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NCT ID: NCT01054417 Completed - Appendicitis Clinical Trials

APPEndicitis and Laparoscopic Criteria; APPEL Study

APPEL
Start date: December 2009
Phase: N/A
Study type: Observational

A diagnostic laparoscopy is frequently used to confirm the diagnosis of appendicitis. However, laparoscopic criteria for determining appendicitis are not defined. If there is any doubt about the presence of an abnormal appendix, it is usually removed. However, an appendectomy of a negative appendix has a certain morbidity and for that reason it should be avoided. The purpose of this study is to establish laparoscopic criteria for the diagnosis appendicitis during diagnostic laparoscopy.

NCT ID: NCT01054170 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Effect on Structural Changes in Airways, Measured by MSCT, of Twice Daily 60mg AZD9668 for 12 Weeks in Chronic Obstructive Pulmonary Disease (COPD) Patients

Start date: January 2010
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to evaluate structural changes effected by AD9668 in the airways of adults with Chronic Obstructive Pulmonary Disease (COPD) by Multi-Slice Computed Tomography (MSCT)

NCT ID: NCT01053611 Completed - Sedation During Clinical Trials

Composite Variability Index Versus Bispectral Index (BIS)

Start date: September 2009
Phase: N/A
Study type: Interventional

The aim of this study is to compare the accuracy of the changes in CVI in response to a standardized noxious stimulus during various targeted pseudo-steady-state concentrations of remifentanil and various steady state level of BIS as guided by propofol effect compartment controlled TCI (closed-loop).

NCT ID: NCT01052506 Completed - Healthy Clinical Trials

BIIB033 Single Ascending Dose Study in Healthy Volunteer Subjects

Start date: January 2010
Phase: Phase 1
Study type: Interventional

The primary objective of the study is to evaluate the safety and tolerability of single dose of BIIB033 administered to healthy adult volunteers.

NCT ID: NCT01051752 Completed - Clinical trials for Nontuberculous Mycobacterial Diseases

PK and PD of Drugs for Nontuberculous Mycobacterial Diseases in Dutch Patients

NTM
Start date: January 2010
Phase: N/A
Study type: Observational

A prospective observational study in which pharmacokinetic and pharmacodynamic parameters are evaluated in a cohort of patients with NTM diseases.

NCT ID: NCT01051622 Completed - Crohn's Disease Clinical Trials

PBMC (Peripheral Blood Mononuclear Cells) /Lymphocyte SPECT (Single Photon Emission Computerized Tomography) Imaging in Crohn's Disease

Start date: January 2010
Phase: Phase 1
Study type: Interventional

Using scintigraphic imaging including planar scintigraphy and SPECT, this study will evaluate the utility of two different ex vivo 99mTc-HMPAO labelled mononuclear cell populations in order to select the optimal methodology (using PBMC or purified lymphocyte subpopulations) for future drug intervention studies in Crohn's disease. Two parallel exploratory approaches will be investigated to enrich for lymphocyte populations expressing leukocyte trafficking inhibitors. In the first, whole blood will be fractionated on a ficoll gradient to purify a heterogeneous population of all the peripheral blood mononuclear cells (PBMC) for labelling. Secondly, further enrichment will be attempted using depletion of PBMC fractions of monocytes and B cells.

NCT ID: NCT01051518 Completed - Clinical trials for Aortic Valve Stenosis

Clinical Evaluation of Percutaneous Implantation of the Medtronic CoreValve Aortic Valve Prosthesis (18Fr-Study)

Start date: May 2006
Phase: N/A
Study type: Interventional

The investigation concerns a prospective, multicenter, single arm safety and performance study evaluating the Medtronic CoreValve system. Approximately 120 patients presenting with symptomatic aortic native valve stenosis necessitating valve replacement which are considered poor surgical candidates, with a high surgical risk, as attested to by both the surgeon and the cardiologist are recruited in the study. Safety and performance will be evaluated at discharge and at 30 days post-procedure. Valve performance and placement will be followed up at 3 and 6 months post-procedure. Further long-term patient follow-up visits will be performed at 12, 24, 36 and 48 months post-procedure.

NCT ID: NCT01051310 Completed - Clinical trials for Aortic Valve Stenosis

Medtronic CoreValve REDO Study

REDO
Start date: June 2008
Phase: N/A
Study type: Interventional

The proposed investigation is a prospective, multicenter, non-randomized study to evaluate the immediate benefits (at discharge and at 30 days) in terms of performance and safety of the implantation of the Medtronic CoreValve PAV in a failing aortic bioprosthesis. In addition, the study aims to evaluate the performance and the safety of the implantation of the Medtronic CoreValve PAV in a failing aortic bioprosthesis at subsequent annual follow-ups out to 48 months post procedure. These objectives will be achieved through the following endpoints: - Primary safety endpoint - Composite of Major Adverse Events - Primary performance endpoint - Technical and procedural success at discharge Patient Population: Eligible subjects will be at least 75 years old, presenting with a failing aortic bioprosthesis (stenotic, incompetent or mixed) including homograft or stented or stentless heterograft, considered poor surgical candidates and necessitating repeat aortic valve replacement. Up to 20 patients will be included in up to four hospitals.

NCT ID: NCT01050582 Completed - Schizophrenia Clinical Trials

A Study to Evaluate the Safety and the Effects of Risperidone Compared With Other Atypical Antipsychotic Drugs on the Growth and Sexual Maturation in Children

Start date: October 2009
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the effects of risperidone compared with other atypical antipsychotic drugs on the physical maturity, growth and development of children, and the risk of prolactin-related adverse events (side effects) associated to these drugs.

NCT ID: NCT01050309 Completed - Pharmacokinetics Clinical Trials

An Open-label, Single-dose, Three Period Study to Determine the Pharmacokinetic Parameters of Hexaminolevulinate (HAL) Hydrochloride After Vaginal, Enema and Intravenous Administration of Healthy Female Volunteers

Start date: November 2009
Phase: Phase 1
Study type: Interventional

The study will determine the extent of systemic absorption of HAL following vaginal and enema administration compared to intravenous administration to healthy female volunteers. In addition, the pharmacokinetic parameters for the combined level of 14C labelled substances (sum of parent and possible metabolites)will be assessed. The safety and tolerability of HAL following vaginal, enema and intravenous administration to healthy female volunteers will be investigated.