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AN OPEN-LABEL, NON-RANDOMIZED, MULTICENTER PHASE I/II TRIAL OF RO5424802 GIVEN ORALLY TO NON - SMALL CELL LUNG CANCER PATIENTS WHO HAVE ALK MUTATION AND FAILED CRIZOTINIB TREATMENT

The primary objectives for Part 1:-To determine the recommended Phase II dose of RO5424802 to be used in Part 2 of the study-To evaluate the safety and tolerability of 600mg and 900mg doses of RO5424802 administered twice daily to subjects with…

Treatment of severe acute GVHD after allogeneic hematopoietic stem cell transplantation with steroids versus MSC and steroids.
A prospective double-blind placebo-controlled randomized phase III trial

To improve the response rate to treatment of severe acute GVHD (grade II-IV with gut involvement ) by adding infusion of Mesenchymal Stroma Cells to standard high dose prednisolone.

Laser therapy for onychomycosis in patients with diabetes at risk for diabetic foot complications
A randomized, double blind controlled trial.

To determine the efficacy and safety of laser therapy in diabetes patients with risk factors for developing diabetic foot complications.

THE EFFECT OF EXTERNAL LEG COMPRESSION ON THE REDUCTION OF FLUID DEMAND IN MECHANICALLY VENTILATED PATIENTS WITH SEVERE SEPSIS OR SEPTIC SHOCK

To study the effect of ELC during mechanical ventilation (MV) on fluid balance in severe sepsis or septic shock.

The ORANGE II PLUS - Trial: An international multicentre randomized controlled trial of open versus laparoscopic liver surgery (hemihepatectomy and postero-superior liver segment resection).

Hypotheses: - For patients undergoing a laparoscopic left or right hemihepatectomy (with or without the need for one additional hepatic wedge resection or metastasectomy), time to functional recovery is reduced by 2 days in comparison with patients…

Lowering infliximab dose in IBD patients in remission, based on infliximab trough levels: the study on Lowering Infliximab in IBD patients in sustained Remission, the LIR study

To assess the number of patients in remission, 12 months after dose adjustment of IFX from 5mg/kg to 3 mg/kg. Secondary objectives include: number of relapses, defined by increase of fecal calprotectin and/or CRP and clinical activity, subsequently…

An integrated approach to sleep improvement

Primary objectives:* To evaluate the relative effectiveness of web-based CBT-I and three different types of CT (light, temperature and physical activity) and their interaction as compared to placebo treatment. * To evaluate whether different…

Joint distraction for thumb base osteoarthritis

To evaluate the effect of CMC1 joint distraction in patients with failed conservative treatment of Eaton Littler grade II or III CMC osteoarthritis. The hypothesis is that results will mirror those in knee and ankle joint distraction, yielding…

A Randomized, Controlled Phase 2 Study Evaluating LY2875358 plus Erlotinib versus Erlotinib as First-Line Treatment in Metastatic Non-Small Cell Lung Cancer Patients with Activating EGFR Mutations Who Have Disease Control after an 8-Week Lead-In Treatment with Erlotinib

The primary objective of this study is to compare PFS with LY2875358 plus erlotinib therapy with erlotinibmonotherapy as first-line treatment in metastatic NSCLC patients with activating EGFR mutations who havedisease control after an 8-week lead-in…

A phase II multicenter, single-arm study of MPDL3280A in patients with PD-L1 positive locally advanced or metastatic non small cell lunch cancer

The primary efficacy objective for this study is to evaluate the efficacy of MPDL3280Ain patients with PD-L1*positive locally advanced or metastatic NSCLC, as measuredby investigator-assessed ORR according to modified RECIST.SECONDARY OBJECTIVESThe…

A Randomized, Open-label Phase 3 Study of Carfilzomib, Melphalan, and Prednisone versus Bortezomib, Melphalan, and Prednisone in Transplant ineligible Patients with Newly Diagnosed Multiple Myeloma

Primary Objective:To compare the progression-free survival (PFS) of transplant-ineligible subjects with newly diagnosed multiple myeloma who are treated withcarfilzomib, melphalan, and prednisone (CMP) versus those treated with bortezomib (Velcade…

Optimizing neoadjuvant systemic treatment in HER2 positive breast cancer - the TRAIN-2 study

To compare the efficacy of six cycles neoadjuvant PTC plus pertuzumab preceded by either three cycles of FEC-T plus pertuzumab or three cycles of PTC plus pertuzumab in HER2 positive breast cancerSecondary objectives• To describe the safety of the…

Investigating the role of rTMS in the treatment of chronic depression

(1) To investigate the effect of rTMS in a treatment set-up of 4 weeks including sham-rTMSas a control in 2 x 50 patients who have had at least two prior antidepressant therapies and psychotherapy according to the Dutch guideline of depression.(2)…

Intra-subject variability in pain scoring and the consequences for analgesia treatment

In the current study we want to further explore the predictability of pre-treatment pain variability on the probability to experience pain relief. Knowledge on the understanding of individual differences in analgesic properties of a drug is of…

PROMOTION-trial: A PROspective randomized Multicenter trial for the treatment of dislocated 3- and 4-part proximal humerus fractures: Open reduction and internal plate fixaTION versus intramedullary nailing.

Goal of this trial is to point out the surgical intervention with the best functional outcome.

A Phase I open-label dose escalation study with expansion to assess the safety and tolerability of INC280 in patients with c-MET dependent advanced solid tumors

Primary objective: To determine the MTD/highest studied dose determined to be safe, the safety and tolerability of INC280 as a single agent when administered orally to adult patients with c-MET dependent advanced solid malignancies.Secondary…

ENGOT-ov11/MILO study (MEK Inhibitor in Low-grade Serous Ovarian Cancer):
A Multinational, Randomized, Open-label Phase 3 Study of MEK162 vs. Physician*s Choice Chemotherapy in Patients with Recurrent or Persistent Low-grade Serous Carcinomas of the Ovary, Fallopian Tube or Primary Peritoneum

Primary: • Demonstrate superior efficacy (increased progression-free survival [PFS]) of MEK162 vs. physician*s choice of selected chemotherapies (liposomal doxorubicin, paclitaxel and topotecan)Key Secondary: • Demonstrate superior efficacy (…

Irreversible Electroporation for treatment of unresectable, locally advanced pancreatic cancer in the Leiden University Medical Centre: a phase I/II study.

Main objectiveTo investigate feasibility and safety of tumor ablation using IRE in patients with irresectable locally advanced pancreatic head carcinomas.Secondary objective(s)To investigate tumor downstaging efficacy, pain perception and hospital…

Use of individual PK-guided pazopanib dosing: A feasibility study in patients with advanced solid tumors

primary• To determine the safety and feasibility of PK guided dosing of pazopanib secondary• Evaluation of the dried blood spot procedure• To determine the objective response rate (according RECIST 1.1)• To determine the time to tumor progression…

Tolerability and physiological effects of elevated inspired carbon dioxide (CO2) concentrations in human volunteers

Measuring the effects of CO2 inhalation (6, 8 and 10%) on the body: EEG, heart rate, blood pressure, cardiac output, ECG, oxygen content in the brain, sedation, cognition, nausea.Amendment:Measuring the effects of CO2 inhalation (10% and 12%) on the…