6142 results about "Phases of clinical research" patented technology

The present invention relates to the discovery, identification and characterization of toxic agents which are lethal to pathogens and methods for targeting such toxic agents to a pathogen or pathogen infected cells in order to treat and / or eradicate the infection. In particular, the present invention relates to toxic agents which target bacteria at different stages of the bacterial life cycle, which are delivered alone or in combination to bacteria or bacteria-infected cells. The invention relates to toxic agents which are lethal to diseased cells and methods for targeting such toxic agents to a diseased cell in order to treat and / or eradicate the disease. The present invention relates to promoter elements which are pathogen-specific or tissue-specific and the use of such promoter elements to achieve pathogen-specific or tissue-specific expression of the toxic agent(s) and / or ribozyme(s) of the present invention. Specifically, the invention relates to the delivery of one or more toxic gene products, antisense RNAs, or ribozymes, or combination thereof. The invention provides a novel system by which multiple pathogenic targets may be simultaneously targeted to cause the death of a pathogen, or cell infected with a pathogen. Further, the invention has important implications in the eradication of drug-resistant bacterium and bacterial pathogens. The invention provides a novel system by which multiple targets may be simultaneously targeted to cause the death of a diseased cell. The invention also has important implications in the eradication of drug-resistant pathogens and drug-resistant diseased cells (such as cancer cells).

A method and system for physiological gating is disclosed. A method and system for detecting and predictably estimating regular cycles of physiological activity or movements is disclosed. Another disclosed aspect of the invention is directed to predictive actuation of gating system components. Yet another disclosed aspect of the invention is directed to physiological gating of radiation treatment based upon the phase of the physiological activity. Gating can be performed, either prospectively or retrospectively, to any type of procedure, including radiation therapy or imaging, or other types of medical devices and procedures such as PET, MRI, SPECT, and CT scans.

A system including methods and apparatus for treatment of a medical disorder such as obstructive sleep apnea or congestive heart failure. The system involves applying separate and independent gains to flow rates of pressurized gas delivered to a patient during inspiratory and expiratory phases of a respiratory cycle to deliver the pressurized gas in proportion to the respective gains during inspiration and expiration. A base pressure may be applied in addition to the gain-modified pressures and an elevated pressure profile may be employed to assist or control inspiration. The system may be fully automated responsive to feedback provided by a flow sensor that determines the estimated patient flow rate. A leak computer can be included to instantaneously calculate gas leakage from the system. The system may be utilized in connection with conventional continuous positive airway pressure (bi-level PAP) equipment to effect various beneficial treatment applications.

The invention concerns methods and instruments for fast, selective replication of deoxyribonucleic acid (DNA) from biomaterial through the known polymerase chain reaction (PCR), working in individual duplication thermocycles. The invention consists of extremely brief cycle times of only a few seconds for the PCR reactions, generated, on the one hand, by reaction chambers for the reception of the reaction solution constructed of a pattern of fine capillaries in close proximity to heating and cooling elements in order to optimally accelerate the temperature setting in the reaction solution for the three temperature phases of the PCR duplication cycles and, on the other hand, by keeping the flow rates in the capillaries to a minimum during the amplification phase so that the polymerase reaction is not disturbed. The capillary pattern can be simply produced by means of microsystern technology.

A method for balancing multiplexed PCR methods is provided. In the method, two or more sequential temporal PCR stages are used to effectively separate two or more PCR reactions in a single tube as an alternative to primer limiting to modulate the relative rate of production of a first amplicon by a first primer set and a second amplicon by a second primer set during the first and second amplification stages. Also provided are rapid RT-PCR methods that find particular use in intraoperative diagnoses and prognoses, for instance in diagnosing malignant esophageal adenocarcenoma by determining expression levels of carcinoembryonic antigen (CEA) in sentinel lymph nodes.

A system including methods and apparatus for treatment of a medical disorder such as obstructive sleep apnea or congestive heart failure. The system involves applying separate and independent gains to flow rates of pressurized gas delivered to a patient during inspiratory and expiratory phases of a respiratory cycle to deliver the pressurized gas in proportion to the respective gains during inspiration and expiration. A base pressure may be applied in addition to the gain-modified pressures and an elevated pressure profile may be employed to assist or control inspiration. The system may be fully automated responsive to feedback provided by a flow sensor that determines the estimated patient flow rate. A leak computer can be included to instantaneously calculate gas leakage from the system. The system may be utilized in connection with conventional continuous positive airway pressure (bi-level PAP) equipment to effect various beneficial treatment applications.

A tissue closure treatment system and method are provided with an external patient interface. A first fluid transfer component (FTC1) can be placed directly on a suture line for transferring fluid exuded therethrough. An underdrape is placed over FTC1 and includes a slot exposing a portion of same. A second fluid transfer component (FTC2) is placed over the underdrape slot in communication with FTC1. Negative pressure is applied to FTC2 through a connecting fluid transfer component (FTC3). The tissue closure method includes a manual operating mode using a manual suction device with an automatic shut off for discontinuing suction when a predetermined volume of fluid has been drained. An automatic operating mode utilizes a microprocessor, which can be preprogrammed to respond to various patient and operating conditions. The method proceeds through several phases with different components in place and different patient interface functions occurring in each.

This invention provides a process and system for a comprehensive surgical assist system, called a Therapy Imaging and Model Management System (TIMMS), which combines and integrates all of the necessary information and communication technology; workflow analysis, data processing and data synthesis; interactive interfaces between surgeon and mechatronic devices; and, cognitive agents; to provide comprehensive assistance and guidance throughout complex medical and surgical therapies, such as image guided surgery. The components of this invention, which are modular, scalable and may be distributed in location, act synergistically to provide functionality and utility that exceeds the sum of its individual parts.A method of performing surgery on a patient comprising the step of comparing a chosen patient's data to statistical data in a repository of patient data to develop a patient specific model, wherein the data comprises information from two or more sub databases selected from the group consisting of workflow data, electronic medical records, diagnostic data, biological data, measurement data, anatomical data, physiological data, genetic data, molecular data, imaging data, chemical data, clinical laboratory data, simulated data, coordinate data and surgical result and wherein the patient specific model aids in the preoperative, operative or post operative phase of surgery performed in real time on the patient.

A device and method is provided for electrically stimulating the diaphragm to control breathing while inhibiting respiratory drive. A stimulation phase is identified. The stimulation phase is a period of time within the breathing cycle in which stimulation will inhibit respiratory drive. The respiratory drive inhibition may be used in a number of applications including but not limited to: improving or remodeling the heart in heart failure patients, treating apnea, chronic obstructive pulmonary disorder (COPD), and hypertension.

Devices, systems and methods to modify memory and / or cognitive function by delivering a sensory stimulus paired with learned material at opportune physiological periods during sleep. Described herein are systems, methods and devices to enhance a user's cognitive function in memorization and learning. A machine (e.g., a system or device) may be used to identify opportune periods of the sleep cycle and to deliver a stimulus during specific phases of the sleep cycle to facilitate or interrupt memory consolidation. The machine may record ambient sensory inputs during awake acquisition or reinforcement / relearning and replay all or an extracted form of the ambient sensory stimuli during a specified portion of the user's sleep. A stimulus may be delivered to a user to affect brain activity during sleep to modulate the phase of a user's sleep, quality of sleep, and / or quality or intensity of brain rhythms during a particular phase of sleep.

A maternal-fetal monitoring system for use during all stages of pregnancy, including antepartum and intrapartum stages. The maternal-fetal monitoring system of the subject invention comprises (1) a set of sensors; (2) an amplifying / filtering means; (3) a computing means; and (4) a graphical user interface. Accurate clinical data, which can be extracted and provided to the user in real-time using the system of the invention, include without limitation, maternal electrocardiogram (ECG) signals, maternal uterine activity signals (EHG), maternal heart rate, fetal ECG signals, and fetal heart rate. In a preferred embodiment, the maternal-fetal monitoring system of the invention includes an intelligence means, such as a neural network system, to analyze and interpret clinical data for use in clinical diagnosis antepartum, intrapartum and postpartum, as well as delivery strategy.

A method of treating a patient, comprising: sensing a biological parameter indicative of respiration; analyzing the biological parameter to identify a respiratory cycle; identifying an inspiratory phase of the respiratory cycle; and delivering stimulation to a hypoglossal nerve of the patient, wherein stimulation is delivered if a duration of the inspiratory phase of the respiratory cycle is greater than a predetermined portion of a duration of the entire respiratory cycle.

A method and device for inducing anaesthesia in mammals by the application of RF energy to create hyperthermia derived neural anaesthesia. An RF generator drives a plurality of electrodes placed in tissue surrounding the target nerve fiber to desiccate the desired length of nerve fiber to be desiccated in a single deployment. The device allows high-speed selection / de-selection of bipolar electrode pairs or sets under continuous RF excitation. Activation of electrode pairs is adapted in response to sensed current density and temperature (by electrodes not in the current discharge activation phase) in order to create lesions of complex and well defined shape necessary for the production of hyperthermia derived neural anaesthesia.

Devices, systems and methods of neurostimulation for treating obstructive sleep apnea. The system is adapted to send an electrical signal from an implanted neurostimulator through a stimulation lead to a patient's nerve at an appropriate phase of the respiratory cycle based on input from a respiration sensing lead. External components are adapted for wireless communication with the neurostimulator. The neurostimulator is adapted to deliver therapeutic stimulation based on inputs.

A method for operating a sleep phase actigraphy synchronized alarm clock that communicates with a remote sleep database, such as an internet server database, and compares user physiological parameters, sleep settings, and actigraphy data with a large database that may include data collected from a large number of other users with similar physiological parameters, sleep settings, and actigraphy data. The remote server may use “black box” analysis approach by running supervised learning algorithms to analyze the database, producing sleep phase correction data which can be uploaded to the alarm clock, and be used by the alarm clock to further improve its REM sleep phase prediction accuracy.

An efficient, objective, flexible and easily deployable system for conducting evaluations of mental and physiological state and recommending individualized treatment to improve said state is described. The method and system are based on commensurate measurement of mental functions, levels of stress and anxiety, and / or biologically active molecules such as neurotransmitters, immune markers including cytokines and hormones. The method and system are designed to assess an individual's cognitive function and the underlying physiology in order to delineate various disease processes, injuries, drug states, training stages, fatigue levels, stress levels, aging processes, predict susceptibility to stress and / or sleep deprivation, identify aptitude for training and / or characterize effects of any experimental conditions. The system and method may be used in recommending individualized treatment protocols, as well as to guide the treatment process by assessing the efficacy of such therapies in the clinical trials process.

The invention encompasses a method of conducting a clinical trial of a test substance from a primary site, via the internet. The internet is used in various phases of a clinical trial, including: recruiting and screening for candidates who are eligible to participate in a clinical trial of a test substance using the internet; obtaining, directly from a participant at a remote site, personal information as well as information allowing a determination of any effect(s) of the test substance on the participant after use (e.g., by evaluation forms completed and transmitted over the internet); compiling data from multiple participants.

Methods, compositions and kits which employ one or more ZEB specific detection reagents for detection and localization of ZEB associated molecules in tumor cells are disclosed. Also provided are methods for determining stage and progression of cancer in a mammal based on alterations in ZEB expression levels and subcellular localization. Also provided are methods for treating a cancer in a mammal by modulating ZEB expression levels and activity.

A maternal-fetal monitoring system for use during all stages of pregnancy, including antepartum and intrapartum stages. The maternal-fetal monitoring system of the subject invention comprises (1) a set of sensors; (2) an amplifying / filtering means; (3) a computing means; and (4) a graphical user interface. Accurate clinical data, which can be extracted and provided to the user in real-time using the system of the invention, include without limitation, maternal electrocardiogram (ECG) signals, maternal uterine activity signals (EHG), maternal heart rate, fetal ECG signals, and fetal heart rate. In a preferred embodiment, the maternal-fetal monitoring system of the invention includes an intelligence means, such as a neural network system, to analyze and interpret clinical data for use in clinical diagnosis antepartum, intrapartum and postpartum, as well as delivery strategy.

A method and device for inducing anaesthesia in mammals by the application of RF energy to create hyperthermia derived neural anaesthesia. An RF generator drives a plurality of electrodes placed in tissue surrounding the target nerve fibre to desiccate the desired length of nerve fibre to be desiccated in a single deployment. The device allows high-speed selection / de-selection of bipolar electrode pairs or sets under continuous RF excitation. Activation of electrode pairs is adapted in response to sensed current density and temperature (by electrodes not in the current discharge activation phase) in order to create lesions of complex and well defined shape necessary for the production of hyperthermia derived neural anaesthesia.

This disclosure describes systems and methods for delivering one or more low flow recruitment maneuvers to a patient while on a ventilator. Embodiments described herein provide methods for delivering low flow recruitment maneuvers wherein either or both of the inspiratory and expiratory phases of the recruitment maneuver are maintained by the ventilator at a low flow. Embodiments described herein provide for single-breath recruitment maneuvers and multi-breath recruitment maneuvers at low flow. Embodiments described herein provide for graphical display of a pressure-volume loop (PV loop) for both single-breath and multi-breath recruitment maneuvers. Embodiments described herein also disclose an automated ventilator functionality whereby recruitment maneuvers settings and / or post-recruitment maneuver settings for resuming prescribed ventilation may be set via a graphical user interface. Other embodiments described herein enable a clinician to configure the ventilator to synchronize the end the recruitment maneuver with patient-triggered inspiration for post-recruitment maneuver ventilation.

A sleep assist system to monitor and assist the user's sleep, comprising a bedside device positioned near the user's bed, the bedside device comprising a loudspeaker and a light source and optionally a microphone, a light sensor, a temperature sensor, a control unit, an air quality sensor, a display unit, a user interface. The sleep assist system further comprises a first sensing unit positioned in the user's bed and comprising one or more sensors adapted to sense at least pressure and / or changes in pressure exerted by the user lying in the bed. The system monitors the user's sleep, assesses the user's sleep cycles and the phase of sleep cycle, and provides the user with at least one light and sound program, the light and sound program being based on the assessment of the user's sleep cycles and the phase of sleep cycle.

The present invention provides improved devices and methods for inhibiting restenosis and hyperplasia after intravascular intervention. In particular, the present invention provides luminal prostheses which allow for programmed and controlled substance delivery with increased efficacy to selected locations within a patient's vasculature to inhibit restenosis. The luminal delivery prosthesis comprises a scaffold which is implantable within a body lumen and means on the scaffold for releasing a substance from the scaffold. The substance is released over a predetermined time pattern comprising an initial phase wherein the substance delivery rate is below a threshold level and a subsequent phase wherein the substance delivery rate is above a threshold level.

Clinical information, molecular information and / or computer-generated morphometric information is used in a predictive model for predicting the occurrence of a medical condition. In an embodiment, a model predicts whether a patient is likely to have a favorable pathological stage of prostate cancer, where the model is based on features including one or more (e.g., all) of preoperative PSA, Gleason Score, a measurement of expression of androgen receptor (AR) in epithelial and stromal nuclei and / or a measurement of expression of Ki67-positive epithelial nuclei, a morphometric measurement of a ratio of area of epithelial nuclei outside gland units to area of epithelial nuclei within gland units, and a morphometric measurement of area of epithelial nuclei distributed away from gland units. In some embodiments, quantitative measurements of protein expression in cell lines are utilized to objectively assess assay (e.g., multiplex immunofluorescence (IF)) performance and / or to normalize features for use within a predictive model.

A malware detection system configured to detect suspiciousness in obfuscated content. A multi-stage static detection logic is utilized to detect obfuscation, make the obfuscated content accessible, identify suspiciousness in the accessible content and filter non-suspicious non-obfuscated content from further analysis. The system is configured to identify obfuscated content, de-obfuscate obfuscated content, identify suspicious characteristics in the de-obfuscated content, execute a virtual machine to process the suspicious network content and detect malicious network content while removing from further analysis non-suspicious network content.

A method and system for programming settings of a medical device surgically implanted within a body of a patient. The system comprises a physician programmer, a patient programmer, an external neural stimulator, and a telemetry component being in communication with the implanted medical device, the external neural stimulator, and the physician programmer. The implantable medical device may be programmed using a two-phase process, a screening phase and an implant phase. During the screening phase, the physician and patient programmers may be used to roughly test the parameters of the stimulation to determine that the treatment therapy is efficacious. During the implant phase, the same physician and patient programmers may be used to fine tune the parameters of the stimulation.