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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…

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…

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.

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 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…

Randomized, open label, multicenter phase III study of Efficacy and Safety in POlycythemia vera subjects who are resistant to or intolerant of hydroxyurea: JAK iNhibitor INC424 tablets verSus bEst available care

Earlier research nas shown the emerging efficacy and safety profile for INC424, which supports further studies in PV subjects who demonstrate resistance or intolerance to HU therapy [Barosi et al.2009]. This pivotal phase III trial (CINC424B2301) is…

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

The primary objectives are:- To evaluate the efficacy of IV induction regimens of ustekinumab in inducing clinical response in subjects with moderately to severely active Crohn*s disease.- To evaluate the safety of IV induction regimens of…

An open-label, randomized, Phase IIIb trial evaluating the efficacy and safety of standard of care +/- continuous bevacizumab treatment beyond progression of disease (PD) in patients with advanced non-squamous non-small cell lung cancer (NSCLC) after first (1st)-line treatment with bevacizumab plus a platinum doublet-containing chemotherapy

The main aim of this study is to find out if the continuation of bevacizumab, in addition to standard 2nd & 3rd -line treatment, can help patients with NSCLC that has progressed to live longer. The study also aims to find out if continued…

Optimisation of cost effectiveness through Individualised FSH Stimulation dosages for IVF Treatment: The OPTIMIST trial.

To evaluate whether in an IVF program routine application of an ORT and a subsequent individualised FSH regimen is cost-effective compared to a standard dose regimen.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis, With optional Open-label Extension

Part 1:The primary objective of the study is to investigate whether treatment with natalizumab slows the accumulation of disability not related to relapses in subjects with SPMS. The secondary objectives of this study are to determine in this study…

Early Beta blocker Administration before reperfusion in patients with ST-Elevation Myocardial Infarction who are planned to undergo primary PCI

The primary objective of this randomized trial is to assess the beneficial effects of early administration of 5 mg Metoprolol intravenously before reperfusion on infarct size in patients with ST elevation myocardial infarction who are planned to…

Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial.

Primary objectives:The primary objectives of this trial are:• To show PK similarity of BI 695500 to MabThera® and Rituxan® and of Rituxan® to MabThera® (three-way PK similarity).• To establish statistical equivalence of efficacy of BI 695500 and…

A phase III randomized study of preoperative radiotherapy plus surgery versus surgery alone for patients with retroperitoneal sarcoma (RPS)

To assess whether preoperative radiotherapy, as an adjunct to curative-intent surgery, improves the abdominal local recurrence-free survival.

A prospective, multicenter, randomized, open-label, active-controlled, phase III study to compare efficacy and safety of masitinib to imatinib at 400 or 600 mg in treatment of patients with gastro-intestinal stromal tumour in first line medical treatment

Safety and efficacy objectives:The objective is to compare the safety and efficacy of masitinib at 6 of 7.5 mg/kg/day to imatinib at 400 or 600 mg, in patients with gastro-intestinal stromal tumour in first line medical treatment.

A Randomized, Controlled, Double-Blind Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of GP2013 plus CVP vs. MabThera® plus Cyclophosphamide,
Vincristine, Prednisone vs. MabThera® plus Cyclophosphamide, Vincristine, Prednisone, followed by GP2013 or MabThera® Maintenance Therapy in Patients with Previously Untreated, Advanced Stage Follicular Lymphoma

*To demonstrate comparability of the ORR in patients with previously untreated, advanced stage FL who receive GP2013-CVP combination treatment to patients who receive MabThera®-CVP treatment. ORR will be determined during the combination treatment…

A prospective randomised Rontgen Stereophotogrammatic Analysis (RSA) study using the uncemented Trident Tritanium acetabular component and the uncemented HA coated Symax hip stem in a single centre.
Assessment of implant migration, bone remodeling and clinical function.

The goal of this clinical investigation is to assess the early migration and bone remodeling of the Symax hip stem and the Trident HA coated or Trident Tritanium acetabulum component with RSA and 18-F PET CT Also the sensitivity of the RSA…

Left Ventricular Thrombus Formation after Acute Myocardial Infarction - a randomized multi-center trial comparing 2 different anti-thrombotic regimens

The objective of this study is to determine in a randomized fashion the risks as well as the benefits of the addition of vitamin K antagonists to dual anti-platelet therapy in patients with PCI-treated STEMI and LV thrombus formation

Dorsal spondylodesis in adolescent idiopathic scoliosis: proximal fixation with screws versus claw construct

The main objective is to compare the coronal Cobb angle correction of proximal hook claw fixation versus proximal pedicle screw fixation after two years of follow-up. The secondary objectives of the study are: comparison of coronal Cobb angle…

A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM
SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN*S DISEASE (OPERA II)

The primary objective of this study is to monitor the safety and tolerability of PF 00547659 during long term treatment. Secondary objectives: * The secondary objective is to assess pharmacokinetics and immunogenicity of PF 00547659.* Exploratory…