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NCT ID: NCT00400790 Completed - Dementia Clinical Trials

Organ Protection for Coronary Artery Bypass Graft (CABG): Propofol Versus Desflurane

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

Background: Different anaesthetic agents have been shown to have different protective effects upon heart, brain and renal function under ischaemic conditions (oxygen starvation). Cardiopulmonary bypass takes over the work of the heart and the lungs during heart surgery, but oxygenation of vital organs such as the brain and heart may not be perfect, and can produce brain or heart damage as a consequence. Propofol and desflurane are commonly used anaesthetic agents, and there has been recent research to suggest that anaesthetic agents may provide some protection during periods where inadequate oxygenation occurs, with the potential to reduce the degree of organ damage. Both types of anaesthetics are used for cardiac surgery with anaesthetists choosing between them largely on the basis of personal preference. Aim: To determine whether the use of either propofol or desflurane as the primary anaesthetic agent, can lead to differences in postoperative brain function, total morbidity or cost, following coronary artery surgery with cardiopulmonary bypass. Methods: Patients will be recruited by professional research staff and will be randomised into one of two groups (90 in each group). They will receive a standardized technique for anaesthesia, cardiopulmonary bypass and postoperative ICU treatment. The only difference between the 2 groups will be as to which anaesthetic agent they receive during the surgical period, desflurane or propofol. Measurements will involve i) brain function testing before and 3 months after surgery ( a set of 10 verbal or manual tests), ii) incidence of delirium in the immediate postoperative period (a survey form), iii) incidence of total postoperative morbidity and iv) cost of hospital stay. Data collection will be by anaesthesia and research staff and a neuropsychologist will employed for performing the brain function testing. Anticipated timeline: Initial recruitment completed by 15-18 months following trial commencement. Follow up completed 3 month after the last enrolment. Data validation, statistical analysis and manuscript preparation completed by 24 months.

NCT ID: NCT00400556 Completed - Multiple Myeloma Clinical Trials

ATRA Plus G-CSF for Mobilization of Hematopoietic Stem and Progenitor Cells

Start date: March 2005
Phase: Phase 1
Study type: Interventional

Hematopoietic stem and progenitor cells (HSPC) are used for transplantation in patients undergoing high dose therapy for the treatment of a range of cancers. - HSPC are collected from the bloodstream after treatment with medications that cause the HSPC to move from the bone marrow into the bloodstream, a process called mobilization - between 5 and 60% of patients can fail to collect enough HSPC for a transplant, using current mobilization techniques - this study aims to assess the safety of combining a derivative of vitamin A, ATRA with G-CSF (the drug most commonly used to mobilize HSPC) - ATRA has never been combined with G-CSF for mobilization of HSPC and therefore a study is needed to assess the safety of this combination, and whether it successfully mobilizes HSPC

NCT ID: NCT00400478 Completed - Clinical trials for Diffuse Large B-Cell Lymphoma (DLBCL)

A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation in Patients With Aggressive B-cell Lymphoma: NHL-13

Start date: January 2006
Phase: Phase 3
Study type: Interventional

This is a randomized, open label, phase III study to evaluate the ability of rituximab maintenance therapy to prolong event-free survival in aggressive NHL. Patients will be screened after successful standard induction therapy (CR or Cru following standard R-CHOP-like therapy with 8 infusions of rituximab plus CHOP-like chemotherapy (4-8 cycles). Patients will be followed until an event occurs as defined in the protocol. To evaluate the clinical efficacy of rituximab maintenance therapy as compared to observation in patients with aggressive B-cell Non-Hodgkins lymphoma or follicular lymphoma grade 3b who have achieved a complete remission after appropriate first-line therapy, measured by event-free survival (EFS), 440 patients with DLCBL or follicular NHL grade 3 (220 per arm) will be recruited.

NCT ID: NCT00400257 Completed - Heart Failure Clinical Trials

Screening Evaluation of the Evolution of New Heart Failure (SCREEN-HF)

Start date: May 2007
Phase: N/A
Study type: Observational

The investigators are hoping to identify early heart failure in patients who do not have symptoms as yet and at the same time assess the usefulness of Brain natriuretic peptide (BNP) in doing this.

NCT ID: NCT00399906 Completed - Psoriasis Clinical Trials

A Study of BMS-582949 in Patients With Moderate to Severe Plaque Psoriasis

Start date: August 2007
Phase: Phase 2
Study type: Interventional

The purpose of this clinical research study is to learn if BMS-582949 alone is an effective treatment for moderate to severe psoriasis. The safety of the drug and the effectiveness of each dose will also be studied.

NCT ID: NCT00398645 Completed - Asthma Clinical Trials

A Randomized Study To Evaluate The Efficacy And Safety Of An Investigational Drug In Adolescent And Adult Subjects With Persistent Asthma.

Start date: November 15, 2006
Phase: Phase 2
Study type: Interventional

This study is designed to determine if the investigational drug is effective and safe in individuals with asthma.

NCT ID: NCT00396981 Completed - Clinical trials for Intracranial Aneurysms

MAPS Trial: Matrix And Platinum Science

MAPS
Start date: March 2007
Phase: Phase 4
Study type: Interventional

Primary Objectives: - To establish Target Aneurysm Recurrence (TAR) rates for Matrix 2® and GDC® Coils used for the treatment of intracranial saccular aneurysms. TAR is defined as clinically relevant recurrence resulting in: target aneurysm reintervention, rupture/re-rupture and/or death from an unknown cause. - To correlate defined angiographic endpoints with TAR rates and assess their predictive value, thereby providing a framework to establish clinically relevant endpoints for future studies. Secondary Objectives: - To evaluate device characteristics, incidence and severity of device-related adverse events, including death, neurological deterioration and changes in functional abilities. - To establish angiographic recurrence rates for Matrix 2® and GDC® Coils used for the treatment of intracranial saccular aneurysms. - To explore an experimental, quantitative and volumetric endpoint and correlate these with existing qualitative assessments.

NCT ID: NCT00396006 Completed - Clinical trials for Alpha 1-Antitrypsin Deficiency

Efficacy and Safety Study of Augmentation Therapy With ARALAST Fraction IV-1 (Human Alpha 1 - Proteinase Inhibitor)

Start date: October 27, 2006
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the effects of weekly augmentation therapy with ARALAST Fraction IV-1 (Fr IV-1) on epithelial lining fluid (ELF) alpha 1-proteinase inhibitor levels and other ELF analytes and to assess the safety of the treatment. Eligible subjects with a diagnosis of severe congenital alpha 1-antitrypsin deficiency will receive 8 consecutive weekly treatments with 60 mg/kg/week of functional ARALAST Fr IV-1 administered intravenously. The efficacy and safety assessments will include two bronchoscopies with bronchoalveolar lavage on study initiation and on study termination and multiple imaging and laboratory safety assessments. Each subject will participate for a minimum of 12 weeks.

NCT ID: NCT00395772 Completed - Clinical trials for Venous Thromboembolism

Once-daily Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Deep-vein Thrombosis

Start date: December 2004
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the optimal dose of BAY 59-7939 and to compare the safety and effectiveness of this new drug with the standard way of treatment of deep vein thrombosis (heparin infusion plus one of the vitamin K antagonists), taking into account new events of thrombosis and pulmonary embolism and bleeding risk.

NCT ID: NCT00395629 Completed - Iron Overload Clinical Trials

Safety and Efficacy of Deferasirox (ICL670) in Patients With Iron Overload Resulting From Hereditary Hemochromatosis

Start date: August 2006
Phase: Phase 1/Phase 2
Study type: Interventional

Brief Summary: This study was designed to explore a safe dose and characterize the preliminary safety and efficacy of ICL670 in adult patients with previously documented history of homozygous C282Y.