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An open-label phase 2A study to investigate drug-drug interactions between AT1001 (migalastat hydrochloride) and agalsidase in subjects with Fabry disease.

The primary objectives of this study are: * To characterize the effects of 150 mg and 450 mg of AT1001 administered 2 hours before administration of agalsidase on the safety and plasma pharmacokinetics of agalsidase in subjects with Fabry Disease*…

Pilot study on effectiveness and safety of Shape Memory Scoliosis Correction Instrument

Primary Objectives:• show effectiveness of the SMSC instrument in 3D correction of the spine prior to placement of the implants.The hypothesis is that to achieve de-rotation of the spine without failure of the pedicle screws, de-rotation has to be…

An Open-Label Study to Evaluate the Effects of Repeated Treatments of Oral QLT091001 on Safety and Vision Outcome in Subjects with Leber Congenital Amaurosis (LCA) or Retinitis Pigmentosa (RP) Due to Inherited Deficiencies of Retinal Pigment Epithelial 65 Protein (RPE65) or Lecithin:Retinol Acyltransferase (LRAT) (Extension of Study RET IRD 01)

• To evaluate the safety of up to 3 additional courses of oral QLT091001 administered once daily for 7 days in subjects with LCA or RP caused by RPE65 or LRAT gene mutations who have been treated previously with a single 7-day course of QLT091001 in…

Dose-escalation by boosting radiation dose within the primary tumor on the basis of a pre-treatment FDG-PET-CT scan in stage IB, II and III NSCLC: A randomized phase II trial

The primary objective of this study is to determine the freedom from local failure in patients alive at 1 year

Long Term Observational Study Of The Safety And Efficacy Of An Active Implantable Vagal Nerve Stimulation Device In Patients With Rheumatoid Arthritis

Primary Efficacy ObjectiveThe primary efficacy objective is to determine the long term efficacy of vagal nerve stimulation as assessed by the DAS28 score.Secondary Efficacy ObjectivesThe secondary efficacy objectives are to determine the long term…

Staging laparoscopy combined with ultrasonography and near-infrared fluorescence imaging to detect occult pancreatic metastases

The main objective of this study is to determine the added value of NIR fluorescence imaging in patients with pancreatic cancer undergoing SL and to identify predictors for patients that may benefit from SL.

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…

A B2-agonist as a CFTR activator in CF - Part 2

Primary objective of this study is to evaluate the clinical effect of a long term treatment (8 weeks) with oral B2-agonists in CF patients with residual CFTR function, especially on lung function (spirometry and airway resistance). Secondary…

Prospective evaluation of the predictive value of a circulating tumor cell (CTC) sensitivity profile to Cisplatin chemotherapy in metastatic breast cancer patients

The aim of this study is to prospectively explore the predictive value of a cDDP-sensitivity profile determined in CTCs of metastatic BC patients previously treated with at least antracycline- and taxane-based chemotherapy.

Internet-delivered cognitive behavioral therapy for posttraumatic stress disorder in humanitarian aid workers: a pilot study

Primary objectives: 1. To translate and adapt the iCBT program TELLUS for use in IFRC humanitarian aid workers2. To determine feasibility of TELLUS in terms of: completion rates and self-reported treatment credibility/ expectancySecondary objective:…

MagSNOLL: Magnetic Sentinel Node and Occult Lesion Localisation: A feasibility study using magnetic nano particles for sentinel node biopsy and localization of occult breast cancers.

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, wire localization).The…

A comprehensive and targeted therapy approach in pediatric malignant pontine gliomas

Phase A:Primary objective: Determining the feasibility of gemcitabine as a radiosensitizer in DIPG Secondary objective: Evaluation of efficacy in terms of clinical and radiological response rate and progression free survivalTertiary objectives:…

A phase II study of ARA 290 as therapeutic strategy in rheumatoid arthritis

This is an open label proof of principle study, in 14 patients. The objective of the study is to test the efficacy and safety of ARA 290 in patients with active rheumatoid arthritis. To assess the efficacy, disease activity is examined based on…

Pilot study of everolimus in the treatment of advanced malignancies in patients with Peutz-Jeghers syndrome

To determine the efficacy (as measured by objective tumor response) of single agent everolimus in the treatment of advanced malignancies or high risk polyps of patients known with PJS .

An open-label non-randomized extension study to evaluate the safety and tolerability of AIN457 (anti interleukin-17 monoclonal antibody) in patients with moderate to severe ankylosing spondylitis

This study is designed as an extension study to the proof-of-concept trial CAIN457A2209 in patients with ankylosing spondylitis and aims to provide continuous treatment with AIN457 for patients in the core trial, to obtain safety and tolerability…

An open-label, multicenter phase II study to compare the efficacy and safety of RAD001 as first-line followed by second-line sunitinib versus sunitinib as first-line followed by second-line RAD001 in the treatment of patients with metastatic renal cell carcinoma

To evaluate the probability that the progression free survival (PFS) in the first-line treatment with RAD001 is non-inferior to the first-line treatment with sunitinib for patients with metastatic renal cell carcinoma (primary objective).…

A Long-term Assessment of Safety and Efficacy of AMG 827 Treatment in Subjects With Crohn's Disease

1.1 Safety To evaluate the safety of long-term exposure with AMG 827 in subjects with Crohn*s disease 1.2 Efficacy * To evaluate the efficacy of AMG 827 as measured by the Harvey-Bradshaw Index (HBI) and the Crohn*s Disease Activity Index (CDAI)* To…

Feasibility Study of the PneumRx, Inc. Lung Volume Reduction Coil for the Treatment of Emphysema

To evaluate the safety and effecacy of the Lung Volume Reduction Coil to improve QOL pulmonary function for emphysema subjects with severe hyperinflation.

Phase II study on the feasibility and efficacy of consolidation with 90Y-ibritumomab tiuxetan in patients with relapsed or refractory aggressive B-cell non-Hodgkin*s lymphoma having achieved partial or complete remission after induction with R-PECC chemotherapy.

To assess the feasibility and efficacy of 90Y-ibritumomab tiuxetan consolidation treatment after R-PECC chemotherapy as second or third line treatment in patients with refractory or relapsed aggressive B-cell NHL, after or not eligible for…

Shockwave treatment for advanced angina in Maastricht (SWAAM). A double blind randomised study.

Goal of the project is to implement the shockwave therapy for no-option CAD patients and to evaluate its potential benefit on regional myocardial perfusion, on regional myocardial function and on the potential improvement in symptoms and quality of…