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NCT ID: NCT01199627 Completed - Clinical trials for Hip Replacement, Total

Tranexamic Acid Versus Placebo for the Reduction of Blood Loss in Total Hip Replacement Surgery

TXA-CRT
Start date: March 2011
Phase: Phase 3
Study type: Interventional

The bleeding caused by hip replacement surgery (CRT) is an important source of demand for blood in the hospital. Tranexamic acid (TXA) is a drug that has proved useful in reducing bleeding associated with other surgeries and CRT results have been positive, but the variety of dosages difficult to evaluate the results To determine the efficacy and safety of TXA in reducing bleeding caused by surgery of total hip replacement. PATIENTS: Patients ASA(American Society of Anesthesiologists) I-III that they are to perform hip replacement surgery and cementless unilateral total that have signed the informed consent. Group A: 1st dose 15mg/kg of TXA in 100ml saline 0.9% after the completion of regional anesthesia, and before the start of surgery. 2nd dose: intravenous infusion over 10 minutes in 100ml of saline 0.9% at three hours after the first administration. Group B: 1st dose: 10mg/kg of TXA in 100ml 0.9% saline after the completion of regional anesthesia, and before the start of surgery. 2nd dose: intravenous infusion over 10 minutes of 10mg/kg of TXA in 100ml saline 0.9% at three hours after the first administration. Group C: 1st dose: intravenous infusion over 10 minutes in 100ml of 0.9% saline after the completion of regional anesthesia, and before the start of surgery. 2nd dose: intravenous infusion over 10 minutes in 100ml of saline 0.9% at three hours after the first administration. STATISTICAL ANALYSIS Comparison of blood loss in groups and comparison of adverse events

NCT ID: NCT01199484 Completed - Clinical trials for Food Hypersensitivity

Specific Oral Tolerance Induction to Cow's Milk Allergy

Start date: n/a
Phase: N/A
Study type: Interventional

Background: Limited published evidence shows specific oral tolerance induction (SOTI) to be a potential intervention option for cow's milk proteins (CMPs) allergy. Our hypothesis is that SOTI should be started early in order to improve its efficacy and prevent CMPs sensitization from evolving towards persistent allergy. The aim of this study was to evaluate the safety and efficacy of SOTI in 2-year-old children with cow's milk allergy, as a treatment alternative to elimination diet. Methods: A total of 60 children between 24-36 months of age with IgE-mediated allergy to CMPs were included in this multicenter study and were randomly divided into two different groups. Thirty children (group A: treatment group) began SOTI immediately, whereas the remaining 30 (group B: control group) were kept on a milk-free diet and followed-up on for one year.

NCT ID: NCT01199276 Completed - Delirium Clinical Trials

Hip Fracture Surgery in Elderly Patients

HIPELD
Start date: September 2010
Phase: Phase 2
Study type: Interventional

The objective of this study is to evaluate the incidence of Post-Operative Delirium (POD), diagnosed with the Confusion Assessment Method (CAM), in elderly patients undergoing hip fracture surgery under general anaesthesia with xenon or sevoflurane, for a period of four days post-surgery.

NCT ID: NCT01199081 Completed - Atrial Fibrillation Clinical Trials

Pharmacokinetics and Optimal Timing of Dronedarone Initiation Following Long-term Amiodarone in Patients With Paroxysmal or Persistent Atrial Fibrillation

ARTEMIS AF LT
Start date: October 2010
Phase: Phase 4
Study type: Interventional

Primary Objective: - Explore Dronedarone and active metabolite pharmacokinetic (PK) profiles according to different timings of Dronedarone initiation. Secondary Objective: - Explore potential PK interaction between Dronedarone and Amiodarone - Evaluate the rate of Atrial Fibrillation (AF) recurrence during the study period (from randomization up to 60 days after) - To assess the safety of the change from Amiodarone to Dronedarone and Dronedarone safety

NCT ID: NCT01198756 Completed - Influenza Clinical Trials

A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Children

Start date: October 1, 2010
Phase: Phase 3
Study type: Interventional

This study is designed to test the immunogenicity and safety of an investigational influenza vaccine, in children compared to two other influenza vaccines.

NCT ID: NCT01198717 Completed - Clinical trials for Essential Thrombocythemia (ET)

Pediatric Disease Registry in Essential Thrombocythaemia (ET)

Start date: September 28, 2010
Phase:
Study type: Observational

The aim of this study is to evaluate the progression of ET in children (aged 6-17years inclusive) over a period of 5 years maximum. The study will also assess how children are diagnosed, treatment options for those children with symptoms and events related to their ET and the outcomes of those treatments.

NCT ID: NCT01197846 Completed - Bipolar Disorder Clinical Trials

Efficacy of Quetiapine XR Versus Placebo as Concomitant Treatment to Mood Stabilizers in the Control of Subsyndromal Symptoms of Bipolar Disorder

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

Pilot multicentric, prospective, placebo controlled, randomized double blinded, study of 12 weeks follow-up Adult patients diagnosed of bipolar disorder I or II, in previous treatment with no more than two concomitant mood stabilizers at stable doses and current subsyndromal symptoms, defined as YMRS ≤14 and/ or MADRS≥8 and ≤14 would be included Sub-acute phases would be excluded (at least 8 weeks from last exacerbation would be required for inclusion).

NCT ID: NCT01197755 Completed - Clinical trials for Rheumatoid Arthritis

Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate and Have Had Inadequate Response to Single TNF-alpha Antagonist

OSKIRA - 3
Start date: September 2010
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the effectiveness of two dosing regimens of fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking methotrexate and have had an inadequate response to a single TNF-alpha antagonist. The study will last for approximately six months.

NCT ID: NCT01197677 Completed - Clinical trials for Consecutive Patients Undergoing CMR

European CMR Registry

Start date: April 2009
Phase: N/A
Study type: Observational

1. The main aim of the first specific protocol initiated by the European CMR registry, suspected CAD, is to demonstrate that patients presenting for work up of suspected coronary artery disease, which have a completely normal CMR scan will have a low risk for cardiovascular events. 2. The main aim of the second specific protocol initiated by the European CMR registry, HCM-SCD, will be to evaluate CMR for risk stratification in hypertrophic cardiomyopathy(HCM). 3. This registry is sought to collect data on the general use of CMR in the European clinical practice, its safety and its therapeutic implications in a high number of cases to 1) substantiate the clinical yield of CMR and 2) to define additional clinical questions worth to be investigated in detail as additional specific protocols in the future.

NCT ID: NCT01197560 Completed - Clinical trials for Diffuse Large B-cell Lymphoma

Study of Lenalidomide to Evaluate Safety and Effectiveness in Patients With Diffuse Large B-Cell Lymphoma (DLBCL)

Start date: September 2, 2010
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to compare lenalidomide to a control drug and see which one delays Diffuse Large B-Cell Lymphoma (DLBCL) disease progression longer.