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NCT ID: NCT00431912 Completed - Clinical trials for Cutaneous T-cell Lymphoma

A Study of APO866 for the Treatment of Cutaneous T-cell Lymphoma

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

This phase II study is designed to determine the efficacy and safety of APO866 for the treatment of patients with advanced forms of cutaneous T-cell lymphoma (CTCL). APO866 has shown to induce growth inhibition in cultures of human CTCL cells as well as in animal models with subcutaneously implanted human CTCL tumors. APO866 was considered to be safe and well-tolerated in a phase I study that treated 24 patients with advanced cancer. APO866 is administered by intravenous infusion continuously for 96 hours and that is repeated every 4 weeks. Patients will receive 3 cycles of treatment and the primary efficacy endpoint will be assessed at Week 16. patients will be followed up for 12 months

NCT ID: NCT00431769 Completed - Multiple Myeloma Clinical Trials

An Efficacy and Safety Study of Bortezomib Re-treatment in Multiple Myeloma

Start date: June 2006
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of bortezomib in participants with multiple myeloma who have previously responded to a bortezomib based therapy.

NCT ID: NCT00431730 Completed - Ocular Physiology Clinical Trials

Is There a Difference in Flicker Induced Vasodilatation Between Smokers and Non-Smokers?

Start date: December 2006
Phase: N/A
Study type: Interventional

Habitual smoking is associated with an increased risk of coronary artery disease, cerebral and peripheral vascular disease, including ocular diseases like age-related macular degeneration or diabetic retinopathy. Data of a recent study performed in the investigators lab revealed abnormal choroidal blood flow regulation in chronic smokers as compared to age-matched non-smoking subjects during isometric exercise. However, no information is yet available about the regulation of retinal vascular tone in habitual smokers. Thus, in the current study, the investigators set out to investigate whether the regulation of retinal vessels diameters is affected in habitual smokers. It has been shown in several reports that stimulation with diffuse luminance flicker, increases retinal arterial and venous diameters, indicating for the ability of the retina to adapt to changing metabolic demands. In the current study we use this effect as a tool to investigate whether the flicker induced vasodilatation is affected in habitual smokers. This would indicate for an impaired vascular regulation process in smokers.

NCT ID: NCT00431691 Completed - Regional Blood Flow Clinical Trials

Effect of Antioxidants on Ocular Blood Flow, Endothelial Function, and Cytokine Levels in LPS Induced Inflammatory Model in Humans.

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

Oxidative stress, which refers to cellular damage caused by reactive oxygen intermediates, has been implicated in many disease processes, especially age-related disorders. Many trials investigating use of antioxidants in protecting different tissues against oxidative stress have been conducted, but the results are ambiguous. Inflammation is generally associated with enhanced oxidative stress and widespread endothelial dysfunction. In the present study, the infusion of LPS, which is a cell wall component of Gram-negative bacteria and a major mediator in the pathogenesis of septic shock, will be used as a standardized experimental model of systemic inflammatory response in humans. The assessment of outcome parameters will include measurements of ocular blood flow, forearm blood flow and plasma concentration of cytokines. Measurements of ocular hemodynamics provide an unique chance to investigate local blood flow in humans non-invasively. Moreover, the retina is especially susceptible to oxidative stress because of its high consumption of oxygen, its high polyunsaturated fatty acid content, and its exposure to visible light. Evidence from literature clearly supports a role for oxidative stress in pathophysiology of several ocular diseases including diabetic retinopathy and age-related macular degeneration. To investigate the retinal vascular reactivity we will use systemic hyperoxia as a stimulus. The measurement of forearm blood flow will be use to assess endothelial function. The main study objective is to investigate the effect of oral vitamins and minerals supplementation on impaired retinal vascular reactivity after LPS administration.

NCT ID: NCT00431665 Completed - Clinical trials for Glomerular Filtration Rate

Effect of Elevated Plasma-Free-Fatty-Acids on Renal Hemodynamic Parameters

Start date: July 1999
Phase: N/A
Study type: Interventional

Type 2 diabetes is frequently associated with elevation of plasma-free fatty acids (FFA). Studies indicate that elevation of plasma-FFA induces insulin resistance and also causes endothelial dysfunction as well as hemodynamic changes which are supposed to be involved in the pathogenesis of diabetic vascular disorders. Glomerular hyperfiltration, which is associated with glomerular hypertension and hypertrophy, a common finding in the early course of type 1 diabetes as well as type 2 diabetes, plays an important role in the development and progression of diabetic nephropathy. These hemodynamic changes are not well understood, but are most likely induced by dilatation of the (precapillary) glomerular arteriole. In humans the hemodynamic effect of FFAs has so far been investigated locally in brachial and femoral arteries and recently in the eye and skin, where FFAs induced a pronounced increase in blood flow probably due to a local decrease in vascular resistance. The aim of the present study is to characterise the hemodynamic effects of FFAs in the kidney. In addition we want to test the hypothesis that FFA-induced changes are mediated via endothelial derived nitric oxide (NO). The results of this study could provide information to what extent elevated FFA-plasma levels contribute to hyperfiltration in the early course of diabetes mellitus. The measurements will be done at baseline and during 4 hour infusion of a triglyceride or placebo infusion, combined with heparin.

NCT ID: NCT00431600 Completed - Healthy Clinical Trials

The Validity of Retinal Blood Flow Measurements During Hyperoxia in Humans Using Fourier Domain Color Doppler Optical Coherence Tomography (CDOCT)

Start date: September 2010
Phase: N/A
Study type: Interventional

Noninvasive monitoring of blood flow in retinal circulation may elucidate the progression and treatment of ocular disorders, including diabetic retinopathy, age-related macular degeneration and glaucoma. Laser Doppler velocimetry (LDV), a noninvasive optical method combined with vessel size determination has been used extensively as a valuable research tool to examine blood flow dynamics in the human retina. However, no information on the velocity profile within the vessel is available. Ophthalmic color Doppler optical coherence tomography (CDOCT) provides laser Doppler information in addition to conventional optical coherence tomography, allowing the observation of blood flow dynamics simultaneously to imaging retinal structure. We have recently demonstrated the feasibility of Fourier domain CDOCT to assess velocity profiles in human retinal vessels in vivo. In the present study the validity of Fourier domain CDOCT for retinal blood flow measurements will be tested at baseline and during hyperoxia-induced vasoconstriction in humans by comparison with retinal blood flow measurements using a commercially available LDV system and the Zeiss retinal vessel analyzer (RVA)

NCT ID: NCT00431561 Completed - Glioblastoma Clinical Trials

Phase IIb Clinical Trial With TGF-β2 Antisense Compound AP 12009 for Recurrent or Refractory High-grade Glioma

Start date: April 2003
Phase: Phase 2
Study type: Interventional

In this multinational dose finding Phase IIb study the efficacy and safety of two doses of AP 12009 compared to standard chemotherapy (temozolomide or PCV) is investigated in adult patients with confirmed recurrent high-grade glioma.

NCT ID: NCT00431548 Completed - HIV Infections Clinical Trials

Retinal Oxygen Reactivity in Patients Infected With Human Immunodeficiency Virus (HIV)

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

Ocular lesions, including cotton wool spots and retinal hemorrhage, are a common feature of HIV infection and acquired immunodeficiency syndrome (AIDS). The aetiology of these apparently vasoocclusive phenomena in HIV related retinopathy is not well understood. Several hypotheses including infectious damage of the retinal vasculature and altered retinal hemodynamics have been postulated. The latter would be compatible with the theory that the retina of HIV patients is hypoxic. However, direct measurement of oxygen tension in the retina is not possible and indirect methods have to be employed. The study objective was to investigate the reactivity in retinal blood flow to 100% oxygen breathing in patients with HIV.

NCT ID: NCT00431392 Completed - Regional Blood Flow Clinical Trials

Mechanisms of Choroidal Blood Flow Changes During Dark/Light Transitions

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

There is evidence from a variety of animal studies that choroidal blood flow is under neural control. By contrast, only little information is available from human studies. Recent results indicate that a light/dark transition is associated with a short lasting reduction in choroidal blood flow. We have shown that during unilateral dark/light transition both eyes react with choroidal vasoconstriction strongly indicating a neural mechanism. The present studies investigate this possibility by using pharmacological interventions. The pharmacological agents tested include a nitric oxide synthase inhibitor, an alpha-receptor agonist (as a control substance for the blood pressure increasing nitric oxide synthase inhibitor), a muscarinic receptor blocker, and a non-specific beta-blocker. These drugs were chosen on the basis of previous animal experiments, as the systems, which are specifically influenced by these substances, are likely involved in neural control of choroidal blood flow.

NCT ID: NCT00431353 Completed - Clinical trials for Cytomegalovirus Infections

VICTOR Study - A Study of Valcyte (Valganciclovir po) Compared to Ganciclovir iv in Patients With Cytomegalovirus (CMV) Disease Who Are Solid Organ Transplant Recipients

Start date: April 2004
Phase: Phase 4
Study type: Interventional

This 2 arm study will evaluate the efficacy and safety of oral Valcyte compared with intravenous ganciclovir for the treatment of CMV disease in solid organ transplant recipients. Eligible patients will be randomized to receive either 1)Valcyte 900mg po bid or 2)ganciclovir 5mg/kg iv bid. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.