Abstract: The present invention is directed to methods and assays for identifying subjects participating in clinical trials that may exhibit a placebo response and identifying treatments for subjects with varying degrees of placebo responses. In one aspect, a method of selecting subjects to participate in a clinical trial is disclosed. In another aspect, methods for treating a subject and determining a treatment dosage are disclosed. In an exemplary embodiment, a method for determining a response to a treatment of a subject having, suspected of having, or at risk for developing a disorder, such as cardiovascular disorder, irritable bowel syndrome, diabetes, autoimmune disorders, inflammation, neurological disorders, chronic pain, cancer, cancer treatments, allergies, depression, migraines, addiction, obesity, and other disorders, syndromes, or diseases, is disclosed.

Abstract: Compositions and methods for producing reconstituted human skin and/or hair follicles in situ are provided. The method for producing the skin is unique in that tissue culture expanded cells including multipotent cells such as neonatal cells as well as cultured epidermal and dermal cells are immediately placed on a substrate such as a membrane and then the membrane with adherent cells is placed on a skin wound. Examples demonstrate formation of hair follicles in situ.

Abstract: Methods and materials for increasing the number of target cells recovered from a fluid sample containing cells are described. The methods include isolating the target cells on a filter and then implanting the filter containing the target cells in an immunodeficient non-human animal, where at least some of the target cells can proliferate.

Abstract: A method is provided for screening anti-adenovirus agents. The method includes reducing the activation of the immune system of a small mammal, administering a human adenovirus vector to the small mammal, monitoring the tumor cells in the mammal, and analyzing infectious virus units within the tumor cells and the organs of the small mammal. Specifically, the immune system of the small mammal is suppressed using cyclophosphamide. The small mammal may be, but is not limited to, one of the following: mice, rabbits, cotton rats, hamsters, rats, and other small rodents.

Abstract: Embodiments of the present invention generally disclose methods, compositions and uses for generating and expressing poxvirus constructs. In some embodiments, constructs may contain an influenza virus gene segment. In certain embodiments, methods generally relate to making and using compositions of constructs including, but not limited to, poxvirus vaccine compositions. In other embodiments, vaccine compositions are reported of use in a subject.

Abstract: In some aspects, the invention provides compositions and methods for inhibiting viral infection. In some aspects, the invention provides compositions and methods useful for identifying antiviral compounds.

Abstract: Provided is a method for producing a glioblastoma mouse model and the mouse model produced thereby, the method including the steps of: (a) dividing a glioblastoma tissue, isolated from a patient, into 4 or more sections, and collecting one or more pieces from each of the sections; (b) dissociating a mixture of the collected pieces into glioblastoma cells as single cells; and (c) orthotopically transplanting a graft sample containing the glioblastoma cells obtained in step (b), into the brain of an immunodeficient mouse. Further provided are a method of screening a glioblastoma therapeutic agent using the mouse model and a method of providing information for selection of a patient-specific glioblastoma therapy using the mouse model. The glioblastoma mouse model shows the same genetic, morphological and pathological characteristics as those of the parental tumor, and it allows screening patient-specific glioblastoma therapeutic agent or selecting safer and more effective patient-specific glioblastoma therapy.

Abstract: The present invention relates to compositions, biomarkers, and their use in treatment of cancer. In some embodiments, the invention relates to the use of several biomarkers in methods for determining the responsiveness of a human subject to a specific compound, methods for monitoring the efficacy of the compound, or methods for treating a human subject.

Abstract: A composition comprising an effective amount of a combination of mitochondrial nutrients sufficient to affect mitochondrial function. A method of affecting an aging process in a subject comprising administering to a subject an effective amount of a combination of mitochondrial nutrients sufficient to affect an aging process. A method of identifying a combination of mitochondrial nutrients sufficient to affect an aging process in a subject, the method comprising: administering a combination of mitochondrial nutrients to a subject; and determining whether the mitochondrial nutrients affect an aging process in the subject.

Abstract: Methods for treating renal cancer by administration of certain 3,3?,4,4?-tetrahydroxy-2,2?-bipyridine-N,N?-dioxide compounds, especially 3,3?,4,4?-tetrahydroxy-2,2?-bipyridine-N,N?-dioxide (Orellanine), conjugated to an alpha-emitting radionuclide (e.g. Astatine-211) to increase the efficacy of the formulation and/or a large molecule (e.g. a oligomer/polymer such as a PEG or a polysaccharide such as a dextran or a Ficoll®) to reduce the filtration and consequently the renal exposure. Particular administration protocols and dosing regimens, as well as pharmaceutical compositions suitable for use in the treatment methods can be used.

Abstract: The present invention relates to Mycobacterial infections and provides a method of diagnosing infections of Mycobacterium avium subsp. paratuberculosis (Map), the causative agent of Johne's disease. In addition, the invention also provides as kits for use in the diagnosis of Map infections and vaccines/immunogenic compositions.

Abstract: The present invention relates to enterococcal cell wall components and their uses in the prevention and therapy of bacterial infection.

Abstract: The present invention relates to methods and compositions for use in modulating, including inhibiting the growth and/or reducing the virulence of gram-positive bacteria. The present invention provides methods and compositions for disrupting the cell wall and/or cell membrane in gram-positive bacteria such that cell wall or cell membrane target(s) are rendered exposed or accessible and sensitive to a modulation thereof. Methods for modulation of one or more gram-positive bacterial cell wall or cell membrane targets in a gram-positive bacteria are provided comprising disrupting the cell wall such that the cell wall or cell membrane target, which is particularly a sortase, is rendered exposed or accessible and sensitive to a modifying, modulating or binding agent, which is particularly an antibody or fragment thereof, wherein the cell wall or cell membrane target is inaccessible or relatively insensitive to the modifying, modulating or binding agent in the absence of cell wall disruption.

Abstract: Embodiments of the present invention generally disclose methods, compositions and uses for generating and expressing poxvirus constructs. In some embodiments, constructs may contain an influenza virus gene segment. In certain embodiments, methods generally relate to making and using compositions of constructs including, but not limited to, poxvirus vaccine compositions having two or more influenza gene segments. In other embodiments, vaccine compositions are reported of use in a subject.

Abstract: This invention relates to, in part, methods and compositions that are useful for the diagnosis, treatment, or prevention of a blinding eye disease, including in the discovery of drugs that are efficacious against these diseases. Diseases include, for example, age related macular degeneration and reticular pseudodrusen disease, and the methods described herein include, for example, the method named delayed near infrared analysis (DNIRA).

Abstract: The present invention relates, in general, to attenuated swine influenza viruses having an impaired ability to antagonize the cellular interferon (IFN) response, and the use of such attenuated viruses in vaccine and pharmaceutical formulations. In particular, the invention relates to attenuated swine influenza viruses having modifications to a swine NS1 gene that diminish or eliminate the ability of the NS1 gene product to antagonize the cellular IFN response. These viruses replicate in vivo, but demonstrate decreased replication, virulence and increased attenuation, and therefore are well suited for use in live virus vaccines, and pharmaceutical formulations.

Abstract: This invention provides isolated or recombinant polypeptides that are useful to vaccinate individuals suffering from chronic/recurrent biofilm disease or as a therapeutic for those with an existing infection. The individual's immune system will then naturally generate antibodies which prevent or clear these bacteria from the host by interfering with the construction and or maintenance of a functional protective biofilm. Alternatively, antibodies to the polypeptides can be administered to treat or prevent infection. Bacteria that cannot form functional biofilms are more readily cleared by the remainder of the host's immune system.

Abstract: This invention relates generally to animal models of anxiety and depression. Specifically, this invention relates to an in vivo high utility, high-throughput model for screening anxiolytic/antidepressant drugs in fowl chicks with stress vulnerability. This new animal model utilizes an inexpensive avian model, measures spontaneous behaviors in very young animals, and is capable of detecting and/or differentiating a compound's anxiolytic and/or antidepressant effects. This new animal model is especially useful in detecting and/or differentiating a compound's anxiolytic and/or antidepressant effects in treatment-resistant subjects. Animal costs are less than 10% of rodent costs and the assay can be run in a high-throughput mode.

Abstract: The present invention relates to a novel composition useful in targeted diagnostic and/or therapy of a target site, such as cancerous tissue. The composition and methods disclosed herein find particular use in diagnosing and imaging cancerous tissue. The present invention provides a new diagnostic tool for the utilization of positron emission tomography (PET) imaging technique.

Abstract: The present application discloses a method of testing for efficacy of a potential drug agent against cancerous cells in a mammal, including generating the cancer cells in a mammal; contacting the cancer cells with a potential drug agent by administering the potential drug agent to the mammal; and measuring effect of the potential drug agent on the cancer cells, wherein reduction of number of cancer cells in the mammal is indicative of efficaciousness of the potential drug agent against cancerous cells.

Abstract: The present invention relates to methods and medicaments useful for treating idiopathic pulmonary fibrosis (IFF) by administering anti-CTGF antibodies. Methods for prognosing individuals with IPF are also provided.

Abstract: The present invention provides systems and methods for performing assays for determining the presence of one or more compounds or analytes in a sample using whole-animals. The systems and methods are particularly suited to high-throughput screening techniques to identify compounds that are effective in a whole animal based system. The methods of the invention have broad application in high-throughput drug discovery and identification, particularly for molecules which are associated with disease and disease progression.

Abstract: The present invention provides reagents and methods for detecting cancer precancerous lesions in a patient.

Abstract: A method for determining whether early stage cancer is present in a subject comprises detecting the expression level of GASP-1 in the subject by detecting the amount of GASP-1 peptide fragments present in a biological sample of the subject. Because cancer can be detected at an early stage, therapeutic targeting may be initiated before cancer reaches late stage (e.g., before the development of overt symptoms). A method for treating early stage cancer in a subject comprises administering to the subject an effective amount of a GASP-1 inhibitor to inhibit the progression of early stage cancer to late stage cancer. A Competitive ELISA capable of detecting GASP-1 peptide fragments at a concentration of less than 1 ng/ml was developed.

Abstract: A unified homeostatic system of cholesterol and steroid hormone pathways is described, in which the uses or modulations of function of the homeostatic system of cholesterol and steroid hormone pathways are linked by lipoproteins, and are used or modulated to achieve a therapeutic benefit, to diagnose a disease or medical condition in humans, or to develop suitable active agents or combinations of active agents. Pharmaceutical compositions, methods of treatment, methods of drug development, and assay methods that rely on the new understanding of the homeostatic system are described.

Abstract: The present invention relates to the use of p11 as a drug target as well as a tool for the diagnosis, treatment and development of p11/5-HT receptor related disorders. The invention further relates to p11 knock-out animals as well as p11 transgenic animals and their use as models for the development of novel psychotherapeutic agents, and to methods of diagnosis, prophylaxis and treatment of p11/5-HT receptor related disorders.

Abstract: The invention concerns a method for monitoring the development of a disease in a patient, and for assessing the efficacy of a therapy influencing on the CD73 level or activity in the patient, in particular a cytokine therapy or a statin therapy. CD73 in a tissue fluid drawn from the patient is used as a biomarker. The invention concerns also methods for determining of CD73 protein in a sample drawn from an individual's tissue fluid.

Abstract: The invention relates to compounds that specifically bind a T1R1/T1R3 or T1R2/T1R3 receptor or fragments or sub-units thereof. The present invention also relates to the use of hetero-oligomeric and chimeric taste receptors comprising T1R1/T1R3 and T1R2/T1R3 in assays to identify compounds that respectively respond to umami taste stimuli and sweet taste stimuli. Further, the invention relates to the constitutive of cell lines that stably or transiently co-express a combination of T1R1 and T1R3; or T1R2 and T1R3; under constitutive or inducible conditions. The use of these cells lines in cell-based assays to identify umami and sweet taste modulatory compounds is also provided, particularly high throughput screening assays that detect receptor activity by use of fluorometric imaging.

Abstract: The presently disclosed subject matter generally relates to methods and compositions for inhibiting the expression and/or activation of hypoxia-inducible factor 1 (HIF-1) genes in a hypoxic cell. More particularly, the methods disclosed herein relate to inhibition of HIF-1 activation in a cell, increasing sensitivity of a tumor cell to radiation and/or chemotherapy, delaying tumor growth, inhibiting tumor blood vessel growth, inhibiting inflammatory responses in a cell through the use of compositions that prevent the nitrosylation of HIF-1, and methods for screening for new inhibitors of HIF-1 activiation. Additionally, the compositions disclosed herein relate to compositions that can be employed in, and are identified by, the disclosed methods.

Abstract: It has been found that efficient screening for a compound having anticancer activity can be achieved by selecting a compound having activity to induce alternative autophagy using, as an index, formation of fluorescent bright spots due to aggregation of a lysosomal protein to which a fluorescent protein is attached in cells expressing the lysosomal protein.

Abstract: The invention encompasses methods and kits used in the detection of invasive glioblastoma based upon the expression of NHERF-1. The methods and kits also allow prediction of disease outcome as well as therapeutic outcome.

Abstract: The invention includes compositions and methods of treatment of cancers susceptible to treatment with nucleotide analog chemotherapeutic agent, including cancers in which nucleotide analog resistant tumors have developed, including identifying a subject having cancer susceptible to treatment with a nucleotide analog chemotherapeutic agent and a mitotic disruptor/polo-like kinase (Plk) pathway inhibitor to a subject; and monitoring the subject for a reduction or stabilization of at least one sign or symptom of cancer.

Abstract: The invention relates to a novel use of ultrafine nanoparticles, of use as a diagnostic, therapeutic or theranostic agent, characterized by their mode of administration via the airways. The invention is also directed toward the applications which follow from this novel mode of administration, in particular for imaging the lungs, and the diagnosis or prognosis of pathological pulmonary conditions. In the therapeutic field, the applications envisioned are those of radiosensitizing or radioactive agents for radiotherapy (and optionally curietherapy), or for neutron therapy, or of agents for PDT (photodynamic therapy), in particular for the treatment of lung tumors.

Abstract: The invention provides methods, uses and compositions for the treatment of psoriasis. The invention describes methods and uses for treating psoriasis, wherein a TNF? inhibitor, such as a human TNF? antibody, or antigen-binding portion thereof, is used to treat psoriasis in a subject. Also described are methods for determining the efficacy of a TNF? inhibitor for treatment psoriasis in a subject.

Abstract: Provided herein are vaccine vectors including an antigenic polypeptide and an HMGB1 polypeptide present on the surface of the vaccine vector. Compositions comprising the vaccine vectors are also provided and include a pharmaceutically acceptable carrier, suitably a carrier for oral or nasal administration. Also provided are methods of enhancing immune responses, in particular antibody immune response and suitably an IgA response, by administering the vaccine vectors or compositions disclosed herein to a subject.

Abstract: The invention relates to a composition comprising: (i) one or more of uridine and cytidine, or salts, phosphates, acyl derivatives or esters thereof; and (ii) a lipid fraction comprising at least one of docosahexaenoic acid (22:6; DHA), eicosapentaenoic acid (20:5; EPA) and docosapentaenoic acid (22:5; DPA), or esters thereof, for use in preserving or improving functional synaptic connectivity and/or preserving brain network organization in a subject in need thereof.

Abstract: The present application relates to use of a Midkine family protein for growing hair on a mammal, or in the manufacture of a medicament for growing hair on a mammal, especially for treatment or prevention of different forms of alopecia.

Abstract: Human-derived fibroblast cells with copy number variation for alpha-synuclein, and methods of use thereof, are provided. For example, compositions and methods for high through-put screening of potential therapies for neurodegenerative disease such as Parkinson's disease are provided.

Abstract: The present invention discloses a multi-target recombination gene and the application of its protein to prevent and cure Helicobacter pylori. It includes a multi-target fusion polypeptide having amino acid sequence shown in SEQ ID NO:2, a multi-target recombination gene of encoding multi-target fusion polypeptide having nucleotide sequence shown in SEQ ID NO:1, and the application of the multi-target recombination gene or the multi-target fusion polypeptide or specific antibody of the multi-target fusion polypeptide as biological products for preventing and curing Helicobacter pylori. The present invention effectively combines the key target protein UreI for Hp gastric colonization, and antigen target of UreB to create the best drug target.

Abstract: The invention described herein relates to novel nucleic acid sequences and their encoded proteins, referred to as 158P1D7 and variants thereof, and to diagnostic and therapeutic methods and compositions useful in the management of various cancers that express 158P1D7 and variants thereof.

Abstract: The invention provides methods for predicting or determining the response of a mammalian tumor to a chemotherapeutic agent and for treating a mammalian tumor comprising detecting and quantifying the SPARC protein or RNA in a sample isolated from the mammal. The invention further provides kit for predicting the response of a mammalian tumor to a chemotherapeutic agent, comprising a means for the isolation of protein or RNA from the tumor, a SPARC protein or RNA detection and quantification means, control RNAs, and rules for predicting the response of the tumor based on the level of SPARC protein or RNA in tumor.

Abstract: This invention relates transgenic animals that overexpress TL1A in a tissue specific manner to model inflammatory bowel disease (IBD), such as colitis, Crohn's disease and ulcerative colitis, fibrosis, and related inflammatory diseases and conditions. TL1A transgenic animals constitutively express both TL1A and GFP in lymphoid and myeloid cell lineages, allowing convenient identification and sorting of immune cells involved in IBD disease progression, such as T-cells, antigen presenting cells (APC), and dendritic cells (DC). TL1A transgenic animals may be induced to exhibit gross fibrosis, or isolated cells may be implanted into immunodeficient mice to establish colitis.

Abstract: The present invention provides compositions comprising polytheylyene-dialkyloxypropyl conjugates (PEG-DAA), liposomes, SNALP, and SPLP comprising such compositions, and methods of using such compositions, liposomes, SNALP, and SPLP.

Abstract: Provided is a pharmaceutical composition that includes one or more inactivated Mycobacterium spp., which are preferably inactivated using gamma irradiation, and which is than formulated for mucosal or pulmonary delivery to a subject. The pharmaceutical compositions are useful for preventing or treating mycobacterium-associated infections in a subject, including a human subject.

Abstract: Nuclear Transport Modifiers such as cSN50 and cSN50.1, afford in vivo islet protection following a 2-day course of intense treatment in autoimmune diabetes-prone, non-obese diabetic (NOD) mice, a widely used model of Type 1 diabetes (T1D), which resulted in a diabetes-free state for one year without apparent toxicity and the need to use insulin. cSN50 precipitously reduces the accumulation of islet-destructive autoreactive lymphocytes while enhancing activation-induced cell death of T and B lymphocytes derived from NOD mice. cSN50 attenuated pro-inflammatory cytokine and chemokine production in immune cells in this model of human T1D. cSN50 also provides cytoprotection of beta cells, therefore preserving residual insulin-producing capacity. Because intracellular delivery of a Nuclear Transport Modifier peptide such as cSN50 and cSN50.

Abstract: The present disclosure provides compositions and methods for the prevention or treatment of ocular neovascularization, such as AMD, in a human subject, by administering subretinally a pharmaceutical composition comprising a pharmaceutically effective amount of a vector comprising a nucleic acid encoding soluble Fms-related tyrosine kinase-1 (sFlt-1) protein to the human subject.

Abstract: Provided is a method for evaluating a flavor-improving agent. The method includes (1) giving subjects a solution prepared by adding a known flavor-improving agent to an aqueous solution of a taste substance and measuring a change in signal strength at a periphery of the temple of the forehead with an apparatus for in vivo optical measurement; (2) selecting a subject showing a change in signal strength (1); (3) giving a solution prepared by adding a test flavor-improving agent to an aqueous solution of the taste substance to the subject in (2) as an object, measuring a change in signal strength at the periphery of the temple of the forehead with an apparatus for in vivo optical measurement, and evaluating the flavor-improving effect from the change in signal strength as an index.

Abstract: Methods are provided for producing novel multicellular compositions comprising cancer cells together with pluripotent human stem cells, which are capable of proliferating and differentiating into various normal cell lines and tissue structures. These novel multicellular compositions are useful for investigating the properties of cancer cells in a normal human tissue microenvironment, and for studying interventions that will modulate these properties including devising, testing and screening therapeutic drugs.

Abstract: The invention relates to methods for producing papilloma-derived nanosphere particles that contain therapeutic, diagnostic, or other agents. The invention also provides nanosphere particle preparations that are useful for selectively delivering therapeutic, diagnostic, and/or other agents to cancer cells of subjects without eliciting a serotype-specific immunogenic response in the subjects.

Abstract: Described herein are methods, systems, and devices for identifying agents and genetic pathways that modulate the effects of traumatic brain injury (TBI) in invertebrate model systems having a brain, e.g., Drosophila or C. elegans.