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NCT ID: NCT01879553 Completed - Human Influenza Clinical Trials

Safety and Immunogenicity of a Subunit Trivalent Influenza Vaccine, Northern Hemisphere Formulation 2013/2014, in Healthy Adults Aged 18 Years and Above

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

The present study is designed to confirm the safety and immunogenicity of trivalent, surface antigen, inactivated influenza vaccine in 2 age cohorts: 18 to ≤60 years and ≥61 years. For the immunogenicity endpoint the antibody response to each influenza vaccine antigen will be evaluated by means of Single Radial Hemolysis (SRH) or Hemagglutination Inhibition (HI) at approximately 21 days post vaccination. The vaccine composition will be based on the WHO-recommended influenza strains for the 2013/2014 Northern Hemisphere vaccine, and the results of this study are intended to support the use of this vaccine in future influenza seasons if the recommended vaccine composition remains the same, in compliance with the requirements of the current European Union (EU) recommendations for clinical trials related to yearly licensing of influenza vaccines.

NCT ID: NCT01879540 Completed - Human Influenza Clinical Trials

Safety and Immunogenicity of a Subunit Trivalent Influenza Vaccine, Northern Hemisphere Formulation 2013/2014, Including MF59C.1 Adjuvant, in Healthy Adults ≥65 Years of Age

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

The present study is designed to confirm the safety and immunogenicity of trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant, formulation 2013/2014 Northern Hemisphere, in adults ≥65 years of age. For the immunogenicity endpoints the antibody response to each influenza vaccine antigen, will be measured by means of Single Radial Hemolysis (SRH) or Hemagglutination Inhibition (HI) at approximately 21 days post immunization. The vaccine composition will be based on the World Health Organization (WHO) recommended influenza strains for 2013/2014 Northern Hemisphere. The results of this study are intended to support the use of this vaccine in future influenza seasons if the recommended vaccine composition remains the same, in compliance with the requirements of the current European Union (EU) recommendations for clinical trials related to yearly licensing of influenza vaccines.

NCT ID: NCT01879488 Completed - Clinical trials for Post-operative Neurosurgery

Effect of Ventilation Mode on Lung Deposition of a Radiolabeled Aerosol During Mechanical Ventilation: Barometric Versus Volumetric

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

Controlling the respiratory pattern of mechanically ventilated patients in volume control mode is recommended during nebulization. No studies looked into conditions of nebulization during assisted mechanical ventilation to define the optimal nebulization technique and its effect on pulmonary deposition. The aim of this study is to analyse the effect of ventilation mode (barometric versus volumetric) on deposition by planar scintigraphy during mechanical ventilation.

NCT ID: NCT01879124 Completed - Kidney Failure Clinical Trials

Resistive Index Measurements After Kidney Transplantation

Start date: March 2004
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate the prognostic performance of intrarenal resistive index in the first years after kidney transplantation on graft function and on patient and graft survival. In addition, the determinants of the intrarenal resistive index, including a detailed analysis of the relation between graft histology and the intrarenal resistive index, will be assessed.

NCT ID: NCT01878760 Completed - Children Clinical Trials

APRICOT: Anaesthesia PRactice In Children Observational Trial

APRICOT
Start date: March 2014
Phase: N/A
Study type: Observational

The aims of the APRICOT study are: - To establish the incidence of severe critical events in children undergoing anesthesia in Europe. - To describe the differences in paediatric anaesthesia practice throughout Europe. - To study the potential impact of this variability on the occurrence of severe critical events (Laryngospasm, Bronchospasm, Pulmonary aspiration, Drug error, Anaphylaxis, Cardiovascular instability, Neurological damage, Perianaesthetic cardiac arrest and postanaesthetic Stridor).

NCT ID: NCT01877668 Completed - Psoriatic Arthritis Clinical Trials

Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator Study

OPAL BROADEN
Start date: January 2014
Phase: Phase 3
Study type: Interventional

This is a 12 month study investigating the effectiveness and safety of tofactinib in treating the signs and symptoms, improving physical function and preserving bone structure in patients with active psoriatic arthritis and had inadequate response to a traditional, non-biologic disease modifying anti-rheumatic drug. Adalimumab is use as a comparator.

NCT ID: NCT01877655 Completed - Clinical trials for Cytomegalovirus (CMV)-Positive Recipients

A Study to Evaluate a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT)

HELIOS
Start date: September 11, 2013
Phase: Phase 3
Study type: Interventional

The purpose of the study was to evaluate the efficacy of ASP0113 compared with placebo as measured by a primary composite endpoint of overall mortality and CMV end organ disease (EOD) through 1 year post-transplant. Safety of ASP0113 in participants undergoing allogeneic HCT will also be evaluated.

NCT ID: NCT01877304 Completed - Healthy Subjects Clinical Trials

Effect of Drug Targeting Nebulization on Lung Deposition

Start date: June 2010
Phase: N/A
Study type: Interventional

To compare deposition between two modalities of nebulization

NCT ID: NCT01877174 Completed - Clinical trials for Internal Carotid Artery Stenosis

MICHI™ Neuroprotection System (NPS+f) Filter Debris Analysis Study (The F-1 Study)

Start date: May 2013
Phase: N/A
Study type: Observational

This study will be conducted in up to 10 hospitals in Europe, up to 75 patients will be enrolled. The purpose of the study is to evaluate any debris that may be captured in the inline filter of the MICHI(TM) Neuroprotection System with Filter (NPS+f) during its use in a transcarotid stenting procedure. The MICHI NPS+f is an embolic protection device that uses reverse flow to protect the brain during stenting of the Internal Carotid Artery. It is CE marked and is used in routine practice for the purpose of this study.

NCT ID: NCT01877005 Completed - Hodgkin's Lymphoma Clinical Trials

A Phase II Study of Oral JAK1/JAK2 Inhibitor INC424 in Adult Patients With Relapsed/Refractory Classical Hodgkin's Lymphoma

HIJAK
Start date: July 4, 2013
Phase: Phase 2
Study type: Interventional

Phase II study to assess the efficacy of 6 cycles of oral JAK1/2 inhibitor ruxolitinib in patients with advanced Hodgkin's lymphoma for whom no curative option is available.