectal peritoneal metastases: feasibility, safety, tolerability, and preliminary efficacy.

To determine the safety, feasibility, and tolerability of adding PIPAC with oxaliplatin (92 mg/m2) to systemic chemotherapy in patients with isolated PM from CRC.

Mandibular advancement device (MAD) therapy in edentulous patients with obstructive sleep apnea: dental implant retained MAD therapy

The main purpose of this pilot study is to assess the feasibility and potential efficacy of implant retained mandibular advancement device (MAD) therapy on a small scale in edentulous patients with mild to moderate OSA in terms of sleep apnea…

Single center, prospective,single-arm feasibility study to evaluate the safety ofthe PlenSat Digestible Balloons in thetreatmentofObesity

The objective of this study is to evaluate the safety of the PlenSat Digestible Balloons.