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This page is updated frequently with new Adverse Event-related patent applications.




 Telemetrics and alert system patent thumbnailnew patent Telemetrics and alert system
A telemetric monitoring system and data analysis tool is provided that assists in trial management by identifying relationships between subject profiles and monitors physiological attributes using telemetric devices. The tool may identify subjects having certain response predispositions based on their profiles, which may be used to better select subjects to enroll in a trial.
Accenture Global Services Limited


 Methods and kits for monitoring the effects of immunomodulators on adaptive immunity patent thumbnailMethods and kits for monitoring the effects of immunomodulators on adaptive immunity
The invention provides for noninvasive assessment of immunocompetence in various situations, for example, when modified by disease or by immunomodulators. The assessment determines the functional activity of germinal centers via measuring levels of immunogolublin isotype class switching.
Millennium Pharmaceuticals, Inc.


 Compositions for treating heartworm infestation patent thumbnailCompositions for treating heartworm infestation
The present invention further relates to ivermectin, most preferably formulated as an implant for administration of pet and domestic animals. These formulations provide long term protection against dirofilaria parasites, without the risks for secondary adverse events of conventional formulations.
Ceva Sante Animale


 Providing status of user devices during an adverse event patent thumbnailProviding status of user devices during an adverse event
A method begins by a processing module of a social network identifying an affected area of an adverse event and identifying a user device of a plurality of user devices of the social network potentially associated with the affected area of the adverse event. The method continues with the processing module issuing a safety notification to the user device, where the safety notification includes one or more of the affected area of the adverse event and a safety status request.

 Magnetic stimulation apparatus patent thumbnailMagnetic stimulation apparatus
A magnetic stimulator includes a coil which applies magnetic stimulation to a head of a living body, an intensity controller which controls an intensity of the magnetic stimulation applied by the coil, an acquiring section which acquires a biological signal from the living body, a detector which detects an adverse event of the living body from the biological signal acquired by the acquiring section, and an intensity suppressing section which, when an adverse event of the living body is detected by the detector, suppresses the intensity of the magnetic stimulation that is controlled by the intensity controller.. .
Nihon Kohden Corporation


 Proximity awareness system for motor vehicles patent thumbnailProximity awareness system for motor vehicles
Various embodiments provide enhanced warnings of potential future adverse events (e.g., automobile crashes) by tracking the location and motion of multiple vehicles, and providing alerts or warnings to the drivers of such vehicles in the event that a risk of an adverse event is identified.. .
Ridar Systems Llc


 Signal detection algorithms to identify drug effects and drug interactions patent thumbnailSignal detection algorithms to identify drug effects and drug interactions
An algorithm according to an embodiment of the present invention provides for latent signal detection of adverse events. Embodiments infer the presence of adverse drug events from large observational databases housed by the fda, who, and other governmental organizations.
The Board Of Trustees Of The Leland Stanford Junior University


 Breath volume monitoring system and method patent thumbnailBreath volume monitoring system and method
A system and method for monitoring the tidal volume of an individual to diagnose a condition is disclosed. The system includes an electrically-conductive, elastomeric band; and a microprocessor having memory.
Myair, Llc


 Automatic baroreflex modulation responsive to adverse event patent thumbnailAutomatic baroreflex modulation responsive to adverse event
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.
Cardiac Pacemakers, Inc.


 Adjuvant immunotherapy for the treatment cancer, of clinical manifestations associated with the diseases like cachexia and correction of adverse effects of drugs such as immunosuppression, secundary cachexia, neutropenia and lymphopenia, comprising the association or combination of a biological response modifier specially selected and other substances with antineoplastic action and/or other treatments patent thumbnailAdjuvant immunotherapy for the treatment cancer, of clinical manifestations associated with the diseases like cachexia and correction of adverse effects of drugs such as immunosuppression, secundary cachexia, neutropenia and lymphopenia, comprising the association or combination of a biological response modifier specially selected and other substances with antineoplastic action and/or other treatments
A compound for use in a method of treatment of cancer, including precancerous lesions, and adverse events caused by the disease or anti-cancer agents and treatments, such as cancer cachexia, lymphopenia, neutropenia, febrile neutropenia includes in combination an immunomodulatory and at least one anti-cancer agent or treatment suitable for treating the disease. The immunomodulator is a proteic aggregate of ammonium and magnesium phospholinoleate-palmitoleate anhydride.

Methods for controlled elimination of therapeutic cells


The technology relates in part to methods for controlling elimination of therapeutic cells, for example, cells that express a chimeric antigen receptor. The technology further relates to a two-step method of controlling destruction of therapeutic cells in a patient following an adverse event.
Bellicum Pharmaceuticals, Inc.


Risk evaluation and management strategy involving patient follow-ups relating to the use or discontinuation of a complement inhibitor


This invention provides, inter alia, a complement-inhibitor-based treatment plan coupled with a risk evaluation and management strategy (“rems”) and a safety support program (“ssp”) for reinforcing the rems. The rems and spp are implemented using one or more computer devices with software tools programmed to enforce conditions of the rems and/or prompt follow-ups by registered nurses enrolled in the ssp.
Alexion Pharmaceuticals, Inc.


Structure, manufacturing and uses of human-derived cell-permeable peptides conjugated with specific biologically active cargo peptides


Embodiments disclosed herein provide compositions for conjugates, including fusion proteins, and methods of using them to treat a variety of conditions. In some embodiments, the conjugates and/or fusion proteins incorporate a 60-amino acid human homeodomain (e.g., peptides derived from human hox genes), to translocate functional and regulatory peptides and proteins or other biologically active molecules such as nucleic acids, which are not naturally associated with the human homeodomain, across cell and nuclear membranes to intended sites of action without provoking an unwanted immune response that may reduce exposure to the conjugate and/or result in a clinical adverse event.
Portage Pharmaceuticals Ltd.


Bolus dose of hydroxycitric acid with glycerol


A method of delivering a daily dose of hydroxycitric acid in the form of a salt as a single bolus that is as effective or more so than the same amount of active delivered via two or three administrations (b.i.d. Or t.i.d.) using current delivery modalities.
Glykon Technologies Group, Llc


Methods of treating ckd using predictors of fluid retention


The disclosure relates to methods of treating chronic kidney disease and diabetic nephropathy using predictors of fluid retention to minimize the risk of adverse events. The methods disclosed are particularly useful in treatments involving endothelin receptor antagonists, and more particularly, atrasentan and pharmaceutically acceptable salts thereof..
Abbvie Inc.


Articles and methods for preventing and treating dermatologic adverse events


The present invention provides articles and methods for preventing or treating dermatologic adverse events.. .

Hydrant monitoring system and method


A method for transferring adverse event information from a plurality of remote hydrants to a municipal monitoring server comprises detecting an adverse event in a hydrant that relates to an adverse hydrant condition; transferring data representative of the adverse condition to a host server by routing the data along a predefined hopping path; and transferring the data from the host monitor to the municipal monitoring server. A system for detecting adverse events at a hydrant and event information to a municipal monitoring sever is also disclosed..
Silversmith, Inc.


Providing status of user devices during an adverse event


A method begins by an application server establishing information regarding a potentially adverse event and determining group constraints for a group regarding the potentially adverse event. The method continues with the application server selecting one or more user devices of a plurality of user devices affiliated with the group to produce selected user devices.

Method of predicting and mitigating adverse events


A patient support apparatus includes a control system operable to gather physiological information about a patient supported on the patient support apparatus. The information may be gathered from sensors, a user interface, or a hospital information system.
Hill-rom Services, Inc.


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Methods and systems for automatic adverse event detection and alerting


A method according to a set of instructions stored on the memory of a computing device can include receiving first motion sensor data of a motion sensor associated with a sporting good. The method may further include activating an activity monitoring application logic.
Tagit Labs, Inc.


Event detection in an implantable auditory prosthesis


Presented herein are techniques for monitoring the physical state of a stimulating assembly to, for example, detect the occurrence of an adverse event. More specifically, an elongate stimulating assembly comprising a plurality of longitudinally spaced contacts is at least partially implanted into a recipient.

Embolic protection during percutaneous heart valve replacement and similar procedures


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.
Lumen Biomedical, Inc.


Targeted treatment of anerobic cancer


The present invention relates to a pharmaceutical cocktail and methods of treatment involving said cocktail, in particular, a combination of effective amounts of a carbonic anhydrase inhibitor, in combination with effective amounts of an angiogenesis inhibitor, including a vascular endothelial growth factor (vegf) inhibitor such as bevacizumab for the treatment of cancer. In other embodiments, it relates to compositions and methods of treating cancer involving effective amounts of a carbonic anhydrase inhibitor.
University Hospitals Cleveland Medical Center


Systems and methods for eeg monitoring


Systems, devices and methods are described for physiological monitoring, for example monitoring eeg signals to detect the onset or probability of adverse events. The systems, devices and methods discussed herein may monitor received eeg signals to identify trends or patterns in the signal that are either indicative of ongoing seizures or indicative of a future risk of seizure.
Cadwell Laboratories Inc.


Systems and methods for identifying unknown drug targets via adverse event data


The present disclosure is directed to systems and methods for identifying unknown drug targets via adverse event data. An analyzer receives an identification of a first drug having one or more unknown target proteins and identifies a second drug related to the first drug.
Molecular Health Gmbh


Use of levosimendan to treat left ventricular systolic dysfunction in patients undergoing cardiac surgery requiring cardiopulmonary bypass


Methods of (i) reducing morbidity and/or mortality in a human patient undergoing cardiac surgery; (ii) preventing, or reducing the risk of development of, lcos in a human patient undergoing cardiac surgery; or (iii) reducing the risk of, intensity of, or occurrence of, one or more postoperative adverse events in a human patient undergoing cardiac surgery. The methods can involve (a) a first period of administering to the patient levosimendan for about 1 hour, in which the administration of levosimendan during the first period is initiated: (i) before skin incision for the cardiac surgery, and (ii) at an infusion dose of about 0.2 μg/kg/min; and (b) a second period of administering to the patient levosimendan for about 23 hours, in which the administration of levosimendan during the second period is initiated at an infusion dose of about 0.1 μg/kg/min..
Tenax Therapeutics, Inc.


System and surveillance and evaluation of safety risks associated with medical interventions


Systems and methods configured for estimating safety-related risks associated with adverse events and poor patient outcomes associated with the use of medical products and treatment (e.g., drugs, vaccines, medications, dietary supplements, and medical devices) are provided. More particularly, the present description relates to a method and system for estimating the downstream medical costs and therefore the risk (e.g., using a safety risk score, ranking, designation, estimate, or the like) associated with the use of an individual medical treatment..
Adverse Events, Inc.


Methods and devices for identifying improper medical reporting


Some embodiments of the invention relate to pharmaceuticals, clinical trials and reporting, and more specifically to finding duplicate medical reporting in clinical trials or when reporting adverse events attributed to drug use. Some embodiments of the invention relate to clinical trials, and more particularly to methods and devices for improving the results of clinical trials by preventing improper participation in clinical trials..

Tumor specific t-cell receptors


The present invention relates to a method for the production of novel t-cell receptors (tcr) which provide a reduced risk of adverse events in immune therapy, specifically in adoptive t cell transfer. The tcrs produced according to the method of the invention are specific for tumor cells and do not react with healthy tissue.
Max-delbrÜck-centrum FÜr Molekulare Medizin (mdc) Berlin-buch


Local safety network


Provided are system, devices and methods for initiating and executing a response to an event, in particular an adverse event. Embodiments of the invention allow a user to use a mobile electronic communication device, such as a smart phone, to access communication channels to generate a list of contactable entities relevant to the event, prioritized by considerations like proximity, appropriateness for the type of event, and appropriateness for the risk level of the event.

Nt-procnp as a biomarker of vascular disorders and pregnancy complication


The present disclosure relates to methods for the prognosis and/or diagnosis of vascular-related disorders in a subject and in particular pregnancy-related vascular disorders. The present disclosure is based on the finding that a positive correlation exists between positive prediction of a vascular disorder event in a subject and the concentration of the circulating marker ntprocnp (also referred to as nt-cnp) in humans and animals.
Otago Innovation Limited


Computer algorithms and methods for product safety


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.
Classen Immunotherapies, Inc.


Web-based search tool for searching literature adverse event case report


A method of developing sematic search engine is used for searching adverse event report from literature articles, references or abstracts. The algorithm of the method comprises web-based semantic search system; medical terminology dictionaries including meddra, icd-10 dictionaries, and others represented as reported medical event; product including drug, medical device, herbal medicine, and/or nutritional food dictionaries such as who drug dictionary; identifiable patient or animal; identifiable reporter (author); and a vast amount of medical/scientific literature databases.

Genetic markers for predicting responsiveness to fgf-18 compound


This application is directed to the use of biomarkers for predicting the sensitivity to treatment with an fgf-18 compound in a patient having a cartilage disorder, such as osteoarthritis, cartilage injury, fractures affecting joint cartilage or surgical procedures with impact on joint cartilage (e.g., microfracture), in order to reduce the risk of adverse events and increase the overall benefit after therapy.. .
Merck Patent Gmbh


Nanoparticle glucagon compositions


The present invention relates to glucagon peptide-carrying nanoparticles, particularly for use in medicine, and includes methods for treatment of hypoglycaemia, such as a diabetic hypoglycaemic adverse event. Nanoparticle composition comprise a nanoparticle comprising a core comprising a metal and/or a semiconductor; and a corona comprising a plurality of ligands covalently linked to the core, wherein said plurality of ligands comprise at least one glutathione; and at least one glucagon peptide that is non-covalently bound to the corona..
Midatech Limited


Article of manufacture comprising aflibercept or ziv-aflibercept


Article of manufacture comprising a packaging material, a polypeptide of seq id no:1, aflibercept or ziv-aflibercept or a biosimilar thereof, and a label comprising a printed statement which informs a prospective user of adverse events or adverse reactions.. .
Sanofi


System and coordinating care of a patient across a care continuum


A care coordination system provides collection and coordination of patient information among subscribed users along a patient care continuum. The care coordination system further enables the subscribed users to interact with the patient data and with one another relative to the patient data.

Methods of diagnosis and risk stratification of adverse events in post myocardial infarction patients using pro-adrenomedullin


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..
Brahms Gmbh


Armrest retractable upon an adverse event and seat assembly employing the same


The present invention in one or more embodiments provides a seat assembly of a vehicle, including a seat base, a seat back communicating with the seat base, an armrest communicating with at least one of the seat back and the seat base, and a pretension unit connected to the armrest such that the armrest is retractable upon an activation of the pretension unit. The pretension unit may include a pretensioner, a pulley, and a cable..
Ford Global Technologies, Llc


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Location-based management of virtual machines in datacenters


Embodiments manage physical locations of virtual machines (vms) in a datacenter. A computing device, such as a cloud management device, aggregates location information for the vms executing on hosts.
Vmware, Inc.


Methods for treating cancer using anti-pd-1 antibodies


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.
Ono Pharmaceutical Co., Ltd.


Adverse event mitigation systems, methods and devices


A method comprises determining a person's level of risk for developing an adverse condition; selecting a care protocol based on the level of risk; displaying a proposed configuration of a person support structure corresponding to the care protocol for a caregiver to approve; and upon approval by the caregiver, implementing the configuration.. .
Hill-rom Services, Inc.


Predictive biomarkers for ctla-4 blockade therapy and for pd-1 blockade therapy


Biomarkers are described for predicting the efficacy, risk of relapse, risk of an immune related adverse event (irae), or combination thereof for a ctla-4 blockade treatment, such as ipilimumab, in a subject with melanoma. Biomarkers are also described for predicting the efficacy and clinical benefit for a pd-1 blockade treatment, such as a pd-1 blocking antibody, in a subject with melanoma..
H. Lee Moffitt Cancer Center And Research Institute, Inc.


Methods for predicting gastrointestinal immune-related adverse events (gi-irae) in patients treated with modulation of the co-stimulatory pathway


The invention described herein relates to diagnostic and therapeutic methods and compositions useful for predicting the likelihood a cancer patient will experience a gastrointestinal immune-related adverse event (gi-irae) after administration of a pharmaceutically acceptable amount of an activator of the immune system.. .
Bristol-myers Squibb Company


Systems and methods for multivariate analysis of adverse event data


The present disclosure describes systems and methods for multivarlate analysis of adverse event data. According to a first aspect, patient-specific genomic information is used to optimize or de-risk therapy for the patient.
Molecular Health Ag


Prognosis of adverse events in patients with suspected chronic heart failure


The present invention is in the field of clinical diagnostics. Particularly the present invention relates to the prognosis of adverse events in patients with stable chronic heart failure or being suspected of having stable chronic heart failure by determination of the level of procalcitonin (pct)..
B.r.a.h.m.s. Gmbh


Method for treatment of pain and inflammation


The present invention relates to a method for the treatment of pain and inflammation. In particular, the present invention relates to a method for the treatment of musculo-skeletal and connective tissue pain/inflammations.
Cadila Healthcare Limited


Materials and methods for differential treatment of cancer


The present invention concerns differential therapeutic treatment of cancer patients based on prognostic antigen/antibody profiles used for predicting (prognosticating) a clinical response (efficacy) and/or adverse event to an immunotherapy for treatment of a malignancy in a subject, and for treating or delaying the onset or relapse of a malignancy in a subject.. .
Serametrix Corporation


Electronic adverse event reporting system


An adverse event reporting system and related methods are provided. Aspects relate to associating a unique identifier of a device with resolution information configured to be automatically transmitted in response to an adverse event with the device.
Jfh Technologies Inc


System for identifying and linking care opportunities and care plans directly to health records


A method and system for improving care and reducing adverse events and cost by identifying patent care opportunities and integrating them directly into electronic hospital records and the provider's routine workflow. The invention enables clinicians, care managers and users to improve care and efficiency by assembling data from disparate sources, identifying care opportunities and integrating them directly into the ehr system and their routine workflow, while tracking that the recommended action was taken..
Lightbeam Health Solutions, Llc


Patient activity alert tool


Systems, methods, and other embodiments associated with a patient activity alert tool are described. In one embodiment, a system includes a risk notification logic configured to receive a risk notification from a patient.
Oracle International Corporation


Patient care surveillance system and method


A patient care surveillance system comprises a data store operable to receive and store clinical and non-clinical data associated with at least one patient, a user interface configured to receive user input of current information related to at least one patient, a monitor configured to sense at least one parameter associated with at least one patient, and further configured to generate real-time patient monitor data, a data analysis module configured to access the data store and analyze the clinical and non-clinical data, receive and analyze the current information and real-time patient monitor data, and identify at least one adverse event associated with the care of at least one patient, and a data presentation module operable to present information associated with at least one adverse event to a healthcare professional, the information including contextual information associated with the adverse event.. .
Parkland Center For Clinical Innovation


Obtaining event response information


A method begins by a processing module establishing information regarding a potentially adverse event. The method continues with the processing module determining group constraints for a group regarding the potentially adverse event, wherein the group constraints includes one or more of: family member devices, neighbor devices, friend devices, first responders, co-workers, and devices of other persons having an affiliating commonality.

Monoclonal antibodies to programmed death 1 (pd-1)


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.

Methods for treating cancer using anti-pd-1 antibodies


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.

Method of treating acne


An improved method for treating acne is described. The method involves 16-week, once daily, oral administration of about 40 mg doxycycline in a pharmaceutical composition containing about 30 mg doxycycline in an immediate release portion and about 10 mg doxycycline in a delayed release portion.

Monoclonal antibodies to programmed death 1 (pd-1)


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.

Adverse event data capture and alert systems and methods


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.

Systems and methods for the adaptive diagnosis of heart failure


A cardiac implant includes a classifier configured analyze the data for comparison to thresholds prioritized according to a boolean decision tree. The implant can generate an indicator of alert status (i.e., alert or no alert).

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Combination als therapy


Provided is a method for treating als in a subject, comprising administering to the subject a therapeutically effective amount of riluzole and a therapeutically effective amount of ck-2017357. Also provided are methods of reducing the variability of riluzole exposure (e.g., cmax and/or auc24h) in a subject, methods of reducing the variability of riluzole exposure (e.g., cmax and/or auc24h) between two or more subjects, methods of decreasing the total daily dose of riluzole in a subject, methods of increasing the half-life of riluzole in a subject, methods for decreasing the frequency of riluzole dosing in the subject, and methods for reducing the incidence and/or severity of adverse events in a subject treated with riluzole..

Pps for the prevention of potential adverse effects caused by cd3 specific binding domains


The present invention relates to a pps for use in the amelioration, treatment or prophylaxis of neurological adverse events caused by a cd3 binding domain. Kits comprising a pps, a cd3 binding domain and instructions for use which indicate that the pps is to be employed for the treatment amelioration and/or prophylaxis of neurological adverse events caused by said cd3 binding domain, are also disclosed..

Anti-leukocyte adhesion for the mitigation of potential adverse events caused by cd3-specific binding domains


The present invention relates in essence to a compound which decreases or inhibits the binding of mammalian t-cells to mammalian endothelial cells for use in a method of prophylaxis and/or amelioration and/or treatment of clinical adverse events caused by therapy which comprises re-directing of t-cells against target cells in a patient. Methods of treatment of patients having or being at risk of clinical adverse events caused by therapy which comprises re-directing of t-cells against target cells are also contemplated..

Altering pharmacokinetics of pirfenidone therapy


The invention relates to methods for reducing adverse events in patients receiving pirfenidone (5-methyl-1-phenyl-2-(1h)-pyridone) therapy.. .

Methods for treating cancer using anti-pd-1 antibodies in combination with anti-ctla-4 antibodies


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.

System and patient care


Embodiments of the present invention may integrate and analyze the output from various medical devices and clinical information systems in order to assist the clinical staff in making the more informed clinical decisions, output intelligent alarms, predict and prevent adverse events, and in some circumstances enable automated patient care.. .

Data collection


Computer implemented methods of collecting data relating to an adverse event relating to use of a substance is provided. One method comprises detecting a user input relating to an identity of the substance or to an identity of the adverse event; determining the identity of the substance or of the adverse event based on the user input; and selectively displaying to the user at least one further request for information, wherein the content of the request displayed to the user is dependent on the identity of the substance or of the adverse event.

Compositions and methods for treating metabolic disorders


Compositions and methods for improving the pharmacokinetics and reducing the risk of adverse events resulting from biguanide compound administration are provided, comprising administering delayed release formulations of such compounds having a lag phase release.. .

Biomarkers for predicting major adverse events


Provided herein are diagnostic markers and uses thereof for predicting if a subject is at risk of a major adverse event. In particular, one aspect provided herein relates to methods to determine if a subject is at risk of having a major adverse effect by measuring at least 2, or at least 3 of the biomarkers beta 2 microglobulin, c-reactive protein and cystatin c..

Clinical trial adverse event reporting system


A system is provided that sends data to a safety compliance management system in response to an adverse event. The system receives a first event in response to a first interaction by a user, where the first event indicates that the adverse event is to be reported to the safety compliance management system.

Clinical trial adverse event data change reporting system


A system is provided that sends data changes to a safety compliance management system. The system defines at least one data field as a significant data field.

Methods to reduce adverse events caused by pharmaceutical preparations comprising plasma derived proteins


The instant invention provides a method to reduce adverse events caused by a pharmaceutical preparation derived from a plasma fraction wherein the method comprises contacting the plasma fraction with heparin or a heparin-like substance thereby reducing the activity of at least one activated serine proteaseper ml of the plasma fraction.. .

Interoperable case series system


A system is provided that integrates a case series repository with one or more software applications. The system receives a case series, where the case series includes one or more adverse event cases, and the system further receives a case revision, where the case revision includes case revision information.

Electrogram-based ablation control


Methods, devices, and systems for predicting, diagnosing, and preventing adverse events during an ablation procedure are described. A method for providing ablation energy includes receiving a first signal based on biological activity of a tissue of a patient.

Sustained release delivery of active agents to treat glaucoma and ocular hypertension


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)..

Systems, methods and devices for performing gynecological procedures


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.

Method and device for reducing dermal filler adverse events


Methods and devices of aesthetically enhancing and improving appearance of aging skin are provided. Methods may include the steps of treating a skin site selected for dermal filler administration with a mechanism effective to enhance drug delivery across the skin, applying to the treated site, a device, compound or formulation including an active agent effective to reduce visible bruising due to administration of a dermal filler into the site, and administering a dermal filler into the skin site thereby reduce the appearance of wrinkles or folds in the skin site without causing significant bruising.

Electronic adverse event reporting system


An adverse event reporting system and related methods are provided. Aspects relate to a associating a unique identifier of a device with resolution information configured to be automatically transmitted in response to an adverse event with the device.

Leveraging public health data for prediction and prevention of adverse events


An adverse event may be prevented by predicting the probability of a given patient to have or undergo the adverse event. The ability to predict the probability of the adverse event may be enhanced when a model is derived from public health data to categorize and propose values for medical record fields.

Personal user dashboard


Systems, methods, and other embodiments associated with a personal user dashboard are described. In one embodiment, a method includes extracting, from one or more databases, case processing information about adverse events processed by a group of users.

Intragastric balloon shell materials and construction


An intragastric balloon with a 12-month lifespan. The intragastric balloon has a shell made of a material with as good as or better than initial mechanical properties of previous materials; i.e.

Correlating brain signal to intentional and unintentional changes in brain state


Methods of analysis to extract and assess brain data collected from subject animals, including humans, to detect intentional and unintentional brain activity and other unexpected signals are disclosed. These signals are correlated to higher cognitive brain functions or unintended, potentially adverse events, such as a stroke or seizure, and to translation of those signals into defined trigger events or tasks..

Medical probes for the treatment of blood vessels


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.

Antibody therapeutics with local activity in the digestive tract


This invention provides methods and compositions of antibody therapeutics that are therapeutically effective in the digestive tract or below the mucosal barrier of the digestive tract but do not deliver levels of antibody to the systemic circulation that have been shown to be necessary for clinical benefit following systemic administration of antibody. This invention further describes therapeutic compositions of antibody therapeutics that are therapeutically effective in the digestive tract or below the mucosal barrier of the digestive tract but do not deliver levels of antibody to the systemic circulation that have been associated with adverse events and systemic immunosuppression following systemic administration of antibody..

Method for treatment of acne using pharmaceutical compositions of clindamycin and adapalene


The present invention relates to a method for treating, reducing or preventing acne. In particular, the present invention relates to methods for reducing the total number, incidence and severity of acne lesions on the skin which includes both inflammatory and non-inflammatory lesions.

Methods for treatment and prevention of opioid induced constipation using oral compositions of methylnaltrexone


Presented herein are methods for treatment or prevention of opioid induced constipation by administration of oral compositions of methylnaltrexone. The methods are based, at least in part, on the identification of subjects that are particularly susceptible to such treatment and optimal dosages of such oral compositions to treat or prevent opioid induced constipation and, further, to minimize the occurrence of adverse events associated with such treatment..

Computer algorithms and methods for product safety


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.

Antibodies selective for cells presenting egfr at high density


Herein described are antibodies to epidermal growth factor receptor (egfr) having an egfr binding affinity that is sufficient to kill disease cells presenting egfr at high density, but is insufficient for binding to normal cells. A therapeutic effect is thus achieved while avoiding adverse events that result from unintended binding to normal cells..

Prevention of adverse effects caused by cd3 specific binding domains


The present invention relates to a glucocorticoid (gc) for use in the amelioration, treatment or prophylaxis of neurological/psychiatric adverse events caused by a cd3 binding domain. Kits comprising a gc, a cd3 binding domain and instructions for use which indicate that the gc is to be employed for the treatment amelioration and/or prophylaxis of neurological adverse events caused by said cd3 binding domain, are also disclosed..

Direct reporting of adverse events


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).

Intragastric balloon shell materials and construction


An intragastric balloon with a 12-month lifespan. The intragastric balloon has a shell made of a material with as good as or better than initial mechanical properties of previous materials; i.e.

Method for treatment of acne using pharmaceutical compositions of clindamycin


The present invention relates to a method for treating, reducing or preventing acne. In particular, the present invention relates to methods for reducing the total number, incidence and severity of acne lesions on the skin which includes both inflammatory and non-inflammatory lesions.

Adverse event-resilient network system


An adverse event-resilient network system consisting of autonomously powered and mobile nodes in communication with each other either through radio, light or other electromagnetic signals or through a physical connection such as through wiring, cables or other physical connected methods capable of carrying information and communication signals. The nodes powered by an energy generator comprising multiple data, information and voice gathering, receiving and emitting devices as well as mechanical, optical and propulsion devices..

Algorithm for predicting and mitigating adverse events


A patient support apparatus includes a control system operable to gather physiological information about a patient supported on the patient support apparatus. The information may be gathered from sensors, a user interface, or a hospital information system.

Methods of distributing complement-inhibiting drugs to patients receiving a complement inhibitor


This disclosure relates to methods of authorizing distribution of complement-inhibiting drugs to patients who have a complement-associated disorder in a manner to ensure that the patients are aware of the possible dangers of discontinuing treatment with the drugs. A database is prepared comprising patient information including experiencing adverse clinical events after discontinuing the drug treatment.

Risk factors and prediction of adverse events


Biomarkers, methods, systems, and related teachings are disclosed for diagnosing the risk of an adverse event in a human, where the adverse event can be unstable angina, ischemic stroke, non-ischemic stroke, all-cause stroke, heart failure, all-cause death, and being a candidate for coronary revascularization surgery.. .

Altering pharmacokinetics of pirfenidone therapy


The invention relates to methods for reducing adverse events in patients receiving pirfenidone (5-methyl-1-phenyl-2-(1h)-pyridone) therapy.. .

Method of providing pirfenidone therapy to a patient


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.

Method of treating acne


An improved method for treating acne is described. The method involves 16-week, once daily, oral administration of about 40 mg doxycycline in a pharmaceutical composition containing about 30 mg doxycycline in an immediate release portion and about 10 mg doxycycline in a delayed release portion.

Signal detection algorithms to identify drug effects and drug interactions


An algorithm according to an embodiment of the present invention provides for latent signal detection of adverse events. Embodiments infer the presence of adverse drug events from large observational databases housed by the fda, who, and other governmental organizations.

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Systems and methods for de-risking patient treatment


The present disclosure describes systems and methods for de-risking patient treatment by identifying medications or combinations of medications to be contraindicated for a specific indication. An analyzer executed by a processor of a computing device from a user may receive an identification of an indication (e.g.

Systems and methods for personalized de-risking based on patient genome data


The present disclosure describes systems and methods for using patient-specific genomic information to optimize or de-risk therapy for the patient. A user may identify a medication for consideration for prescription to a patient, and a genetic variant of the patient affecting a first protein.

Systems and methods for using adverse event data to predict potential side effects


The present disclosure describes systems and methods for predicting a likely side effect profile for even new, untested medications. A predicted side effect profile may be generated based on intersections of side effect profiles of other medications that affect the same or related molecular entities, such as the nearby target proteins, involve the same pathways, or are otherwise similarly related.

Systems and methods for identifying unknown drug targets via adverse event data


The present disclosure is directed to systems and methods for identifying unknown drug targets via adverse event data. An analyzer receives an identification of a first drug having one or more unknown target proteins and identifies a second drug related to the first drug.



Adverse Event topics:
  • Adverse Event
  • Clindamycin
  • User Interface
  • Pirfenidone
  • Adverse Effect
  • Doxycycline
  • Glucocorticoid
  • Psychiatric
  • Amelioration
  • Neurological
  • Prophylaxis
  • Gastric Balloon
  • Food And Drug Administration
  • Computer Readable
  • Electronic Health Record


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