Treatment Trials

7 Clinical Trials for Various Conditions

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COMPLETED
18F-FPPRGD2 PET/CT or PET/MRI in Predicting Early Response in Patients With Cancer Receiving Anti-Angiogenesis Therapy
Description

The purpose of the study is to conduct research of a new PET radiopharmaceutical in cancer patients. The uptake of the novel radiopharmaceutical 18F-FPPRGD2 will be assessed in study participants with glioblastoma multiforme (GBM), gynecological cancers, and renal cell carcinoma (RCC) who are receiving antiangiogenesis treatment.

Conditions
Adult Giant Cell GlioblastomaAdult GlioblastomaAdult GliosarcomaMale Breast CancerMetastatic Squamous Neck Cancer With Occult Primary Squamous Cell CarcinomaRecurrent Adenoid Cystic Carcinoma of the Oral CavityRecurrent Adult Brain TumorRecurrent Basal Cell Carcinoma of the LipRecurrent Colon CancerRecurrent Esthesioneuroblastoma of the Paranasal Sinus and Nasal CavityRecurrent Hypopharyngeal CancerRecurrent Inverted Papilloma of the Paranasal Sinus and Nasal CavityRecurrent Laryngeal CancerRecurrent Lip and Oral Cavity CancerRecurrent Lymphoepithelioma of the NasopharynxRecurrent Lymphoepithelioma of the OropharynxRecurrent Metastatic Squamous Neck Cancer With Occult PrimaryRecurrent Midline Lethal Granuloma of the Paranasal Sinus and Nasal CavityRecurrent Mucoepidermoid Carcinoma of the Oral CavityRecurrent Nasopharyngeal CancerRecurrent Non-small Cell Lung CancerRecurrent Oropharyngeal CancerRecurrent Pancreatic CancerRecurrent Paranasal Sinus and Nasal Cavity CancerRecurrent Rectal CancerRecurrent Renal Cell CancerRecurrent Salivary Gland CancerStage IIIA Breast CancerStage IIIA Non-small Cell Lung CancerStage IIIB Breast CancerStage IIIB Non-small Cell Lung CancerStage IIIC Breast CancerStage IV Breast CancerStage IV Non-small Cell Lung CancerStage IV Pancreatic CancerStage IV Renal Cell CancerStage IVA Colon CancerStage IVA Rectal CancerStage IVA Salivary Gland CancerStage IVB Colon CancerStage IVB Salivary Gland CancerStage IVC Salivary Gland CancerTongue CancerUnspecified Adult Solid Tumor, Protocol Specific
COMPLETED
Biodistribution and Safety of the PET Probes [18F]FPRGD2 and [18F]FPPRGD2
Description

The purpose of the study was to conduct a pilot test of new tracers (\[18F\]FPRGD2 and \[18F\]FPPRGD2) to define normal tracer biodistribution (where the tracer goes), stability (how much metabolises), pharmacokinetics (how much stays in which organs and for how long), and radiation dosimetry (organ radiation dose). Healthy volunteers provided the normal biodistribution data. The same radiopharmaceutical was also tested in breast cancer, glioblastoma multiform (brain cancer), and lung cancer.

COMPLETED
Nutritional Regulation of Leukocyte Function
Description

The objective of the current study is to determine the dose at which Fermented Papaya Preparation ( FPP) is able to improve inducible respiratory burst outcomes in peripheral blood mononuclear cells (PBMC) and neutrophils of participants. Our investigators have reported that supplementation with standardized fermented papaya preparation (FPP) in mice improves dermal wound healing outcomes. Therefore, based on these observations, the investigators propose to study the dose at which FPP supplementation induces respiratory burst in blood-derived myeloid cells in healthy subjects.

COMPLETED
Molecular and Clinical Effects of Green Tea and Fermented Papaya Preparation on Diabetes and Cardiovascular Diseases
Description

Type 2 diabetes is common in ethnic and, minority groups in developing and developed countries such as Africans, African Americans, Asians, Native Americans, Hispano-Latinos and Alaskan indians. A randomized controlled study to assess the efficacy of fermented papaya preparation and green tea infusates in latent diabetes (individuals newly diagnosed as diabetics) is proposed. Glycation products from excess glucose autooxidation can chemically modify DNA causing mutations and cause complex DNA rearrangements. Advanced glycation end-products which play a role as proinflammatory mediators in gestational diabetes can accelerate vascular occlusion by quenching the vasodilating agent nitric oxide. Interaction with high-affinity receptors located on monocytes and macrophages can enhance the production of free radicals and reactive oxygen/nitrogen species, the secretion of tumor necrosis factor-α, interleukin-1 and insulin-like growth factor I which can proliferate endothelial, mesangial and smooth muscle cells and hence contribute significantly to the pathogenesis of cardiovascular complications. The clinical markers include C-reactive proteins (inflammation indicators), protein C (markers of reno vascular injury), uric acid, natriuretic peptides, and the integrity of isolated adipocytes, glucose levels, lipid indices (triglycerides, total cholesterol, VLDL, HDL and LDL). Given that decreased functional activity of activated protein C affects the permeability of the glomerular capillary wall and enhances apoptosis of glomerular endothelial cells and adipodocytes, this has relevance to the pathophysiology of diabetic nephropathy. A second phase of the study is expected to commence after the first 16 weeks in order to assess the ability of the dietary factors to modulate atheroma formation and the integrity of drug therapy (upon commencement of treatment)on the prognosis of diabetes. This will be expected to last up to 3 years.

COMPLETED
Nutritional Regulation of Wound Inflammation: Part II
Description

Fermented Papaya Preparation (FPP) is a sweet and granular substance available over the counter. FPP possesses antioxidant properties, which provide benefit against age-related complications, and is also known to protect red blood cells (RBCs) against oxidative damage and to help protect against severe forms of thalassemia. The investigators recently showed that ex vivo supplementation of FPP can correct respiratory burst performance of diabetic peripheral blood mononuclear cells (PBMC) via a Sp-1 dependant pathway. Based on these observations, the investigators propose to study the outcome that FPP supplementation has in patients with diabetes.

Conditions
WITHDRAWN
Targeted PET/CT and PET/MRI Imaging of Vascular Inflammation
Description

Stroke and abdominal aortic aneurysms (AAAs) are common and highly lethal vascular diseases. Angiogenesis and infiltration of inflammatory cells such as macrophages may cause stroke and AAAs. The purpose of this study is to test PET/CT and PET/MRI imaging to specifically detect those diseases using a new developed agent (18F-FPPRGD2) that can target angiogenesis and macrophages.

COMPLETED
Nutritional Regulation of Wound Inflammation: Part III
Description

The purpose of this study is to examine the changes that result in the wound healing of a type II Diabetic using Negative Pressure Therapy after 12 weeks of daily supplementation of ImmunAge (Fermented Papaya Preparation (FPP). ImmunAge (FPP) is a supplement made from Carica papaya Linn and is available over the counter. ImmunAge (FPP) is an investigational drug, which means it has not been approved by the U. S. Food and Drug Administration (FDA). Approximately 30 subjects will participate in this study. 15 subjects will take the supplementation and 15 subjects to take no supplementation as the control. The