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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…

Phase III trial on Concurrent and Adjuvant Temozolomide chemotherapy in non-1p/19q deleted anaplastic glioma. The CATNON Intergroup trial.

PRIMARY OBJECTIVESthe assessment if survival in grade III glioma without combined 1p/19q loss is improved by - daily temozolomide chemotherapy during radiotherapy - the administration of temozolomide after the end of radiotherapy SECONDARY…

A randomised, double-blind, parallel group PhIII study to assess the clinical efficacy and safety of 100 mg SC Mepolizumab as an add on to maintenance treatment in adults with severe bilateral nasal polyps (study 205687, SYNAPSE)

Primary:To evaluate the efficacy of 100mg mepolizumab compared to placebo.Secondary:The impact on actual nasal surgery. Further efficacy assessment. Quality of life.

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 prospective, multicenter, randomized, open-label, active-controlled, phase III study to compare efficacy and safety of masitinib to imatinib at 400 or 600 mg in treatment of patients with gastro-intestinal stromal tumour in first line medical treatment

Safety and efficacy objectives:The objective is to compare the safety and efficacy of masitinib at 6 of 7.5 mg/kg/day to imatinib at 400 or 600 mg, in patients with gastro-intestinal stromal tumour in first line medical treatment.

A placebo-controlled double blind randomized trial to investigate the efficacy and safety of the combination of Penicillin G / Hydrocortisone treatment in ALS patients (PHALS).

The objective is to compare the efficacy and safety of intravenous high-dose penicillin G and hydrocortisone versus placebo in combination with riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS).

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…

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…

Uniform FDG-PET guided gradient dose prescription to reduce late radiation toxicity (UPGRADE RT): a randomised controlled trial with dose reduction to the elective neck in head and neck squamous cell carcinoma

The UPGRADE-RT trial will investigate whether de-escalation of the elective radiation dose and introduction of an intermediate dose-level in the treatment of head and neck cancer will results in less radiation sequelae and improved quality of life…

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?

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

Influenza vaccination in patients with Myasthenia Gravis

The main objective of this study is to investigate the effectiveness of the humeral immune response after influenza revaccination in patients with MG with acetylcholine antibodies (AChR MG). The secondary objectives are to determine if vaccination…

A Randomized, Placebocontrolled, Double blind, Single Ascending Dose Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-61393215 in Healthy Subjects

The primary objectives of this study in healthy subjects are:- To investigate the safety and tolerability of JNJ-61393215 versus placebo after single oral dose administration under fasted (ascending dose levels) and fed condition.- To characterize…

RCT to investigate the quality of the of endometrial sample obtained by aspiration when performed before or after the SIS in postmenopausal women.

The primary objective is to investigate the quality (whether assessable by a pathologist or not) of the endometrial sample obtained by aspiration when performed directly before or after the SIS in postmenopausal women. Secondary objectives are to…

Somatosensory electrical stimulation to augment skill acquisition and motor memory consolidation: An electroencephalography study

To determine the mechanisms underlying motor skill training, somatosensory electrical stimulation, and a combined intervention on motor skill acquisition, motor memory consolidation, and interlimb transfer in healthy younger and older adults.

A Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Oral Doses of LTI-291 in Healthy Middle-Aged to Elderly Subjects

- To evaluate the safety and tolerability of four oral dose levels of LTI-291 following multiple administrations in healthy middle-aged to elderly subjects. - To characterize the plasma and cerebrospinal fluid (CSF) pharmacokinetics (PK) of LTI-291…

A phase 2, double-blind, randomized, placebo-controlled pharmacokinetic trial in two parallel groups to investigate possible drug- drug interactions between stiripentol or valproate and GWP42003-P in patients with epilepsy.

Primary Objective: To determine whether GWP42003-P affects the pharmacokinetic (PK) profile of stiripentol (STP) or valproate (VPA).Secondary Objective: To assess the safety and tolerability of GWP42003-P in the presence of STP or VPA.To assess…

European Fans in Training (EuroFIT): A multicentre randomised controlled trial of a gender-sensitised programme to increase physcal activity and reduce sedentary time delivered to men aged 30-65 in elite European football clubs

The main aim of the EuroFIT trial is to assess the effectiveness and cost-effectiveness of the EuroFIT programme in supporting men to achieve an increase of at least 1000 steps per day (about 10 minutes on average per day, or 70 minutes per week)…

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…

Randomized Efficacy and Safety Trial with Oral S 44819 after Recent ischemic cerebral Event
International, multi-centre, randomized, double-blind placebo-controlled phase II study.

Efficacy and safety trial with S 44819 after recent ischemic cerebral Event