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NCT ID: NCT02263144 Recruiting - Adenomatous Polyps Clinical Trials

Resect and Discard Extension to FICE of NIcE Classification

FICE;NICE
Start date: May 2014
Phase: N/A
Study type: Observational

The purpose of this prospective, non-interventional study is to validate the Narrow Band Imaging International Colorectal Endoscopic (NICE) classification for differentiating subcentimetric hyperplastic and adenomatous polyps by using Fuji Intelligent Color Enhancement (FICE) technology with high-definition without optical magnification.

NCT ID: NCT02260102 Recruiting - Infection Clinical Trials

Temocillin Pharmacokinetics in Paediatrics

TEMOPEDI
Start date: February 17, 2016
Phase: Phase 4
Study type: Interventional

Temocillin (6-methoxy-ticarcillin) is a beta-lactam antibiotic with exceptional resistance to most beta-lactamases. In this context, it is now increasingly used as carbapenem-sparing antibiotic in patients with suspected infection by Enterobactreriaceae suspected to produce extended-spectrum beta-lactamases. Little is known about dosing and elimination of temocillin in children. While available literature of temocillin use in paediatrics refers mainly to its clinical efficacy in the treatment of urinary tract infections, the drug is also used for the treatment of suspicion of cholangitis in cirrhotic paediatric patients, and as antibiotic prophylaxis following an hepatic transplant in children (both off-label indications). There is, therefore, a pressing need to explore the pharmacokinetics and pharmacodynamics of temocillin in the paediatric population, in order to provide clear guidance on an appropriate dosing regimen. The study objectives are: (1) characterisation of the pharmacokinetics (PK) of temocillin in 3 paediatric populations, (2) proposal and development of a dosing schedule that can ensure therapeutic concentrations (40% ƒT > MIC) and optimize treatment chances of success, and (3) characterization of MICs of microbiological strains (when available) to temocillin.

NCT ID: NCT02253290 Recruiting - Clinical trials for Neuromuscular Diseases

Neuropsychological and Psychosocial Follow up of Children and Adolescents With Neuromuscular Disease

Start date: December 2014
Phase:
Study type: Observational [Patient Registry]

This project is a retrospective and prospective investigation of neuropsychological and psychosocial development of children with a neuromuscular disease.

NCT ID: NCT02240576 Recruiting - Nasal Fracture Clinical Trials

Possible Manifestation of Rhinitis After Nasal Fracture

Start date: December 2014
Phase: N/A
Study type: Observational

We would like to investigate our hypothesis of a higher prevalence of nasal fracture in the history of idiopathic rhinitis (IR) patients compared to healthy controls. Therefore a retrospective analysis of 310 patients with a nasal fracture in the past would be useful to investigate the incidence of IR in this cohort afterwards (5-10 y later).

NCT ID: NCT02238353 Recruiting - Allergic Rhinitis Clinical Trials

AZELASTINE/FLUTICASONE (AZE/FLU) Nasal Spray on Symptom Control, Nasal Mediators and Nasal Hyperresponsiveness in Allergic Rhinitis (AR)

Start date: October 2014
Phase: Phase 4
Study type: Interventional

Comparative analysis of the efficacy of intranasal MP29-02 (a novel formulation of azelastine and FP) has already been conducted in patients with moderate-to-severe seasonal AR. The combination formulation appeared to be superior in these patients with better symptomatic relief. However, objective analysis of the effect of this treatment on nasal mediators and/or nasal hyperreactivity has not yet been performed and would help in understanding the additional benefit of the combination treatment over monotherapy with nasal corticosteroids.

NCT ID: NCT02235129 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Six Minute Walking Test and Breath-holding

Start date: September 2014
Phase: N/A
Study type: Interventional

To compare the relationship between breath-hold time and the distance in a Six Minute Walking Test in chronic obstructive pulmonary disease population.

NCT ID: NCT02234804 Recruiting - Coronary Disease Clinical Trials

The Does Optical Coherence Tomography Optimize Revascularization (DOCTOR) Recross Study

DOCTOR Recross
Start date: July 2013
Phase: N/A
Study type: Interventional

Prospective, controlled, double randomized, non-blinded, multicenter, investigator initiated, academic superiority trial comparing optical coherence tomography (OCT) guided vs. angiography guided wire recrossing in jailed side branches (SB) (1. randomization 1:1)(superiority) and comparing Medtronic Resolute Integrity and Xience Prime for stent strut apposition in the SB ostium (2. randomization 1:1) (superiority). Acute primary endpoint and 30 days clinical follow-up. Hypothesis: OCT guided wire recrossing in bifurcation stenting results in less malapposed struts in the segment facing the SB ostium. Secondary hypothesis: Treatment by Medtronic Resolute Integrity stent results in less malapposed struts at the bifurcation segment compared to treatment by the Abbott Xience Prime stent.

NCT ID: NCT02228356 Recruiting - Neoplasm Metastasis Clinical Trials

Non-interventional Observational Study of Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Cancer

Start date: June 2012
Phase: N/A
Study type: Observational

The investigators recently published 2 phase II trials on the use of helical tomotherapy for oligometastatic colorectal cancer [1,2]. Despite a dose increase from 40 to 50 Gy, delivered in 2 weeks time, the one-year local control was 54% only [1,2]. The high local failure rate is probably the result of geographical misses due to tumor motion and a biologically effective dose (BED) of < 100 Gy. The current study will investigate whether the one-year local control rate can be improved to 70%, using respiration correlated CT to individualize the margin needed to account for tumor motion, to avoid geographical miss, together with a Monte Carlo or collapsed cone dose calculation algorithm delivering 50 Gy to the 80% isodose, allowing higher doses in the tumor core. As the concept of an internal target volume (ITV) may result in large margins for patients displaying metastases in high mobile organs, such as liver and lung, which may lead to exposure of a relatively high dose to a large volume of normal tissue, dynamic tumor tracking by the VERO SBRT system will be applied in those patients.

NCT ID: NCT02227251 Recruiting - Clinical trials for Diffuse Large B-cell Lymphoma

Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Start date: November 2014
Phase: Phase 2
Study type: Interventional

A multicenter, open-label Phase 2b study of selinexor (KPT-330) in participants with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have no therapeutic options of demonstrated clinical benefit.

NCT ID: NCT02224547 Recruiting - Clinical trials for Non-Small Cell Lung Carcinoma

Risk-adapted Stereotactic Body Radiotherapy for Early Non-Small Cell Lung Cancer Using the VERO Stereotactic Body Radio Therapy System

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

The purpose of this study is to perform prospective data analysis on tumor response in terms of local tumor control after 2 years, potential acute and late toxicity and survival in patients with non-metastatic, non-small-cell lung cancer treated by radiotherapy that are medically inoperable due to coexisting comorbidities or that refuse surgery. SBRT regimens used will be 4 fractions of 12 Gy or 3 fractions of 17 Gy depending on tumor location in a risk-adapted approach.