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Inventi Impact - Clinical Research

Patent Watch

  • Determination of the anesthetic state of a patient

    The invention relates to the determination of the anesthetic state of a patient. In order to achieve a mechanism that enables establishment and maintenance of balanced anesthesia, values are established for a set of diagnostic indices. The set includes at least two diagnostic indices of which a first diagnostic index is indicative of the level of hypnosis and a second diagnostic index of the level of nociception in the patient. The combination of the at least two index values obtained is employed for indicating the anesthetic state of the patient. The combination of the at least two index values may further be employed to control the administration of drugs to the patient.

  • Method and apparatus for determining cardiac performance in a patient with a conductance catheter

    An apparatus for determining cardiac performance in the patient involving a conductance catheter (12) for measuring conductance and blood volume in a heart chamber of the patient. The apparatus includes a processor (14) for determining instantaneous volume of the ventricle by applying a non-linear relationship between the measured conductance and the volume of blood in the heart chamber to identify mechanical strength of the chamber. The processor (14) is in communication with the conductance catheter (12).

  • Pulse oximeter based techniques for controlling anesthesia levels and ventilation levels in subjects

    Medical devices and techniques derive breath rate, breath distention, and pulse distention measurements of a subject from a pulse oximeter system coupled to the subject. These parameters together with the conventional physiologic parameters obtained from a pulse oximeter system can be used to assist in controlling the ventilation levels and the anesthesia levels of the subject. The development has human applications and particular application for animal research.

  • Integration-site directed vector systems

    Some aspects of the application describe materials and methods for making a molecular tether. A molecular tether, in certain embodiments, includes a target-DNA-binding domain having a specific binding affinity for a target-DNA segment in a host chromosome, a carrier-binding domain that specifically binds to a DNA segment on a carrier, and a spacer covalently bonded to the target DNA-binding domain and the carrier-binding domain.

  • Hematopoietic stem cell identification and isolation

    The present invention relates to methods of identifying, collecting and isolating hematopoietic stem cells (HSCs) and compositions of purified HSCs. Specifically, the present invention provides methods of isolating and purifying CD150.sup.+ HSCs, CD48.sup.- HSCs, and CD244.sup.- HSCs. The present invention also relates to purified cell samples with enriched CD150.sup.+ HSCs, CD48.sup.- HSCs, and CD244.sup.- HSCs populations, as well as methods of treating subjects with such compositions.

  • Tissue analysis and kits therefor

    This invention relates to methods of analyzing a tissue sample from a subject. In particular, the invention combines morphological staining and/or immunohistochemistry (IHC) with fluorescence in situ hybridization (FISH) within the same section of a tissue sample. The analysis can be automated or manual. The invention also relates to kits for use in the above methods.

  • Methods for treating obesity

    Methods for treating obesity are disclosed which comprise administration of a therapeutically effective amount of an amylin or an amylin agonist alone or in conjunction with another obesity relief agent.

  • Stem cell expansion and uses

    The invention relates to methods to prevent, treat, ameliorate or slow the progression of one or more of a blood cell deficiency, unwanted inflammation, allergy, immune suppression condition, immunosenescence, autoimmune disorder, infection, neurological disorder, cardiovascular disorder, pulmonary disorder, trauma, hemorrhage, bone fracture or unwanted or excess bone loss with steroid compounds containing carbon-carbon double bonds within the fused four-ring system such that the steroid compounds are unsaturated. The unsaturated steroid compounds include 3,16.alpha.,17.beta.-trihydroxy-7-acetoxy-androst-1,3,5(10),6-tet- raene, 3,16.alpha.,17.beta.-trihydroxy-7-methoxy-androst-1,3,5(10),6-tetra- ene, 3,17.beta.-dihydroxy-7-acetoxy-16.alpha.-fluoro-androst-1,3,5(10),6-t- etraene, 3,17.beta.-dihydroxy-7-methoxy-16.alpha.-fluoro-androst-1,3,5(10)- ,6-tetraene, 3,17.beta.-dihydroxy-7,16.alpha.-diacetoxy-androst-1,3,5(10),6-tetraene and 3,17.beta.-dihydroxy-7-methoxy-16.alpha.-acetoxy-androst-1,3,5(10),6-- tetraene.

  • Cystic fibrosis treatment methods

    The invention relates to the use of compounds to ameliorate or treat an condition such as a cystic fibrosis, neutropenia or other exemplified conditions. Exemplary compounds that can be used include 3.beta.-hydroxy-17.beta.-aminoandrost-5-ene, 3.beta.-hydroxy-16.alpha.-fluoro-17.beta.-aminoandrost-5-ene, 3.alpha.-hydroxy-16.alpha.-fluoro-17.beta.-aminoandrost-5-ene, 3.beta.-hydroxy-16.beta.-fluoro-17.beta.-aminoandrost-5-ene, 1.alpha.,3.beta.-dihydroxy-4.alpha.-fluoroandrost-5-ene-17-one, 1.alpha.,3.beta.,17.beta.-trihydroxy-4.alpha.-fluoroandrost-5-ene, 1.beta.,3.beta.-dihydroxy-6.alpha.-bromoandrost-5-ene, 1.alpha.-fluoro-3.beta.,12.alpha.-dihydroxyandrost-5-ene-17-one, 1.alpha.-fluoro-3.beta.,4.alpha.-dihydroxyandrost-5-ene and 4.alpha.-fluoro-3.beta.,6.alpha.,17.beta.-trihydroxyandrostane.

  • PTHrP, its isoforms and antagonist thereto in the diagnosis and treatment of disease

    The present invention is directed to the diagnosis and treatment of diseases, preferably the inhibition of tumor growth and its progression to metastatic sites, through the inhibition of the production of PTHrP, its isoforms or PTHrP signalling. The present invention is also directed to methods of inhibiting the PTHrP1-173 isoform through antagonists thereof, including monoclonal antibodies and siRNA directed there against. The invention may be applicable to many disease states, including but not limited to several types of cancer (such as breast, lung, prostate, melanoma and squamous) expressing PTHrP and its isoforms, alone or in combination with other therapeutic agents.

  • Methods of diagnosing Alzheimer's disease

    Methods and compositions relating to Alzheimer's disease are provided. Specifically, proteins that are differentially expressed in the Alzheimer's disease state relative to their expression in the normal state are provided. Proteins associated with Alzheimer's disease are identified and described. Methods of diagnosis of Alzheimer's disease using the differentially expressed proteins are also provided, as are methods for the identification and therapeutic use of compounds for the prevention and treatment of Alzheimer's disease.

  • Viral chemokine-antigen fusion proteins

    The present invention relates to a vaccine for increasing the immunogenicity of a tumor antigen thus allowing treatment of cancer, as well as a vaccine that increases the immunogenicity of a viral antigen, thus allowing treatment of viral infection, including immunodeficiency virus (HIV) infection. In particular, the present invention provides a fusion protein comprising a viral chemokine fused to either a tumor antigen or viral antigen which is administered as either a protein or nucleic acid vaccine to elicit an immune response effective in treating cancer or effective in treating or preventing viral infection.

  • Use of relaxin to increase arterial compliance

    The present invention provides methods for increasing arterial compliance. The methods generally involve administering to an individual in need thereof an effective amount of relaxin. The present invention further provides methods of increasing arterial compliance in individuals who have Type 1 or Type 2 diabetes. The present invention further provides methods of increasing arterial compliance in perimenopausal, menopausal, and post-menopausal women. The present invention further provides methods of increasing arterial compliance in individuals who have or who are at risk of developing age-associated arterial stiffness.

  • Detection and monitoring of liver damage

    A method of detecting liver damage in a subject comprises measuring the level of caspase-3 generated cytokeratin-18 fragments in the bodily sample. The level of measuring the level of caspase-3 generated cytokeratin-18 fragments is then correlated with liver disease progression.

  • Purine and imidazopyridine derivatives for immunosuppression

    The present invention provides novel purine and imidazopyridine derivatives useful for the prevention and treatment of autoimmune diseases, inflammatory disease, mast cell mediated disease and transplant rejection. The compounds are of the general formulas: ##STR00001##

  • Anti-inflammatory compounds and uses thereof

    The present invention provides anti-inflammatory compounds, pharmaceutical compositions thereof, and methods of use thereof for treating inflammatory disorders. The present invention also provides methods of identifying anti-inflammatory compounds and methods of inhibiting NF-.kappa.B-dependent target gene expression in a cell.

  • Use of stimulated peripheral-blood mononuclear cells for the treatment of cancerous diseases

    The invention relates to the use of peripheral-blood mononuclear cells that have been stimulated via cascade priming (CAPRI cells) for the purpose of providing an agent for the treatment of cancerous diseases. The CAPRI cells may also be administered in combination with CD3-activated cells.

  • Optimized probe selection method

    The present invention provides methods for optimizing oligonucleotide hybridization probes for use in basic and clinical research. Specifically, the invention involves hybridizing serially diluted genomic sample to the oligonucleotide probes on the array, such that a signal intensity is produced for each of the probes; computationally identifying optimized probes which exhibit signal intensities that correspond to the serial dilutions of genomic sample and are reproducibly strong relative to non-optimized probes.

  • Solid-phase extraction method of steroid hormones by entrapped .beta.-cyclodextrin polymers

    Provided is a method for selective extraction of steroid compounds using entrapped .beta.-cyclodextrin polymers. Particularly, steroid hormones can be effectively selected from a biological sample by selectively extracting steroid compounds using entrapped .beta.-cyclodextrin polymers, prepared by adding epichlorohydrin to .beta.-cyclodextrin to prepare a polymer in a gel state, entrapping the polymer and pulverizing the products without using an additional device required in conventional solid-phase extraction.

  • CaR receptor as a mediator of migratory cell chemotaxis and/or chemokinesis

    This invention relates to methods and compositions for modulating movement of eukaryotic cells with migratory capacity. More specifically, the invention relates to methods and compositions for modulating movement of CaR receptor expressing cells of hematopoietic, neural, epithelial, endothelial, or mesenchymal origin, in a specific site in a subject. The foregoing are useful, inter alia, in the treatment of conditions characterized by a need to modulate migratory-cell movement associated with specific sites in a subject. Specific sites include sites of inflammation and modulation of migratory-cell movement is movement away from an agent source, or repulsion. The invention also relates to methods for manipulating hematopoeitic progenitor cells and related products. In particular the invention includes methods and products for using CaR receptor-related compositions to enhance mobilization of hematopoietic progenitor cells, to improve the efficiency of targeting cells to the bone marrow, and/or to modulate hematopoietic progenitor cell function.

  • Method and apparatus for determining familial risk of disease

    Personal and family health history information can be used to assess familial risk of disease. For example, information can be collected about the disease history of a person and the person's first- and second-degree relatives and then analyzed to determine the familial risk of common diseases such as coronary heart disease, stroke, type 2 diabetes, and colorectal, breast, and ovarian cancer. Assessed familial risk of disease can then be used by researchers to better estimate the contribution of personal history and family history to the etiology and natural history of a disease of interest, and by consumers and health professionals to determine recommendations for disease management, prevention and screening that are personalized and targeted to the familial risk. Other embodiments are also described and claimed.

  • Cytotoxicity mediation of cells evidencing surface expression of CD44

    This invention relates to the diagnosis and treatment of cancerous diseases, particularly to the mediation of cytotoxicity of tumor cells; and most particularly to the use of cancerous disease modifying antibodies (CDMAB), optionally in combination with one or more chemotherapeutic agents, as a means for initiating the cytotoxic response. The invention further relates to binding assays which utilize the CDMAB of the instant invention.

  • Systems and methods for inducing electric field pulses in a body organ

    Systems and methods for providing controllable pulse parameter magnetic stimulation are described. One aspect is directed to a magnetic stimulation system for inducing approximately rectangular electric field pulses in a body organ, comprising an electrical energy storage device, a stimulating coil, and a switching means for electrically coupling said electrical energy storage device to said stimulating coil to produce current pulses in said stimulating coil which generates, in response to the current pulses, magnetic field pulses that can induce approximately rectangular electric field pulses in the body organ.

  • Bioimpedance methods and apparatus

    Methods and apparatus for providing bioimpedance analysis are provided. In certain aspects, equivalent circuit frequency response models are provided which lead to improved correlations with MRI data. The frequency response models take account of body composition, including the fat component of a body segment. Data obtained by performing bioimpedance spectroscopy (BIS) and MRI on the calves of subjects illustrates the improved correlations achieved compared to single frequency analyses at 50 kilohertz and analyses performed using the conventional Cole-Cole model.

  • System and method for monitoring or treating nervous system disorders

    A medical device system for comparing a cardiopulmonary signal to a brain signal. In one embodiment of the invention, a medical device system is provided that includes a brain monitoring element, respiratory monitoring element and a processor. The processor is configured to receive a brain signal from the brain monitoring element and a respiratory signal from the respiratory monitoring element. The processor is further configured to compare the brain signal to the respiratory signal. Methods of comparing a brain signal to a cardiopulmonary signal are also provided.

  • Genes and polypeptides relating to human pancreatic cancers

    The present application provides novel human genes C1958V1 or C1958V2 whose expression is markedly elevated in pancreatic cancers compared to corresponding non-cancerous tissues. The genes and polypeptides encoded by the genes can be used, for example, in the diagnosis of pancreatic cancer, and as target molecules for developing drugs against the disease.

  • High potency dopaminergic treatment of neurological impairment associated with brain injury

    Methods and compositions are described for treating impaired neurological function, including altered state of consciousness disorders, in an individual who has sustained a brain injury comprising administering to the individual apomorphine. Methods and compositions are described for treating impaired neurological function, including altered state of consciousness disorders, in an individual who has sustained a brain injury comprising administering to the individual at least 1000 mg or more of L-dopa (levodopa) per day. The use of potent dopaminergic agents to stimulate emergence from an altered consciousness state, such as a coma, is disclosed.

  • Supported molecular biofluid viscosity sensors for in vitro and in vivo use

    A device and a method for measuring viscosity that includes attaching molecular rotors to a solid surface, exposing the solid surface to a fluid having a viscosity to be measured, and taking optical measurements to determine viscosity. The solid surface is preferably quartz, polystyrene or silicate glass, such as a fiber optic probe or a glass cuvette. The molecular rotors are of the type that includes an electron-donor group and electron-acceptor group that are linked by a single bond so that the groups may rotate with respect to one another, and that exhibit a fluorescence emission when rotation is hindered.

  • Method for determining fluctuation in attentional state and overall attentional state

    The invention provides methods for determining shifts in the attentional state of a subject. These methods are useful for diagnosing subjects with a psychological or behavioral disorder. The invention also features methods for determining the effect of a therapy on the overall attentional state and shifts in the attentional state of a subject.

  • Method for administering GLP-1 molecules

    The invention relates to formulations that demonstrate the feasibility of oral absorption comprising glucose-like peptide-1 compounds and specified delivery agents, and to methods of stimulating GLP-1 receptor in a subject in need of such stimulation, by administration of the formulation of the present invention.

  • Breast cancer related gene ZNFN3A1

    Objective methods for detecting and diagnosing breast cancer (BRC) are described herein. Also described are methods of treating and preventing breast cancer and breast cancer metastasis as well as methods of assessing the prognosis of a breast cancer subject and the efficacy of a breast cancer therapy. In one embodiment, the diagnostic method involves determining the expression level of ZNFN3A1, a gene whose expression is markedly elevated in breast cancers, that therefore can be used to discriminate between BRC cells and normal cells. The present invention further provides methods of screening for therapeutic agents useful in the treatment of BRC, methods of treating BRC and method for vaccinating a subject against BRC.

  • Compositions and methods for treating and diagnosing cancer

    The present invention relates to compositions and methods for treating, characterizing, and diagnosing cancer. In particular, the present invention provides gene expression profiles and signatures associated with solid tumor stem cells, as well as novel stem cell cancer markers useful for the diagnosis, characterization, prognosis and treatment of solid tumor stem cells. More particularly, the present invention identifies two profiles of cancer stem cells useful for the diagnosis, characterization, and treatment of cancer and cancer metastases. The invention also provides a variety of reagents such as stem cell gene signatures for use in the diagnosis and management of cancer.

  • Artery- and vein-specific proteins and uses therefor

    Arterial and venous endothelial cells are molecularly distinct from the earliest stages of angiogenesis. This distinction is revealed by expression on arterial cells of a transmembrane ligand, called EphrinB2 whose receptor EphB4 is expressed on venous cells. Targeted disruption of the EphrinB2 gene prevents the remodeling of veins from a capillary plexus into properly branched structures. Moreover, it also disrupts the remodeling of arteries, suggesting that reciprocal interactions between pre-specified arterial and venous endothelial cells are necessary for angiogenesis. This distinction can be used to advantage in methods to alter angiogenesis, methods to assess the effect of drugs on artery cells and vein cells, and methods to identify and isolate artery cells and vein cells, for example.

  • Systems and methods of conducting clinical research

    Information management systems for clinical research, and related methods, are disclosed. The management system may have a database of biometric sample information. At least some of the pieces of sample information in the database may have been received from a test-subject in a first clinical research effort, and each piece of sample information may have a related pointer stored in the database. Each pointer may identify the location of clinical research information obtained during the first clinical research effort.

  • RNA interference mediated inhibition of hepatitis C virus (HCV) expression using short interfering nucleic acid (siNA)

    The present invention relates to compounds, compositions, and methods for the study, diagnosis, and treatment of traits, diseases and conditions that respond to the modulation of hepatitis C virus (HCV) gene expression and/or activity. The present invention is also directed to compounds, compositions, and methods relating to traits, diseases and conditions that respond to the modulation of expression and/or activity of genes involved in hepatitis C virus (HCV) gene expression pathways or other cellular processes that mediate the maintenance or development of such traits, diseases and conditions. Specifically, the invention relates to double stranded nucleic acid molecules capable of mediating or that mediate RNA interference (RNAi) against hepatitis C virus (HCV) gene expression, including cocktails of such small nucleic acid molecules and lipid nanoparticle (LNP) formulations of such small nucleic acid molecules.

  • RNA detection assays

    The present invention provides novel cleavage agents and polymerases for the cleavage and modification of nucleic acid. The cleavage agents and polymerases find use, for example, for the detection and characterization of nucleic acid sequences and variations in nucleic acid sequences. In some embodiments, the 5' nuclease activity of a variety of enzymes is used to cleave a target-dependent cleavage structure, thereby indicating the presence of specific nucleic acid sequences or specific variations thereof.

  • Quality assurance scorecard for diagnostic medical agent administration

    The present invention relates to a method and apparatus where pre-defined diagnostic medical agent administration data are prospectively collected and analyzed, in order to provide an objective contrast administration risk-benefit analysis, and provide an impartial analysis for pre-testing assessment, as well as optimization of examination, contrast selection and performance parameters. By storing this data in a standardized and centralized fashion, the data could in turn be used for clinical outcome analysis on a local, regional, and national level.

  • Distributed system for neurostimulation therapy programming

    A distributed system comprises a programming device and a remotely located server. During a programming session, the programming device transmits programs and rating information associated with the programs to the server. The server presents the rating information to a clinician to assist the clinician in selecting from among programs tested during the programming session. The programming device may also transmit patient information and device configuration information to the server for storage with selected programs and rating information within a database as part of a patient record. Programs and information received from a plurality of programming devices and for a plurality of patients may be stored in the database and analyzed by the server to provide responses to user queries made by clinicians via programming devices.

  • Detection, isolation and uses of renalase (monoamine oxidase C)

    The present invention provides for the identification, isolation and uses of mammalian Monoamine Oxidase C (MAO-C), also known as renalase.

  • dUTP-based compositions for reducing primer-aggregate formations during nucleic acid amplification

    Methods and compositions are provided for enhanced specificity and sensitivity of amplification reaction mixtures. Compositions in accordance with the present invention provide for reduced formation of primer-aggregates during amplification reactions. Reaction mixes include dNTPs, where a portion of the dNTPs has been replaced with an unconventional nucleotide, e.g., dUTP. Unconventional nucleotide concentrations are typically between 10% to 50% of the concentration of one of the standard dNTP. In some compositions the unconventional nucleotide is dUTP which replaces from about 10% to about 50% of the dTTP in the dNTP mix.

  • Serpentine transmembrane antigens expressed in human cancers and uses thereof

    Described is a novel family of cell surface serpentine transmembrane antigens. Two of the proteins in this family are exclusively or predominantly expressed in the prostate, as well as in prostate cancer, and thus members of this family have been termed "STEAP" (Six Transmembrane Epithelial Antigens of the Prostate). Four particular human STEAPs are described and characterized herein. The prototype member of the STEAP family, STEAP-1, appears to be a type IIIa membrane protein expressed predominantly in prostate cells in normal human tissues. Structurally, STEAP-1 is a 339 amino acid protein characterized by a molecular topology of six transmembrane domains and intracellular N- and C-termini, suggesting that it folds in a "serpentine" manner into three extracellular and two intracellular loops. STEAP-1 protein expression is maintained at high levels across various stages of prostate cancer. Moreover, STEAP-1 is highly over-expressed in certain other human cancers.

  • MAPC administration for the treatment of lysosomal storage disorders

    The present invention relates to methods for providing lysosomal enzymes to a subject by administering stem cells, preferably Multipotent Adult Progenitor Cells (MAPCs). The invention further relates to methods for treating lysosomal storage disorders by administering stem cells.

  • Virtual data room with access to clinical trial status reports based on real-time clinical trial data

    A virtual data room distributes information associated with an investigational product, such as an investigational compound. The information includes documents associated with the investigational product; and reports based on live clinical study data of the investigational product. The live clinical study data includes cleaned and not cleaned data records. For a designated subset of data records, the reports use data associated with only cleaned data records, and for the remaining data records, the reports use data regardless of whether the data is associated with cleaned or not cleaned data records.

  • BACTERIAL COMPOSITIONS FOR PROPHYLAXIS AND TREATMENT OF DEGENERATIVE DISEASE

    The disclosure provides an oral composition for reducing serum cholesterol, serum lipids, body fat, or atherogenic index or for prophylaxis or treatment of atherosclerosis, cardiovascular or cerebrovascular diseases, comprising a highly bsh active bacteria, isolate or supernatant thereof; wherein the highly bsh active bacteria degrades >50 .mu.mol glycodeoxycholic acid (GDCA)/gram/hour and >2 .mu.mol taurodeoxycholic acid (TDCA)/gram/hour when measured over 1 hour and 5 hours, respectively, or degrades >65 .mu.mol GDCA/g/hr and >7 .mu.mol TDCA/g/hr when measured over 30 minutes.

  • Methods and compositions for universal detection of nucleic acids

    Provided are methods and compositions for detecting the presence or amount of one or more target nucleic acids in a sample. Methods of the present invention include linking universal nucleic acid segments into a single molecule in a linking reaction dependent on a target nucleic acid of interest. A variety of universal segment linking strategies are provided, including preamplification by polymerase chain reaction, ligation-based strategies, reverse transcription and linear polymerase extension. Linking the universal segments into a single molecule generates a tagged target nucleic acid which is detected in a manner dependent on an intramolecular interaction between one universal segment and a second portion of the tagged target nucleic acid. In certain embodiments, the intramolecular interaction includes the formation of a hairpin having a stem between a universal segment at one end of the tagged target nucleic acid and a second universal segment at the opposite end of the tagged target nucleic acid. A variety of detection formats are provided, including solution-phase and surface-based formats. The methods and compositions are well-suited for highly multiplexed nucleic acid detection, and are applicable for the detection of any target nucleic acid of interest in both research and clinical settings.

  • METHOD, SYSTEM AND MEDIUM FOR ASSESSING THE IMPACT OF VARIOUS AILMENTS ON HEALTH RELATED QUALITY OF LIFE

    The present invention relates to a system and method for assessing the impact of an ailment on a health related quality of life domain of a patient using a standardized common metric. The standardized common metric of the present invention enables the impact of various ailments to be compared.

  • METHOD AND APPARATUS FOR IDENTIFYING A SAFE AND EFFICACIOUS DOSING REGIMEN

    The invention features methods and systems to provide, in one test session, information on the patient's sensitivity to a probe drug for treating attentional disorders. The methods and systems of the invention can enable clinicians and consumers to ascertain how much benefit an individual would derive from treatment, what dose would be required, and the acute effect of that dose on regularity and rhythmicity of their heartbeat.

  • FORMULATION OF DUAL CYCLOXYGENASE (COX) AND LIPOXYGENASE (LOX) INHIBITORS FOR MAMMAL SKIN CARE

    The present invention provides a novel composition of matter comprised of a mixture of two specific classes of compounds--Free-B-Ring flavonoids and flavans--for use in the prevention and treatment of diseases and conditions associated with the skin. This composition of matter simultaneously inhibits cyclooxygenase (COX) and lipoxygenase (LOX) enzymatic activity in normal, aged and damaged dermal cells and tissues. This invention further provides a method for the prevention and treatment of diseases and conditions of the skin mediated by cyclooxygenase (COX) and lipoxygenase (LOX). The method for preventing and treating COX and LOX mediated diseases and conditions of the skin is comprised of topically administering to a host in need thereof a therapeutically effective amount of a composition comprising a mixture of Free-B-Ring flavonoids and flavans synthesized and/or isolated from a single plant or multiple plants, preferably in the Scutellaria and Acacia genus of plants and pharmaceutically and/or cosmetically acceptable carriers. Finally the present invention provides a method for the prevention and treatment of COX and LOX mediated diseases and conditions, including but not limited to sun burns, thermal burns, acne, topical wounds, minor inflammatory conditions caused by fungal, microbial and viral infections, vitilago, systemic lupus erythromatosus, psoriasis, carcinoma, melanoma, as well as other mammal skin cancers, skin damage resulting from exposure to ultraviolet (UV) radiation, chemicals, heat, wind and dry environments, wrinkles, saggy skin, lines and dark circles around the eyes, dermatitis and other allergy related conditions of the skin. Use of the composition described herein also affords the benefit of smooth and youthful skin with improved elasticity, reduced and delayed aging, enhanced youthful appearance and texture, and increased flexibility, firmness, smoothness and suppleness.

  • COMPOSITIONS AND METHODS FOR TREATING PSYCHIATRIC DISORDERS

    Methods of treating psychiatric disorders are provided which include administration of one or more anti-epileptic agents and, optionally, one or more a psychostimulants. Also provided are pharmaceutical compositions comprising, in combination, one or more anti-epileptic agents and one or more psychostimulants. Psychiatric disorders include those associated with impaired cognitive processing, degenerative disorders such as Mild Cognitive Impairment, Parkinson's disease, dementia, non-compliance with therapeutic regimes and eating disorders, although without limitation thereto.

  • Oral B12 Therapy

    Methods of normalizing vitamin B.sub.12 levels in patients with low vitamin B.sub.12 and methods of normalizing intersubject variability in the treatment of such patients are described. Methods of reducing MMA and/or homocysteine levels, and pharmaceutical compositions useful to effect such changes are also described.

  • Non-Typeable Haemophilus Influenzae Vaccines and Their Uses

    Provided are non-typeable Haemophilus influenzae vaccines useful for the treatment of chronic obstructive pulmonary disease and asthma in a patient. In certain aspects, the vaccine is a monobacterial vaccine. Bacterial strains for use in the vaccines of the present application are also provided.

  • AUTOMATED METHOD OF DISPLAYING AND UPDATING THE STATUS OF CLINICAL RESEARCH SITES IN A CLINICAL TRIAL TO IDENTIFY READINESS OF SITES TO ACCEPT PATIENTS

    An automated process generates a displayable report of the status of clinical research sites in a clinical trial to identify readiness of sites to accept patients. The clinical trial has a plurality of sites in multiple countries which accept patients. A plurality of electronically tracked site-based milestones and separate country-based milestones are provided for the clinical trial. Each site is associated with a country. The status of the site-based milestones and country-based milestones are electronically tracked in a database. The site-based milestones and the country-based milestones are tracked separately from each other. A displayable report of the status of the electronically tracked site-based milestones and country-based milestones is automatically generated in a processor. The report separately identifies the status of the site-based milestones and the country-based milestones. Also, each site-based milestone is categorized into one of the plurality of milestone groups, and the report shows the status of the site-based milestone groups.

  • METHODS FOR DETECTING A MYCOBACTERIUM TUBERCULOSIS INFECTION

    Methods for detecting an infection with Mycobacterium tuberculosis (Mtb) in a subject are disclosed, wherein the subject is a child, a subject with a latent Mycobacterium tuberculosis infection. Method are also disclose for detecting an extra-pulmonary Mycobacterium tuberculosis infection in a subject. The methods include detecting the presence of CD8.sup.+ T cells that specifically recognize an Mtb polypeptide. The methods include in vitro assays for detecting the presence of CD8.sup.+ T cells in a biological sample.

  • Oral recombinant helicobacter pylori vaccine and preparing method thereof

    The invention relates to a recombinant protein used for immunoprophylaxis of human Helicobacter pylori infection and a degradable slow-releasing microsphere-encapsulated oral vaccine preparation prepared from the same, and the preparation method thereof. Said recombinant protein is composed of A2 subunit and B subunit of the LT of enterotoxigenic Escherichia coli and urease B subunit. The vaccine provided in the invention used in human Helicobacter pylori infection is safe and effective and convenient for oral intake.

  • Antibodies Against Human Cytomegalovirus (HCMV)

    The present invention provides novel antibodies sequences that bind human cytomegalovirus (hCMV) and neutralize hCMV infection. The novel sequences can be used for the medical management of hCMV infections, in particular for preparing pharmaceutical compositions to be used in the prophylactic or therapeutic treatment of hCMV infections.

  • METHODS AND DEVICES FOR MEASURING TEAR FILM AND DIAGNOSING TEAR DISORDERS

    Methods and devices measure eye blinks and tear film lipid and aqueous layer thickness before and following ophthalmic formula application onto the ocular surface, especially wherein the ophthalmic formula is an artificial tear. The methods and devices are suitable for dry eye diagnosis. The methods and devices are suitable for use to evaluate ophthalmic formula effects on the tear film and to use such information to diagnose ophthalmic formula treatment of ocular disease conditions such as dry eye in the absence of contact lens wear or post-surgical eye drop treatment and diagnosis. The methods and devices are also suitable for use in the optimization of ophthalmic drug dosage forms and sustained drug release.

  • SOLID FORMS OF 4--N,N-DIETHYLBENZAMIDE, COMPOSITIONS THEREOF, AND USES THEREWITH

    Solid forms comprising salts of 4-{(R)-(3-aminophenyl)[4-(4-fluorobenzyl)piperazin-1-yl]methyl}-N,N-dieth- ylbenzamide, compositions comprising the solid forms, methods of making the solid forms, and methods of their use for the treatment of various diseases and/or disorders are provided herein.

  • SYSTEM FOR PERFORMING CLINICAL TRIALS

    A system, method and device for monitoring a clinical trial and remotely evaluating the accuracy of data generated during the clinical trial.

  • SERUM MARKERS PREDICTING CLINICAL RESPONSE TO ANTI-TNFa ANTIBODIES IN PATIENTS WITH ANKYLOSING SPONDYLITIS

    The invention provides tools for management of patients diagnosed with ankylosing spondylitis and prior to the initiation of therapy with an anti-TNFalpha agent. The tools are specific markers and algorithms of predicting response to therapy based on standard clinical primary and secondary end-points using serum marker concentrations. In one embodiment the baseline level of leptin or osteocalcin is used to predict the response at Week 14 after the initiation of therapy. In another embodiment, the change in a serum protein biomarker after 4 weeks of therapy is used such as complement component 3.

  • Clinical Method for Individualized Epithelial Cancer Screening Involving ERCC5 and IGF2R Genetic Testing and Gene-Environment Interactions

    A system for determining individualized risk of developing aerodigestive cancers or cancers of the liver is described. Methods and compositions for assessing ERCC5 and/or IGF2R genetic variation and expression and their effects in view of certain environmental exposures in determining the risk of an individual for developing one or more epithelial cancers are provided. The system includes a kit used to collect a DNA sample from an individual and data related to the individual's medical and occupational history, use of tobacco and alcohol products as well as the individual's environment. An algorithm may be applied to transform the DNA sample and data into an individualized risk score, accounting for inter-individual variation in genetic profile and environmental/lifestyle exposures. The risk score may be indicative of the individual's risk of having or developing epithelial cancer, and the cancers prognosis. The risk score may be distributed to one or more of the individual, physician and other personnel. Test results and risk score have novel clinical utilities; diagnosis, prognosis, and treatment programs and activities may be facilitated by one or more of the kit and the risk score.

  • Compliant Blood Vessel Graft

    Stents and methods of using stents are provided. Stents of the invention provide external support structure for a blood vessel segment disposed within, wherein the stents are capable of resilient radial expansion in a manner mimicking the compliance properties of an artery. The stent may be formed of a knitted or braided mesh formed so as to provide the needed compliance properties. A venous graft with the stent and a vein segment disposed within is provided, wherein graft is capable of mimicking the compliance properties of an artery. Methods of selecting stents for downsizing and methods of using the stents of the invention in downsizing and smoothening are provided. Methods of replacing a section of an artery with a venous graft including a stent of the invention are provided. Methods of reducing intimal hyperplasia in implanted vein segment in a venous graft using stents of the invention are provided.

  • HPV E6 protein T cell epitopes and uses thereof

    The present invention is directed to the examination of the pattern of immunodominant T cell epitopes in the E6 protein of Human Papilloma virus and its further characterization in terms of its amino acid sequence and Human Leukocyte Antigen restriction. These epitopes are identified based on their ability to induce specific T cell responses and therefore, are important as sources of antigens for immunotherapies to treat cervical and other cancers. The present invention contemplates identifying a number of similar epitopes restricted by a wide variety of Human Leukocyte Antigen types so that they can be used together to develop preventative or therapeutic vaccines, which can be used for the general human population. The present invention also contemplates using E6 peptides of Human Papilloma virus as a diagnosis method to predict the probability of developing persistent cervical neoplasia in an individual.

  • Methods and Compositions for Correlating Genetic Markers with Conversion of Medium Chain Polyunsaturated Fatty Acids to Long Chain Polyunsaturated Fatty Acids

    The present invention provides methods of identifying a subject having an increased or decreased ability to convert medium chain-polyunsaturated fatty acids (MC-PUFAs) to long chain polyunsaturated fatty acids (LC-PUFAs), comprising: (a) correlating the presence of one or more than one genetic marker in chromosome 11ql2-13, between build 37.1 position 61548559 and build 37.1 position 61560261, with an increased ability to convert MC-PUFAs to LC-PUFAs; and b) detecting the one or more than one genetic marker of step (a) in the subject, thereby identifying the subject as having an increased ability to convert MC-PUFAs to LC-PUFAs. Also provided are methods of correlating one or more genetic markers with an ability to convert MC-PUFAs to LC-PUFAs.

  • Method For Genetic Analysis Of DNA To Detect Sequence Variances

    Methods for determining genotypes and haplotypes of genes are described. Also described are single nucleotide polymorphisms and haplotypes in the ApoE gene and methods of using that information.

  • VIRTUAL DATA ROOM FOR DISPLAYING CLINICAL TRIAL STATUS REPORTS BASED ON REAL-TIME CLINICAL TRIAL DATA, WITH INFORMATION CONTROL ADMINISTRATION MODULE THAT SPECIFIES WHICH REPORTS ARE AVAILABLE FOR DISPLAY

    A system is provided for use in distributing information associated with an investigational product, such as a pharmaceutical drug. The information includes electronic documents associated with the investigational product, and a plurality of different electronic reports based on real-time patient clinical study data of the investigational product. The system includes a database that stores the electronic documents, a virtual data room that is in electronic communication with the database and which includes a memory that stores the electronic reports, an information presentation module, and an information control administration module. The information presentation module causes a display of the information to a user of the virtual data room via a display screen. The electronic reports are generated using the real-time patient clinical study data when requested to be displayed. The information control administration module specifies which electronic reports will be made available to the user. Only the specified electronic reports are selectable for display on the display screen by the user of the virtual data room. In this manner, only the specified electronic reports may be generated for display to a user of the virtual data room.

  • METHOD FOR COLLECTING, PROCESSING, AND STORING DISCRETE DATA RECORDS BASED UPON A SINGLE DATA INPUT

    A method for the collection, capture, processing, storage and tracking of data for both electronic source health records and for electronic clinical trial purposes by electronically collecting clinical trial data at a clinical trial site, instantly preserving all of the clinical trial data as an electronic source document, archiving the clinical trial data in a trusted data server maintained by a third party, transmitting an acknowledgement upon successful archiving of the clinical trial data, and transmitting the clinical trial data to a clinical trial database only after successful archiving of said clinical trial data. A method for electronically gathering clinical trial data. A method of maintaining discrete data records based upon a single clinical data input.

  • AUTOLOGOUS AND ALLOGENIC ADIPOSE-DERIVED STROMAL STEM CELL COMPOSITION FOR TREATING FISTULAS

    The present invention relates to a method for producing clinically effective quantities of human adipose tissue-derived stromal cells for treating fistulas and a composition made with the same. The method of the present invention can efficiently produce clinically effective number of adipose tissue-derived stromal cells within a short period by improving conventional standard culturing methods. The adipose stem cells composition containing the adipose tissue-derived stromal cells obtained by the method of the present invention exhibit superior multipotency and immunomodulatory activity over those of a cell composition produced by conventional methods, and thus is more suitable for treating fistulas. The cell composition of the present invention has excellent clinical usages especially since immune response is suppressed in allogenic adipose-derived stem cells.

  • MATERIAL AND METHODS FOR TREATING DEVELOPMENTAL DISORDERS INCLUDING COMORBID AND IDIOPATHIC AUTISM

    Subjects who were diagnosed with either comorbid or idiopathic autism were treated with acamprosate. Patients generally showed marked improvements in primary outcomes as assessed using, for example, standard clinic measures for functionality including the Clinical Global Impressions Improvement (CGI-I) and the Clinical Global Impressions Severity (CGI-S) scales.

  • TOPICAL TREATMENT OF NEUROPATHIC PAIN AND METHODS OF DIAGNOSIS

    Alpha-2 adrenergic agonists such as clonidine may be used to treat the pain associated with painful diabetic neuropathy (PDN) only in a subset of these patients. Targeted nociceptors (pain fibers) must be functionally expressed in the skin in order for clonidine to have a therapeutic effect. Neuropathies associated with pain differ with respect to the expression of nociceptors in the skin. Clonidine targets alpha-2 adrenergic receptors on the terminals of nociceptors. The presence of the targeted nociceptors may be determined by topical application of a TRPV1 agonist such as capsaicin. Patients who detect the capsaicin as a pain stimulus applied near the painful area have expression in the skin of the requisite targeted nociceptors and the targeted alpha-2 adrenergic receptors. The test is referred to as a capsaicin challenge test. This test significantly improves clinical outcomes in topical neuropathic pain treatment.

  • METHOD FOR THERAPY PREDICTION IN TUMORS HAVING IRREGULARITIES IN THE EXPRESSION OF AT LEAST ONE VEGF LIGAND AND/OR AT LEAST ONE ERBB-RECEPTOR

    The present invention is related to a method for predicting a clinical response of a patient suffering from or at risk of developing a neoplastic disease towards a given mode of treatment, said method comprising the steps of: a) obtaining a biological sample from said patient; b) determining, on a non protein basis, the expression level of at least one gene encoding for a ligand from the Vascular endothelial growth factor (VEGF) family and of and of at least one gene encoding for a receptor from the ErbB-family, or a gene co-expressed therewith, in said sample, c) comparing the pattern of expression levels determined in (b) with one or several reference pattern (s) of expression levels; and d) predicting therapeutic success for said given mode of treatment in said patient or implementing therapeutic regimen targeting the signalling pathway of said ligand and/or receptor is related to in said patient from the outcome of the comparison in step (c).

  • Methods and kits for the differential diagnosis of Alzheimer's disease versus frontotemporal dementia and for the diagnosis of frontotemporal dementia, comprising FAS-L and CK 18 as biomarkers

    The invention relates to methods and kits for the differential diagnosis of Alzheimer's disease (AD) versus frontotemporal dementia (FTD), using biomarkers TNF-.alpha., FAS-L and CK18, taken from a biological sample. Differences in biomarker levels can be used to distinguish between AD and FTD The invention is based on a discovered correlation between FTD and markers FAS-L and CK18. Therefore the invention also relates to the diagnosis of FTD using FAS-L and CK18. The serum concentrations of these biomarkers can further be used as an index of the severity of disease, and may occur in conjunction with clinical-based diagnostic testing and neuro-imaging assessment.

  • AVIRULENT, IMMUNOGENIC FLAVIVIRUS CHIMERAS

    Chimeric flaviviruses that are avirulent and immunogenic are provided. The chimeric viruses are constructed to contain amino acid mutations in the nonstructural viral proteins of a flavivirus. Chimeric viruses containing the attenuation-mutated nonstructural genes of the virus are used as a backbone into which the structural genes of a second flavivirus strain are inserted. These chimeric viruses elicit pronounced immunogenicity yet lack the accompanying clinical symptoms of viral disease. The attenuated chimeric viruses are effective as immunogens or vaccines and may be combined in a pharmaceutical composition to confer simultaneous immunity against several strains of pathogenic flaviviruses.

  • METHODS AND COMPOSITIONS TO REDUCE LIVER DAMAGE ASSOCIATED WITH CONDITIONS OR THERAPIES THAT AFFECT THE IMMUNE SYSTEM

    One side-effect arising from the use of antibodies against TNF receptor family members as therapeutics can be liver damage which precludes the completion of clinical trial. A novel LT-dependent pathway is described that mediates liver cell injury in several disease models.

  • USE OF COMPUTATIONALLY DERIVED PROTEIN STRUCTURES OF GENETIC POLYMORPHISMS IN PHARMACOGENOMICS FOR DRUG DESIGN AND CLINICAL APPLICATIONS

    Provided herein are computer-based methods for generating and using three-dimensional (3-D) structural models of target biomolecules. In particular, the target biomolecules are protein structural variants derived from genes containing genetic variations, or polymorphisms. The models are generated using molecular modeling techniques, such as homology modeling. The models can be used in structure-based drug design studies to identify drugs that bind to particular structural variants in structure-based drug design studies, for designing allele-specific drugs, population-specific drugs and for predicting clinical responses in patients. Molecular structure databases containing protein structural variant models also are provided.

  • PARP1 TARGETED THERAPY

    The present invention relates to compositions and methods for cancer therapy, including but not limited to, targeted inhibition of cancer markers. In particular, the present invention relates to PARP1 proteins and nucleic acids as clinical and research targets for cancer.

  • MICRORNA AS A BIOMARKER OF PANCREATIC ISLET BETA-CELL ENGAGEMENT

    MicroRNAs (miRNAs) are short non-coding RNAs that regulate gene expression and which play important roles in many cell types, including as described herein, the pancreatic .beta.-cell. Glucagon like peptide-1 (GLP-1), a hormone released from intestinal L-cells following meal intake, exerts pleiotropic effects on .beta.-cell function including raising intracellular cAMP levels and now represents an important therapy for type 2 diabetes. Expression of miR-132 and miR212 is upregulated by CREB protein in response increased cAMP levels in the cell; therefore, methods for detecting and evaluating .beta.-cell engagement by GLP-1 receptor agonists by monitoring miR-132 and miR-212 expression in a subject is described. The methods herein are particularly useful in the context of longitudinal clinical trials, such as those designed for testing the durability of any single or combination therapy in type 2 diabetes populations. Because the expression of these miRNAs is not affected by glucose, fatty acid, insulin, or .beta.-cell function, monitoring miR-132 and miR-212 expression can be used to monitor the efficacy of any agent that effects an increase cAMP in .beta.-cells. Such agents include for example, GLP-1, glucagon, GPR-119, and GIP receptor agonists; dipeptidyl peptidase IV (DPP IV) inhibitors; and phosphodiesterase inhibitors.

  • Methods and Systems for Assessing Clinical Outcomes

    Described herein are methods and systems useful for characterizing clinical outcomes of a subject. Provided herein includes computer-assessed methods, medical information systems, and computer-readable instructions that can aid an end-user in diagnosis, prognosis, and treatment of a clinical outcome.

  • METHOD AND SYSTEM FOR FACILITATING CLINICAL RESEARCH

    A method of facilitating clinical research. The method includes receiving at least one research criteria and at least one comparison criteria, e.g., demographical information, patient characteristic, patient health, type of drug, drug classification, insurance type, etc. A database storing medical records associated with patients may be accessed. Information within the database may be filtered based on the research criteria to identify a group of patients. The information within medical records of the group of patients is processed to generate processed information, wherein the information is associated with the at least one comparison criteria. The processed information is output, e.g., to a memory component for storage, to a display for rendering, etc. The processing may include purging confidential information associated with the group of patients according to HIPAA. A number may be assigned to each patient within the group of patients for identification thereof.

  • INTEGRATED INTERACTIVE SYSTEMS AND METHODS WITH SINGLE TRANSACTIONAL DATABASE AND REPORTING APPLICATION FOR e CLINICAL TRIALS

    The present invention relates to a fully integrated systems and methods to offer end-to-end solution in designing, managing, recording, analyzing, mining and reporting of traditional as well as adaptive clinical trials with single transaction database. Particularly, the present invention relates to a system and method for clinical trial which will help pharmaceuticals/biotech/medical device companies and clinical research organizations (CROs) to manage various activities as per the business flow of a clinical trial, right from protocol design to submission of clinical study reports through their various functionalities/modules. Specifically, the present invention is suitable for adaptive clinical trials where the clinical plans are modified based on the results obtained in the single or multiple interim data analysis. More specifically, the present invention offers a closed loop feedback control of trial parameters and expectations to enhance trial success and addresses safety and efficacy concerns without compromising blinding and statistical validity.

  • VIRTUAL CARE TEAM RECORD FOR TRACKING PATIENT DATA

    A system and method for managing healthcare information is disclosed. The data servers each include a data manager that comprises a controller, applications, an application manager, a virtual care team module, and a user interface engine. The controller manages the core functions and the transmission of data between data manager components. The applications are applications that are created by the user or downloaded as third-party applications. The application manager manages the creation and communication between applications. The virtual care team module manages the transmission of patient data between data servers. The user interface engine generates user interfaces for displaying the applications and collecting clinical trial data.

  • METHODS FOR MANAGING CANCER PATIENT CARE

    Methods for managing the care of a cancer patient are provided. Generally, the methods comprise calculating a risk score from characteristics obtained from a cancer patient with a plurality of nomograms comprising the characteristics and a plurality of competing risk factors, using a program to calculate risk scores; determining the patient's prognosis based on the risk score; and treating the patient with a regimen capable of improving the prognosis of a cancer patient having substantially the same risk score. Systems and computer readable media for practicing the methods are also provided.

  • SYSTEMS AND METHODS FOR MANAGING CLINICAL TRIAL SITE VISIT REPORTS

    Systems and methods are disclosed for managing site visit report creation. Data relationships and process flow rules can be utilized to output reminder messages regarding deadlines associated with a site visit report completion and determine and present proper questions to associates to elicit relevant information about a site visit. Site visit reports can be generated in an efficient and accurate manner and submitted quickly to a sponsor.

  • SYSTEM AND METHOD FOR FACILITATING CANDIDATE AND SUBJECT PARTICIPATION IN CLINICAL TRIALSTUDIES

    The present invention discloses systems and methods for facilitating candidate and subject participation in clinical trial studies. Medical professionals participating in the study at satellite sites assist in recruitment of their pre-existing patients as subjects in the study. Clinical trial data collected from the subjects is communicated over a computer network from the satellite sites to core sites. Study coordination is performed at the core sites. The collected clinical trial data is analyzed in accordance with the study at an interested party site.

  • Systems and Methods for Using Online Resources to Design a Clinical Study and Recruit Participants

    The present application is directed to methods and systems for tapping online resources to design a clinical trial and/or recruit participants for the clinical trial. In one embodiment, a system for using online resources to design a clinical trial and/or recruit participants includes one or more web crawlers. Each of the web crawler may be configured to collect data related to one or more specified topics during a community identification phase. A data engine of the system processes the collected data into filtered, relevant information that identifies communities of individuals suitable for recruitment. A patient discovery module may, in a patient discovery phase, develop or use a survey to further target interested patients for recruitment and collect information for designing a suitable study or trial. The system may, in an assessment and communication phase, design a study which may be self-managed by the recruited patients. The study may provide feedback for refining or modifying any one of the above phases. The study may also aim to address certain issues faced by the recruited patients, such as ensuring compliant use of a drug, elimination of side-effects, and using a modified therapy to improve the effectiveness of a drug, etc.

  • Method and means to address and make use of multiple electrodes for measurements and electrical stimulation in neurons and other cells including brain and heart

    A cell stimulating and measuring device which contains a larger number of electrodes than used in current stimulators and measuring devices. The larger number of electrodes is possible with the implementation of an addressing system to choose one or a plurality of electrodes from a larger set of available electrodes to be active. Moreover, the digital address and control lines passing from the battery/control electronics unit, to the stimulator and measuring device which contains the electrodes, are sent in serial form, which decreases the space used by the wires that must be minimized in a device implanted in a living organism. The system can be used to send current to electrically stimulate cells, and to connect the same, or other electrodes to a measuring unit for data collection, which can be used either for clinical or for research use.

  • DETERMINING CLINICAL TRIAL CANDIDATES FROM AUTOMATICALLY COLLECTED NON-PERSONALLY IDENTIFIABLE DEMOGRAPHICS

    Non-personally identifiable demographics associated with a patient during a communication session can be collected. The patient can be associated with one or more healthcare providers which can be associated with a one or more healthcare professionals. The demographics can be compared against a clinical trial profile associated with a clinical trial. The clinical trial profile can specify one or more target group parameters associated with a target group of the clinical trial. The clinical trial can be associated with a clinical research organization and/or a sponsor. When the comparing produces a match between the demographics and the profile, a clinical trial can be identified as suitable for the patient.

  • DETERMINING CLINICAL TRIAL CANDIDATES FROM AUTOMATICALLY COLLECTED NON-PERSONALLY IDENTIFIABLE DEMOGRAPHICS

    Non-personally identifiable demographics associated with a patient during a communication session can be collected. The patient can be associated with one or more healthcare providers which can be associated with a one or more healthcare professionals. The demographics can be compared against a clinical trial profile associated with a clinical trial. The clinical trial profile can specify one or more target group parameters associated with a target group of the clinical trial. The clinical trial can be associated with a clinical research organization and/or a sponsor. When the comparing produces a match between the demographics and the profile, a clinical trial can be identified as suitable for the patient.

  • PATIENT ENABLED METHODS, APPARATUS, AND SYSTEMS FOR EARLY HEALTH AND PREVENTIVE CARE USING WEARABLE SENSORS

    Certain exam PATIENT ENABLED METHODS, APPARATUS, AND SYSTEMS FOR EARLY HEALTH AND PREVENTIVE CARE USING WEARABLE SENSORS ples provide systems, methods, and apparatus for patient-enabled early health and prevention. An example patient preventive health system includes a monitoring application interface to receive data from one or more sensors positioned with respect to a patient. The system includes a sensor data processor to process the received data from the one or more sensors to identify one or more readings based on the received data. The system includes an event analyzer to process the one or more readings to generate an event output. The system includes a patient notifier to notify the patient based on the event output. The system includes a biomarker transmitter to identify and transmit a biomarker to a clinical research cloud based on the one or more readings.

  • DETERMINING CLINICAL TRIAL CANDIDATES FROM AUTOMATICALLY COLLECTED NON-PERSONALLY IDENTIFABLE DEMOGRAPHICS

    Non-personally identifiable demographics associated with a patient during a communication session can be collected. The patient can be associated with one or more healthcare providers which can be associated with a one or more healthcare professionals. The demographics can be compared against a clinical trial profile associated with a clinical trial. The clinical trial profile can specify one or more target group parameters associated with a target group of the clinical trial. The clinical trial can be associated with a clinical research organization and/or a sponsor. When the comparing produces a match between the demographics and the profile, a clinical trial can be identified as suitable for the patient. Related apparatus, methods, systems and articles are also described.

  • Systems and Methods for Clinical Trial Documenting Using a Mobile Communications Device

    Systems and methods presented herein may involve documenting clinical trials through use of a mobile communications device, such as a camera phone. Using the mobile communications device, the participant may record video of themselves administering a health intervention that is the subject of the clinical trial and/or report serious adverse events that occur. The video clips may be sent to a documentation server for documentation. The documentation server may also route serious adverse event notifications to a plurality of locations, such as the doctor's office, the study center, and/or the pharmaceutical company that developed the health intervention being tested.

  • Method and means to address and make use of multiple electrodes for measurements and electrical stimulation in neurons and other cells including brain and heart

    A cell stimulating and measuring device which contains a larger number of electrodes than used in current stimulators and measuring devices. The larger number of electrodes is possible with the implementation of an addressing system to choose one or a plurality of electrodes from a larger set of available electrodes to be active. Moreover, the digital address and control lines passing from the battery/control electronics unit, to the stimulator and measuring device which contains the electrodes, are sent in serial form, which decreases the space used by the wires that must be minimized in a device implanted in a living organism. The system can be used to send current to electrically stimulate cells, and to connect the same, or other electrodes to a measuring unit for data collection, which can be used either for clinical or for research use.

  • DETERMINING CLINICAL TRIAL CANDIDATES FROM AUTOMATICALLY COLLECTED NON-PERSONALLY IDENTIFIABLE DEMOGRAPHICS

    Non-personally identifiable demographics associated with a patient during a communication session can be collected. The patient can be associated with one or more healthcare providers which can be associated with a one or more healthcare professionals. The demographics can be compared against a clinical trial profile associated with a clinical trial. The clinical trial profile can specify one or more target group parameters associated with a target group of the clinical trial. The clinical trial can be associated with a clinical research organization and/or a sponsor. When the comparing produces a match between the demographics and the profile, a clinical trial can be identified as suitable for the patient.

  • PATIENT ENABLED METHODS, APPARATUS, AND SYSTEMS FOR EARLY HEALTH AND PREVENTIVE CARE USING WEARABLE SENSORS

    Certain examples provide systems, methods, and apparatus for patient-enabled early health and prevention. An example patient preventive health system includes a monitoring application interface to receive data from one or more sensors positioned with respect to a patient. The system includes a sensor data processor to process the received data from the one or more sensors to identify one or more readings based on the received data. The system includes an event analyzer to process the one or more readings to generate an event output. The system includes a patient notifier to notify the patient based on the event output. The system includes a biomarker transmitter to identify and transmit a biomarker to a clinical research cloud based on the one or more readings.

  • DETERMINING CLINICAL TRIAL CANDIDATES FROM AUTOMATICALLY COLLECTED NON-PERSONALLY IDENTIFABLE DEMOGRAPHICS

    Non-personally identifiable demographics associated with a patient during a communication session can be collected. The patient can be associated with one or more healthcare providers which can be associated with a one or more healthcare professionals. The demographics can be compared against a clinical trial profile associated with a clinical trial. The clinical trial profile can specify one or more target group parameters associated with a target group of the clinical trial. The clinical trial can be associated with a clinical research organization and/or a sponsor. When the comparing produces a match between the demographics and the profile, a clinical trial can be identified as suitable for the patient. Related apparatus, methods, systems and articles are also described.

  • Systems and Methods for Clinical Trial Documenting Using a Mobile Communications Device

    Systems and methods presented herein may involve documenting clinical trials through use of a mobile communications device, such as a camera phone. Using the mobile communications device, the participant may record video of themselves administering a health intervention that is the subject of the clinical trial and/or report serious adverse events that occur. The video clips may be sent to a documentation server for documentation. The documentation server may also route serious adverse event notifications to a plurality of locations, such as the doctor's office, the study center, and/or the pharmaceutical company that developed the health intervention being tested.

  • SYSTEMS AND METHODS FOR MANAGING CLINICAL TRIAL SITE VISIT REPORTS

    Systems and methods are disclosed for managing site visit report creation. Data relationships and process flow rules can be utilized to output reminder messages regarding deadlines associated with a site visit report completion and determine and present proper questions to associates to elicit relevant information about a site visit. Site visit reports can be generated in an efficient and accurate manner and submitted quickly to a sponsor.

  • SYSTEM AND METHOD FOR FACILITATING CANDIDATE AND SUBJECT PARTICIPATION IN CLINICAL TRIAL STUDIES

    The present invention discloses systems and methods for facilitating candidate and subject participation in clinical trial studies. Medical professionals participating in the study at satellite sites assist in recruitment of their pre-existing patients as subjects in the study. Clinical trial data collected from the subjects is communicated over a computer network from the satellite sites to core sites. Study coordination is performed at the core sites. The collected clinical trial data is analyzed in accordance with the study at an interested party site.

  • System for Clinical Trial Subject Compliance

    The present invention is designed to develop research protocols for clinical trials. The invention also can track and enhance subject compliance with a research protocol. The invention further provides evaluability data related to subject performance in the clinical trial. According to an alternative embodiment of the invention, a portable electronic device is used to query and collect data from the subject.

  • Method of Inducing Cellular Growth and Materials for Use Therewith

    The present invention relates generally to a method of producing a population of cells and materials for use therewith. More particularly, the present invention is directed to a method of generating the growth of a population of blood-derived cells and materials for use therewith. The method of the present invention facilitates cell growth by virtue of the migration of blood-derived cells from the vasculature of a vascularised receptacle to the acellular tissue support matrix of said receptacle. These findings have now facilitated the design of means for reliably and efficiently deriving cellular populations from blood-derived cells, such as the generation of bone marrow cells including haemopoietic stem cells and mesenchymal stem cells, for use in a wide variety of clinical and research settings. The method of the present invention is particularly useful for the therapeutic or prophylactic treatment of a range of conditions via the administration of the cells generated in accordance with the method of the present invention.

  • CRYOPRESERVATION OF ARTICULAR CARTILAGE

    The invention relates generally to methods and compositions for the cryopreservation and/or vitrification of tissue including articular cartilage and the preparation of said tissue for clinical or research use, including but not limited to joint replacement and the treatment and prevention of osteoarthritis.

  • MAGNETIC RESONANCE METHOD FOR QUANTIFICATION OF MOLECULAR DIFFUSION USING DOUBLE ECHO STEADY STATE SEQUENCES

    Disclosed is a magnetic resonance method for the quantification of molecular diffusion. The method uses a diffusion-weighted (dw) double echo steady state sequence (DESS). In particular, the method allows direct quantification of molecular diffusion from two steady state scans with differing diffusion weighting such as one with diffusion-weighting and preferably one without diffusion weighting. Such a quantification of molecular diffusion allows for rapid and/or quantitative measurements of physiological and/or functional parameters of living tissue. Quantitative measurements are often a prerequisite for pre-clinical and clinical research as well as for clinical trials in drug research performed at different sites. Especially for the early diagnosis of subtle or diffuse pathological changes, quantitative MR promises to have a very significant impact.

  • METHOD FOR ORGANIZING CLINICAL TRIAL DATA

    A method for creating multiple tagged clinical trial data and a tool therefrom is disclosed. The method comprises receiving clinical trial information from different sources, and removing redundancies from the clinical trial information received from the plurality of sources to form collated clinical trial data. The method further involves baseline tagging of the collated clinical data using non-indication parameters, creating a disease specific list of indication parameters, where indication parameters are classified into at least main indication parameters and sub indication parameters. The method further includes advanced tagging of the collated clinical trial data using indication parameters and creating multiple tagged clinical data using baseline tagging and advanced tagging.

  • AUTOMATED METHOD OF GENERATING RECONCILIATION REPORTS REGARDING MISMATCHES OF CLINICAL DATA RECEIVED FROM MULTIPLE SOURCES DURING A CLINICAL TRIAL

    An automated method is provided of generating a report of data collected from multiple sources during a clinical trial. The data includes a plurality of different data fields. A plurality of patients participate in the clinical trial. A first set of data obtained from case report forms associated with the patients is received at a processor. The case report forms are one source of data. A second set of data obtained from at least one source other than the case report forms is also received at the processor. At least some of the data in the first and second set of data include data associated with the same data fields. The processor identifies any mismatches in data associated with the same data fields in the first and second set of data. Mismatches associated with data fields obtained from the same case report forms are electronically grouped. A report is then generated of the data. The report shows the status of mismatches for each case report form or type of case report form.

  • AUTOMATED METHOD OF GENERATING RECONCILIATION REPORTS REGARDING MISMATCHES OF CLINICAL DATA RECEIVED FROM MULTIPLE SOURCES DURING A CLINICAL TRIAL

    An automated method is provided of generating a report of data collected from multiple sources during a clinical trial. The data includes a plurality of different data fields. A plurality of patients participate in the clinical trial. A first set of data obtained from case report forms associated with the patients is received at a processor. The case report forms are one source of data. A second set of data obtained from at least one source other than the case report forms is also received at the processor. At least some of the data in the first and second set of data include data associated with the same data fields. The processor identifies any mismatches in data associated with the same data fields in the first and second set of data. Mismatches associated with data fields obtained from the same case report forms are electronically grouped. A report is then generated of the data. The report shows the status of mismatches for each case report form or type of case report form.

  • System for Clinical Trial Subject Compliance

    The present invention is designed to develop research protocols for clinical trials. The invention also can track and enhance subject compliance with a research protocol. The invention further provides evaluability data related to subject performance in the clinical trial. According to an alternative embodiment of the invention, a portable electronic device is used to query and collect data from the subject.

  • Tracking and Using Clinical Trial Protocol Feasibility Information

    Systems and methods are disclosed for managing information from a feasibility study of a clinical trial protocol. Data relationships in a database can be utilized to, for example, formulate bids for managing a clinical trial protocol, track information about a feasibility study, output reminder notifications regarding overdue documents in connection with the feasibility study, provide information for use in site start-up or other processes implemented in conducting the clinical trial protocol, and allow feasibility study information to be analyzed after a clinical trial protocol has been conducted.

  • SYSTEM AND METHOD FOR ENSURING INTEGRITY OF CLINICAL TRIAL RESULTS

    The system and method utilize the inter-relationship of items in a psychological instrument or instruments and have been demonstrated empirically to detect problematic conceptualizations of constructs. Scores from the instruments are submitted for review. The scores are analyzed by a computer program that compares item level scores with expected values based on the item inter-relationships. If inconsistencies are discovered a flag is generated. If inconsistencies are deemed actionable then remedial action or contact is scheduled with the site-based clinician or "rater" who conducted the patient assessment using the instrument or instruments. The site-based clinician is contacted and an information exchange about the case occurs in which the site-based clinician provides an overview of symptom presentation. This symptom presentation is then matched to the item level scores on the instrument to determine if it was scored in a manner consistent with the conceptual basis for the items.

  • TOOL FOR CLINICAL DATA MINING AND ANALYSIS

    In one aspect, the invention provides a clinical trial information management tool. The tool comprises an interface with a multiple tagged clinical trial database; a user interface for receiving user inputs, a search engine to query the multiple tagged clinical trial database in one or more levels based on user inputs; a display platform to display results from the query in one or more views; an analytics engine to provide at least one of parameter based analysis and graphical analysis; and a personalization platform to store the query and the results. The tool provides the advantage through the rapid, facile and user-friendly manner in which clinical trial information from a wide variety of sources may be searched, analyzed and reported by a user, which allows for easy strategizing regarding clinical trial related matters, among other unique advantages.

  • TOOL FOR CLINICAL DATA MINING AND ANALYSIS

    In one aspect, the invention provides a clinical trial information management tool. The tool comprises an interface with a multiple tagged clinical trial database; a user interface for receiving user inputs, a search engine to query the multiple tagged clinical trial database in one or more levels based on user inputs; a display platform to display results from the query in one or more views; an analytics engine to provide at least one of parameter based analysis and graphical analysis; and a personalization platform to store the query and the results. The tool provides the advantage through the rapid, facile and user-friendly manner in which clinical trial information from a wide variety of sources may be searched, analyzed and reported by a user, which allows for easy strategizing regarding clinical trial related matters, among other unique advantages.

  • BIOMARKERS PREDICTIVE OF PROGRESSION OF FIBROSIS

    The present invention provides methods and kits for prognosing the progression of fibrosis in a subject having fibrosis, as well as methods for identifying a compound that can slow down the progression of fibrosis in a subject having fibrosis, methods of monitoring the effectiveness of a therapy in reducing the progression of fibrosis in a subject having fibrosis, methods of selecting a subject for participation in a clinical trial for the treatment of fibrosis, and methods for inhibiting progression of fibrosis in a cell or a subject having fibrosis. The methods are based on determining the level of Toll-like recepter 9 (TLR9).

  • SYSTEM AND METHOD FOR PERFORMING PHARMACOVIGILANCE

    A method and system for tracking patient's response during a clinical trial of a drug, includes publishing an informational item about the clinical trial at a social media platform or a file sharing website; inducing patients to post trial related response at the social media platform or to obtain the informational item from the file sharing website; aggregating patients' responses from the social media platform, download information of the informational item published on the file sharing website, or search queries from search engines; and analyzing aggregated patients' responses, download information, or search queries to obtain knowledge related to theclinical trial.

  • Clinical Monitoring Device With Time Shifting Capability

    The present invention is designed to develop research protocols for clinical trials. The invention can track and enhance subject compliance with a research protocol. The invention further provides evaluability data related to subject performance in the clinical trial. According to an alternative embodiment of the invention, a portable electronic device is used to query and collect data from the subject.

  • CLINICAL DECISION SUPPORT SYSTEMS, APPARATUS, AND METHODS

    A system includes a centralized repository for tracking rule content and managing subscriptions to rule content by organizations and providers utilizing the system; a rule-evaluation server for receiving requests for rule-evaluations for specific patients, wherein the server determines content needing to be evaluated and retrieves the content to be used; a rule engine for performing the evaluations, wherein content, patient data, and rule evaluation parameters are provided to the engine, and the engine returns recommendations triggered by the evaluation, if any; an aggregator for aggregating recommendations from multiple sources, detecting and coordinating related recommendations, and applying configuration settings based on the patient and/or provider in context; and a client component for coordinating communication between an electronic health records system, the server, and the aggregator.

  • Clinical application utilizing genetic data for effective medication management

    The present disclosure relates a predictive method, based on a subject's genetic profile, which defines variability in a specific disease or condition to determine medication response, including determining select VNTR and SNP occurrence combinations which are associated with specific responses to medications, kits and DNA chips/arrays containing such combinations so as to effectuate better medication management.

  • CLINICAL APPLICATIONS OF A RECOMBINANT HUMAN ENDOSTATIN ADENOVIRUS (E10A) INJECTION

    The present invention relates to the genetic engineering field of angiogenesis-targeted therapy. Particularly, a recombinant human endostatin adenovirus injection is used along with certain antitumor agents for treating specific tumors. The methods of the invention offer significant improvement of effective response rate, disease control rate, survival and quality of life. The injection and treatment has no significant adverse reactions and side effects.

  • CLINICAL APPLICATIONS OF A RECOMBINANT HUMAN ENDOSTATIN ADENOVIRUS (E10A) INJECTION

    The present invention relates to the genetic engineering field of angiogenesis-targeted therapy. Particularly, a recombinant human endostatin adenovirus injection is used along with certain antitumor agents for treating specific tumors. The methods of the invention offer significant improvement of effective response rate, disease control rate, survival and quality of life. The injection and treatment has no significant adverse reactions and side effects.

  • SYSTEM AND METHOD FOR PREEMPTIVE DETERMINATION OF THE POTENTIAL FOR AN ATYPICAL CLINICAL EVENT RELATED TO THE ADMINISTERING OF MEDICATION

    Systems and methods provide for the preemptive determination of the potential of atypical clinical event occurrence related to administering of medications to a person. One method involves receiving a list of possible medications that may be administered to the person during a medical procedure. Subsequently, the medication list is compared to information in the person's medical record. Based on this comparison, a determination is made as to whether one or more matches exist between any of the medications included in the list and the medical record information, the match relating to the potential of an atypical clinical event occurring if the associated medication were to be administered to the person. If a match in fact exists, a response is outputted relating to each match.

  • METHODS FOR PREDICTION OF CLINICAL OUTCOME TO EPIDERMAL GROWTH FACTOR RECEPTOR INHIBITORS BY CANCER PATIENTS

    Disclosed are biomarkers, methods and assay kits for the identification of cancer patients who are predicted to benefit, or not to benefit, from the therapeutic administration of an epidermal growth factor receptor (EGFR) inhibitor. The biomarkers of the present invention include detection of EGFR and HER 2 gene amplification and polysomy, EGFR protein expression, EGFR mutations, phosphorylated Akt protein expression, and various combinations of such biomarkers, as well as the combination of these biomarkers with mutations in the tyrosine kinase domain of the EGFR gene. Increased EGFR gene copy number, increased HER2 gene copy number, increased EGFR protein expression, activated AKT protein expression (phosphorylated AKT) and EGFR mutations are all associated with better outcome for cancer patients treated with EGFR inhibitors. The invention provides a diagnostic paradigm based on each of these tests and combinations of these tests to select cancer patients who will benefit from EGFR inhibitor therapy, as well as a diagnostic paradigm to select cancer patients who will not benefit from EGFR inhibitor therapy.

  • QUANTITATIVE NMR CLINICAL ANALYZERS WITH AUTOMATIC NMR TEMPERATURE SENSITIVITY COMPENSATION THAT ACCOMMODATE LARGE AMBIENT OPERATIONAL TEMPERATURE RANGES

    NMR analyzers and associated methods, circuits and computer program products that allow NMR operation in fluctuating ambient temperature environments of at least +/-5 degrees F. in a relatively large operating temperature range, typically between about 60-85 degrees F.) with the ability to still generate accurate quantitative measurements using an electronically applied temperature sensitivity adjustment based on an a priori model of temperature sensitivity and a detected temperature proximate the NMR signal acquisition (e.g., scan). The clinical NMR analyzers can be remotely accessed to evaluate linearity and temperature compensation adjustments.

  • SCALABLE DETERMINATION OF PROBABLE PATIENT ELIGIBILITY FOR CLINICAL TRIALS AND ASSOCIATED PROCESS FOR ACTIVE SOLICITATION OF PATIENTS FOR CLINICAL TRIALS VIA THEIR HEALTHCARE PROVIDERS

    This twenty-step business process uses a clinical trials matching system to perform scalable searches of derived patient data records for patients that may be eligible for clinical trials. The patent-bearing business contracts with healthcare providers of patients found in derived patient data records to review the likely matches of those patients to clinical trials. Contracted healthcare providers also provide sufficient data for the patent-bearing business to determine if their patients qualify for clinical trials. Probabilistic matching techniques are used for this determination. The healthcare provider solicits qualified patients for clinical trials and interacts to enroll patients in trials. Solicitation is active in that the patent bearing business need not wait for a patient to initiate contact in order to seek determination of a patient's potential eligibility to participate in a clinical trial. Patient privacy is protected by limiting patient contact to be only through the patient's healthcare provider.

  • Method and Apparatus for Verification of Clinical Trial Adherence

    A system and method of confirming administration of medication in a clinical trial is provided. The method comprises the steps of receiving information identifying a particular medication prescription regimen in accordance with the clinical trial, determining one or more procedures for administering such prescription regimen and identifying one or more activity sequences associated with such procedures. Activity sequences of actual administration of such prescription regimen are captured and then compared to the identified activity sequences to determine differences therebetween. A notice is provided if differences are determined.

  • Method, System, And Apparatus For Clinical Trial Management Over A Communications Network

    A centralized, online clinical study system configured to coordinate aspects of a clinical study can include a training module configured to evaluate whether users have completed training for selected workflows for the clinical study that are available from the clinical study system, and to provide training to registered users for the selected workflows. The system also can include a financial engine configured to determine when a participating site meets or exceeds a milestone of the clinical study and to initiate a payment to the participating site. Further, the system can include a module configured to receive and verify clinical research data and to designate the verified clinical research data as official source data for the clinical study.

  • METHOD AND SYSTEM FOR PRESENTING COMPOSITE RISK ASSESSMENT DATA AND CLINICAL TRIAL DATA FOR PHARMACEUTICAL DRUGS

    A risk metrics information platform implemented as a reimbursement risk tracker application facilitates gathering, synthesizing, and presenting risk related data to users to foster a better understanding of pricing and reimbursement market risk for pipeline compounds and marketed pharmaceutical products. In one embodiment, the reimbursement risk tracker application provides a visually intuitive dashboard to help demonstrate how different global agencies look at a drug class or a therapeutic area. In another embodiment, a clinical trial tracker similarly facilitates gathering, synthesizing, and presenting of data relating to studies and outcomes across a number of different markets to foster a better understanding of the evaluation criteria as well as the conclusions of clinical trial studies.

  • Systems and Methods for Using Online Resources to Design a Clinical Study and Recruit Participants

    The present application is directed to methods and systems for tapping online resources to design a clinical trial and/or recruit participants for the clinical trial. In one embodiment, a system for using online resources to design a clinical trial and/or recruit participants includes one or more web crawlers. Each of the web crawler may be configured to collect data related to one or more specified topics during a community identification phase. A data engine of the system processes the collected data into filtered, relevant information that identifies communities of individuals suitable for recruitment. A patient discovery module may, in a patient discovery phase, develop or use a survey to further target interested patients for recruitment and collect information for designing a suitable study or trial. The system may, in an assessment and communication phase, design a study which may be self-managed by the recruited patients. The study may provide feedback for refining or modifying any one of the above phases. The study may also aim to address certain issues faced by the recruited patients, such as ensuring compliant use of a drug, elimination of side-effects, and using a modified therapy to improve the effectiveness of a drug, etc.

  • Qualifying Raters for Clinical Trials

    The invention provides an efficient approach to qualifying raters to serve in a clinical trial or study, where efficiency includes all aspects pertinent to study raters: creating of qualification profile; identification of appropriate study sites and raters, selection, training, and supplemental qualification of raters during the course of a clinical study or trial, as may be necessitated by study protocol changes or other changes that may occur.

  • BIOMARKERS FOR PI3K-DRIVEN CANCER

    Disclosed is the discovery that the mTORC2 complex plays a role in the regulation of PKN3 phosphorylation at the turn motif threonine; and the use of the phosphorylation status of the turn motif threonine of PKN3 as a biomarker. In some embodiments, the phosphorylation status of the turn motif threonine of PKN3 is determined using an antibody that specifically binds to the turn motif threonine of a PKN3 protein, such as an anti-phosphoT860 antibody. In some embodiments, the invention relates to methods for screening compounds that have cancer therapeutic potential, methods for diagnosing cancer, methods for determining the prognosis of a patient suffering from cancer, methods for stratifying patients in a clinical trial, methods for treating a patient suffering from cancer, and methods for determining the effectiveness of a particular treatment regimen.

  • Biomarker to Measure Drug Efficacy in Enteropathic Disease

    The diagnosis of a patient with an enteropathic disease or the response of a patient with an enteropathic disease to therapy, particularly a candidate therapy in a clinical trial setting, is assessed by detecting the ability of the patient to metabolize an orally administered CYP3A substrate. The CYP3A metabolism may be monitored in a variety of ways. Conveniently, the appearance of a metabolite of the CYP3A substrate is detected in a patient sample over a period of time following oral administration, e.g. in urine, plasma, serum breath, saliva, etc. The CYP3A substrate is optionally labeled, e.g. with an isotopic, fluorescent, etc. label.

  • METHOD AND SYSTEM FOR PRESENTING COMPOSITE RISK ASSESSMENT DATA AND CLINICAL TRIAL DATA FOR PHARMACEUTICAL DRUGS

    A risk metrics information platform implemented as a reimbursement risk tracker application facilitates gathering, synthesizing, and presenting risk related data to users to foster a better understanding of pricing and reimbursement market risk for pipeline compounds and marketed pharmaceutical products. In one embodiment, the reimbursement risk tracker application provides a visually intuitive dashboard to help demonstrate how different global agencies look at a drug class or a therapeutic area. In another embodiment, a clinical trial tracker similarly facilitates gathering, synthesizing, and presenting of data relating to studies and outcomes across a number of different markets to foster a better understanding of the evaluation criteria as well as the conclusions of clinical trial studies.

  • COMPUTER SYSTEM AND METHOD FOR TRAINING, CERTIFYING OR MONITORING HUMAN CLINICAL RATERS

    A method and system are disclosed for computerized training, monitoring, certification or re-certification of human raters in clinical trials. The invention provides an interactive computerized interview that can be compared scores obtained by human raters to monitor and train clinical raters on a continuing basis in order to reduce rater drift and variance during clinical trials. Remediation can be automatically flagged or provided to improve a deviating rater's performance. Computerized assessment of symptom severity is provided without the need for human clinical raters. The system and method enable screening of prospective patients for inclusion or exclusion from a clinical trial by automatically obtaining computerized ratings of symptom severity.

  • Qualifying Raters for Clinical Trials

    The invention provides an efficient approach to qualifying raters to serve in a clinical trial or study, where efficiency includes all aspects pertinent to study raters: creating of qualification profile; identification of appropriate study sites and raters, selection, training, and supplemental qualification of raters during the course of a clinical study or trial, as may be necessitated by study protocol changes or other changes that may occur.

  • Method, System, And Apparatus For Clinical Trial Management Over A Communications Network

    A centralized, online clinical study system configured to coordinate aspects of a clinical study can include a training module configured to evaluate whether users have completed training for selected workflows for theclinical study that are available from the clinical study system, and to provide training to registered users for the selected workflows. The system also can include a financial engine configured to determine when a participating site meets or exceeds a milestone of the clinical study and to initiate a payment to the participating site. Further, the system can include a module configured to receive and verify clinical research data and to designate the verified clinical research data as official source data for the clinical study.

  • METHODS OF PREDICTING AND DECREASING THE RISK OF PREGNANCY LOSS

    Described are methods for diagnosing and predicting the risk of pregnancy loss in a subject based on the presence of an aberrant humoral response to three proteins, Apolipoprotein B-100, alpha2macrogloblin (alpha2M), and fibronectin. The presence or a detectable level of maternal IgG antibodies to trophoblast-derived fibronectin and/or ApoB-100, and/or the absence or a non-detectable level of antibodies specifically binding to alpha2M is associated with a history of RPL and an increased risk of pregnancy loss. Also described are methods for identifying subjects at risk of pregnancy loss, selecting subjects for participation in a clinical study, and methods of decreasing the risk of pregnancy loss in a subject which include detecting the presence or absence of antibodies to one or more of trophoblast-derived ApoB-100, alpha2M, and fibronectin. Also provided are kits that contain ApoB-100, alpha2M, and fibronectin.

  • POSACONAZOLE INTRAVENOUS SOLUTION FORMULATIONS STABILIZED BY SUBSTITUTED BETA-CYCLODEXTRIN

    The present invention relates to aqueous solutions useful as pharmaceutical compositions of posaconazole for intravenous administration. These compositions include a solubilizing agent, such as a modified .beta.-cyclodextrin in an acidified solution, which can also include a chelating agent such as disodium edetate (EDTA). In clinical trials, a 200 mg posaconazole dose of the selected composition was found to achieve acceptable pharmacokinetic properties.

  • NEUREGULIN BASED COMPOSITIONS AND USES THEREOF FOR PREVENTING, TREATING OR DELAYING THE MYOCARDIAL ISCHEMIA-REPERFUSION INJURY

    The present invention elates to the applications of neuregulin in the preparation of drugs for preventing, treating or delaying the ischemia-reperfusion injury (IRI) in mammals, particularly in humans. In particular, the present invention provides the neuregulin based compositions and methods for preventing, treating or delaying the myocardial ischemia-reperfusion injury. Specifically, although it has been shown in cytological experiments, animal studies and clinical trials that neuregulin can improve the cytoskeleton structure of myocytes and cardiac function, it is still unknown whether neuregulin has effects on the myocardial ischemia-reperfusion injury. The present invention proves that neuregulin reduces the infarction size in the rat IRI model, which indicates that neuregulin can be used for preventing, treating or delaying the myocardial ischemia-reperfusion injury.

  • COMPOSITION FOR TREATING ATOPIC DERMATITIS COMPRISING EXTRACTS OF BAMBOO AND SCUTELLARIA

    The present invention relates to a composition comprising of plant extract as an active component, specifically, Bamboo extract and Scutellaria extract, for the treatment and prevention of atopic dermatitis. The present invention is a natural ingredient obtained from a plant. The present invention can control immune responses by inhibiting the release of histamine and leukotrien, and thus, has effect in the treatment or prevention of allergic diseases, inflammatory diseases and skin diseases, specifically atopic dermatitis. The present invention has been proven safe and beneficial effecting the treatment of atopic dermatitis through clinical trials, and thus, can be used for the treatment and prevention of atopic dermatitis.

  • COMPUTER SYSTEM AND METHOD FOR TRAINING, CERTIFYING OR MONITORING HUMAN CLINICAL RATERS

    A method and system are disclosed for computerized training, monitoring, certification or re-certification of human raters in clinical trials. The invention provides an interactive computerized interview that can be compared scores obtained by human raters to monitor and train clinical raters on a continuing basis in order to reduce rater drift and variance during clinical trials. Remediation can be automatically flagged or provided to improve a deviating rater's performance. Computerized assessment of symptom severity is provided without the need for human clinical raters. The system and method enable screening of prospective patients for inclusion or exclusion from a clinical trial by automatically obtaining computerized ratings of symptom severity.

  • System and Method for Management of Research Subject or Patient Events for Clinical Research Trials

    A system and method for managing clinical research trials is disclosed. The system and method may include a centralized secure database with information on clinical research trial participants, clinical research trial events, investigator and administrator inputs, and communication of participants, investigators and administrators. In one embodiment, the system and method allows investigators to contact participants without disclosing confidential contact information of the participants to the investigators by storing health information and contact information in separate databases. In one embodiment, administrators may access clinical research trial information through a secure web portal.

  • SYSTEM AND METHOD FOR CLINICAL RESEARCH CENTER NETWORK BUILDING AND USE

    The invention generally relates to computer-based systems for evaluating and marketing clinical trial research centers. In certain aspects, the invention provides computer-based systems for collecting information about clinical research centers. Systems include a tangible, non-transitory memory coupled to a processor operable to retrieve information identifying global networks of clinical trial capacity.

  • SYSTEM AND METHOD FOR CLINICAL RESEARCH CENTER LOCATION PROFILING

    The invention generally relates to computer-based systems for evaluating and marketing clinical trial research centers. In certain aspects, the invention provides computer-based systems for collecting information about clinical research centers. Systems include a tangible, non-transitory memory coupled to a processor operable to retrieve, based on a user's input, an identity of a clinical research center and prompt the user for information relating generally to the center. The system can collect disease-specific information by prompting the user for a selection of a disease and then collecting from the user information identifying an ability of the center to perform one or more tests relating to the disease.

  • SYSTEM AND METHOD FOR CLINICAL RESEARCH CENTER ANALYTICS

    The invention generally relates to computer-based systems for evaluating and marketing clinical trial research centers. In certain aspects, the invention provides computer-based systems for collecting information about clinical research centers. Systems include a tangible, non-transitory memory coupled to a processor operable to retrieve, based on a user's input, an identity of a clinical research center and prompt the user for information relating generally to the center. The system can collect disease-specific information by prompting the user for a selection of a disease and then collecting from the user information identifying an ability of the center to perform one or more tests relating to the disease.

  • PROFILE RENDERING FOR CLINICAL RESEARCH ENTITIES

    The invention uses a database of clinical research centers to allow a trial planner to view profiles of those centers to pre-qualify centers for inclusion in a prospective clinical trial. Systems and methods of the invention operate to display clinical research capacity by using a computer system for receiving, from a trial planner, a subject disease and a selection of a research center and retrieving a plurality of clinical capacities that are associated with the subject disease for the research center. A profile of the research center that includes the plurality of clinical capacities associated with the subject disease is rendered.

  • SYSTEM AND METHOD FOR CLINICAL TRIAL DESIGN

    A method of collecting input from individuals comprising searching a database containing a plurality of individual's electronic health records (EHRs), assigning a unique patient key to each individual's EHR and removing the individual's identifying characteristics from the EHR with a computer having a memory and a processor operating a HIPAA privacy filter to provide de-identified EHRs, maintaining a confidential record of each individual's identifying characteristics associated with the unique patient key. De-identified EHRs are analyzed to define members of a target group. An electronic communication including a survey is passed through a linker/delinker to link contact information associated with the unique patient key of a member of the target group and sent to a member of the target group. A response from the member is received and passed through the HIPAA privacy filter to associate the response with the unique patient key.

  • BI-DIRECTIONAL BIOMARKER BASED CLINICAL TRIAL MATCHER

    A computer-based system configured to organize, analyze, locate and distribute information related to clinical trials is described herein. More particularly, a computer-based system for providing a bi-directional clinical trial matching process (e.g., locate patients based on trial information or locate trials based on patient information) based on biomarkers associated with both a patient and a clinical trial are described herein.

  • CLINICAL INFORMATION DISPLAY APPARATUS, CLINICAL INFORMATION DISPLAY METHOD, AND CLINICAL INFORMATION DISPLAY PROGRAM

    Based on summary extraction information in which each disease and each clinical information item extracted from a summary related information of at least one of (1) a treatment result summary, (2) a treatment review summary, (3) a history of a series of operations for generating the treatment result summary, and (4) a history of a series of operations for generating the treatment review summary are related, calculating a degree of appearance of each clinical information item, item by item, with respect to each disease as item information, determining a clinical information item whose calculated item information satisfies a predetermined condition as an important clinical information item, generating a display filter in which a disease and an important clinical information item corresponding to the disease are related, and displaying clinical information based on a display target disease and a display filter corresponding to the display target disease.

  • CORRELATION OF DE NOVO-INDUCED TUMOR-ASSOCIATED HUMORAL IMMUNE RESPONSES WITH IMPROVED CLINICAL OUTCOME

    The present invention refers to a method for predicting an improved therapeutic benefit for an individual suffering from a tumor carrying a known tumor-associated cell surface antigen (such as EpCAM). The present invention further refers to a method for the induction of secondary humoral immune responses directed against a second tumor-associated antigen (e.g., another tumor-associated antigen, like HER2/neu) different from the first tumor-associated antigen in an individual suffering from a tumor comprising tumor cells expressing the first tumor-associated antigen, e.g., EpCAM.)

  • CLINICAL TRIALS SUBJECT IDENTIFICATION SYSTEM

    Matching a subject with a clinical trial includes steps of: collecting patient data associated with the subject; collecting clinical trial data from multiple sources; matching the subject to a clinical trial scheduled in a location accessible to the subject; notifying a health care provider associated with the subject about the clinical trial; and receiving a response.

  • SYSTEM AND METHOD FOR CLINICAL STRATEGY FOR THERAPEUTIC PHARMACIES

    A system and method of distributing pharmaceutical prescriptions within a network of pharmacies based on the review of prescription claim data and patient medical state to enable stratification of patients, wherein each pharmacy within the network has been established to handle one or more particular patient medical states.

  • ELECTRONIC MEDICAL RECORDS SYSTEM WITH ACTIVE CLINICAL GUIDELINES AND PATIENT DATA

    An active guidelines capability or component is linked to a computerized patient record system to integrate the use of clinical guidelines in the workflow of clinicians treating patients. Many healthcare entities maintain sets of clinical guidelines describing recommended treatment or analysis options for patients displaying sets of symptoms or for whom certain diagnoses have been made. The active guidelines feature adds an active guidelines tag to such clinical guidelines so that when the clinician accesses the clinical guidelines and wishes to follow the recommendation, the clinician merely has to click on a hypertext created from the tag which then transmits action orders, also contained in the tag, to be transmitted to the computerized patient record system for implementation. Patient data associated with the recommendations, such as relevant test or lab results, interaction or allergy information, or other current treatments, is also identified and displayed.

  • METHODS FOR ASSESSING DRUG EFFICACY AND RESPONSE OF A PATIENT TO THERAPY

    Methods of identifying, monitoring and matching patients with appropriate treatments using a systemic mediator-associated physiologic test profile are provided. The methods of the present invention increase the likelihood of demonstrating clinical efficacy in clinical trial datasets.

  • PP2A REGULATORY SUBUNIT MODIFICATION IN DISEASE

    Disclosed herein are methods for the diagnosis, detection, and treatment of cardiovascular disease and symptoms thereof in a subject. Disclosed herein are methods of diagnosing ischemic heart disease, non-ischemic heart disease, myocardial infarction, tachy-pacing induced non-ischemic heart disease, heart failure, and catecholaminergic-induced arrhythmia and symptoms thereof in a subject. Disclosed herein are methods of screening the efficacy of a pharmaceutical agent for treating cardiovascular disease and symptoms thereof in a subject. Disclosed herein are methods of identifying a subject eligible for a cardiovascular disease treatment clinical trial

  • DESIGN ASSISTANCE FOR CLINICAL TRIAL PROTOCOLS

    Roughly described, a user instantiates protocol elements in a structured clinical trial protocol database and then draws from them in the development of one or more protocol related documents. The system helps the user select tasks to be performed during the study by reference to a historical database of tasks previously associated with similar protocols. The system automatically generates complex content from protocol elements in the database, and can render overlapping sets of protocol elements differently at different locations in the document. The system can automatically provide advisories indicating aspects of the document that still require completion or highlighting other issues that a sponsoring authority deems important for the document type. After all protocol elements are instantiated in the protocol database, it can then be used to drive the operation of most downstream aspects of the study.

  • PROVIDING INDICATIONS OF CLINICAL-TRIAL CRITERIA MODIFICATIONS

    Systems and method for providing indications of trial-related attributes are provided. In embodiments, the method includes providing an indication to view a suggested clinical-trial criteria modification(s) that, if implemented, is expected to increase a number of patients eligible for a clinical trial. Thereafter, a suggested criterion modification for a clinical-trial criterion is received. The suggested criterion modification is based on a comparison of aggregated patient data associated with the clinical-trial criterion to the clinical-trial criterion. The indication of the suggested criterion modification for the clinical-trial criterion can be displayed.

  • COMPUTER NETWORK FOR QUALITY TESTING CLINICAL TRIAL DATA

    A computer network system and a method for quality testing input clinical trial data are disclosed. The trial data is recorded by way of a form provided on a patient device or a physician device and is passed on in an encrypted, anonymized form to a central server. A quality testing device is installed on the server in order to test the recorded medical data sets with regard to the quality thereof. The scope of the quality test is configurable. In the event of successful testing, an incentive attribute is read out from a database in order to generate an incentive signal and to transmit the signal to the respective terminal device.

  • Clinical Laboratory-Based Disease Management Program, With Automated Patient-Specific Treatment Advice

    A method is provided, the method including receiving a test result data, wherein said test result data represents a result of a test on a physical specimen, associating said test result data with a standard-of-care data, wherein said standard-of-care data represents a recommended course of action for the condition represented by the test result data, and transforming said specimen data and said standard-of-care data into a human-readable form. A system including a processor is provided, a software adapted to be executed on said processor, said software comprising instructions for receiving a test result data, wherein said test result data represents a result of a test on a physical specimen, associating said test result data with a standard-of-care data, wherein said standard-of-care data represents a recommended course of action for the condition represented by the test result data, and transforming said specimen data and said standard-of-care data into a human-readable form.

  • METHOD OF PAYMENT ASSESSMENT TO CLINICAL STUDY VOLUNTEERS

    Systems, methods, and other embodiments associated with generating payments to volunteers in clinical trials are described. In one embodiment, a method includes receiving volunteer data that specifies a clinical event that has been completed by a given volunteer. The example method also includes determining a payment associated with the clinical event. A financial record is generated that records the determined payment. The financial record is transmitted using a web based browser to a financial system to populate at least one field in a financial database table that is used to generate payments to the volunteer.

  • SYSTEM AND METHOD FOR PROVIDING CLINICAL DECISION SUPPORT

    A clinical decision support system comprises a memory device having a plurality of routines stored therein, a processor configured to execute the plurality of routines stored in the memory device, the plurality of routines comprising a routine configured to receive primary clinical information from a user associated with a patient, a routine configured to derive expanded clinical information from the user-provided primary clinical information, a routine configured to identify relevant rules from a data store based on the user-provided clinical information and the expanded clinical information, a routine configured to compute a diagnostic relevancy score for each of the identified relevant rules; a routine configured to assign by the processing device the computed diagnostic relevancy score to each identified relevant rule, and a routine configured to display each identified rule in ranked order based on the rule's assigned diagnostic relevancy score.