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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…

A prospective, multicenter, randomised, open-label, active controlled, 2 parallel groups, phase 3 study to compare the efficay and safety of masitinib to sunitinib in patients with gastrointestinal stromal tumor after progression with imitinib

The objective is to compare the efficacy and safety of masitinib 12 mg/kg/day to sinutinib 50 mg/day

A randomized, single blinded trial to evaluate the efficacy of Imiquimod in women with residual/recurrent Cervical Intraepithelial Neoplasia (CIN) after previous treatment

Primary objectives: Evaluation of the efficacy of imiquimod 5% cream compared to treatment with Large Loop excision of the transformation zone (LLETZ) for recurrent/residual CIN.Secondary objectives: evaluation of the effect of treatments on HPV DNA…

Prospective randomized trial to evaluate and to compare the impact of hysteroscopic Essure® intratubal device placement and laparoscopic salpingectomy on IVF-ET outcomes of patients with hydrosalpinx.

1. To evaluate and compare the impact of hysteroscopic Essure® intratubal device placement and laparoscopic salpingectomy on IVF-ET outcomes of patients with hydrosalpinx.2. It is still uncertain whether laparoscopic salpingectomy for hydrosalpinx…

Phase III Randomized Double-Blind Trial of Bepanthen® Cream Versus Cetomacrogol Cream in the Prevention of Papulopustular eruption in Patients Receiving Epidermal Growth Factor Receptor Inhibitors (EGFRI): BeCet

To assess the preemptive effect of Bepanthen® on decreasing the incidence of specific >= grade 2 dermatological side effects of interest in respect of compliance to EGFRI agents, HRQoL and the adherence during the 6-week skin treatment period…

A Randomized, Open Label, Phase III, Multicenter, 2-Arm Study of Androgen deprivation +/- Taxoterere* (Docetaxel) for Non metastatic Prostate Cancer Patients with a Rising PSA.

To evaluate and compare progression free survival (PSA) between the two treatment arms.

Randomized trial on chest irradiation in extensive disease small cell lung cancer

to evaluate the role of thoracic irradiation in patients with ED-SCLC who respond to chemotherapy and to assess the effect on 1 year survival

Efficacy of routine elastic stockings after varicose vein surgery: a prospective randomised trial.

The main objective is to determine whether the post-operative application of elastic stockings after varicose vein surgery is useful to reduce post-operative pain. Secondly we want to determine whether there is a difference in physical functioning…

Long term prospective follow-up study of tocilizumab (RoActermraR) administered to patients with rheumatoid arthritis in daily clinical practice.

To determine the efficacy and safety of tocilizumab in the daily clinical practice situation for at least 36 months in comparison to the reported efficacy and safety in clinical trials.There will be a particular focus of the effect of tocilizumab on…

International, multicentre, open, prospective, randomized study: Banded versus Conventional Laparoscopic Roux-en-Y Gastric Bypass (GABY)

This study will evaluate the effectiveness and safety of the use of the gastric ring in preventing weight increase after 2 years

Intra-articular drain position versus subfascial drain position in autologous blood retransfusion in total hip arthroplasty

Objective of this study is to evaluate the amount of shed blood in patients treated with a postoperative retransfusion system. The influence of the position of the drain will be analysed by comparing intra-articular position versus subfascial…

Liver toxicity of azathioprine and 6-mercaptopurine in IBD patients.

The primary goal of the study is the prevalence of NRH in patients with IBD, who have been treated for at least five years with azathioprin or 6-mercaptopurin. A MRI of the liver, using the Seiderer protocol, and a percutaneous liver biopsy will be…

Morphine versus piritramide (Dipidolor??) in postoperative analgesia. Time of onset of analgesia and incidence of postoperatieve nausea and vomiting after intravenous injecttion. A comparison.

The investigation of differences between morphine and piritramide concerning the incidence of postoperative nausea and vomiting and the time of onset of adequate analgesia.

INCH-trial: A multicenter randomized controlled trial comparing the efficacy of conventional open surgery and laparoscopic surgery for incisional-hernia repair.

The main goal of the trial is to establish whether laparoscopic incisional hernia repair is superior to conventional open incisional hernia repair in terms of cost-effectiveness. This is measured through length of hospital stay and quality of life.…

Physiotherapy WORKs: a randomized controlled trial on the (cost-)effectiveness of a multimodal, personalized, work-oriented physiotherapy intervention in inflammatory arthritis.

The present project aims to evaluate the effectiveness of a multi-modal, personalized, work-oriented physiotherapy intervention in optimizing work ability (primary outcome) and improving clinical outcomes (secondary outcomes), compared to usual care…

A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Adolescent Patients 12 to 17 Years of Age with Chronic Migraine - the REBUILD-2

This study has been transitioned to CTIS with ID 2023-505835-11-00 check the CTIS register for the current data. PrimaryTo demonstrate the superiority of galcanezumab versus placebo in the prevention of migraine in an adolescent population (12 to 17…

EFFECT OF FERRIC CARBOXYMALTOSE ON EXERCISE CAPACITY AFTER KIDNEY TRANSPLANTATION: A MULTICENTER RANDOMIZED CONTROLLED TRIAL

To study the effects of FCM on exercise tolerance, haematinic parameters, quality of life, cardiac function, muscle function, bone and mineral parameters, microbiota, the immune system, the incidence of infections, allograft failure and mortality in…

Comparison of subcutaneous and intravenous retreatment with ultra-low dose rituximab in rheumatoid arthritis: a randomised open-label non-inferiority trial

The aim of this study is to investigate non-inferiority of rituximab SC 336 mg to rituximab IV 200 mg.

Sentix: A prospective observational trial on sentinel lymph node biopsy in patients
with early stage cervical cancer

To evaluate whether a less radical surgical approach with sentinel lymph node biopsy is non-inferior to treatment with systematic pelvic lymphadenectomy.The null hypothesis is that the recurrence rate after SLN biopsy is non-inferior to the…

A Clinical Randomized Controlled RSA Trial Comparing the Cemented ATTUNE (S+Tibia tray) Fixed Bearing Cruciate Retaining Knee System with the Cemented PFC Sigma Fixed Bearing Cruciate Retaining Knee System

The objective of this study is to accurately assess and compare migration, clinical and radiological outcome and patient reported outcomes of two TKR prostheses: the Cemented ATTUNE (S+Tibia component) Fixed Bearing Cruciate Retaining Knee System…