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NCT ID: NCT00712881 Completed - Breast Cancer Clinical Trials

Combination Therapy With MYOCET® (Doxorubicin HCL Liposome for Injection) in Participants With HER2-Positive Breast Cancer

Start date: October 13, 2008
Phase: Phase 2
Study type: Interventional

To evaluate the efficacy and safety of treatment with MYOCET® (doxorubicin hydrochloride) in combination with cyclophosphamide and trastuzumab, 4 cycles, followed by docetaxel plus trastuzumab, 4 cycles, in women with stage II or III breast cancer whose tumour overexpresses the human epidermal growth factor receptor 2 (HER2) gene.

NCT ID: NCT00712842 Completed - Clinical trials for Diabetic Retinopathy

Neurovascular Coupling in Patients With Early Stage Diabetes Retinopathy

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

A variety of studies demonstrate that ocular blood flow is altered in diabetes and retinal perfusion abnormalities have been proposed to contribute to the pathogenesis of diabetic retinopathy. Various animal and human studies have demonstrated that retinal and optic nerve blood flow increase in response to diffuse luminance flicker. Based on studies with ERG, this effect has been attributed to augmented activity in the retinal ganglion cells and associated axons indicating a coupling mechanism between neuronal activity and retinal blood flow. Whereas a variety of studies describe the effects of flickering light on retinal and optic nerve head blood flow, the knowledge about this coupling in the diabetic retina is sparse. In view of the fact that neural activity and blood flow are strongly coupled in the human retina, one could hypothesize that neurodegenerative changes in the retina could contribute to the vascular dysregulation and in turn lead to changes of ocular perfusion. The investigators set out to investigate whether the coupling of neural activity and blood flow is impaired in patients with early stage diabetic retinopathy compared to those in healthy volunteers.

NCT ID: NCT00712764 Completed - Microcirculation Clinical Trials

Role of Adenosine in the Control of Choroidal Blood Flow During Changes in Ocular Perfusion Pressure.

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

Autoregulation is the ability of a vascular bed to maintain blood flow despite changes in perfusion pressure. For a long time it had been assumed that the choroid is a strictly passive vascular bed, which shows no autoregulation. However, recently several groups have identified some autoregulatory capacity of the human choroid. In the brain and the retina the mechanism behind autoregulation is most likely linked to changes in transmural pressure. In this model arterioles change their vascular tone depending on the pressure inside the vessel and outside the vessel. In the choroid, several observations argue against a direct involvement of arterioles. However, the mechanism behind choroidal autoregulation remains unclear. Adenosine, an endogenous purine metabolic end product with a potent vasodilatory effect on multiple vascular beds, leads to an increase in retinal and choroidal vessel diameter. The present study aims to investigate whether adenosine plays a role in choroidal autoregulation during a decrease in ocular perfusion pressure, which will be achieved by an increase in intraocular pressure. Pressure/flow relationships will be investigated in the absence and presence of adenosine.

NCT ID: NCT00712400 Completed - Clinical trials for Intraocular Pressure

Effects of Latanoprost on Choroidal Blood Flow Regulation in Human Subjects

Start date: June 2005
Phase: N/A
Study type: Interventional

Latanoprost is a synthetic prodrug of 17-phenyl-substituted prostaglandin F2α analog. Used at a dose of one drop per day, it has been reported to produce a 30 to 35% reduction in intraocular pressure. Its mechanism of activation involves augmentation of the eye's natural uveoscleral outflow capacity . There is evidence that ocular blood flow plays a role in the clinical course of glaucoma. Glaucoma medication that lowers IOP simultaneously increases ocular blood perfusion pressure, which in turn may increase ocular blood flow. This could well contribute to the partially contradicting results concerning ocular hemodynamic effects of latanoprost. In vitro studies indicate that latanoprost has no effect on ocular vascular tone in therapeutical doses. By contrast, it has been reported in several studies that latanoprost 0.005% increases pulsatile ocular blood flow in patients with primary open angle glaucoma and normal tension glaucoma. This increase in pulsatile ocular blood flow mainly reflects an increase in the choroidal circulation. Little is known about the potential effect of latanoprost on choroidal blood flow regulation in humans. The present study therefore tries to elucidate whether treatment with latanoprost may alter choroidal blood flow regulation during artificial changes in ocular perfusion pressure. In addition, the present study aims to clarify whether the change in choroidal blood flow after latanoprost administration are due to direct vasoactive effects or due to the increase in ocular perfusion pressure. The second alternative may have important implications on our understanding of glaucoma treatment, because reduction of IOP may then per se result in normalization of ocular blood flow regulation.

NCT ID: NCT00712218 Completed - Ovarian Cancer Clinical Trials

Lymphadenectomy In Ovarian Neoplasms

LION
Start date: December 2008
Phase: N/A
Study type: Interventional

To assess the efficacy of systematic pelvic and para-aortic lymphadenectomy in patients with advanced ovarian cancer and intra-abdominal complete debulking. Secondary: progression-free survival, complications and quality of life; Exploratory: Role of number of resected lymph nodes for primary and secondary objectives

NCT ID: NCT00711893 Completed - Heart Failure Clinical Trials

Feature Assessment Study for Indications Based Programming

FASt-IBP
Start date: June 2008
Phase: N/A
Study type: Observational

The purpose of this evaluation is to assess the acceptance level of specific programming recommendations based on the patient's clinical needs and primary indications when using the feature 'Indications Based Programming' (IBP) available in the ZOOMVIEW Software Application for the TELIGEN DR / VR and COGNIS family of devices compared to daily life programming chosen by physicians.

NCT ID: NCT00711321 Completed - Alzheimer's Disease Clinical Trials

Long-term Safety and Tolerability of AFFITOPE AD02

Start date: November 2008
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate the long-term tolerability and -safety of AFFITOPE AD02 applied during AFFiRiS 002

NCT ID: NCT00711295 Completed - Influenza Clinical Trials

Phase 3 Study of a H5N1 Vaccine in Adults, Elderly and Specified Risk Groups

Start date: August 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of, and the immune response to a non-adjuvanted H5N1 influenza vaccine in an adult and elderly population and in specified risk groups. Furthermore, persistence of H5N1 influenza antibodies after vaccination with this vaccine will be assessed.

NCT ID: NCT00711139 Completed - Alzheimer's Disease Clinical Trials

Long-term Safety and Tolerability of AFFITOPE AD01

Start date: June 2008
Phase: N/A
Study type: Observational

The purpose of this study is to assess the long-term tolerability and -safety of AFFITOPE AD01 applied during AFFiRiS 001

NCT ID: NCT00710710 Completed - Clinical trials for Pancreatic Neoplasms

Open, Randomized Phase II Trial to Investigate the Efficacy and Safety of the PLK-1 Inhibitor BI 2536 in Patients With Advanced, Unresectable Pancreatic Cancer

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

The trial is conducted in order to evaluate the efficacy, safety and pharmacokinetics of BI 2536 in the treatment of unresectable advanced pancreatic cancer as first line or second line therapy. A secondary aim is to identify the most suitable dosage regimen for the further phase II and III clinical programme of BI 2536. To achieve this objective, two dosage regimens are compared in patients receiving first line therapy.