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Pilot study of everolimus in the treatment of advanced malignancies in patients with Peutz-Jeghers syndrome

To determine the efficacy (as measured by objective tumor response) of single agent everolimus in the treatment of advanced malignancies or high risk polyps of patients known with PJS .

Efficacy of agomelatine 25 mg/day (with possible increase to 50 mg/day after 8 weeks of treatment) given orally during 16 weeks in patients with Obsessive-Compulsive Disorder.A randomised, double-blind, placebo-controlled, parallel groups, international study.

The primary objective of the study is to evaluate the efficacy of agomelatine (25-50 mg/day) compared to placebo on the reduction of Obsessive and Compulsive symptoms by using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) after 16 weeks of…

A prospective, double-blind, placebo-controlled trial investigating the efficacy and safety of Org 25935 in relapse prevention in subjects with alcohol dependence

Primary objective- To assess the effects of Org 25935 on heavy drinking in subjects with alcohol dependence.Secondary objectives- assess the effects of Org 25935 on the amount of drinking- To assess the effects of Org 25935 on the first relapse to…

An Investigation of the Effect of Long-Term Electrical Stimulation on Lower Esophageal Sphincter (LES) Pressure and Esophageal Acid Exposure in Patients with Gastroesophageal Reflux Disease (GERD)

Primary Safety Endpoint:Safety will be assessed by incidence and severity of adverse events through 12-weeks (3 month) follow-up. Included in this assessment will be the proportion of subjects with any of the following outcomes between device…

APD Perfusion Measurement Study

The primary objective of this study is to test safety and performance of the APD Perfusion Measurement Catheter & Monitor for the measurement of gut perfusion in humans. The secondary objectives of this study are to assess the normal values…

The safety, tolerability, and analgesic efficacy of Δ9-THC (Namisol®) in chronic pancreatitis patients suffering from persistent abdominal pain

Primary Objective: - To investigate the efficacy of Namisol® after a single dose of Δ9-THC on the experienced pain intensity (measured by the VASpain in rest and on movement) in patients with chronic pancreatitis.Secondary Objectives:- To…

A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study Comparing Siltuximab Plus Best Supportive Care to Placebo Plus Best Supportive Care in Anemic Subjects with International Prognostic Scoring System Low- or Intermediate-1-Risk Myelodysplastic Syndrome

The primary objective is to assess the clinical efficacy of siltuximab (a chimeric (murine-human) IgG1* mAb that specifically binds human IL-6 with high affinity and prevents its interaction with the IL-6 receptor, glycoprotein (GP) 80),…

An Open-Label, Randomized, Multicenter Phase IIa Study;Evaluating Pertuzumab in Combination with Trastuzumab and;Chemotherapy in Patients with HER2-Positive Advanced;Gastric Cancer

Pertuzumab is an investigational agent being studied for the treatment of HER2-positive gastric cancer. This study intends to provide a dose of pertuzumab to find an acceptable minimum pertuzumabconcentratie pertuzumab effective when administered in…

Pain treatment of newborns: paracetamol rectal versus intraveneous administration, an open randomised clinical trial.

The aim of the present study is to investigate the effectiveness of paracetamol as intravenous subscription form versus paracetamol as rectal subscription form in order to prevent pain in neonates. To study this, therapeutic doses, the doses…

Randomised, controlled, open label, cross-over trial to evaluate the tolerance of a new smoothie-style paediatric sip feed in children in need of oral nutritional support.

The primary objective of this study is to evaluate the tolerance of a new smoothie-style paediatric sip feed compared to a standard paediatric sip feed for a period of 6 weeks in children in need of oral nutritional support. The secondary objectives…

A partially blinded, prospective, randomized multicenter study evaluating efficacy, safety and tolerability of oral sotrastaurin plus standard or reduced exposure tacrolimus vs. myfortic plus tacrolimus in de novo renal transplant recipients (CAEB071A2214)

Primary objectivesThe primary objective of the study is demonstrate that at least one of the sotrastaurin treatment arms is non-inferior to the active control regimen myfortic + tacrolimus with respect to composite efficacy failure (treated BPAR of…

The effect of positivity training on treatment result in an outpatient population.

The main objective of the present study is to investigate whether addition of CBM to regular CBT treatment aimed at retraining a positive action bias has a positive influence of the affect of the participants, and on treatment result in terms of…

The impact of the macronutrient composition of a nutritional supplement on postprandial skeletal muscle protein synthesis in elderly

Obtain more insight in the preferred macronutrient composition of an oral nutritional supplement.

Mesenchymal stromal cell (MSC) transplantation in septic shock.

Evaluation of therapeutic safety and clinical efficacy of MSC transplantation in septic shock.

Memantine Add-On Therapy to Clozapine

This proposal entails a proof-of-concept study into the neuropsychological effects of memantine augmentation in a random cross-over comparison to placebo, as add-on treatment to ongoing clozapine in severely mentally ill (SMI) patients with…

A multicenter, randomized, partially-blinded, Phase IIb dose-finding study on ovarian function, vaginal bleeding pattern, and pharmacokinetics associated with the use of combined vaginal rings releasing 17*-estradiol plus three different doses of either nomegestrol acetate or etonogestrel in healthy women aged 18-35 years;

The main objective of the trial is to identify at least one NGR that will demonstrate all of the following:1. Inhibition of ovulation2. Cycle control that is non-inferior to NuvaRing®, as judged by the incidence ofBTB-S during Treatment Cycle 3. The…

Prophylactic infusion of CD4 positive donor lymphocytes early after T-cell depleted allogeneic stem cell transplantation in patients with an unrelated donor

In this phase II study, the toxicity and treatment effects of early donor derived CD4+ lymphocyte infusion, three months after allo-SCT, will be evaluated

An extension to a 12-month, open-label, randomised, multicenter, sequential cohort, dose finding study to evaluate the efficacy, safety and tolerability of oral AEB071 versus Neoral® in combination with Certican®, Simulect® and corticosteroids in de novo adult renal transplant recipients

The purpose of this extension is to provide continued treatment and to assess the long term safety, efficacy and tolerability of oral AEB071 plus Certican® vs. Neoral® plus Certican® in de novo renal transplant recipients. The study is a…

Δ9-THC (Namisol®) in chronic pancreatitis patients suffering from persistent abdominal pain: a randomized, double-blinded, placebo-controlled, parallel design

Primary objective:- To investigate the analgesic efficacy of a stable dose treatment Namisol® in chronic pancreatitis patients suffering from abdominal pain. Analgesic efficacy is measured as mean difference in visual analogue scale (VAS) score (i.e…

A Randomized, 4-Arm, Placebo-Controlled Phase 2 Trial of AMG 386 in Combination with Bevacizumab and Paclitaxel or AMG386 plus Paclitaxel as First-Line Therapy in Subjects with Her2-Negative, Metastatic or Locally Recurrent Breast Cancer.

To estimate the treatment effect as measured by progression free survival(PFS) of subjects receiving AMG 386 (at 2 doses) in combination with paclitaxel + bevacizumabrelative to paclitaxel + bevacizumab + placebo.