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NCT ID: NCT01229371 Completed - Influenza Clinical Trials

Immunogenicity and Safety Study to Assess Influenza Vaccine Formulated With Haemagglutinin (HA) Antigen From Two Suppliers

Start date: October 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the humoral immune response and safety of the parenteral formulation of the 2010/2011-season virosomal subunit influenza vaccine Inflexal V using two different HA antigen suppliers (AdImmune and CSL), in groups of young and elderly adults, using the EMA (European Medicines Agency) regulation as a guideline.

NCT ID: NCT01228812 Completed - Clinical trials for Rheumatoid Arthritis

Physical Activity Behavior of Rheumatoid Arthritis Patients and Healthy Controls

Start date: April 2010
Phase:
Study type: Observational

The purpose of the study is to compare physical activity behaviour of rheumatoid arthritis patients with healthy matched controls.

NCT ID: NCT01228721 Terminated - Glaucoma Clinical Trials

Reproducibility of Retinal Nerve Fiber Layer Thickness Measurements Using the Eye Tracker and Retest Function of Spectralis® SD-OCT in Glaucomatous Eyes and Healthy Controls

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

PURPOSE. To evaluate the impact of self-acting eyetracking and retest software on the reproducibility of retinal nerve fiber layer (RNFL) thickness measurements in glaucoma patients and healthy control subjects using Spectralis® SD-OCT. METHODS. RNFL thickness was measured in 56 normal and 47 glaucomatous eyes by one operator within one session with a brief rest between measurements. Three measurements were taken with the eye-tracker and retest function, and three were taken without this function, alternating between measurement methods. - Trial with medical device

NCT ID: NCT01228669 Completed - Healthy Clinical Trials

Safety of NNC 0172-0000-2021 in Healthy Male Subjects and Subjects With Haemophilia A or B

Explorer 1
Start date: October 25, 2010
Phase: Phase 1
Study type: Interventional

This trial is conducted in Europe and Asia. The aim of this clinical trial is to investigate the safety, pharmacokinetics (how the trial drug is distributed in the body) and pharmacodynamics (physiological effects of the drug on the body) of NNC 0172-0000-2021 administered intravenously and subcutaneously to healthy male subjects and subjects with haemophilia A or B

NCT ID: NCT01224886 Recruiting - Obesity Clinical Trials

Age and Insulin Resistance

AGIR
Start date: October 2010
Phase: N/A
Study type: Interventional

Insulin resistance is a crucial factor for the development of type 2 diabetes and a major health problem for older adults. It is the principal mechanism by which obesity is considered to increase the risk for type 2 diabetes and is a key feature of the metabolic syndrome. The elevated prevalence of obesity and type 2 diabetes in the older population has important consequences on the morbidity and mortality as well as on the economic burden on society. Controversy currently exists as to whether or not aging contributes to insulin resistance. Many potential factors confound the association between aging and insulin resistance, including obesity and physical inactivity. Ectopic lipid depositions, defined as an excess accumulation of triglycerides in non adipose tissues such as in the liver (intrahepatic lipids) and within the muscle fibers (intramyocellular lipids), are positively associated with obesity and insulin resistance. Furthermore, the accumulation of intracellular lipids is often cited as being a key determinant in the underlying mechanisms of insulin resistance. In addition of playing an important role in obesity and type 2 diabetes, these ectopic fat depositions are also observed in common conditions such as aging and physical inactivity. The intervention trial will test in skeletal muscle, liver and heart of sedentary obese volunteers, normal weight volunteers and masters athletes, the overall hypotheses that exercise improvement of fat oxidation capacity and/or decrease of damaging fat metabolites is a primary factor that predicts the improvement in insulin resistance.

NCT ID: NCT01224314 Completed - Haemodialysis Clinical Trials

Potassium in Haemodialysis Fluids and Haemodynamics

Start date: September 2007
Phase: N/A
Study type: Interventional

In a study published in 1995 in the American Journal of Kidney Diseases, Dolson et al demonstrated that a rapid decrease of serum potassium concentrations during haemodialysis would produce a significant increase in systolic blood pressure at the end of the session, even though there were no clear effects on intra-dialytic blood pressure. The authors defined this post-dialysis blood pressure behaviour as "rebound hypertension". Paradoxically, in animal models, other than in the context of end-stage renal disease, potassium is a vasodilator. Considering that the removal of potassium during the haemodialysis session could be theoretically modulated in profiles (as with sodium and bicarbonate), it was deemed suitable to delve deeper into this argument by studying, in detail, the (non invasive) hemodynamic repercussions of changes in the potassium concentration of the dialysate. Not being able to linearly modify the concentration, we decided to divide the dialysis session in 3 tertiles, randomising the patients to all possible dialysate sequences containing the usual concentration of potassium or two cut-off points at +1 and -1 mmol/l. Haemodynamic measurements were performed using a finger beat-to-beat monitor.

NCT ID: NCT01224106 Completed - Alzheimer's Disease Clinical Trials

A Study of Gantenerumab in Participants With Prodromal Alzheimer's Disease

Scarlet Road
Start date: November 30, 2010
Phase: Phase 3
Study type: Interventional

This multi-center, randomized, double-blind, placebo-controlled parallel-group study will evaluate the effect of gantenerumab (RO4909832) on cognition and functioning and the safety and pharmacokinetics in participants with prodromal Alzheimer's Disease. Participants will be randomized to receive subcutaneous (SC) injections of either gantenerumab or placebo. Participants who consent to be part of the sub study will undergo positron emission tomography (PET) scanning to assess brain amyloid. The anticipated time on study treatment is 104 weeks in Part 1, with an option for an additional up to 2 years of treatment in Part 2, followed by an open-label extension (Part 3) until July 2020. The dosing for Parts 1 and 2 was stopped after a planned futility interim analysis showed a low probability of meeting the primary outcome measure with the doses studied. The study has converted to open-label to investigate higher gantenerumab doses.

NCT ID: NCT01223027 Completed - Clinical trials for Metastatic Renal Cell Carcinoma

Study of Dovitinib Versus Sorafenib in Patients With Metastatic Renal Cell Carcinoma

Start date: March 2011
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety and efficacy of Dovitinib versus sorafenib in patients with metastatic renal cell cancer.

NCT ID: NCT01222637 Completed - Solid Tumors Clinical Trials

CetuGEX™: Phase 1 Study in Cancer Patients

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

This was a prospective, open label, multicenter study evaluating the safety, tolerability and pharmacokinetics of CetuGEX™ after intravenous administration in patients with EGFR positive, locally advanced and/or metastatic solid cancers. The effect of CetuGEX™ on the development of anti-drug antibodies and on tumour response was also evaluated.

NCT ID: NCT01222624 Completed - Solid Tumors Clinical Trials

PankoMab-GEX™: Phase 1 Dose Escalation Study

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

Prospective, open label, dose escalating, multicenter, phase I study measuring the safety, tolerability, and pharmacokinetics of PankoMab-GEX™ after intravenous administration in patients with locally advanced or metastatic solid cancers refractory to standard treatment. The effect of PankoMab-GEX™ on the development of antibodies and tumor response was also evaluated.