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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.

Neo-adjuvant chemotherapy, cytoreductive surgery with hypethermic intraperitoneal chemotherapy for peritoneal carcinomatosis of colorectal origin.

To investigate wether neo-adjuvant chemotherapy followed by cytoreductive syurgery and hyperthermic chemotherapy is feasible and reduces the number of irresectable patients with acceptable morbidity and mortality rates.

CINCOR* Trial III:Clinical Study of the CINCOR Contrast Removal Study for Patients with Chronic Kidney Disesease

The purpose of this clinical study is to provide confirmation of the clinical safety and performance of the CINCOR* System in removing contrast in patients at risk of developing CIN who are undergoing percutaneous coronary procedures.

ADMINISTRATION OF HA-1 TCR TRANSDUCED VIRUS-SPECIFIC T-CELLS AFTER ALLOGENEIC STEM CELL TRANSPLANTATION IN PATIENTS WITH HIGH-RISK LEUKEMIA (LUMC 2010-02)

Primary Objective• To investigate the feasibility and safety of administration of donor HA-1 TCR transduced virus-specific T-cells after allo-SCT.Secondary Objectives• To evaluate the persistence of donor HA-1 TCR transduced virus-specific T-cells…

Efficacy and safety of delta-9-tetrahydrocannabinol (delta-THC) in behavioural disturbances in dementia

The primary objective is to evaluate the efficacy of Namisol® in the management of behavioural disturbances in patients with dementia. Secondary objectives are:- To evaluate the efficacy of Namisol® on secondary outcome measures, such as quality of…

Pharmacokinetics and safety of Meropenem in infants below 90 days of age (inclusive) with probable and confirmed meningitis: a European multicenter phase I- II trial

Primairy objectivesTo study the pharmacokinetics (plasma and cerebrospinal fluid) of meropenem in infants <= 90 days of postnatal age with probable or confirmed bacterial meningitis (BM); To describe the safety profile of meropenem in the…

The Safety and Efficacy of Irreversible Electroporation for the Ablation of Prostate Cancer Assessed by Procedural Related Side Effects and Post Prostatectomy Histology: A Prospective Human In-Vivo Study

To evaluate the safety, efficacy and to acquire data on patient experience of minimally invasive, percutaneous, image guided IRE for the ablation of prostate cancer.

A Phase 2, Open Label, Multicenter, Randomized Trial Comparing Tivozanib in Combination with mFOLFOX6 with Bevacizumab in Combination with mFOLFOX6 in Stage IV Metastatic Corectal Cancer (mCRC) Subjects

PrimaryTo compare progression-free survival (PFS) between tivozanib in combination with mFOLFOX6 and bevacizumab in combination withmFOLFOX6 based on investigator radiological tumor assessmentSecondary• Progression Free Survival (PFS) based on…

Local Infiltration Anaesthesia in Total Hip Arthroplasty by Anterior Supine Intermuscular Approach

Determining the outcome of reversed and antegrade LIA in THA with ASI by analysing postoperative pain with the 100 mm Visual Analogue Scale (NRS), length of hospital stay, the amount of postoperative consumption of opioid pain medication as well as…

A Phase 2b, Double-Blind, Placebo-Controlled, Multinational, Multicenter, Randomized Study Evaluating the Safety and Efficacy of Intracoronary Administration of MYDICAR® (AAV1/SERCA2a) in Subjects with Heart Failure

The study primary goal is to determine the effectiveness of a single infusion of 1 x 10E13 DRP MYDICAR® in the coronary arteries in addition to an optimal HF regimen in patients with ischemic or non-ischemic cardiomyopathy and moderate to advanced…

Double umbilical cord blood transplantation in high-risk haematological patients.
A phase II study focussing on the mechanism of graft predominance

Objective of the study is to evaluate whether parameters can be identified that predict which graft ultimately prevails following cord blood transplantation after a reduced intensity conditioning regimen in adult patients .In addition engraftment,…

A multicenter, open label, phase I / II study to evaluate safety, pharmacokinetics and efficacy of BIBF 1120 in comparison with oral sorafenib for advanced hepatocellular carcinoma patients.

To evaluate the efficacy and safety of BIBF 1120 in HCC patients without prior systemic treatment as compared to Sorafenib.

A single arm, open-label, phase II, multicentre study to assess the safety of vismodegib (GDC-0449) in patients with locally advanced or metastatic basal cell carcinoma (BCC).

The primary objective of this phase II study is to assess the safety of vismodegib in patients with (inoperable) locally advanced BCC or metastatic BCC.

Evaluation of the subcutaneous administration of 30 mg of S78989 versus placebo and evaluation of the subcutaneous administration of 60mg of S78989 versus placebo, on the reduction of arterial wall inflammation in patients with marked atherosclerotic plaque inflammation.
A 28-weeks, randomized, double-blind, parallel-group, placebo controlled, international multicenter exploratory pilot study.

The objective of this study is to evaluate the effect of the 4 successive monthly subcutaneous administrations of 30 mg of gevokizumab (in part A) , as well as 60mg (in part B) of the protocol, versus placebo on the reduction of arterial wall…

Assessment of Safety, Tolerability, and Pharmacodynamic Effects of LY2886721 in Patients with Mild Cognitive Impairment Due to Alzheimer*s Disease or Mild Alzheimer's Disease

Assessment of Safety, Tolerability, and Pharmacodynamic Effects of LY2886721 in Patients withMild Cognitive Impairment Due to Alzheimer*s Disease or Mild Alzheimer's Disease

Radioactive holmium microspheres for the treatment of patients with unresectable liver metastases; a single center, interventional, non-randomized, phase II efficacy (HEPAR II) trial.

Primary objective:To determine target lesions tumour response.Secondary objectives:* To determine overall tumour response.* To determine the liver specific progression-free survival.* To determine non-liver specific progression-free survival.* To…

A PHASE II, DOUBLE-BLIND, PLACEBO CONTROLLED, RANDOMIZED STUDY EVALUATING THE SAFETY AND EFFICACY OF CARBOPLATIN/PACLITAXEL AND CARBOPLATIN/PACLITAXEL/BEVACIZUMAB WITH AND WITHOUT GDC-0941 IN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED OR RECURRENT NON-SMALL CELL LUNG CANCER.

PRIMARY OBJECTIVES Part I - To evaluate the efficacy (as measured by PFS) of GDC-0941 340 mg +carboplatin * paclitaxel (Arm A) versus carboplatin * paclitaxel (Arm B) in all patients with squamous NSCLC -To evaluate the efficacy (as measured by PFS…

A multicenter, open-label, randomized phase II study to evaluate the efficacy of AUY922 vs pemetrexed or docetaxel in NSCLC patients with EGFR mutations who have progressed on prior EGFR TKI treatment (CAUY922A2207)

Primary: Progression Free Survival (PFS) in patients treated with AUY922 versus pemetrexed or docetaxel.Secondary: Overall response rate, disease control rate, overall survival, safety and tolerability, PK.

Sentinel Node Biopsy using Magnetic Nanoparticles: A prospective multicentre phase II non-randomised clinical trial to compare sentinel node biopsy using magnetic nanoparticles vs.
standard technique

The principal objective of the study is to determine if the performance of the new technique (magnetic tracer and magnetometer) is equivalent to the performance of the standard technique (patent blue dye and radioisotope; or radioisotope alone).The…

Assessment of the Photopill Capsule Treatment for Safety and Feasibility in Patients with Ulcerative Proctitis, a Pilot Study

The evaluation of the safety and feasibilty of the Photopill capsule treatment in patients with Ulcerative Proctitis