15 results
The study is designed to compare the 24-h spirometry profile of two doses of indacaterol (150o.d. and 300 *g o.d.) with that of placebo (o.d.) and with tiotropium (18 *g o.d.) as an activecontrol in patients with COPD.
Detection of breast carcinoma with an ICG enhanced optical imaging device in breast cancer patients.
Ergonomics and function of the imaging system - the NIRF imaging system should not interfere with the standard lumpectomy procedure and used safely by the surgeon while detection of ICG within the tumour takes place. Duration: 1,5 hour clinical…
To demonstrate the superiority of indacaterol 150 µg o.d. in combination with tiotropium 18 µg o.d. versus tiotropium 18 µg o.d. with respect to standardized area under the curve (AUC) for forced expiratory volume in 1 second (FEV1) between 5 min *…
Feasibility study: The potential use of intraoperative, ICG based, fluorescence imaging of LN*s during CRC lymphadenectomy.
The purpose of this study is to evaluate the effects of QVA149 300/50, a fixed dose combination of QAB149 300µg and NVA237 50µg, versus placebo and two doses of QAB149 300µg and 600µg, in terms of lung function in patients with moderate to severe…
Prospective study: The potential use of intraoperative, ICG based, fluorescence imaging of LN's during CRC lymphadenectomy.
Primary objective: To demonstrate the superiority of QVA 110/50 µg compared to both QAB149 150 µg and NVA237 50 µg in terms of trough FEV1 (mean of 23 h 15 min and 23 h 45 min post-dose) following 26 weeks of treatment in patients with moderate to…
Primary objective: To evaluate the non-inferiority of QVA149 110/50 µg qd as compared to concurrentadministration of QAB149 150 µg qd plus NVA237 50 µg qd in terms of its effect on trough FEV1 (mean of 23 h 15 min and 23 h 45 min post-dose)…
This study is designed to demonstrate non inferiority of 150 *g o.d. of indacaterol versus tiotropium 18 *g o.d. with respect to 24 hour post dose (trough) FEV1 after 12 weeks of treatment.
To assess indacaterol (300 and 600 ug once daily via SDDPI) superiority in patients with COPD as compared to placebo with respect to 24 h post dose (through) FEV1 after 12 weeks of treatment.
The primary objective is to achieve intraoperative detection of histologically or cytologically proven GIST and metastases with ICG and NIR fluorescence imaging. The primary end-point is the diagnostic value of ICG in detecting GIST with NIR…
To evaluate the bilateral SLN detection rate of intraoperative ICG with NIR fluorescence imaging compared to the current standard of care of 99mTc (with preoperative SPECT/CT) and blue dye.
To assess safety, tolerability and pharmacokinetics of a single subcutaneous administration of HPV-NIRD1.
In this non-inferiority study, we aim to identify the diagnostic value of indocyanine green (ICG) fluorescence imaging for SLN mapping versus the standard-of-care 99mTc in the SLN procedure for breast cancer patients.
The objective of this prospective, multi-center trial is to assess the effectiveness of the Carillon Mitral Contour System in treating patients with moderate-to-severe atrial functional mitral regurgitation (aFMR).