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A multi-centre, double-blind, randomised, placebo-controlled trial using CD133 enriched bone marrow cells following primary angioplasty for acute myocardial infarction with central core laboratory analysis.

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A phase II study of ARA 290 as therapeutic strategy in rheumatoid arthritis

This is an open label proof of principle study, in 14 patients. The objective of the study is to test the efficacy and safety of ARA 290 in patients with active rheumatoid arthritis. To assess the efficacy, disease activity is examined based on…

A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and
Safety of CNTO 328 (Anti-IL-6 Monoclonal Antibody) Plus Best Supportive Care
Compared With Best Supportive Care in Subjects With Multicentric Castleman*s
Disease

Primary Objective:The primary objective of this study is to demonstrate that CNTO 328 in combination with BSC is superiorto BSC in terms of objective response (complete response [CR] + partial response [PR]) among subjectswith multicentric Castleman…

Effects of acute and chronic oral administration of S 44121 versus placebo on cardiac arrhythmia during exercise testing in patients with catecholaminergic polymorphic ventricular tachycardia type 1 - A randomized, parallel-group, international multicentre study including a 8-week double-blind placebo controlled period followed by a 8-week single-blind period - Phase II exploratory study

The objective of this study is to assess the effects of a single and chronic oral administration of S 44121 versus placebo on the occurrence of cardiac arrhythmia during standardized exercise tests (ETs) in patients with CPVT type 1. The safety…

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…

89Zr-RO5323441 PET imaging in patients with recurrent glioblastoma treated with bevacizumab

The objectives of this study are to assess the penetration of RO532441 into recurrent GBM by 89Zr-RO5323441 PET imaging and to quantify its uptake, to visualize and quantify 89Zr-RO5323441 organ distribution, and to measure effect of bevacizumab…

Stereotactic ablative radiotherapy (SABR) after systemic antineoplastic treatment for patients with unresectable oligometastases (lung; liver; adrenal glands) from solid tumours:
SARASTRO Trial
(Stereotactic Ablative Radiotherapy After Systemic TReatment for Oligometastases)
A randomised phase II trial

To explore, whether the magnitude of the effect - in terms of progression free survival at one year - due to the addition of SABR after chemotherapy for selected patients with metastatic disease from solid (non-germinoma) tumours might justify a…

Characterisation of ovulation inhibition and effects on metabolic parameters and haemostatic system of multiple administrations of a fixed-dose combination product containing 0.02 mg ethinylestradiol and 2 mg dienogest (24+4) in a multiple administration, comparative parallel-group trial vs. a marketed product containing 0.02 mg ethinylestradiol and 0.10 mg levonorgestrel with healthy females of childbearing potential

descriptive characterisation of the influence of Test or Reference on ovarian activity determined by means of maximum follicular diameter and Hoogland scoredescriptive characterisation of the effect of Test or Reference on endometrial thickness,…

Transarterial Chemoembolization with Drug-Eluting Beads
Loaded with Doxorubicin for the Treatment of Metastatic
Breast Cancer to the Liver: a pilot study

To study the safety, feasibility ,t oxicity , tolerance and respons rate (RECIST-criteria) of the intra-arterial treatment with Doxirubicin -loaded Beads (DEBDOX) in patients with liver dominant metastasized breast cancer.

A Phase 2 Study of LY2157299 Monohydrate Monotherapy or LY2157299 Monohydrate plus Lomustine Therapy compared to Lomustine Monotherapy in Patients with Recurrent Glioblastoma

The primary objective of this study is to compare the overall survival (OS) distributions between LY2157299 monohydrate plus lomustine therapy with lomustine plus placebo therapy (control arm), in patients who have relapsed or have progressive GB…

An open-label phase II trial of erlotinib and bevacizumab in patients with advanced non-small cell lung cancer and activating EGFR mutations

To determine long-term outcome of patients with advanced non-squamous NSCLC harbouring at diagnosis EGFR mutations with and without T790M mutation and treated with the combination of erlotinib and bevacizumab.

Effects of levosimendan on diaphragm function in mechanically ventilated patients

To determine the effect of levosimendan on diaphragm function in mechanically ventilated patients.

The analgesic efficacy of Δ9-THC (Namisol®) in patients with persistent postsurgical abdominal pain: a randomized, double-blinded, placebo-controlled, parallel design

Primary Objective: - To investigate the analgesic efficacy of a stable dose Namisol® in patients suffering from persistent postsurgical abdominal pain. Secondary Objectives:- To investigate the effect of a stable dose Namisol® on central nervous…

Phase IIa, 2:2:1 randomised, double-blind, placebocontrolled, parallel group, multi-centre clinical trial to investigate the safety, efficacy and pharmacokinetics of recombinant human soluble Fc-gamma receptor IIb (SM101) for intravenous application in the treatment of systemic lupus erythematosus (SLE) patients with or without a history of lupus nephritis

The primary objective of the study is:Evaluate the safety of 6.0 mg/kg and 12 mg/kg SM101 per week in SLE patients with or without a history of lupus nephritis.The Secondary objective is:Evaluate the efficacy and pharmacokinetics (PK) of 6.0 mg/kg…

SNIPP study - A investigator initiated phase II study of sunitinib in patients with recurrent paraganglioma/pheochromocytoma

To investigate if sunitinib has clinical significant activity in patients with metastatic/recurrent paraganglioma/pheochromocytoma.

A phase I/II *minor histocompatibility antigen (mHag)-based Dendritic cell (DC) vaccination trial after allogeneic Stem Cell Transplantation (allo-SCT) to improve the safety and efficacy of donor lymphocyte infusions.

The objective of the study is to improve the T cell killing by treating the patient with in the laboratory cultured professional antigen presenting cells (DCs) which are loaded with specific antigens that are only present on blood and cancer cells…

Hydroxychloroquine as an anti-autophagy and chromatin modulating drug in combination with erlotinib in non-small cell lung cancer (NSCLC) patients: a single-center single arm open-label phase II trial

To evaluate the efficacy of the drug combination. Translational work is aimed to explore pharmacodynamic, predictive and surrogate endpoint biomarkers in tumor tissue and blood.

Attention Defficity Hyperactivity Disorder and fMRI neurofeedback: A randomized controlled trial on the effects of self-modulating anterior cingulate cortex activation levels.

The principal objective of this study will be to critically evaluate if the fMRI-neurofeedback training is successful in reducing ADHD symptoms and improving cognitive functioning. Thus, the first goal is to show that ADHD patients are able to…

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.

Dasatinib treatment combination for fludarabine-refractory Chronic Lymphocytic Leukemia (CLL)

Primary:To determine the response rate and response quality of dasatinib monotherapy or dasatinib/fludarabine combination in fludarabine refractory CLL patientsSecundaryTo asses the overall safety profile of this treatment approachTo asses event…