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NCT ID: NCT01146652 Completed - Clinical trials for Rheumatoid Arthritis

Long Term Evaluation of Sarilumab in Rheumatoid Arthritis Patients (SARIL-RA-EXTEND)

Start date: June 21, 2010
Phase: Phase 3
Study type: Interventional

Main Study: Primary Objective: Assess the long term safety of sarilumab in participants with rheumatoid arthritis (RA). Secondary Objective: Assess the long term efficacy of sarilumab in participants with RA. Sub-Study: This phase 3, open label sub-study was aimed to assess the usability of PFS-S when used by participants with moderate or severe RA, or their professional or non-professional healthcare providers in an unsupervised real-world situation. To mimic the real-world practice, the sub-study was incorporated into the LTS11210 study without additional visits compared to the scheduled visits in the main study. The duration of this sub-study was 12 weeks.

NCT ID: NCT01146301 Completed - Carotid Stenosis Clinical Trials

Platelet Inhibition and Transcranial Doppler (TCD)-Detected Microemboli During and After Carotid Artery Stenting (CAS) in Asymptomatic Patients Prior to Cardiac Surgery

IMPACT
Start date: March 2008
Phase: Phase 4
Study type: Interventional

As with coronary artery stenting, activation and embolisation of platelets occurs with carotid artery stenting (CAS). Based on promising data on the use of clopidogrel plus aspirin in coronary stenting this dual antiplatelet regimen has been introduced as adjunctive treatment during CAS. There is as yet, however, no randomized controlled trial which compared different loading doses of clopidogrel during CAS. Taking into account that a wide interindividual variability in the response to a loading of clopidogrel exists, this study is intended to establish the optimal loading dose of clopidogrel. Therefore platelet function testing and a 1-hour of postprocedural TCD (transcranial doppler) monitoring will be performed. Objective: Firstly, to investigate whether the absolute magnitude of Platelet Inhibition inversely correlates with the number of TCD-detected microemboli during and after CAS in patients who are being pre-treated with either a 300 mg or a 600 mg loading dose of clopidogrel. Secondly, if there is any impact on early neurological outcome determined by the loading dose of clopidogrel.

NCT ID: NCT01145300 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Biomarkers in Chronic Obstructive Pulmonary Disease (COPD)

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

Chronic obstructive pulmonary disease (COPD) is one of the leading causes of morbidity and mortality worldwide and is characterized by fixed airflow obstruction. The cornerstone of the disease is chronic inflammation leading to narrowing of the small airways and thus impairment of lung function. Compared to spirometry, the single breath N2-washout-test is more sensitive to identify the regional heterogeneity of bronchial airflow obstruction in the small airways. The aim of this study is to evaluate whether there is a correlation between the sbN2-test, markers in exhaled air and the inflammatory cells in the small airways.

NCT ID: NCT01145131 Completed - Aging Clinical Trials

Dietary Interventions for Muscle Mass

Start date: May 2011
Phase: N/A
Study type: Interventional

Dietary intervention to prevent sarcopenia in elderly people. The objective of this study is to test whether meat structure plays an important role in protein digestion, to maximise the amino acid availability and to stimulate the muscle protein growth in elderly people.

NCT ID: NCT01144962 Completed - Crohn's Disease Clinical Trials

Dose-escalating Therapeutic Study of Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Fistulas in Patients With Refractory Perianal Crohn's Disease

Start date: June 2010
Phase: Phase 1/Phase 2
Study type: Interventional

In a dose escalation study we will determine the safety and preliminary efficacy of allogeneic bone marrow mesenchymal stem cells (bmMSCs) in the induction of response for active fistulizing Crohn's Disease (CD).

NCT ID: NCT01144611 Completed - Inflammation Clinical Trials

Efficacy and Safety of Bovine Intestinal Alkaline Phosphatase (bIAP) During Heart Surgery

APPIRED-II
Start date: April 2010
Phase: Phase 3
Study type: Interventional

This multi-centre prospective, randomised, double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of bovine intestinal alkaline phosphatase (bIAP) in reducing the pro-inflammatory post-surgical responses and thereby preserving organ functions in patients undergoing invasive cardiac surgery: combined aortic valve replacement and coronary artery bypass grafting.

NCT ID: NCT01144338 Completed - Clinical trials for Type 2 Diabetes Mellitus

Exenatide Study of Cardiovascular Event Lowering Trial (EXSCEL): A Trial To Evaluate Cardiovascular Outcomes After Treatment With Exenatide Once Weekly In Patients With Type 2 Diabetes Mellitus

Start date: June 18, 2010
Phase: Phase 3
Study type: Interventional

This study will compare the impact of including exenatide once weekly in addition to usual care vs. usual care without exenatide on major cardiovascular outcomes as measured by the primary composite endpoint of cardiovascular-related death, nonfatal myocardial infarction (MI), or nonfatal stroke.

NCT ID: NCT01143909 Completed - Hemorrhage Clinical Trials

Transfusion of Fresh Frozen Plasma in Non-bleeding Intensive Care Unit (ICU) Patients

TOPIC
Start date: May 2010
Phase: N/A
Study type: Interventional

With the aim to restrict inappropriate fresh frozen plasma (FFP) transfusions to critically ill patients, a randomized clinical trial will be conducted in a subgroup of intensive care (ICU) patients undergoing an invasive procedure. The objective is to assess the effectiveness and costs of omitting prophylactic FFP transfusion compared to current practice of prophylactic transfusion, in non-bleeding ICU patients with a coagulopathy.

NCT ID: NCT01143324 Completed - Clinical trials for Lumbar Spine Degeneration

A Prospective, Multicenter Observational Study on MASTâ„¢ (Minimal Access Spinal Technologies) Fusion Procedures for the Treatment of the Degenerative Lumbar Spine

MASTERS-D
Start date: June 2010
Phase:
Study type: Observational

The aim of the study is to observe and document surgical practice and evaluate patients' outcomes following a MASTâ„¢ single or double level instrumented fusion procedure using PLIF (Posterior Lumbar Interbody Fusion) or TLIF (Transforaminal Lumbar Interbody Fusion) techniques for the treatment of the degenerative lumbar spine in a "real-world" patient population.

NCT ID: NCT01143129 Completed - Atrial Fibrillation Clinical Trials

Postoperative New-onset Atrial Fibrillation in Cardiac Surgery: DECS-PNAF Project

DECS-PNAF
Start date: January 2011
Phase: Phase 4
Study type: Interventional

The DExamethasone for Cardiac Surgery - Postoperative New-onset Atrial Fibrillation (DECS-PNAF) project described in this protocol aims to elucidate how corticosteroids protect cardiac surgical patients from Postoperative New-onset Atrial Fibrillation (PNAF). Patients will be randomized to receive either a single high dose of dexamethasone or a placebo. Continuous ECG-monitoring, echocardiography and biochemical and genomic analyses will be used to investigate the mechanisms responsible for the known protective effect of corticosteroids in the development of PNAF.