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NCT ID: NCT01995487 Completed - Clinical trials for Coronary Artery Stenosis

Study of BioNIR Drug Eluting Stent System in Coronary Stenosis

BIONICS
Start date: January 2014
Phase: N/A
Study type: Interventional

The BioNIR study aims to show that the BioNIR ridaforolimus eluting stent is non-inferior to the Resolute zotarolimus-eluting stent for the primary clinical endpoint of target lesion failure (TLF) at 12 months; that it is non-inferior to the Resolute for the secondary endpoint of angiographic in-stent late loss at 13 months; and that it is more cost-effective.

NCT ID: NCT01995240 Completed - Pancreatic Cancer Clinical Trials

Functional Magnetic Resonance Imaging of Pancreatic Cancer: a Feasibility and Reproducibility Study

REMP
Start date: April 2013
Phase: N/A
Study type: Interventional

Novel predictive markers are needed to determine treatment efficacy in pancreatic cancer at an early stage. Preferably, these markers could be determined non-invasively and provide insight into the biology of pancreatic cancer. Several MR techniques can serve for this purpose. However, optimalisation of these techniques is needed and their reproducibility should be assessed.

NCT ID: NCT01995084 Completed - Pancreatic Cancer Clinical Trials

In Vivo Assessment of Hypoxia in Gastro-intestinal Cancer Using 18F-HX4-PET: an Optimization and Reproducibility Study

HYPE
Start date: May 2012
Phase: N/A
Study type: Interventional

Several studies have shown that tumour hypoxia may have a negative impact on the outcome of anticancer treatment. Assessment of tumor hypoxia at baseline or shortly after start of treatment may serve as a predictive marker to determine treatment efficacy at an early stage. Preferably, such an assessment is performed in vivo and non-invasively.Non-invasive imaging with positron emission tomography (PET) using the 2-nitroimidazole nucleoside analogue, 3-18F-fluoro-2-(4-((2-nitro-1H-imidazol-1-yl)methyl)-1H-1,2,3-triazol-1- yl)propan-1-ol (18F-HX4), was tested as a new marker of tumor hypoxia. Before hypoxia-measurements can be clinically implemented for response prediction, the reproducibility of the technique should be assessed for each specific tumor type. Knowledge of reproducibility is needed to determine what change in parameters between two examinations can be considered relevant in an individual patient. Assessment of reproducibility becomes even more important in early response monitoring since the changes in the tumor induced by the treatment may be smaller during the treatment compared to response monitoring after completion of treatment. Also, as image quality of 18F-HX4-PET increases with increasing time intervals after injection, determination of the optimal time point for measurement of hypoxia is warranted.

NCT ID: NCT01994889 Completed - Clinical trials for Transthyretin (TTR) Amyloid Cardiomyopathy

Safety and Efficacy of Tafamidis in Patients With Transthyretin Cardiomyopathy

ATTR-ACT
Start date: December 9, 2013
Phase: Phase 3
Study type: Interventional

This Phase 3 study will investigate the efficacy, safety and tolerability of an oral daily dose of 20 mg or 80 mg tafamidis meglumine capsules compared to placebo in subjects with either transthyretin genetic variants or wild-type transthyretin resulting in amyloid cardiomyopathy.

NCT ID: NCT01994876 Completed - Ileostomy - Stoma Clinical Trials

Investigation of Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy

Start date: September 2012
Phase: N/A
Study type: Interventional

To investigate the performance and safety of two newly developed convex 1-piece ostomy appliances

NCT ID: NCT01994863 Terminated - Ileostomy - Stoma Clinical Trials

Safety and Performance Investigation of a New 1-piece Ostomy Product Compared to Standard of Care 1-piece in Subjects With Ileostomy

Start date: September 2012
Phase: Phase 2
Study type: Interventional

The objective of the investigation is to document New Mio 1-piece is non-inferior (no worse) in reducing leakage (4-point scale) compared to Standard of Care.

NCT ID: NCT01994616 Completed - Keloid Clinical Trials

Prospective Evaluation of the Use of Intralesional Cryotherapy for Treatment of Keloid and Hypertrophic Scars

Start date: January 2009
Phase: N/A
Study type: Observational

This prospective evaluation studies the effectiveness of IL cryotherapy in treating keloids and hypertrophic scars in a large population of mixed Fitzpatrick skin types.

NCT ID: NCT01994096 Completed - Critically Ill Clinical Trials

Optimal Dosage of Caspofungin in Critically Ill Patients

Start date: November 2013
Phase: Phase 4
Study type: Interventional

Intensive care unit (ICU) patients are especially at risk for invasive candidiasis due to the presence of risk factors. It is known that in critically ill patients, alterations in function of various organs and body systems can influence the pharmacokinetics and hence the plasma concentration of a drug. A study of caspofungin in ICU patients has found a high inter- and intra-individual variability in caspofungin concentration. Factors that caused subtherapeutic caspofungin plasma concentrations were body weight > 75 kg and hypoalbuminemia. Furthermore, an efficacy study showed a lower response rate for caspofungin among patients with a higher disease severity score. As a result of the altered pharmacokinetics, under- or over-exposure of caspofungin can occur in critically ill patients and an adjusted dosage might be necessary in these patients.

NCT ID: NCT01993459 Completed - Depression Clinical Trials

The Effects of Midazolam on the Quality of Postoperative Recovery

WOLII
Start date: February 2014
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether Midazolam given pre-operatively to patients undergoing abdominal surgery improves the quality of recovery.

NCT ID: NCT01992276 Withdrawn - Influenza Clinical Trials

Assessment of Efficacy of CR8020 and CR6261, Monoclonal Antibodies, Against Influenza Infection

Start date: December 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the rate of decline in quantitative viral load measured in hospitalized patients with Influenza A infection