 Patent Application Title |
Patent App Num. |
Date |
| System and method for providing insurance | 20130132125 | 20130523 |
 A system and method for providing post-operative insurance in a surgical procedure involving implantation of a foreign material into a human body includes underwriting an insurance policy to cover an adverse event resulting from the procedure that may occur from a completion date of the procedure up to at least one year from the completion date of the procedure from a completion date of the procedure. The method further includes determining eligibility for enrollment of a patient undergoing the procedure and providing the insurance policy to the patient if the patient is eligible to enroll. Upon receiving a policy claim for the event, the claim is evaluated and insurance coverage is provided for the patient if the event is covered by the policy.
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| Prediction and recognition of acute kidney injury after surgery | 20130122530 | 20130516 |
 Systems, kits, and methods for predicting the risk of an adverse event related to acute kidney injury AKI as a consequence of a surgical intervention in a subject. Embodiments of the system and methods include means and steps for determining an amount of liver-type fatty acid binding protein (L-FABP) in a sample, such as a urine-sample of a subject; comparing the amounts of the L-FABP with a reference amount, and predicting the risk of an adverse event related to acute kidney injury as a consequence of surgical intervention in the subject.
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| Tractor | 20120245795 | 20120927 |
 A tractor is improved for suppressing pitching in which a front part of a traveling vehicle body is lifted upward, while a suspension mechanism effectively functions when work is carried out with a ground implement. When a raise control signal for raising the plow is detected in draft control for elevating/lowering the plow based on a draw load value detected by a draw load sensor, mode switching means suppresses or limits the suspension function, via control of the suspension control means to suppress an adverse event in which the front part of the traveling vehicle body is lifted upward. When the raise control signal is not detected, the mode switching means causes the suspension mechanism to effectively function via control of the suspension control means.
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| Processing drug data | 20120209864 | 20120816 |
 Computer-assisted methods and systems of processing a drug information source. Characterizing the drug by the set comprising: syntax-parsed drug rule elements, adverse event data, mapped terms, and metadata. A method includes: creating a drug rule syntax; extracting metadata from the drug information source; extracting verbatim adverse event data from the drug information source; identifying drug rule content from the drug information source; mapping terms from verbatim data to a reference source; and parsing drug rule elements from at least one identified instance of drug rule content into the drug rule syntax, retaining associations between those drug rule elements that form a drug rule.
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| Method and system for an online patient community based on "structured dialog" | 20120173256 | 20120705 |
 A system for an online community based on Structured Dialogs offering organizations the opportunity to create online communities and have a dialog with users on their status, condition, and progress without the risk of adverse event reports by users. The system may include an interface that limits user communication to Structured Dialogs comprising controlled vocabulary elements of specific choices, including pop-ups, drop downs, and sliders. The system includes a personal health and wellness management tool coupled with the community to enable the user to manage his or her medication and condition using Structured Dialogs and thus making the interaction more interesting and effective for users. The system may also include an information repository “Info” Layer that can offer articles that are relevant to users. The “We”,... |
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| Procalcitonin for the prognosis of adverse events | 20120149131 | 20120614 |
| The present invention relates to an in vitro method for the prognosis of an adverse event in asymptomatic subjects comprising the determination of the level of Procalcitonin (PCT) or a fragment thereof or a precursor or fragment thereof having at least 12 amino acid residues in a sample of a bodily fluid from said subject and the correlation of the determined level to a potential risk of sustaining an adverse event.
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| Systems and methods for clinical trial documenting using a mobile communications device | 20120143617 | 20120607 |
| 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.
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| Stable pharmaceutical composition for atherosclerosis | 20120027849 | 20120202 |
| The present invention relates to a stable solid oral pharmaceutical multi-component composition comprising combination of blood pressure lowering drugs with lipid lowering agent/s and optionally a platelet aggregation inhibitor in a single dosage form. The blood pressure lowering agents are selected from β-adrenergic receptor blocking agent, ACE inhibitor and diuretic. The lipid lowering agent is selected from HMG Co-enzyme-A reductase inhibitor. The pharmaceutical composition made as per present invention a) overcomes any drug-drug interactions, b) exhibits pharmacokinetic and pharmacodynamic profile of individual therapeutic agent, c) has minimal side effects. The invention provides multi-component composition (MCC) to increase adherences to therapy. The MCC as per present invention provides compositions that maintain activity of all active ingredients without significant increase in adverse event profile. The present invention further... |
| Automated ontology generation system and method | 20110004628 | 20110106 |
| An automated method for ontology generation is provided. In one embodiment, a user inputs a single clinical term or portion of a clinical term representing an adverse event that a patient has experienced. In response, the system causes a list of conceptually related terms to be generated.
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| Methods of treating term and near-term neonates having hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension | 20100331405 | 20101230 |
| The invention relates methods of reducing the risk or preventing the occurrence of an adverse event (AE) or a serious adverse event (SAE) associated with a medical treatment comprising inhalation of nitric oxide.
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| Methods of treating term and near-term neonates having hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension | 20100330206 | 20101230 |
| The invention relates methods of reducing the risk or preventing the occurrence of an adverse event (AE) or a serious adverse event (SAE) associated with a medical treatment comprising inhalation of nitric oxide.
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| Methods of treating term and near-term neonates having hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension | 20100330207 | 20101230 |
| The invention relates methods of reducing the risk or preventing the occurrence of an adverse event (AE) or a serious adverse event (SAE) associated with a medical treatment comprising inhalation of nitric oxide.
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| Methods of treating term and near-term neonates having hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension | 20100330193 | 20101230 |
| The invention relates methods of reducing the risk or preventing the occurrence of an adverse event (AE) or a serious adverse event (SAE) associated with a medical treatment comprising inhalation of nitric oxide.
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| Method of providing pirfenidone therapy to a patient | 20100324097 | 20101223 |
| The invention relates to methods for decreasing adverse events associated with pirfenidone (5-methyl-1-phenyl-2-(1H)-pyridone) therapy. The invention discloses an optimized dose escalation scheme that results in the patient having increased tolerance to adverse events associated with the administration of pirfenidone. The invention also discloses a starter pack that may be used in conjunction with the dose escalation scheme.
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| Baroreflex activation for arrhythmia treatment | 20100298898 | 20101125 |
| An aspect of the present subject matter relates to a system for providing baroreflex stimulation. An embodiment of the system comprises an adverse event detector to sense an adverse event and provide a signal indicative of the adverse event, and a baroreflex stimulator. The stimulator includes a pulse generator to provide a baroreflex stimulation signal adapted to provide a baroreflex therapy, and a modulator to receive the signal indicative of the adverse event and modulate the baroreflex stimulation signal based on the signal indicative of the adverse event to change the baroreflex therapy from a first baroreflex therapy to a second baroreflex therapy. Other aspects are provided herein.
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| Medical assessment support system and method | 20100235378 | 20100916 |
| The invention is directed to a medical assessment support system. In one embodiment, a user inputs a query that identifies an adverse event that a patient has experienced and the ailments (diseases, disorders, symptoms, conditions etc.) that the patient has experienced. In response, the system causes one or more database searches to be performed to identify one or more possible causes of the adverse event for a patient with the identified ailments. In another embodiment, the user inputs a combination of one or more drugs that a patient has taken and one or more ailments that the patient has experienced. The system operates to determine if there is an adverse event associated with the specified combination and reports any such adverse event to the user. The... |
| Use of natriuretic peptides for treating angioedema syndromes | 20100204446 | 20100812 |
| The present invention relates to the use of a natriuretic peptide, urodilatin, for treating patients suffering from acute drug induced angioedema, such as ACE inhibitor related adverse events. Preferably, a composition comprising an effective amount of urodilatin is intravenously administered to the patient continuously for 18 hours to 72 hours.
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| Automatic baroreflex modulation responsive to adverse event | 20100191303 | 20100729 |
| A system for providing baroreflex stimulation comprises a sensor to detect a parameter and provide a signal indicative of the parameter, and a baroreflex stimulator. The baroreflex stimulator includes a driver to provide a control signal adapted to deliver a baroreflex therapy, and a controller to receive the signal indicative of the parameter and modulate the control signal based on the signal indicative of the parameter to change the baroreflex therapy from a first baroreflex therapy to a second baroreflex therapy.
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| Method to maintain the efficacy of orlistat | 20100183686 | 20100722 |
| A method to effectively treat the adverse events of ingested orlistat, and to maintain the effectiveness of ingested orlistat, the method comprising the steps of: ingesting a compound of orlistat to irreversibly bind with lipase enzymes of the gastrointestinal tract; ingesting a compound of simethicone to cause undigested fats to remain in an emulsified state in the bowel; and ingesting an enteric coated activated charcoal member to absorb emulsified fats only in the lower bowel, thus preventing the adverse events associated with the ingestion of orlistat alone.
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| Direct reporting of adverse events | 20100179829 | 20100715 |
| Systems, methods, and computer readable media are described for communicating an adverse event report directly to an end-user receiving party and tracking one or more adverse event reports. An adverse event may be detected manually or automatically by a system and an electronic adverse event reporting form presented to a user with one or more data fields pre-populated with data from a patient's electronic health record (EHR). The user may enter and edit data in the electronic form and may submit the data in the electronic form directly to an end-user receiving party such as the U.S. Food and Drug Administration. One or more receipts may be received from the receiving party and indicia from the receipts recorded to one or more records. The submitted adverse... |
| Tracking direct reported adverse events | 20100179821 | 20100715 |
| Systems, methods, and computer readable media are described for communicating an adverse event report directly to an end-user receiving party and tracking one or more adverse event reports. An adverse event may be detected manually or automatically by a system and an electronic adverse event reporting form presented to a user with one or more data fields pre-populated with data from a patient's electronic health record (EHR). The user may enter and edit data in the electronic form and may submit the data in the electronic form directly to an end-user receiving party such as the U.S. Food and Drug Administration. One or more receipts may be received from the receiving party and indicia from the receipts recorded to one or more records. The submitted adverse... |
| Ischemic biomarkers and their use to predict adverse neurological events from surgery | 20100173789 | 20100708 |
| Methods are provided for predicting the occurrence of adverse neurological events from surgery. Such adverse events include, for example, stroke, delirium and transient ischemic attack (TIA). The methods are based on the discovery that levels of circulating cerebral NMDA receptor peptides and antibodies can be used to identify patients who are likely to suffer from an adverse neurological event. Also provided are diagnostic procedures for practicing the predictive methods of the current invention, and interventional strategies for reducing the risk of adverse neurological events from surgery.
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| Application of sedoisoprosan for preparation of medicine for treatment of human hbeag positive chronic hepatitis b | 20100144855 | 20100610 |
| The present invention disclosed the application of sedoisoprosan for preparation of medicine for therapy on human HBeAg positive chronic hepatitis B. Results of the clinical trials indicated that sedoisoprosan could effectively inhibit hepatitis B virus, the anti-virus effect is enhanced as the dose is increased and the incidence of adverse events is low. Thus, sedoisoprosan is safe and effective for therapy on human HBeAg positive chronic hepatitis B.
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| Processing drug data | 20100125615 | 20100520 |
| Computer-assisted methods and systems of processing a drug information source. Characterizing the drug by the set comprising: syntax-parsed drug rule elements, adverse event data, mapped terms, and metadata. A method includes: creating a drug rule syntax; extracting metadata from the drug information source; extracting verbatim adverse event data from the drug information source; identifying drug rule content from the drug information source; mapping terms from verbatim data to a reference source; and parsing drug rule elements from at least one identified instance of drug rule content into the drug rule syntax, retaining associations between those drug rule elements that form a drug rule.
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| Systems, methods and devices for using a flowable medium for distending a hollow organ | 20100087798 | 20100408 |
| Systems, methods, apparatus and devices for performing improved gynecologic and urologic procedures using a flowable distension media are disclosed. The system and devices provide simplified use and reduced risk of adverse events. Patient benefit is achieved through improved outcomes, reduced pain, especially peri-procedural pain, and reduced recovery times. The various embodiments enable procedures to be performed outside the hospital setting, such as in a doctor's office or clinic.
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| Computer system and computer-implemented method for providing personalized health information for multiple patients and caregivers | 20100076786 | 20100325 |
| Personalized health information is provided by maintaining a patient profile over time and matching information from the patient profile to appropriate patient-centric information related to that patient's specific medical condition. The patient profile can include a variety of medical information. The patient profile is matched, for example, to patient-centric options for care, clinical trials for which the patient is eligible, drug treatment regimens directly related to each patient's specific condition, scheduling of the treatments, survivorship plans and data, information about managing symptoms, nutritional information, rehabilitation recommendations, possible adverse events based on specific treatments to monitor, and personalized education and information. The patient profile can be populated with information from a database, such as one associated with a cancer registry.
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| Medical probes for the treatment of blood vessels | 20100076416 | 20100325 |
| Devices and methods for thermally-mediated treatment of blood vessels to elicit an immune response to cause rapid endothelial growth over at least portions of an implant or stent to prevent adverse events such as restenosis. Devices and methods for thermally-mediated treatment to inhibit contraction of vessels to
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| Electrohydrodynamic fluid accelerator device with collector electrode exhibiting curved leading edge profile | 20100052540 | 20100304 |
| Performance of an electrohydrodynamic fluid accelerator device may be improved and adverse events such as sparking or arcing may be reduced based, amongst other things, on electrode geometries and/or positional interrelationships of the electrodes. For example, in a class of EHD devices that employ a longitudinally elongated corona discharge electrode (often, but not necessarily, a wire), a plurality of generally planar, collector electrodes may be positioned so as to present respective leading surfaces toward the corona discharge electrode. The generally planar collector electrodes may be oriented so that their major surfaces are generally orthogonal to the longitudinal extent of the corona discharge electrode. In such EHD devices, a high intensity electric field can be established in the “gap” between the corona discharge electrode and leading surfaces... |
| Embolic protection during percutaneous heart valve replacement and similar procedures | 20090326575 | 20091231 |
| Various devices are described to provide filtering of flow from the aorta to the left carotid artery and the right carotid artery. The filters can be brought into a desired position through one or more peripheral arteries. A single filter device can provide the desired filtering or a plurality of devices can be used. In particular a single filter device can span between the brachiocephalic artery and the left carotid artery. These filter devices can be used effectively to capture emboli generated during procedures on the heart so that emboli do not travel to the patient's brain where the emboli can cause a stroke or other adverse event. In particular, these filters can be used during percutaneous procedures on the heart, such as endovascular heart valve... |
| System and techniques for reporting adverse effects | 20090319299 | 20091224 |
| Techniques for collecting and reporting adverse events associated with a patient are disclosed. The techniques include providing a user interface to identify drug and medical conditions associated with the patient using standardized drug and medical terminology. The techniques also include generating and displaying a cumulative narrative of user selections on the interface. The cumulative narrative can be directly transmitted to one or more companies and/or and regulatory agencies.
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| Colchicine products, method of manufacture, and methods of use | 20090318561 | 20091224 |
| Disclosed herein is a method of using colchicine. In one embodiment, the method comprises administering to a patient colchicine and a substrate of cytochrome P450 1A2 and monitoring the patient during administration of colchicine and the substrate for an adverse event. Also disclosed are articles of manufacture comprising a container containing a dosage form of colchicine and a method of manufacturing a colchicine product.
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| Method and apparatus for delivery and detection of transmural cardiac ablation lesions | 20090306643 | 20091210 |
| During cardiac wall tissue ablation with an RF catheter, the observation of an 8 to 12 ohm drop in the tissue impedance is indicative of the production of a transmural lesion. Due to a magnetic catheter's ability to stay in the same position throughout the cardiac cycle and the consistency of forces applied throughout the cardiac cycle, the impedance measurement from the distal electrode of the magnetic catheter is uniquely useful in determining the achievement of a transmural lesion. The use of this impedance measurement during ablation with a magnetic catheter can thus be used as an indication of when the ablation has achieved a successful treatment endpoint. An RF generator's impedance measurement along with knowledge of the navigational state of a magnetic catheter can thus... |
| Selection, propagation and use of mosaic aneuploid stem cells | 20090305244 | 20091210 |
| The distribution of cell karyotypes within a population of cells can determine the phenotype and ability of stem cells to differentiate into desired cell types, to function normally, as well as represent risk for adverse events like cancer. Therefore, determination of the aneuploid mosaic status of a cell population is useful in identifying and/or maintaining desirable traits and eliminating undesirable traits in stem cells, and for defining them at the level of their chromosomal complement.
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| Sustained release delivery of active agents to treat glaucoma and ocular hypertension | 20090280158 | 20091112 |
| The methods described herein provide treatment of glaucoma, ocular hypertension, and elevated intraocular pressure with latanoprost or other therapeutic agent(s). Implant devices for insertion into a punctum of a patient provide sustained release of latanoprost or other therapeutic agent(s) that is maintained for 7, 14, 21, 30, 45, 60, or 90 days or more, thus avoiding patient noncompliance and reducing or lowering adverse events associated with eye drop administration of latanoprost or other therapeutic agent(s) and other therapeutic agent(s).
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| Sustained release delivery of active agents to treat glaucoma and ocular hypertension | 20090280158 | 20091112 |
| The methods described herein provide treatment of glaucoma, ocular hypertension, and elevated intraocular pressure with latanoprost or other therapeutic agent(s). Implant devices for insertion into a punctum of a patient provide sustained release of latanoprost or other therapeutic agent(s) that is maintained for 7, 14, 21, 30, 45, 60, or 90 days or more, thus avoiding patient noncompliance and reducing or lowering adverse events associated with eye drop administration of latanoprost or other therapeutic agent(s) and other therapeutic agent(s).
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| Methods and compositions relating to pharmacogenetics of different gene variants in the context of irinotecan-based therapies | 20090247475 | 20091001 |
| The present invention is directed to methods and compositions for determining the presence or absence of polymorphisms within an ABCC2, UGT1A1, and/or SLCO1B1 gene and correlating these polymorphisms with activity levels of their gene products and making evaluations regarding the effect on their substrates, particularly those substrates that are drugs. In addition, there are methods and compositions of evaluating the risk of an individual for developing toxicity or adverse event(s) to an ABCC2, UGT1A1, and/or SLCO1B1 substrate. In some embodiments, the invention concerns methods and compositions for determining the presence or absence of ABCC2 3972C>T variant and predicting or anticipating the level of activity of ABCC2 and determining dosages of an ABCC2 drug substrate, such as irinotecan, in a patient. Such methods and compositions can be... |
| Quinine dosage forms and methods of use thereof | 20090239902 | 20090924 |
| Disclosed herein are quinine formulations and methods of using quinine formulations. Specifically disclosed are methods of using quinine and informing a user of information, including potential adverse effects, the effect of food on quinine's pharmacokinetics, effect of dosing various strengths of quinine, effect of maximum plasma concentrations of quinine in a patient as it relates to adverse events, effects of deviating from the prescribed dosage, etc.
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| Method for discovering new uses of pharmaceutical products through assessment of beneficial side effects in clinical trials | 20090240635 | 20090924 |
| A method for discovering new indications of any pharmaceutical product through systematically assessing the beneficial side effects of it directly from patients and their care takers in clinical trials, without first specifying what those effects might be. One embodiment of the method ensures that all collected beneficial side effects can be coded with a standard dictionary for adverse events, and that all important aspects of them are captured and summarized. The beneficial side effect data collected and analyzed will lead to more and faster discoveries of new indications and better understanding of pharmaceutical products. It is especially promising for diseases that are least understood or least researched. The standard animal-to-human drug research and development model does not work when a drug works in only humans, not... |
| System, method and computer program product for performing automatic surveillance and tracking of adverse events | 20090216555 | 20090827 |
| A system, method and computer program product are provided for automatically detecting and tracking adverse events. The system may include one or more data sources configured to provide a combination of clinical, operational and financial data associated with each of a plurality of patients. The system may further include a network entity configured to receive at least part of the combination of data and to apply one or more trigger rules to the combinations of data to identify one or more suspected adverse events. The network entity may further be configured to receive an indication of one or more confirmed adverse events from among the suspected adverse events, and to automatically compile at least part of the combination of data associated with respective patients in association... |
| Human monoclonal antibodies to programmed death 1(pd-1) and methods for treating cancer using anti-pd-1 antibodies alone or in combination with other immunotherapeutics | 20090217401 | 20090827 |
| The present invention provides isolated monoclonal antibodies, particularly human monoclonal antibodies, that specifically bind to PD-1 with high affinity. Nucleic acid molecules encoding the antibodies of the invention, expression vectors, host cells and methods for expressing the antibodies of the invention are also provided. Immunoconjugates, bispecific molecules and pharmaceutical compositions comprising the antibodies of the invention are also provided. The invention also provides methods for detecting PD-1, as well as methods for treating various diseases, including cancer and infectious diseases, using anti-PD-1 antibodies. The present invention further provides methods for using a combination immunotherapy, such as the combination of anti-CTLA-4 and anti-PD-1 antibodies, to treat hyperproliferative disease, such as cancer. The invention also provides methods for altering adverse events related to treatment with such antibodies individually.
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| System, method and computer program product for performing automatic surveillance and tracking of adverse events | 20090216555 | 20090827 |
| A system, method and computer program product are provided for automatically detecting and tracking adverse events. The system may include one or more data sources configured to provide a combination of clinical, operational and financial data associated with each of a plurality of patients. The system may further include a network entity configured to receive at least part of the combination of data and to apply one or more trigger rules to the combinations of data to identify one or more suspected adverse events. The network entity may further be configured to receive an indication of one or more confirmed adverse events from among the suspected adverse events, and to automatically compile at least part of the combination of data associated with respective patients in association... |
| Human monoclonal antibodies to programmed death 1(pd-1) and methods for treating cancer using anti-pd-1 antibodies alone or in combination with other immunotherapeutics | 20090217401 | 20090827 |
| The present invention provides isolated monoclonal antibodies, particularly human monoclonal antibodies, that specifically bind to PD-1 with high affinity. Nucleic acid molecules encoding the antibodies of the invention, expression vectors, host cells and methods for expressing the antibodies of the invention are also provided. Immunoconjugates, bispecific molecules and pharmaceutical compositions comprising the antibodies of the invention are also provided. The invention also provides methods for detecting PD-1, as well as methods for treating various diseases, including cancer and infectious diseases, using anti-PD-1 antibodies. The present invention further provides methods for using a combination immunotherapy, such as the combination of anti-CTLA-4 and anti-PD-1 antibodies, to treat hyperproliferative disease, such as cancer. The invention also provides methods for altering adverse events related to treatment with such antibodies individually.
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| System, method and computer program product for performing automatic surveillance and tracking of adverse events | 20090216555 | 20090827 |
| A system, method and computer program product are provided for automatically detecting and tracking adverse events. The system may include one or more data sources configured to provide a combination of clinical, operational and financial data associated with each of a plurality of patients. The system may further include a network entity configured to receive at least part of the combination of data and to apply one or more trigger rules to the combinations of data to identify one or more suspected adverse events. The network entity may further be configured to receive an indication of one or more confirmed adverse events from among the suspected adverse events, and to automatically compile at least part of the combination of data associated with respective patients in association... |
| Human monoclonal antibodies to programmed death 1(pd-1) and methods for treating cancer using anti-pd-1 antibodies alone or in combination with other immunotherapeutics | 20090217401 | 20090827 |
| The present invention provides isolated monoclonal antibodies, particularly human monoclonal antibodies, that specifically bind to PD-1 with high affinity. Nucleic acid molecules encoding the antibodies of the invention, expression vectors, host cells and methods for expressing the antibodies of the invention are also provided. Immunoconjugates, bispecific molecules and pharmaceutical compositions comprising the antibodies of the invention are also provided. The invention also provides methods for detecting PD-1, as well as methods for treating various diseases, including cancer and infectious diseases, using anti-PD-1 antibodies. The present invention further provides methods for using a combination immunotherapy, such as the combination of anti-CTLA-4 and anti-PD-1 antibodies, to treat hyperproliferative disease, such as cancer. The invention also provides methods for altering adverse events related to treatment with such antibodies individually.
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| System, method and computer program product for performing automatic surveillance and tracking of adverse events | 20090216555 | 20090827 |
| A system, method and computer program product are provided for automatically detecting and tracking adverse events. The system may include one or more data sources configured to provide a combination of clinical, operational and financial data associated with each of a plurality of patients. The system may further include a network entity configured to receive at least part of the combination of data and to apply one or more trigger rules to the combinations of data to identify one or more suspected adverse events. The network entity may further be configured to receive an indication of one or more confirmed adverse events from among the suspected adverse events, and to automatically compile at least part of the combination of data associated with respective patients in association... |
| Human monoclonal antibodies to programmed death 1(pd-1) and methods for treating cancer using anti-pd-1 antibodies alone or in combination with other immunotherapeutics | 20090217401 | 20090827 |
| The present invention provides isolated monoclonal antibodies, particularly human monoclonal antibodies, that specifically bind to PD-1 with high affinity. Nucleic acid molecules encoding the antibodies of the invention, expression vectors, host cells and methods for expressing the antibodies of the invention are also provided. Immunoconjugates, bispecific molecules and pharmaceutical compositions comprising the antibodies of the invention are also provided. The invention also provides methods for detecting PD-1, as well as methods for treating various diseases, including cancer and infectious diseases, using anti-PD-1 antibodies. The present invention further provides methods for using a combination immunotherapy, such as the combination of anti-CTLA-4 and anti-PD-1 antibodies, to treat hyperproliferative disease, such as cancer. The invention also provides methods for altering adverse events related to treatment with such antibodies individually.
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| System, method and computer program product for performing automatic surveillance and tracking of adverse events | 20090216555 | 20090827 |
| A system, method and computer program product are provided for automatically detecting and tracking adverse events. The system may include one or more data sources configured to provide a combination of clinical, operational and financial data associated with each of a plurality of patients. The system may further include a network entity configured to receive at least part of the combination of data and to apply one or more trigger rules to the combinations of data to identify one or more suspected adverse events. The network entity may further be configured to receive an indication of one or more confirmed adverse events from among the suspected adverse events, and to automatically compile at least part of the combination of data associated with respective patients in association... |
| Human monoclonal antibodies to programmed death 1(pd-1) and methods for treating cancer using anti-pd-1 antibodies alone or in combination with other immunotherapeutics | 20090217401 | 20090827 |
| The present invention provides isolated monoclonal antibodies, particularly human monoclonal antibodies, that specifically bind to PD-1 with high affinity. Nucleic acid molecules encoding the antibodies of the invention, expression vectors, host cells and methods for expressing the antibodies of the invention are also provided. Immunoconjugates, bispecific molecules and pharmaceutical compositions comprising the antibodies of the invention are also provided. The invention also provides methods for detecting PD-1, as well as methods for treating various diseases, including cancer and infectious diseases, using anti-PD-1 antibodies. The present invention further provides methods for using a combination immunotherapy, such as the combination of anti-CTLA-4 and anti-PD-1 antibodies, to treat hyperproliferative disease, such as cancer. The invention also provides methods for altering adverse events related to treatment with such antibodies individually.
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| Method of applying an injectable filler | 20090204101 | 20090813 |
| Methods for applying injectable fillers are provided. In some embodiments, the methods can result in a reduced risk of an adverse event occurring from the administration of the injectable filler. Also disclosed are devices and kits related to this method.
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| Method of providing pirfenidone therapy to a patient | 20090197923 | 20090806 |
| The invention relates to methods for decreasing adverse events associated with pirfenidone (5-methyl-1-phenyl-2-(1H)-pyridone) therapy. The invention discloses an optimized dose escalation scheme that results in the patient having increased tolerance to adverse events associated with the administration of pirfenidone. The invention also discloses a starter pack that may be used in conjunction with the dose escalation scheme.
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| Methods for conducting a clinical trial | 20090164240 | 20090625 |
| The present disclosure relates generally to methods for selecting subjects for a clinical trial and includes methods for conducting a clinical trial to study the efficacy and/or safety of a drug by selecting subjects, for inclusion in a subsequent double-blind treatment period of the clinical trial, that do not exhibit adverse events to the drug. Methods for conducting a clinical trial may comprise the following: (1) an open-label titration period, (2) an adjustable dose treatment period and (3) a fixed dose treatment period. Optionally, the clinical trial may comprise a washout period prior to the open-label titration period. Also provided are methods for doing business by selecting subjects for a clinical trial for a drug that do not exhibit adverse events to the drug. Such methods... |
| Methods for conducting a clinical trial | 20090164240 | 20090625 |
| The present disclosure relates generally to methods for selecting subjects for a clinical trial and includes methods for conducting a clinical trial to study the efficacy and/or safety of a drug by selecting subjects, for inclusion in a subsequent double-blind treatment period of the clinical trial, that do not exhibit adverse events to the drug. Methods for conducting a clinical trial may comprise the following: (1) an open-label titration period, (2) an adjustable dose treatment period and (3) a fixed dose treatment period. Optionally, the clinical trial may comprise a washout period prior to the open-label titration period. Also provided are methods for doing business by selecting subjects for a clinical trial for a drug that do not exhibit adverse events to the drug. Such methods... |
| Pigf and flt-1 as prognostic parameters for cardiovascular diseases | 20090155827 | 20090618 |
| The present invention refers to a use of an ex vivo method comprising the determination of PlGF and sFlt-1 in a sample for diagnosis, risk stratification and/or monitoring of a vascular disease with atherosclerotic etiology, in particular a coronary heart disease such a unstable angina pectoris or myocardial infarction, and/or for estimation of the probability of developing such a disease, as well as for identification of a patient supposed to benefit from a therapy by agents reducing the risk for a cardiovascular disease. In the method (i) a ratio of [PlGF=high:sFlt-1=low], and/or (ii) a PlGF concentration in the upper two tertiles of a reference collective, and an sFlt-1 concentration in the lower tertile of the reference collective, and/or (iii) a PlGF result above a PlGF reference... |
| Automatic baroreflex modulation responsive to adverse event | 20090143834 | 20090604 |
| An aspect of the present subject matter relates to a system for providing baroreflex stimulation. An embodiment of the system comprises an adverse event detector to sense an adverse event and provide a signal indicative of the adverse event, and a baroreflex stimulator. The stimulator includes a pulse generator to provide a baroreflex stimulation signal adapted to provide a baroreflex therapy, and a modulator to receive the signal indicative of the adverse event and modulate the baroreflex stimulation signal based on the signal indicative of the adverse event to change the baroreflex therapy from a first baroreflex therapy to a second baroreflex therapy. Other aspects are provided herein.
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| Security system and network | 20090122143 | 20090514 |
| A security system and network used to detect and deter adverse events in an area to be secured. The security system may include an operator for supervising the area, and a wireless communication system for transceiving data indicative of detection events received from the secured area, wherein the operator can determine if a deter device is to be actuated based on the data. The security system may include an intelligence system for distinguishing between false alarms and actual alarm events, for also actuating a deter device, and for notifying operators. The security system and network may also include a plurality of areas to be secured, wherein each area is serviced by a different wireless hub within the wireless communication system.
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| Method, system and database for post-marketing surveillance and evaluation of drugs | 20090099903 | 20090416 |
| A system and a method for surveying and assessing the contribution of drugs risks of adverse events, comprising a) identification and studying: a plurality of case-groups of different categories of adverse events, each case of a given case-group being faced with a given adverse event; a pool of potential referents identified regardless of a previous medical history thereof; and a large number of drugs and vaccines used by the cases and the potential referents; b) selecting controls sampled from the pool of potential referents according to predetermined criteria; c) matching the controls to specific cases of the case-groups; and d) conducting statistical analyses by comparing cases and controls to identify drugs that are susceptible to be associated with a modified risk of at least one of... |
| System and methods for management of risk data and analytics | 20090083334 | 20090326 |
| Managing and analyzing occurrences of certain types of adverse events associated with a distribution of a prescription drug into the commercial marketplace, such as a drug having an associated abuse liability potential. Data concerning an occurrence of an adverse event associated with such distribution is received and selectively logged as an event if the data satisfies one or more predetermined criteria which can be used to filter the received data. If the received data are logged as an event, a score is computed and assigned to the event. If the score meets or exceeds a pre-established threshold, a field researcher is assigned to investigate the logged event. Further data from the field researcher are stored in association with the logged event. Automated review of further data... |
| Method and system for the analysis and association of patient-specific and population-based genomic data with drug safety adverse event data | 20090076847 | 20090319 |
| A method for assessing and analyzing one or more drugs, adverse effects and associated risks, and patient characteristics resulting from the use of at least drug of interest is disclosed. The method comprises the steps of selecting one or more cases for analysis, said cases describing the behavior between at least one drug of interest and a patient genotype; profiling statistically derived values from multiple cases related to the safety of the at least one drug, wherein at least one filter is employed for deriving said values; at least one data mining engine; and an output device for displaying the analytic results from the data mining engine. A system for performing the method is likewise disclosed.
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| Method for quantification of methylated dna | 20080311566 | 20081218 |
| The present invention relates to a method for the quantification of methylated cytosines in DNA. In the first step of the invention unmethylated cytosines in the DNA to be analysed are chemically converted into uracil while 5-methylcytosines remain unchanged. In a second step the converted DNA is amplified methylation specifically in a real time PCR using a methylation specific probe. Finally the amount of uniformly methylated DNA is calculated by combining criteria derived from the shape of the real time curve and from the signal intensity. The method is preferably used for diagnosis and/or prognosis of adverse events for individuals, for distinguishing cell types and tissues, or for investigating cell differentiation.
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| Method of identifying locations experiencing elevated levels of abuse of opioid analgesic drugs | 20080300902 | 20081204 |
| In the field of pharmacovigilance (monitoring of adverse events associated with the use of marketed prescription drugs), an improved method of detecting “signals” of abuse or diversion of pharmaceuticals is needed, in order to more reliably distinguish real anomalies in pharmaceutical consumption in particular locations from apparent anomalies which are statistical artifacts of high local concentrations of authorized pharmaceutical users. An improved method relies upon government statistics on adverse drug reactions and on census statistics, and employs a Poisson statistical model to adjust for both fixed effects and random effects, such as spatial relations between different locations. The more accurate “signals” provided by the improved method permit public health and law enforcement officials to allocate public resources more efficiently and effectively.
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| Intelligent boot services | 20080301424 | 20081204 |
| An information handling system is provided with an intelligent boot service which addresses and resolves unbootable system scenarios. The intelligent boot service detects and corrects adverse events before booting into the operating system. The intelligent boot service architecture is extensible to add newer events and is extensible to include extensible firmware interface (EFI) technology.
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| Metaxalone products, method of manufacture, and method of use | 20080292584 | 20081127 |
| Disclosed herein are methods of using metaxalone. In one embodiment, the method comprises determining that a patient in need metaxalone therapy is taking a substance that is a n inhibitor or an inducer of a cytochrome p450 isozyme, wherein the cytochrome P450 is CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A4, and adjusting administration to the patient of metaxalone or the substance to avoid an adverse event associated with metaxalone. In another embodiment, the method comprises informing a user that metaxalone ais metabolized by a cytochrome p450 isozyme, wherein the cytochrome P450 is CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A4. Also included are articles of manufacture comprising a container containing a dosage form of metaxalone, wherein the container is associated with published material informing that... |
| Transdermal patch containing isosorbide dinitrate and bisoprolol | 20080292685 | 20081127 |
| This invention relates to a transdermal patch in the form of a layer complex, comprising a backing layer, a drug-reservoir layer comprising pharmacologically active ingredients and pharmaceutically acceptable adjuvants, and a release liner covering the drug-reservoir layer, characterized in that the drug-reservoir layer comprises isosorbide dinitrate and Bisoprolol at a ratio of 1:3 to 3:1 by weight, as the pharmacologically active ingredients. Animal tests show that said patch can reduce the elevation of T wave of cardiogram, the increase of the level of myocardial enzyme in blood serum, and the extension of the range of myocardial infarction caused by ligating the coronary artery in animals. Results show that said patch exhibits a considerable synergistic effect in the treatment of cardiovascular diseases and has good preventive and... |
| Altering pharmacokinetics of pirfenidone therapy | 20080287508 | 20081120 |
| The invention relates to methods for reducing adverse events in patients receiving pirfenidone (5-methyl-1-phenyl-2-(1H)-pyridone) therapy.
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| Auto-detecting and auto-correcting system state changes before booting into operating systems | 20080273550 | 20081106 |
| A mechanism via which system state changes can be detected and corrected automatically prior to a customer initiated boot. The mechanism is extensible to address newly added or discovered system state changes that result in a locked condition. The mechanism detects and corrects adverse events before booting into the operating system.
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| Systems, methods and devices for performing gynecological procedures | 20080245371 | 20081009 |
| Systems, methods, apparatus and devices for performing improved gynecologic and urologic procedures are disclosed. The system and devices provide simplified use and reduced risk of adverse events. Patient benefit is achieved through improved outcomes, reduced pain, especially peri-procedural pain, and reduced recovery times. The various embodiments enable procedures to be performed outside the hospital setting, such as in a doctor's office or clinic.
... |
| Method and composition of a carminative herb or natural supplement to decrease the adverse events of orlistat, an oral lipase inhibitor | 20080241288 | 20081002 |
| A medicament to decrease the adverse events of Orlistat, an oral lipase inhibitor, arranged to be taken in combination with Orlistat, comprising: an admixture of carminative herbs and one or more chelating agents to absorb and mechanically agitate non-digested fats.
... |
| Reduction of adverse events after percutaneous intervention by use of a thrombin receptor antagonist | 20080234236 | 20080925 |
| Disclosed are methods of preventing adverse clinical events in a patient undergoing a percutaneous coronary intervention procedure or a peripheral percutaneous interventional procedure comprising administering a therapeutically effective amount of a thrombin receptor antagonist, such as SCH 530348, to the patient. Administration of a loading dose of about 40 mg of SCH 530348 in as little as one hour prior to the procedure can result in therapeutically effective levels of platelet aggregation.
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| Methods of diagnosis and risk stratification of adverse events in post myocardial infarction patients using pro-adrenomedullin | 20080213746 | 20080904 |
| The invention provides methods for the diagnosis and risk stratification of adverse events in post-myocardial infarction patients by means of proADM, whereby a determination of the marker pro-adrenomedullin or partial sequence or a fragment thereof or contained in a marker combination (panel, cluster) is carried out on a post-myocardial infarction patient. The invention also provides a diagnostic device and a kit for the performance of the method of the method of the invention.
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| Clinical management system and methods | 20080215374 | 20080904 |
| An automated data processing method for obtaining clinical data for safety, efficacy, and adverse event assessments pertaining to a therapy prescribed for the treatment of a malady, comprising the step of receiving at a location remote from a plurality of patients outcome digital information pertaining to the outcome of therapies performed on said patients, and for the efficient delivery of medications to a patient ordered pursuant to an electronic prescription from a dispensary optimized for delivery of the medication.
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| Ischemic biomarkers and their use to predict adverse neurological events from surgery | 20080206793 | 20080828 |
| Methods are provided for predicting the occurrence of adverse neurological events from surgery. Such adverse events include, for example, stroke, delirium and transient ischemic attach (TIA). The methods are based on the discovery that levels of circulating cerebral NMDA receptor peptides and antibodies can be used to identify patients who are likely to suffer from an adverse neurological event. Also provided are diagnostic procedures for practicing the predictive methods of the current invention, and interventional strategies for reducing the risk of adverse neurological events from surgery (FIG. 1).
... |
| Method of providing pirfenidone therapy to a patient | 20080194644 | 20080814 |
| The invention relates to methods for decreasing adverse events associated with pirfenidone (5-methyl-1-phenyl-2-(1H)-pyridone) therapy. The invention discloses an optimized dose escalation scheme that results in the patient having increased tolerance to adverse events associated with the administration of pirfenidone. The invention also discloses a starter pack that may be used in conjunction with the dose escalation scheme.
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| Drug combination for hypertensive disorders | 20080139483 | 20080612 |
| Therapeutic combinations and pharmaceutical compositions are provided comprising ambrisentan and an inhibitor of renin activity or release. Such combinations and compositions are useful to treat hypertensive disorders, particularly pulmonary hypertension conditions such as pulmonary arterial hypertension, to prevent cardiovascular adverse events related thereto, to enhance pulmonary function and to extend time to clinical worsening in a subject having a pulmonary hypertension condition.
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| Methods to identify patients at risk of developing adverse events during treatment with antidepressant medication | 20080102467 | 20080501 |
| The invention provides a method of screening patients to identify those patients more likely to exhibit an increased risk of treatment-emergent suicidal ideation comprising: (a) obtaining a sample of genetic material from the patients, and (b) assaying the sample for the presence of a genotype in the patients which is associated with an increased risk of treatment-emergent suicidal ideation, wherein the genotype is characterized by a polymorphism in a gene selected from the group consisting of glutamine receptor, ionotropic, kainate 2 (GRIK2); glutamate receptor ionotropic AMPA 3 (GRIA3); and combinations thereof.
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| Adverse event data capture software, systems and methodologies | 20080104613 | 20080501 |
| Electronic capture of adverse event information includes selective input of adverse event information into a machine in response to prompt provided to the user based on a site visit. Such adverse event information is forwardable to a location over a communication link. The machine produces one or more alerts, if adverse event information has been input, after a prescribed period of time has transpired unless the machine is informed that the same information has already been forwarded to the location. In a preferred embodiment, the customer is a clinician. Optionally, received adverse event information can be parsed to audit whether any of the information, in fact, concerns an adverse event. Systems and software concerning related technological improvements are disclosed.
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| Systems for performing gynecological procedures with mechanical distension | 20080097470 | 20080424 |
| Systems, methods, apparatus and devices for performing improved gynecologic and urologic procedures are disclosed. The system and devices provide simplified use and reduced risk of adverse events. Patient benefit is achieved through improved outcomes, reduced pain, especially peri-procedural pain, and reduced recovery times. The various embodiments enable procedures to be performed outside the hospital setting, such as in a doctor's office or clinic. An intrauterine access end procedure system includes a mechanical distension element, to eliminate the need for liquid distension media at pressure sufficient to create a risk of intravasation.
... |
| Topiramate compositions and methods of enhancing its bioavailability | 20080085306 | 20080410 |
| The present invention is directed to pharmaceutical compositions that allow for once-daily or alternate day dosage forms of topiramate. The proposed delayed/extended release single dosage form is equivalent to the immediate-release multiple dose daily regimen, and upon administration, provides steady state blood levels of topiramate. Formulations with increased bioavailability and improved pharmacokinetics are disclosed. A once-a-day administration of topiramate is advantageous over the multiple dose regimen both in terms of patient compliance and reduced adverse events, thus providing better treatment of the conditions for which the topiramate is indicated.
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| Computational systems for biomedical data | 20080081957 | 20080403 |
| Methods, apparatuses, computer program products, devices and systems are described that accepting an input identifying at least one treatment target in search of an agent; accessing at least one dataset containing at least one agent for use in the context of the at least one treatment target; applying at least one filter criterion to the at least one dataset to identify a subset of the at least one dataset, the subset of the at least one dataset associated with a defined level of at least one adverse event associated with administration of the at least one agent; and presenting the at least one agent in response to the subset of the at least one dataset.
... |
| Computational systems for biomedical data | 20080081959 | 20080403 |
| Methods, apparatuses, computer program products, devices and systems are described that accepting an input identifying a treatment target in search of an agent, the input associated with at least one query parameter; determining, based on the input, at least one subset of study data for which at least one adverse event profile associated with administration of at least one agent is acceptable within a defined limit relative to a population for which the at least one adverse event profile is unacceptable with respect to the defined limit; and presenting the agent, based on the at least one subset and the at least one query parameter.
... |
| Computational systems for biomedical data | 20080082359 | 20080403 |
| Methods, apparatuses, computer program products, devices and systems are described that accepting an input identifying a treatment target in search of an agent, the input associated with at least one query parameter; determining, based on the input, at least one subset of study data for which at least one adverse event profile associated with administration of at least one agent is acceptable within a defined limit relative to a population for which the at least one adverse event profile is unacceptable with respect to the defined limit; and presenting the agent, based on the at least one subset and the at least one query parameter.
... |
| Computational systems for biomedical data | 20080082500 | 20080403 |
| An apparatus, device, methods, computer program product, and system are described that accept an input defining at least one medical condition; identify within one or more sets of study data at least one agent having a defined level of efficacy in treating the at least one medical condition; identify at least one subpopulation having a defined tolerance for at least one adverse event associated with administration of the at least one agent, the at least one subpopulation exhibiting at least some defined level of efficacy upon administration of the at least one agent to the subpopulation; and present the at least one agent in response to said identification of the at least one subpopulation.
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| Computational systems for biomedical data | 20080082503 | 20080403 |
| Methods, apparatuses, computer program products, devices and systems are described that accepting an input identifying a treatment target in search of an agent, the input associated with at least one query parameter; determining, based on the input, at least one subset of study data for which at least one adverse event profile associated with administration of at least one agent is acceptable within a defined limit relative to a population for which the at least one adverse event profile is unacceptable with respect to the defined limit; and presenting the agent, based on the at least one subset and the at least one query parameter.
... |
| Computational systems for biomedical data | 20080082522 | 20080403 |
| Methods, apparatuses, computer program products, devices and systems are described that accepting an input identifying at least one treatment target in search of an agent; accessing at least one dataset containing at least one agent for use in the context of the at least one treatment target; applying at least one filter criterion to the at least one dataset to identify a subset of the at least one dataset, the subset of the at least one dataset associated with a defined level of at least one adverse event associated with administration of the at least one agent; and presenting the at least one agent in response to the subset of the at least one dataset.
... |
| Computational systems for biomedical data | 20080082582 | 20080403 |
| Methods, apparatuses, computer program products, devices and systems are described that accepting an input identifying at least one treatment target in search of an agent; accessing at least one dataset containing at least one agent for use in the context of the at least one treatment target; applying at least one filter criterion to tile at least one dataset to identify a subset of the at least one dataset, the subset of tile at least one dataset associated with a defined level of at least one adverse event associated with administration of the at least one agent: and presenting the at least one agent in response to the subset of the at least one dataset.
... |
| Method and composition of a carminative herb or natural supplement to decrease the adverse effects of orlistat, and oral lipase inhibitor | 20080069906 | 20080320 |
| A medicament to decrease the adverse events of Orlistat, an oral lipase inhibitor, arranged to be taken in combination with Orlistat, comprising: an admixture of carminative herbs and one or more chelating agents to absorb and mechanically agitate non-digested fats.
... |
| Method and composition of a medicament to decrease the adverse events of olistat, an oral lipase inhibitor | 20080070977 | 20080320 |
| A medicament to decrease the adverse events of Olistat, an oral lipase inhibitor, arranged in combination with Olistat, comprising: an emulsifier, a bowel relaxant and one or more chelating agents to absorb and mechanically agitate non-digested fats.
... |
| Clinical trail support system using medical imaging information | 20070271214 | 20071122 |
| A clinical trial support system suitable for the investigation of an adverse event or the like. A clinical trial database stores: information about sponsors; information about trial sites; product information including the product names, classification, chemical structure, and pharmacokinetics of trial drugs; trial information including trial name, target disease, phase, and completed status; contract information including trial site name, contracted number of cases, and completed status; trial subject information including sex, birth of date, height, weight, and completed status; and visit information including visit date, inspection result, and medical imaging data. An information control unit distributes a search interface for the analysis of an adverse event to the trial sponsor and a retrieval result to the trial site.
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| Method for the analysis of methylated dna | 20070254293 | 20071101 |
| The present invention relates to a method for the analysis of methylated cytosines in DNA. In the first step of the invention unmethylated cytosines in the DNA to be analysed are chemically converted into uracil while 5-methylcytosines remain unchanged. In a second step a methylation specific oligonucleotide carrying a non-extendable 3′ end is annealed to the converted DNA. Subsequently, the non-extendable 3′ terminus of the oligonucleotide is removed in case the oligonucleotide is bound to the DNA with the methylation status to be detected. Finally the unblocked oligonucleotide is extended, and the methylation status is concluded from the absence or presence of an extended oligonucleotide product. The method is preferably used for diagnosis and/or prognosis of adverse events for individuals, for distinguishing cell types and tissues,... |
| Tnf-alpha blocker treatment for enterocolitis associated with immunostimulatory therapeutic antibody therapy | 20070248595 | 20071025 |
| The present invention provides methods for treating adverse events related to immunotherapy. More specifically, the present invention provides methods for treating the enterocolitis associated with anti-CTLA-4 antibody immunotherapy.
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| Prophylaxis and treatment of enterocolitis associated with anti-ctla-4 antibody therapy | 20070243184 | 20071018 |
| The present invention provides methods for reducing the incidence of adverse events related to immunotherapy. More specifically, the present invention provides methods for reducing the incidence of enterocolitis associated with anti-CTLA-4 antibody immunotherapy.
... |
| Automated medical safety monitoring systems and methods | 20070226175 | 20070927 |
| In one aspect, a medical surveillance system for monitoring the safety of at least one medical entity is provided. The medical surveillance system comprises at least one database to store information related to the at least one medical entity, the at least one database being periodically updated with current information about the at least one medical entity, and at least one controller coupled to the database, the at least one controller configured to perform at least one statistical operation on at least a portion of the information stored in the at least one database, the at least one statistical operation being performed periodically so as to generate at least one continuous outcome, the controller configured to trigger an alert when the at least one continuous outcome... |
| Generating a reliability analysis by identifying causal relationships between events in an event-based manufacturing system | 20070220344 | 20070920 |
| Analyzing an event chronology record to permit identification of periods of a production sequence that correspond to a high probability of failure. Systems and methods include receiving an event chronology for a particular machine in the production sequence and for a particular time interval. A reliability analysis system accesses process flow information to determine whether a particular event in the event chronology is related to a subsequent adverse event within a predefined event window.
... |
| Methods of reducing adverse events associated with pirfenidone therapy | 20070203202 | 20070830 |
| The invention relates to methods for reducing adverse events in patients receiving pirfenidone (5-methyl-1-phenyl-2-(1H)-pyridone) therapy.
... |
| In vitro cell-based methods for biological validation and pharmacological screening of chemical entities and biologicals | 20070166754 | 20070719 |
| This patent describes a novel in vitro cell-based method for biological validation and pharmacological screening of drugs, new chemical entities (NCEs) and biologics, which is predictive of in vivo testing for efficacy and adverse events in patients, as occurs in clinical trials. The same method can be used to create an in vitro cell-based assay to identify the ‘right marketed medication for the right patient’ (personalized medicine), and to identify responders and non-responders in ongoing clinical trials with NCEs.
... |
| Fentanyl composition for nasal administration | 20070134164 | 20070614 |
| The treatment of acute pain with a sufficient dosage by intranasal administration of fentanyl results in a time to onset of action comparable to intravenous administration and a significantly faster onset of action than nasal titration of fentanyl. The nasal administration of a sufficient amount of fentanyl to obtain pain relief has lower maximum plasma concentrations comparable to intravenous administration and results in lower rates of adverse events like respiratory depression, nausea and vomiting. Compositions fur use in the method are also disclosed.
... |
| Quinine dosage forms and methods of use thereof | 20070117838 | 20070524 |
| Disclosed herein are quinine formulations and methods of using quinine formulations. Specifically disclosed are methods of using quinine and informing a user of information, including potential adverse effects, the effect of food on quinine's pharmacokinetics, effect of dosing various strengths of quinine, effect of maximum plasma concentrations of quinine in a patient as it relates to adverse events, effects of deviating from the prescribed dosage, etc.
... |
| Stabilized interferon liquid formulations | 20070104682 | 20070510 |
| Stabilized liquid pharmaceutical composition comprising an interferon (IFN) or an isoform, mutein, fused protein, functional derivative, active fraction or salt thereof, wherein said formulation is a solution that comprises a buffer, a cyclodextrin, an isotonicity agent and an anti-oxidant are described here. Preferably the interferon is interferon beta-1a and the cyclodextrin is HPBCD. These formulations are stable at room temperature, thus bringing the advantage of lower costs for formulation storage and increased safety for the patient with respect to possible “errors” during handling. As a matter of fact, having such formulations stable at room temperature reduces the risk of formation of degradation products potentially responsible for adverse events (e.g. immunogenicity).
... |
| Extended release formulation of levetiracetam | 20070092569 | 20070426 |
| The present invention relates to extended release pharmaceutical compositions of Levetiracetam and processes for preparing the same. The extended release tablet of Levetiracetam is with a core comprising of Levetiracetam and water dispersible rate controlling polymer, and the tablet core is optionally functional coated comprising a combination of water non-dispersible and/or water dispersible polymer. It provides extended therapeutically effective plasma levels over a twenty four hour period with diminished incidences of neuropsychiatric adverse events by eliminating the troughs and peaks of drug concentration in a patient's blood plasma. The composition also exhibits no food effect.
... |
| Metal reinforced biodegradable intraluminal stents | 20070043433 | 20070222 |
| The present invention provides an intraluminal stent comprising a metallic reinforcing component and a biodegradable polymeric material covering at least a portion of the metallic reinforcing component. The metallic reinforcing component provides structural reinforcement for the stent, but this reinforcement is insufficient, in the absence of the biodegradable polymeric material, to provide a stent capable of maintaining patency of a lumen upon implantation of the stent into the lumen. One advantage of the present invention, among others, is that a stent is provided in which reduced amounts of metallic component remain after degradation of the biodegradable polymeric material covering, in turn reducing the incidence of metal-associated adverse events that frequently follow implantation.
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| Automatic baroreflex modulation responsive to adverse event | 20070021790 | 20070125 |
| A system for providing baroreflex stimulation comprises a sensor to detect a parameter and provide a signal indicative of the parameter, and a baroreflex stimulator. The baroreflex stimulator includes a driver to provide a control signal adapted to deliver a baroreflex therapy, and a controller to receive the signal indicative of the parameter and modulate the control signal based on the signal indicative of the parameter to change the baroreflex therapy from a first baroreflex therapy to a second baroreflex therapy.
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| Quinine dosage forms and methods of use thereof | 20060264458 | 20061123 |
| Disclosed herein are quinine formulations and methods of using quinine formulations. Specifically disclosed are methods of using quinine and informing a user of information, including potential adverse effects, the effect of food on quinine's pharmacokinetics, effect of dosing various strengths of quinine, effect of maximum plasma concentrations of quinine in a patient as it relates to adverse events, effects of deviating from the prescribed dosage, etc.
... |
| Ischemic biomarkers and their use to predict adverse neurological events from surgery | 20060257943 | 20061116 |
| Methods are provided for predicting the occurrence of adverse neurological events from surgery. Such adverse events include, for example, stroke, delirium and transient ischemic attack (TIA). The methods are based on the discovery that levels of circulating cerebral NMDA receptor peptides and antibodies can be used to identify patients who are likely to suffer from an adverse neurological event. Also provided are diagnostic procedures for practicing the predictive methods of the current invention, and interventional strategies for reducing the risk of adverse neurological events from surgery.
... |
| Device and method for automatically regulating supplemental oxygen flow-rate | 20060225737 | 20061012 |
| Device and method for limiting adverse events during supplemental oxygen therapy are disclosed. In the present invention, the oxygen flow between a patient and an oxygen source is controlled with a valve such as a proportional solenoid capable of constraining flow-rates within a continuous range. The flow-rate of oxygen is accurately controlled in a closed-loop with flow-rate measurements. Measures of a patient's vital physiological statistics are used to automatically determine optimum therapeutic oxygen flow-rate. Controller signal filtering is disclosed to improve the overall response and stability. The control algorithm varies flow-rates to minimize disturbances in the patient feedback measurements.
... |
| Ascomycin derivatives for combination treatment with tazorotene | 20060211726 | 20060921 |
| A method is disclosed herein comprising administering a therapeutically effective amount of an ascomycin derivative topically in combination with tazarotene, wherein said method is effective in reducing adverse events associated with tazarotene. A method is also disclosed herein comprising administering a therapeutically effective amount of an ascomycin derivative topically in combination with tazarotene to a person for the treatment or prevention of psoriasis. Thus, a composition comprising a therapeutically effective amount of tazarotene and an ascomycin derivative is disclosed herein.
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| Computer algorithms and methods for product safety | 20060195418 | 20060831 |
| The invention comprises systems, methods and a computerized data management device for creating and using data relating to a medical or non-medical product or device to enhance the safety of the product or device. A vast amount of data regarding adverse events associated with a particular product or device is analyzed to identify new essential adverse events associated with the product or device. At least one database of new essential adverse event information is created and utilized, and new characteristics of or uses for the product or device related to the new essential adverse event information are determined. Adverse event information is gathered for a large number of population sub-groups. The system may also be programmed to incorporate the information into intellectual property and contract documents.... |
| Extended release formulation of levetiracetam | 20060165796 | 20060727 |
| An extended release pharmaceutical composition of Levetiracetam with once a day dosage regime and the process of preparing it. The extended release tablet of Levetiracetam is with the core comprising of Levetiracetam and water dispersible rate controlling polymer, and the tablet core is optionally functional coated comprising a combination of water non-dispersible and/or water dispersible polymer. It provides extended therapeutically effective plasma levels over a twenty four hour period with diminished incidences of neuropsychiatric adverse events by eliminating the troughs and peaks of drug concentration in a patients blood plasma, which comprises administering orally to a patient in need thereof, an extended release tablet that provides a peak blood plasma level of Levetiracetam in from about eight to about Sixteen hours. The core is prepared by... |
| System and method for prediction of adverse events during treatment of psychological and neurological disorders | 20060167370 | 20060727 |
| The present invention is a system and method of deriving and computing features and indices that predict the likelihood of psychological and neurological adverse events such as suicidal thoughts and/or actions. The method of the present invention further predicts the likelihood of suicidal thoughts and/or actions prior to and or during treatment for psychological disease. To obtain such features and indices, power spectrum and time domain values are derived from biopotential signals acquired from the subject being tested. The system and method identify people who are likely to experience changing, especially worsening, symptoms of psychological and neurological adverse events such as suicidal thoughts or actions and who therefore may be at risk (e.g. suicide).
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| Event analysis system, method and software | 20060150022 | 20060706 |
| An event analysis system employs a Failure Path™ methodology to extract useful information concerning an adverse event that has happened or is being conjectured, to assist subsequent decision making. An exemplary event analysis system may be implemented in software on a desktop computer and employs linked data to identify in an objective manner those contributing factors of an adverse event and possible rectification actions to prevent similar adverse events occurring in future.
... |
