161 results about "Clinical trial" patented technology

The invention provides a clinical test data security sharing method and device based on a block chain. The method is applied to the technical field of data processing, and comprises the following steps: extracting feature dimensions corresponding to various types of data, and calculating corresponding data sensitivity coefficients; determining a data sensitivity level of the corresponding data category; extracting corresponding associated metadata; selecting a corresponding encryption algorithm to encrypt the data, and generating corresponding encrypted data and a data abstract; uploading the associated metadata, the encrypted data and the data abstract to a block chain node, constructing a clinical test data sharing account book, and recording a timestamp and a node signature of data operation; extracting identity authentication information and historical access records of visitors, and calculating access credibility; judging whether the visitor is allowed to acquire the decryption key or not; after the visitor obtains the encrypted data, the integrity in the data transmission process is verified based on the non-tampering property of the block chain. Therefore, the security of clinical test data sharing based on the block chain is improved.

Methods and systems including computer programs encoded on computer storage media, for a method for detecting signals related to subjects participating in a clinical trial. In some implementations, a computer collects clinical data from multiple sources. The computer standardizes and redacts personally identifiable information and determines predictive features that correspond to characteristics of the data that correlate with efficacy and safety signals. The computer obtains training data and trains machine learning models to predict one or both of a predicted efficacy signal and a predicted safety signal for a subject. The computer receives clinical data for a particular clinical trial subject enrolled in an ongoing clinical trial and predicts one or more signals and receives a review of the signals through a user interface. The computer updates the predictive components of the system based on the review.

A system for aiding in a medical clinical trial involving one or more pediatric patients includes a patient passport, individual achievement stickers that are awarded to pediatric patients and that are placed within the patient passport, and an interactive companion toy having distinctive patterns thereon. A camera of a mobile device scans the individual achievement stickers in the patient passport and / or the distinctive patterns on the interactive companion toy, and an interactive incentivization application logic section of the mobile device unlocks and display reward content to the pediatric patient. The interactive companion toy, the mobile application, and the physical passport can be customized to match particular protocols of the clinical trial. The pediatric patient is thus incentivized to participate and continue the clinical trial. Virtual medical play associated with the clinical trial can be practiced on the interactive companion toy in an augmented reality environment. Parents are assisted through automatic text message reminders, and electronic patient-reported outcomes are collected, transmitted, processed, and summarized for visualization and insights via a cloud-based clinical trial portal.

Methods and systems for retrieving data from at least one database based on a query input related to a clinical trial. A system processes a received query input related to a clinical trial using a pre-trained language model neural network. The neural network generates a structured representation of the query input. The system maps a first data field of the structured representation to a first column name and maps a second data field of the structured representation to a second column name. The system generates a database query based on (i) a database schema, (ii) the first column name, (iii) the second column name, (iv) data values associated with the first data field, and (v) data values associated with the second data field. The database query specifies an operation for joining data associated with the first column name with data associated with the second column name.

Methods and systems for retrieving data from at least one database based on a query input related to a clinical trial. A system processes a received query input related to a clinical trial using a pre-trained language model neural network. The neural network generates a structured representation of the query input. The system maps a first data field of the structured representation to a first column name and maps a second data field of the structured representation to a second column name. The system generates a database query based on (i) a database schema, (ii) the first column name, (iii) the second column name, (iv) data values associated with the first data field, and (v) data values associated with the second data field. The database query specifies an operation for joining data associated with the first column name with data associated with the second column name.

According to an embodiment, disclosed is a system comprising a processor configured to define, one or more risk categories for monitoring a risk associated with a clinical trial, wherein the risk categories comprise one or more risk elements; calculate, a first risk profile data of the risk categories based on a risk factor and a weighting assigned to the risk elements; generate, a machine learning (ML) model; train, the ML model; receive, a second risk profile data; analyse, the second risk profile data to identify a pattern based on the first risk profile data using a database; predict, an overall risk score; recommend, one or more of a type of monitoring, a level of monitoring, and the overall risk score; and wherein the ML model comprises a feed-back layer to enable continuous learning and improve the prediction of the overall risk score and monitoring decisions of the clinical trial.

A method includes displaying a cohort report; receiving a request to determine a therapy identification; causing information to be transmitted to a remote cloud server; receiving clinical trial data; and updating the cohort report. A computing system includes a processor; and a memory having stored thereon computer-executable instructions that, when executed by the one or more processors, cause the computing system to: display a cohort report; receive a request to determine a therapy identification; cause information to be transmitted to a remote cloud server; receive clinical trial data; and update the cohort report. A computer-readable medium having stored thereon a set of computer-executable instructions that, when executed by one or more processors, cause a computer to: display a cohort report; receive a request to determine a therapy identification; cause information to be transmitted to a remote cloud server; receive clinical trial data; and update the cohort report.

The present disclosure provides a device, a method, and a computer program for performing a clinical trial. The method according to one embodiment of the present disclosure comprises the steps of: acquiring electrocardiogram data of a clinical trial applicant; and determining whether the applicant is suitable for the clinical trial on the basis of the acquired electrocardiogram data through a pre-trained neural network model.

The invention discloses application of a yang-warming and cold-dispelling traditional Chinese medicine composition in preparation of a medicine for improving cold limbs, and belongs to the field of traditional Chinese medicines. The prescription consists of folium artemisiae argyi, cassia twig, ligusticum wallichii, notopterygium root, divaricate saposhnikovia root, ginger, pepper, safflower, radix clematidis, radix aconiti carmichaeli, dried ginger and cinnamon according to a specific mass part ratio. The prescription disclosed by the invention has the effects of warming channels and expelling cold, and promoting blood circulation to remove meridian obstruction, and is mainly used for improving the symptoms such as cold hands and feet, intolerance of cold and sensation of chill, joint crymodynia and the like caused by insufficiency of yang qi and congealing cold in meridians. The invention also provides a preparation method of dosage forms such as an application agent of the prescription. Clinical tests show that the prescription preparation, especially the acupoint application agent, can obviously improve the symptoms, the total effective rate can reach 93.3%, the safety is good, and a safe, effective and convenient-to-use external treatment choice is provided for related diseases.

The invention discloses a wind-dispelling, pain-relieving, blood-activating and blood-stasis-removing black plaster formula and a preparation process, and belongs to the field of traditional Chinese medicine external preparations. According to the formula, pseudo-ginseng and angelica sinensis are used as monarch drugs, ligusticum wallichii, radix angelicae pubescentis and the like are used as ministers, frankincense, myrrh and the like are used as assistants, musk and borneol are used as guides, sesame oil and fried yellow lead are matched as matrixes, and the compatibility of the monarch, the ministers, the assistants and the guides is rigorous. The preparation method comprises the following steps: performing targeted processing (stir-frying with wine, stir-frying with vinegar and the like) on each medicinal material, extracting medicinal oil, refining oil into paste, removing fire toxin, blending fine materials at low temperature, spreading, forming and the like, and performing standardized control on key process parameters. The traditional Chinese medicine composition integrates the holism concept of traditional Chinese medicine and the modern processing technology, aims at wind-cold-dampness arthralgia and blood stasis collateral obstruction syndromes in a targeted mode, and is high in effective component transdermal absorption efficiency, lasting in medicine effect and good in safety. Clinical verification shows that the total effective rate reaches 92.5%, the black plaster can be used for diseases such as neck-shoulder and lumbocrural pain and rheumatism arthralgia, the problems that a traditional black plaster is unstable in medicine effect and high in toxicity risk are solved, and the black plaster has remarkable clinical application and industrialization value.

Disclosed embodiments may provide techniques for generating data-collection scripts. A computer-implemented method can include accessing input data. The computer-implemented method can also include processing the input data using a machine-learning model to generate a data-collection script. The data-collection script can include a set of questions for screening a plurality of candidates associated with the particular clinical trial. The computer-implemented method can also include generating evaluation metrics associated with the data-collection script. An evaluation metric can be associated with a particular question of the set of questions. The computer-implemented method can also include generating a modified data-collection script based on the evaluation metrics. The modified data-collection script can include a subset of the set of questions. A question of the subset can include an evaluation metric that exceeds an evaluation-threshold value. The computer-implemented method can also include transmitting the modified data-collection script to candidates associated with the particular clinical trial.

A system for predicting clinical trial participation may comprise a participation probability (PP) server connected to a machine learning (ML) module. The PP server may receive clinical trial (CT) parameters from a user device. The PP server may query a patient database using the CT parameters to identify potential participants. The PP server may collect social media data for the potential CT participants. The PP server may generate feature vectors based on the social media data. The PP server may provide the feature vectors to the ML module and receive participation probability index (PPI) scores for the potential CT participants from the ML module. The PP server may generate a ranked list of likely CT participants based on the PPI scores. The PP server may provide targeted content to potential participants with low PPI scores. The PP server may update the PPI scores based on engagement with the targeted content.

This invention belongs to the field of traditional Chinese medicine, specifically relating to a ginseng and licorice root formula for treating renal hematuria, its preparation method, and its application. The ginseng and licorice root formula for treating renal hematuria of this invention comprises the following raw materials in parts by weight: 5-15 parts of Codonopsis pilosula, 15-30 parts of Rehmannia glutinosa, 5-15 parts of Ligustrum lucidum, 5-15 parts of Eclipta prostrata, 5-15 parts of Imperata cylindrica, 5-15 parts of Rubia cordifolia, 5-15 parts of Cirsium japonicum, 5-15 parts of Taraxacum mongolicum, 5-8 parts of Prunus persica, and 3-5 parts of Glycyrrhiza uralensis. Clinical trials have shown that the ginseng and licorice root formula for treating renal hematuria of this invention not only reduces urinary red blood cells but also improves traditional Chinese medicine clinical symptoms such as lower back and knee weakness, fixed or stabbing lower back pain, pale complexion, fatigue, dry mouth, bitter taste, sore throat, rough skin, and poor appetite. It has good therapeutic effects, reliable safety, and can significantly improve the treatment efficacy of chronic nephritis syndrome.

The p300 inhibitor specifically regulates the expression of genes that induce fibrosis, thereby acting only on fibrotic tissues and reducing the risk of adverse effects on normal tissues. Because the inhibitor blocks multiple fibrotic signaling pathways, it may be effective for fibrosis in various organs such as the liver, lungs, and kidneys. In addition, by modulating gene expression, the inhibitor has the potential to address the fundamental cause of the fibrotic process. The present invention is characterized in that bronopol is first identified as a specific example of such a p300 inhibitor. In particular, bronopol is an FDA-approved drug with established safety, and therefore is expected to reduce the time and cost required for conducting clinical trials.

This invention provides an intelligent anti-extubation vest and its application control method. Through sensor fusion and intelligent control technologies, it upgrades traditional passive fixation to an active protection system, shifting from "post-event handling" to "pre-event warning." Clinical trials show that it can reduce unplanned extubation rates, shorten nurse response times, and significantly improve the safety and quality of care for thoracic surgery patients. This invention achieves active protection through a closed-loop control system of "real-time monitoring - automatic clamping - multi-level alarms," ​​realizing an active anti-extubation mechanism and improving fixation reliability.

The formulation is an antibacterial and antifungal ointment which comprises of oil of Raphanus sativa seeds, white wax and white petroleum jelly. The ointment acts as a potent antibacterial and antifungal agent and is especially effective against dermatophytes. In clinical trials the ointment was found to be effective, well tolerated and free from irritative and allergic reactions.

The application discloses an ethical review method and device of a clinical trial file and a storage medium, and relates to the technical field of clinical trial ethical review. The method comprises the following steps: analyzing a file related to clinical trial ethical review, obtaining text content, extracting structured information after determining the file type according to the text content; determining the special review task of the current file type according to the file type; obtaining the compliance basis matched with the special review task based on the pre-established regulation knowledge base; taking the structured information, the special review task and the compliance basis as inputs, generating the structured special review opinion of the corresponding file type through the pre-trained special review model. The application can shorten the review period, improve the file review efficiency, ensure the effective compliance of the review regulations, and improve the stability and accuracy of the review results.

A clinical test item visit process automatic generation system relates to the technical field of clinical test visit and comprises a data input end, a visit plan generation end, a visit process automation end, a visit task and reminding end, a visit process updating end and a visit document generation end. The data input end, the visit plan generation end, the visit process automation end, the visit task and reminding end, the visit process updating end and the visit document generation end are in data communication through a private network and a private line network. The system can improve the efficiency and accuracy of clinical tests, and simplify the planning and management work of the visit process.

The present disclosure provides methods of identifying a disease or condition suitable for treatment with dupilumab. The present disclosure also provides methods of identifying a subject having a disease or condition suitable for treatment with dupilumab. The present disclosure also provides methods of carrying out a clinical trial for dupilumab treatment of a disease or condition.

Blinding Device for Injection Devices In one aspect the present disclosure relates to a blinding device (50) for concealing an injection device (1) in clinical trials, wherein the injection device (1) comprises a movable plunger (20) and an elongated barrel (10) extending in a longitudinal direction (2, 3) and filled with a medicament (8) or with a placebo, wherein the plunger (20) is longitudinally movable relative to the barrel (10) for expelling the medicament (8) or the placebo from the barrel (10) and wherein the injection device (1) comprises a flange portion (17, 18) at or near a proximal end of the barrel (10), the blinding device (50) comprising: - an opaque housing (52) to cover the barrel (10) and the plunger (20), the opaque housing (60) comprising: - a barrel cover portion (54) to receive and to cover the barrel (10), - a plunger cover portion (56) of variable longitudinal extent to receive and to cover the plunger (20), and - a housing flange portion (55) protruding outwardly from the barrel cover portion (54), wherein the housing flange portion (55) comprises a first flange part (61) and a second flange part (62), which are mutually connectable to form a flange assembly (66) connecting the barrel cover portion (54) with the plunger cover portion (56). (Fig. 1)

The invention relates to a screening method of anti-breast cancer key targets of a traditional Chinese medicine composition for treating triple-negative breast cancer pulmonary metastasis, which sequentially comprises the following steps: component-target preliminary screening, two sample Mendel randomization, SMR and co-localization, full phenotype association and side effect evaluation, pathway enrichment, clinical expression verification, molecular docking verification and the like. After Mendel randomization (MR) and SMR are placed in network pharmacology, population genetic variation is used as a natural randomization tool, evidence of causal relationship between exposure (target level) and outcome (breast cancer risk) is provided on a public GWAS level, traditional association analysis mixing and reverse causal risk are reduced, and the false positive rate of network pharmacology prediction is greatly reduced; pheWAS-MR is introduced to perform system identification on phenotypes of various diseases, so that a potential off-target effect can be identified in advance, the multiple effects and possible adverse reactions of potential treatment targets in traditional Chinese medicine compound targets can be evaluated, powerful data support is provided for subsequent clinical test design and drug alert strategies, and the risk of later failure of research and development is effectively reduced.

This invention relates to the field of traditional Chinese medicine preparation technology, specifically to a traditional Chinese medicine composition for treating rheumatoid arthritis, its preparation method, and its application. The traditional Chinese medicine composition consists of *Sargentodoxa cuneata*, *Acanthopanax senticosus*, *Ligusticum striatum*, *Drynaria fortunei*, and *Clematis chinensis*. Its preparation method includes the following steps: extraction; filtration; and concentration. Animal experiments and clinical trials have confirmed that the traditional Chinese medicine composition provided by this invention has a significant therapeutic effect on rheumatoid arthritis, with good safety and no obvious adverse reactions, and has great clinical application value.

The invention discloses a clinical test data report management system and method, and relates to the field of data report management, and the method comprises the steps: carrying out the deep semantic analysis of original clinical test table data, and carrying out the multi-dimensional semantic mining in combination with a preset medical analysis rule set, therefore, key discovery points with remarkable clinical significance can be automatically identified and screened out. Furthermore, the discovery points are subjected to priority ranking and pruning to form a structured core discovery point sequence, and the structured core discovery point sequence is injected into a prompt template to construct accurate guidance for a large language model. And finally, converting the guide instruction into an abstract text with clear logic and highlighted key points by utilizing a large language model. In this way, automatic conversion from an original data table to a high-quality narrative abstract can be achieved, and therefore the writing efficiency and the intelligent level of a clinical test report are remarkably improved.

The invention discloses a clinical test quality control system which comprises a test process and specification management end, a quality index and index monitoring end, an auditing and checking management end, a file management and version control end, a risk management and problem solving end, a training and education management end and an approval and authorization management end. The test flow and specification management end, the quality index and index monitoring end, the auditing and checking management end, the file management and version control end, the risk management and problem solving end, the training and education management end and the approval and authorization management end are in data communication through a private network and a private line network. According to the method, the quality of the test can be effectively monitored, potential problems can be effectively recognized and corrected, it is ensured that the test meets the requirements of laws and regulations and standards, the credibility and reliability of the clinical test are improved, the rights and interests of subjects are protected, and a reliable basis is provided for explanation and popularization of test results.

A vector associated with a clinical trial is obtained from one or more data sources. The vector comprises one or more fixed elements and one or more optimizable elements. A trial outcome predictor, trained on data related to a plurality of historical clinical trials, is used to determine a probabilistic model of an outcome of the clinical trial based on the vector. An explainability model is used to determine contribution scores for the vector based on the probabilistic model. Each contribution score is indicative of a relative contribution of an associated element of the vector to the outcome of the clinical trial. An explainable prediction of the trial outcome of the clinical trial is generated based on the probabilistic model and one or more of the contribution scores which are associated with the one or more optimizable elements. The explainable prediction is output for review by a user.

This invention belongs to the field of data processing technology, specifically relating to a clinical trial data processing method and system based on an IRT (Initial Timeout) system. The method includes: after the coordinator's timeout failure, any participating system initiates a self-decision-making process: calculating the local transaction urgency related to business importance and waiting time; detecting and integrating the status of other participating systems; calculating the consensus confidence level; combining a preset asymmetric risk coefficient to assess the expected risk cost of either submit or rollback; and automatically executing the decision with the lower risk cost. This invention, through a decentralized autonomous decision-making mechanism, effectively avoids indefinite system waiting, achieves intelligent fault tolerance based on quantitative risk assessment, and improves the robustness and security of the clinical trial system.

The invention discloses a construction and evaluation method for an applicant drug clinical test quality management system, and aims to solve the problems that traceable evidence chains are lacked among applicant clinical test quality system elements, evidence materials and evaluation conclusions, evaluation is difficult to quantify, and closed-loop improvement based on evaluation results is difficult. According to the method, quality system element data, evidence material data and evidence source data are obtained and standardized, and a time heterogeneous evidence graph comprising element nodes, evidence nodes, version nodes, responsibility nodes and evidence source nodes is constructed; executing graph neural network representation learning on the evidence graph to generate a relationship likelihood parameter and an evidence credibility likelihood parameter; constructing a Bayesian factor graph containing conflict factors, and executing belief propagation to obtain element compliance posterior distribution and evidence credibility posterior distribution; and further calculating a compliance score, an uncertainty score and a coverage rate score to form a three-dimensional score result, and extracting an evidence chain to generate traceable output, thereby achieving the technical effects of automatic establishment of the evidence chain, compliance quantitative evaluation, conflict evidence suppression and evaluation result driven closed-loop improvement.

Methods and systems for retrieving data from at least one database based on a query input related to a clinical trial. A system processes a received query input related to a clinical trial using a pre-trained language model neural network. The neural network generates a structured representation of the query input. The system maps a first data field of the structured representation to a first column name and maps a second data field of the structured representation to a second column name. The system generates a database query based on (i) a database schema, (ii) the first column name, (iii) the second column name, (iv) data values associated with the first data field, and (v) data values associated with the second data field. The database query specifies an operation for joining data associated with the first column name with data associated with the second column name.

This invention discloses a myocarditis treatment prediction system integrating Transformer and causal reinforcement learning, comprising a data preprocessing module, a temporal encoding module, a causal decision-making module, and an interpretation regularization module. The data preprocessing module transforms multimodal clinical data into equally spaced state representation sequences; the temporal encoding module extracts global temporal dependencies through the multi-head self-attention mechanism of a Transformer encoder, outputting an abstract state vector; the causal decision-making module uses the abstract state vector as input to construct a Markov decision process, employs offline strategies to evaluate and estimate the expected clinical benefits of different intervention timings, and outputs individualized intervention recommendations and confidence levels through policy gradient optimization. This invention can capture the dynamic evolution of myocarditis disease under limited case conditions, assess the causal effects of different intervention strategies without real clinical trials, and provides a transparent and interpretable decision-making process, effectively assisting clinicians in identifying the optimal timing for immunosuppressive therapy.

The invention belongs to the technical field of medication safety, and discloses a children medication evaluation method, and the children medication evaluation comprises the following specific operation steps: S1, checking the safety of a medicine: checking the toxicity and adverse events of the medicine according to the medication condition of a child, and particularly paying attention to the special reaction of the child; according to the invention, the body data of the child patient is imported into the evaluation system, so that the body data is compared with the internal information of the data management module, and then similar cases are found and compared with the medication conditions, so that the situation that the cases are far away from the medication conditions is avoided; meanwhile, the medicine use condition of medical staff is checked through the medicine information module and the clinical test management module, the situation that whether medicine conflicts exist or not and potential safety hazards are caused is avoided, the treatment condition is connected through feedback after medicine use of a patient, and data in the data management module are compared; therefore, the medication condition of children can be evaluated conveniently.