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NCT ID: NCT00314002 Terminated - Pulmonary Embolism Clinical Trials

Catheter Thrombectomy in Patients With Massive Pulmonary Embolism

Start date: October 2005
Phase: Phase 1/Phase 2
Study type: Interventional

Official Title: Compassionate Use of Catheter Thrombectomy (Aspirex 11F) in Patients With Massive Pulmonary Embolism Study Population: Patients >/= 18 years of age with massive pulmonary embolism suitable for mechanical thrombectomy with Aspirex 11F. Treatment: Aspirex 11F assisted thrombectomy _________ The study was terminated early. After having treated seven (7) patients, it was decided in April 2007 that the handling characteristics of the test device should be upgraded before continuing the trial as planned. Therefore, the study was long-term interrupted and finally terminated early. This decision was made by the sponsor in full accordance with the principal investigator. Further studies shall be conducted to show effectiveness and safety of the Aspirex PE catheter thrombectomy device. _________ Primary Endpoints: 1. Thrombectomy with the Aspirex catheter device is associated with an immediate decrease in mean pulmonary artery pressure (PAP) and pulmonary vascular resistance (PVP). 2. The Aspirex thrombectomy catheter does not cause perforation/dissection to treated and untreated cardiovascular structures. Secondary Endpoints: 1. Thrombectomy with the Aspirex catheter device is associated with improved flow in the treated main and lobar pulmonary arteries as assessed by the angiographic Miller index. 2. There will be no significant mechanical haemolysis as assessed by plasma free haemoglobin levels. 3. In-hospital mortality will not exceed 20%. Study Design: A prospective international multicenter non-randomized registry assessing the safety and efficacy of the Aspirex 11F mechanical thrombectomy device. Sample Size: Maximum of 50 patients Inclusion Criteria: - Patients with massive pulmonary embolism and cardiogenic shock with failed thrombolysis or at least contraindication for lysis. Exclusion Criteria: - Systemic embolism in the presence of an arterial septal defect or patent foramen ovale. - Free floating right heart thrombi, left heart thrombi. - Life expectancy, due to underlying disease, less than one month.

NCT ID: NCT00313092 Terminated - Glaucoma Clinical Trials

Obstructive Sleep Apnea Syndrome in Glaucoma

Start date: January 2005
Phase: N/A
Study type: Observational

The aim of the study is to determine if plasma matrix-metalloproteinase activity can predict glaucoma in patients with OSAS and if the level of plasma matrix-metalloproteinase activity will decrease after one month of nCPAP-treatment.

NCT ID: NCT00305526 Terminated - Heart Failure Clinical Trials

REBEAT Resynchronisation and Beta-Blocker European Trial

Start date: April 2006
Phase: Phase 4
Study type: Interventional

This protocol will evaluate the effect of cardiac resynchronization therapy (CRT) combined with beta-blocker therapy in patients with symptomatic heart failure in whom beta-blocker therapy was either not tolerated or could not be up titrated to optimal doses before CRT. Cardiac resynchronization therapy will be combined with automatic implantable cardioverter defibrillator (AICD, CRT-D) as it has been shown to be associated with an improvement in prognosis in the patients with left ventricular systolic dysfunction and heart failure.

NCT ID: NCT00304252 Terminated - Crohn's Disease Clinical Trials

Safety and Efficacy of Treatment With Interferon Beta-1a Rebif® in Patients With Crohn's Disease

Start date: November 2001
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the safety and efficacy of interferon beta-1a in maintaining remission in patients with Crohn's disease.

NCT ID: NCT00303407 Terminated - Cancer Clinical Trials

Prophylaxis of Venous Thrombo-Embolism in Cancer Patients Under Palliative Care

Start date: January 2001
Phase: Phase 4
Study type: Observational

To determine the efficacy and to measure the complications of prophylactic anticoagulation using low-molecular weight heparin in adult cancer patients under palliative care

NCT ID: NCT00300196 Terminated - Stroke Clinical Trials

ASP-II: Ancrod Stroke Program: Ancrod (Viprinex™) for the Treatment of Acute, Ischemic Stroke

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

The primary purpose of this study is to determine whether a brief intravenous infusion of ancrod started within 6 hours of stroke onset improves functional outcome at 3 months.

NCT ID: NCT00298324 Terminated - Clinical trials for Graft vs Host Disease

Myfortic - Treatment for Extensive cGvHD

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

The purpose of this study is to determine whether the response to treatment for extensive chronic Graft versus Host Disease (cGvHD)is improved with the addition of myfortic alongside cyclosporine A and prednisone, compared to the reference treatment of cyclosporine A and prednisone alone.

NCT ID: NCT00297232 Terminated - Clinical trials for Relapsing-Remitting Multiple Sclerosis

Natalizumab (Tysabri) Re-Initiation of Dosing

STRATA
Start date: March 2006
Phase: Phase 3
Study type: Interventional

The primary objectives for the initial treatment period of this study are to further evaluate the safety of natalizumab monotherapy by evaluating the risk of hypersensitivity reactions and immunogenicity following re-exposure to natalizumab and confirming the safety of switching from interferon (IFN), glatiramer acetate, or other multiple sclerosis (MS) therapies to natalizumab. The primary objective for the long-term treatment period of this study is to evaluate the long-term impact of natalizumab monotherapy on the progression of disability measured by Expanded Disability Status Scale (EDSS) changes over time.

NCT ID: NCT00297193 Terminated - Crohn Disease Clinical Trials

ASTIC Autologous Stem Cell Transplantation for Crohn's Disease

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

Transplant study for patients with relapsing Crohn's disease demonstrating clear intolerance or toxicity to conventional treatment. The purpose of this study is to determine whether there is a potential clinical benefit of hematopoietic stem cell mobilisation followed by high dose immuno-ablation and autologous stem cell transplantation versus hematopoietic stem cell mobilisation only followed by best clinical practice.

NCT ID: NCT00296010 Terminated - Breast Cancer Clinical Trials

Liposomal Doxorubicin Compared With Observation or Cyclophosphamide and Methotrexate in Treating Older Women Who Have Undergone Surgery for Breast Cancer

CASA
Start date: August 2005
Phase: Phase 3
Study type: Interventional

RATIONALE: Drugs used in chemotherapy, such as methotrexate, cyclophosphamide, and liposomal doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving liposomal doxorubicin after surgery is more effective than observation or cyclophosphamide and methotrexate in treating breast cancer. PURPOSE: This randomized phase III trial is studying liposomal doxorubicin to see how well it works compared with observation or cyclophosphamide and methotrexate in treating older women who have undergone surgery for breast cancer.