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A multicentre, open label, randomized Phase II trial of the MEK inhibitor pimasertib or dacarbazine in previously untreated subjects with N-Ras mutated locally advanced or metastatic malignant cutaneous melanoma

Primary objectiveTo compare the progression-free survival (PFS) of subjects treated with either pimasertib or dacarbazine.Secondary objectivesEfficacy- To compare the objective response of subjects treated with either pimasertib or dacarbazine.- To…

Multicenter, Double-Blind, Randomized, 2-Part, Dose Ranging Study to Compare the Safety, and Antiretroviral Activity of MK-1439 Plus TRUVADA® Versus Efavirenz Plus TRUVADA® in Antiretroviral Treatment-Naïve, HIV-1 Infected Patients

MK-1439 is a promising NNRTI to be used in combination with other antiretrovirals (ARTs) for the treatment of HIV infection. It is a potent inhibitor of HIV-1 replication in vitro and is active against both wild type virus and most common NNRTI…

A phase I/II trial of Cabazitaxel +/- Rhenium-188 HEDP in patients with metastatic castration resistant prostate cancer who progressed on or after a docetaxel containing treatment.
The ReCab trial

Primary objectives:To establish a safe and effective dosing schedule for repeated administration of Rhenium-188 HEDP combined with Cabazitaxel in order to proceed with a Randomised Phase 2 trial designed to determine the clinical value of Rhenium-…

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,…

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…

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 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.

Randomized phase II study of BEZ235 or everolimus in advanced pancreatic neuroendocrine tumors

To assess the treatment effect of BEZ235 relative to everolimus on progression free survival in patients with advanced pancreatic neuroendocrine tumors who have not been previously treated with an mTOR inhibitor.

A randomized, double-blind, parallel group study to evaluate metabolic effects of LCZ696 and amlodipine in obese hypertensive subjects: the CLCZ696B2207 study

The objective of this study is to investigate what the effects of LCZ696 or amlodipine are on insulin sensitivity as assessed by hyperinsulinemic euglycemic glucose clamp (HEGC) after 8 weeks of treatment. Furthermore, the effects on subcutaneous…

Anti-depressant Effecte of Pulsed ElectroMagnetic Fields (PEMF) in patients with treatment resistant depression

Can this effect be utilised clinically, especially in patients with major depressive disorder?

A randomised, controlled, double-blind trial to investigate the effects of a new infant formula on growth, tolerance and safety in healthy term infants.

The primary objective of this study is to investigate equivalence of weight gain from randomisation until the age of 17 weeks in infants receiving the test product compared to infants receiving the control product. Secondary objectives of this study…

Misophonia: an imaging study on the neurobiology and the efficacy of cognitive behavioural therapy

The objective for this study is threefold. The first goal is to objectify differences in brain function between patients and normal controls. The second objective is to support preliminary findings that the combination of CBT/PMT is an effective…

Local infiltration anesthesia in total knee arthroplasty

Optimizing the amount of ropivacain and gabapentin, used for local infiltration (LIA) during TKA procedures by measuring the outcomes of pain (by using the 100 mm Visual Analogue Scale (VAS)), adverse effects, length of hospital stay, cumulative…

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…

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…

Remote ischemic preconditioning to reduce contrast-induced nephropathy.

To demonstrate that remote ischemic preconditioning reduces contrast-induced nephropathy in patients ar high-rish of CIN (according CBO guidelines) next to the use of pre- and posthydration.

Using the Vestibular Labyrinthine Substitution system in daily life

To objectify the effect of the VLS-system during daily use regarding postural stability and quality of life.

Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastatic Tumors (SABR-COMET): A Randomized Phase II Trial

To assess the impact of a comprehensive oligometastatic SABR treatment program on overall survival and quality of life in patients with up to 5 metastatic cancer lesions, compared to patients who receive standard of care treatment alone.

A randomized, controlled study to evaluate the safety and cardiovascular effects of Algisyl-LVR* as a method of left ventricular augmentation in patients with dilated cardiomyopathy (AUGMENT-HF)

The objective of the AUGMENT-HF study is to provide evidence for the safety profile associated with the Algisyl-LVR* device and initial evidence for the efficacy of the device.

COSIRA - COronary SInus Reducer* for Treatment of Refractory Angina

The objective of this study is to confirm the safety and effectiveness of the Reducer when used in patients with refractory angina who demonstrate evidence of reversible ischemia.