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Phase 1-2 study of everolimus and low-dose oral cyclophosphamide in patients with metastatic renal cell cancer.

Primary: Phase I part 1) Assessment of the recommended dosing and schedule for metronomic cyclophosphamide when administered in combination with fixed dose (10 mg) oral everolimus in patients with mRCC with respect to the selective induction of CD4+…

A phase Ib, open-label, multi-center, dose escalation and expansion study of an orally administered combination of BKM120 plus MEK162 in adult patients with selected advanced solid tumors

Primary:To determine the MTD and/or RP2D of BKM120 and MEK162 in combination when administered orally to adult patients with selected advanced solid tumors. Secondary:• To characterize the safety and tolerability of the oral combination of BKM120…

Characterizing the bone marrow environment in advanced-stage myelofibrosis. A PET/MRI study.

Primary objectivesTo characterize the bone marrow microenvironment in advanced stage myelofibrosis (MF) before and during treatment with ruxolitinib, regarding osteoblastic activity, marrow fibrosis and - osteosclerosis and perfusion- and diffusion…

A multi-centre, double-blind, parallel-group, randomised controlled study to investigate efficacy, safety and tolerability of orally administered BI 409306 during a 12-week treatment period compared to placebo in patients with cognitive impairment due to Alzheimer's Disease.

The primary objective of this study is to assess efficacy and safety of BI 409306 at doses of 10 mg, 25 mg and 50 mg once daily, 25 mg twice daily compared to placebo over a 12-week treatment period in patients with the following criteria: mild…

A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis

The primary objective of this study is to assess whether the efficacy of ocrelizumab given as two dose regimens of 600 mg (given as 300 mg infusions on days 1 and 15 and 600 mg infusion in the following cycles) or 400 mg (given as 200 mg infusions…

Multi-center, Randomized, Open-label, Parallel-arm, Single-dose, Pharmacokinetic Study of rVIIa-FP (CSL689) in Subjects with Congenital Factor VII Deficiency

- to evaluate the FVIIa activity PK of 2 CSL689 dose levels in subjects with congenital FVII deficiency- to determine the PK characteristics of FVIIa activity of CSL689- to evaluate the safety and tolerability of intravenous administration of CSL689

A Phase 2 Trial to Evaluate the Efficacy of PRM-151 in Subjects with Idiopathic Pulmonary Fibrosis (IPF)

To determine the effect size of PRM-151 relative to placebo in change from Baseline to Week 28 in mean FVC% predicted, pooling subjects on a stable dose of pirfenidone or nintedanib and subjects not on other treatment for IPF.

Role of different phosphate binders on absorption of vitamin K, metabolism of matrix *-carboxy-glutamaat (Gla) proteïne (MGP).

This research will have as aim to look at progression or decrease of vascular calcification in dialysis population with use of different phosphate binders. There is a possibility that differect phosphate binders bind vitamin K in a different way in…

Influence of early goal-directed therapy using arterial waveform cardiac output measurement in high-risk surgery

To determine whether early goal-directed therapy, aimed at optimizing cardiac output measured by arterial waveform analysis, improves outcome in high-risk, abdominal surgery.

A phase I trial of actively personalized peptide vaccinations plus immunomodulators in patients with newly diagnosed glioblastoma concurrent to first line temozolomide maintenance therapy

Primary objective of this study is to assess the safety and tolerability, feasibility and biological activity (immunogenicity) of the actively personalized vaccination (APVAC) concept in newly diagnosed glioblastoma (GB) patients.Secondary study…

PreCARA: Preconception Counselling in Active Rheumatoid Artritis and other chronic inflammatory arthritides;
Preconception counselling for women with rheumatoid arthritis (RA) or another chronic inflammatory arthritis and a pregnancy wish, which is evaluated in a prospective observational study monitoring pregnancy, delivery, postpartum period of the mother, and (growth) parameters of the child.

In the present study we will evaluate the standardized care protocol developed in our outpatient clinic, intended to guide counselling for medication use prior to pregnancy. This protocol guides treatment decisions based on disease activity,…

A Multi-national Trial Evaluating Safety and Efficacy, including Pharmacokinetics, of NNC 0129-0000-1003 (N8-GP) when Administered for Treatment and Prophylaxis of Bleeding in Patients with Haemophilia A

Co-Primary Objectives* To evaluate the immunogenicity of N8-GP in previously treated patients with haemophilia A* To evaluate the clinical efficacy of N8-GP in bleeding prohylaxis (number of bleeds during prophylaxis)Secondary Objectives* To…

Utility of BOLD MRI as diagnostic tool in renal artery stenosis in patients with hypertension and chronic kidney disease

Is the BOLD MRI able to show the difference in the level of oxygenation as a mesurement of ischemia between a in a healthy kidney (<30% renal artery stenosis) and a kidney with more than 70% artery stenosis?

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn*s Disease

The primary objectives are:- To evaluate clinical remission for the 2 subcutaneous (SC) maintenance regimens of ustekinumab in subjects with moderately to severely active Crohn*s disease induced into clinical response with ustekinumab in the…

APC & Behaviour

The above anounced studies suggest that some abnormalities in the Wnt pathway can be expected to affect development and function of the brain, potentially leading to recognizable behavioural phenotypes. Given the key role of APC in the Wnt pathway,…

Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non-cystic fibrosis bronchiectasis.

Page 18 of the protocol (v1.0, 4-Nov-2013):The primary objectives of this study are:- To evaluate the efficacy of ciprofloxacin DPI administered BID intermittently for 28 days on study treatment / 28 days off study treatment or 14 days on study…

The effects of intravenous TRH administration on brown adipose tissue activity in healthy, lean men.

To investigate whether BAT tissue can be activated by intravenous administration of TRH. Secondary objectives are to determine whether intravenous TRH increases the degree of cardiovascular sympathetic stimulation and the response of skin…

A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066, an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy.

the main objectives of the study are to evaluate the efficacy of different doses of BI655066 + to evaluate the pharmacokinetics (how the body handles the study drug) and pharmacokinetics (interaction of the study drug with the body) for subjects…

The efficacy of the walk-bike on quality of life and exercise capacity in patients with idiopathic pulmonary fibrosis: a pilot study.

Primary objective• To assess the effect of use of a walk-bike in IPF patients for 8 weeks on health-related quality of life, measured with the St. George Respiratory Questionnaire, at baseline, week 9 and week 18, in patients with IPF.Secondary…

Effect of renal denervation on Muscle Sympathetic Nerve Activity in patients with uncontrolled hypertension

The goal of this study (mono-center study) is to study the effect of renal denervation with the EnligHTN Renal Denervation System on sympathetic nerve activity.