Clinical Research Directory

Predictive Value of Gastrointestinal Blood Flow for Enteral Nutrition Intolerance in Critically Ill Patients

This study aims to explore the correlation between gastrointestinal blood flow and the incidence of enteral nutrition intolerance (ENI) and its symptoms in critically ill patients, construct and compare predictive models including blood flow parameters, and evaluate their incremental predictive value.

Predicting Pathological Complete Response in Rectal Cancer Using Machine Learning

This study aims to develop and validate a robust machine learning-based prediction model utilizing baseline clinical data and magnetic resonance imaging (MRI) features. The objective is to preoperatively predict the probability of achieving a pathological complete response (pCR) in patients with locally advanced rectal cancer (CRC) following neoadjuvant chemoradiotherapy (nCRT).

Timely Ordering of Pharmacogenetic Testing

The goal of this trial is to learn if a machine learning (ML) model can help optimize drug therapy in the pediatric population. The main question\[s\] it aims to answer are whether a machine learning model predicting receipt of a targeted medication within the next three months: * Increases the offering of pharmacogenetic testing prior to receipt of a targeted medication * Increases the number of patients with pharmacogenetic results prior to receipt of a targeted medication * Increases the number of patients who have alteration in medication choice or dose based on pharmacogenetic results This trial only focuses on the prediction and provision of participants with a high-risk of receiving a medication with a pharmacogenetic indication in the next three months.

PACT Involvement in Cardiology Patients

The goal of this trial is to determine the effectiveness of a machine-learning (ML) model predicting a serious cardiac event within the next three months, when compared pre- versus post-deployment, in pediatric cardiac inpatients. The main questions it aims to answer are whether deployment of the ML model: 1. Increases PACT consultation within the next three months among admissions without PACT involvement in the previous 100 days 2. Increases PACT consultation or visit within the next three months among those who experience a serious cardiac event during this period 3. Decreases time to PACT consultation or visit among those seen by PACT during this period 4. Decreases the incidence of death in the intensive care unit (ICU) 5. Increases documentation of goals of care High-risk cardiology patients will be identified by an ML model each morning. If the patient has been seen by the PACT team within the past year, the update will go to the PACT team members. If the patient hasn't been seen by the PACT team, the email will be sent to the cardiology physician in charge of the patient. This physician will decide whether a PACT consultation is necessary based on their clinical judgment. If so, a referral will be made using the usual process. Outcomes of the identified patients will be compared pre- and post-deployment.

Evaluation of a Machine Learning-Based Prediction Strategy for Extrahepatic Metastasis in Hepatocellular Carcinoma

This is a multicenter prospective observational cohort study in patients with hepatocellular carcinoma (HCC) after curative-intent treatment. The study aims to prospectively validate previously developed machine learning-based risk stratification models for extrahepatic metastasis (with a focus on lung and bone metastasis) and to evaluate their potential clinical utility in real-world postoperative surveillance and management pathways. The study does not assign treatments or surveillance strategies to participants. Clinical care is determined by treating physicians according to local practice. The study will assess model performance (including discrimination and calibration), risk stratification ability, and implementation-related outcomes such as model adoption, decision impact, and changes in monitoring intensity or referral pathways. The study will also explore clinical and resource-related outcomes associated with model-informed risk stratification in routine practice.

Machine Learning Prediction of Mortality After Prone Positioning in ARDS

Acute respiratory distress syndrome (ARDS) is a life-threatening condition with high mortality. Prone position ventilation (PPV) is an evidence-based therapy that improves oxygenation and survival in patients with moderate to severe ARDS; however, outcomes remain heterogeneous. Early identification of patients at high risk of mortality after PPV may improve clinical decision-making and individualized management. This retrospective observational study aims to develop and validate a machine learning model to predict intensive care unit (ICU) mortality in ARDS patients receiving prone position ventilation. Clinical, laboratory, and treatment variables collected from ICU electronic medical records will be used to construct prediction models using multiple machine learning algorithms. The performance of these models will be evaluated and compared to identify the optimal model for mortality prediction.

Development and Pre-validation of a Machine Learning-based Prediction Algorithm for Early Functional Recovery in Patients Undergoing Hip and Knee Replacement Surgery

The goal of this observational study is to develop and pre-validate a machine learning algorithm to predict early recovery of mobility in patients undergoing hip or knee joint replacement surgery. The primary research question is: Can a machine learning model accurately classify patients with faster versus slower recovery of autonomous mobility in the first days after joint replacement surgery? Patients who have undergone elective hip or knee arthroplasty and received post-operative physiotherapy will have their clinical and perioperative data collected retrospectively (2020-2023) and prospectively (March 2026-December 2027). The algorithm will be trained on retrospective data and tested prospectively to evaluate its predictive performance for early mobilization and length of hospital stay.

Predicting Vaccine Hesitancy Using Machine Learning

In recent years, emerging technologies such as the Internet of Things (IoT), Artificial Intelligence (AI), and Virtual Reality (VR) have rapidly become integrated into daily life. The widespread use of these applications has led to the accumulation of vast amounts of data, giving rise to what is commonly referred to as "Big Data." Due to the sheer volume, manual processing and analysis of these large datasets are not feasible. Therefore, software tools and libraries-such as Python and R libraries-have been developed to perform these analyses efficiently and to generate predictions for the future by leveraging historical data through Machine Learning (ML) algorithms. The primary goal of machine learning algorithms is to discover patterns within existing data and use these patterns to make accurate predictions on new data. The use of machine learning in the field of healthcare has gained significant momentum in recent years. However, a review of the literature reveals that research specifically addressing childhood vaccine hesitancy remains limited. This study aims to identify the factors contributing to vaccine hesitancy among parents of children aged 0-48 months and to develop a predictive model using machine learning techniques based on these factors. Such a model could help anticipate the likelihood of vaccine refusal among parents and thereby support the development of targeted public health strategies for at-risk populations.

A Machine Learning Approach for Predicting tDCS Treatment Outcomes of Adolescents With Autism Spectrum Disorders

Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by disturbances in communication, poor social skills, and aberrant behaviors. Particularly detrimental are the presence of restricted and repetitive stereotyped behaviors and uncontrollable temper outbursts over trivial changes in the environment, which often cause emotional stress for the children, their families, schools and neighborhood communities. Fundamental to these cognitive and behavioral problems is the disordered cortical connectivity and resultant executive dysfunction that underpin the use of effective strategies to integrate information across contexts. Brain connectivity problems affect the rate at which information travels across the brain. Slow processing speed relates to a reduced capacity of executive function to recall and formulate thoughts and actions automatically, with the result that autistic children with poor processing speed have great difficulty learning or perceiving relationships across multiple experiences. In consequence, these children compensate for the impaired ability to integrate information from the environment by memorizing visual details or individual rules from each situation. This explains why children with autism tend to follow routines in precise detail and show great distress over seemingly trivial changes in the environment. To date, there is no known cure for ASD, and the disorder remains a highly disabling condition. Recently, a non-invasive brain stimulation technique, transcranial direct current Stimulation (tDCS) has shown great promise as a potentially effective and costeffective tool for reducing core symptoms such as anxiety, aggression, impulsivity, and inattention in patients with autism. This technique has been shown to modify behavior by inducing changes in cortical excitability and enhancing connectivity between the targeted brain areas. However, not all ASD patients respond to this intervention the same way and predicting the behavioral impact of tDCS in patients with ASD remains a clinical challenge. This proposed study thus aims to address these challenges by determining whether resting-state EEG and clinical data at baseline can be used to differentiate responders from non-responders to tDCS treatment. Findings from the study will provide new guidance for designing intervention programs for individuals with ASD.

Remote Monitoring of Asthma in Children and Young People

The objective of this study is to determine whether healthcare data and remotely collected patient data can accurately predict asthma attacks in children and young people aged 5-17 years. The main outcome is: when using this new system, is there a reduction in asthma attacks compared with a historic average. The whole population of children and young people with asthma will have routine healthcare data monitored, with a subset of people with high risk asthma asked to participate in a more detail study involving remotely monitored data.

Multimodal Exercise Therapy for Non-Surgical Intervention of Nonspecific Low Back Pain.

This multicenter, assessor-blinded, two-arm parallel randomized controlled trial (N = 314) will compare the efficacy and safety of a 6-week multidimensional exercise program plus usual pharmacological care (experimental arm) versus usual pharmacological care alone (control arm) in adults ≥ 60 years with chronic non-specific low-back pain (LBP) and imaging evidence of paraspinal muscle degeneration. The primary endpoint is change in Oswestry Disability Index (ODI) at 12 months. Secondary endpoints include pain VAS, JOA score, recurrence rate, and patient satisfaction measured repeatedly to 12 months. Advanced MRI radiomics and machine-learning algorithms will be used to build a "paraspinal muscle imaging-function-prognosis" prediction model and an open-access web tool for risk stratification. The study will generate a standardized, evidence-based non-operative care pathway for chronic LBP driven by paraspinal muscle degeneration

Research on the Development and Validation of an Early Prediction Model for Delirium

Delirium has a high incidence rate and significantly affects patient prognosis. Diagnosis often relies on manual assessment, which is subject to strong subjectivity, high rates of missed diagnosis, and poor stability. This study employs non-contact identification technology based on machine vision analysis to quantitatively analyze characteristic biological feature data such as micro-expressions. It then investigates the correlation between these features and delirium subtypes. By integrating clinical phenotypic data and using machine learning algorithms, a multi-modal early prediction model for delirium is constructed to meet the clinical need for early warning of delirium subtypes and enhance the efficacy of delirium identification.

MUSCLE-ML: Multimodal Integration of Muscle Strength, Structure by Machine Learning for Precision Rehabilitation After ACL Injury

The goal of this clinical trial is to use machine learning (ML) to predict functional recovery by integrating muscle-related factors and other relevant parameters for identification of non-responders to conventional rehabilitation. The main questions it aims to answer are: Do deficit clusters lead to poorer functional recovery compared to non-deficit clusters? Does an ML-derived composite score that integrates quadriceps/hamstring strength and size outperform isolated metrics in predicting RTP success? Researchers will compare deficit clusters against non-deficit clusters to determine if deficit clusters lead to poorer functional recovery. Participants will: Return for 5 follow-up timepoints in total for PRO and functional assessments including pre-operation, 1-, 3-, 6- and 12-months post-operation.

Machine Learning for Predicting Spinal Anesthesia Duration

Spinal anesthesia provides significant advantages over general anesthesia in knee arthroplasty, including reduced blood loss, faster recovery, and fewer complications. However, predicting its duration is critical for patient safety and effective postoperative management. This study evaluates the usability of machine learning (ML) algorithms to predict the termination time of spinal anesthesia and the patient's readiness for mobilization. Using demographic, surgical, and anesthetic variables, ML models were trained to estimate anesthesia duration. Accurate predictions may improve intraoperative planning, optimize postoperative care, and enhance patient outcomes. Integrating ML-based predictive systems into anesthesia practice can contribute to safer, more efficient, and personalized perioperative management.

A Deep Learning Model for Blood Volume Estimation From Multi-modal Ultrasound

1. Background \& Rationale: Accurate assessment of a patient's blood volume (BV) status before surgery is critical for preventing perioperative complications. However, there is currently no clinically feasible, accurate, and non-invasive method for direct BV quantification. We hypothesize that dynamic ultrasound videos of major blood vessels contain rich, sub-visual spatiotemporal information about vascular compliance and filling that can be leveraged to estimate BV. 2. Objective: To develop and validate a deep learning model that integrates multi-modal ultrasound video data to achieve non-invasive, quantitative estimation of preoperative blood volume. 3. Study Design: A prospective, single-center, observational study. 4. Methods: Participants: Adult patients scheduled for surgery. Data Acquisition: Input (Features): Preoperative ultrasound video clips will be recorded in standardized views of four key vessels: the Internal Jugular Vein (IJV), Subclavian Vein (SCV), Inferior Vena Cava (IVC), and Common Carotid Artery (CA). Target (Label): The true Blood Volume (BV) will be calculated for each patient using the acute normovolemic hemodilution (ANH) method. The change in hemoglobin concentration before and after this process is used to calculate the total blood volume with high clinical reliability. Model Development: A hybrid deep learning architecture (e.g., CNN + LSTM/Transformer) will be trained to extract features from the ultrasound videos and learn the complex, non-linear mapping to the BV value derived from ANH. The model will be trained and internally validated using a k-fold cross-validation approach. 5. Expected Outcome \& Significance: We anticipate the development of a novel, end-to-end deep learning model capable of providing a quantitative BV estimate from routine ultrasound scans. This technology has the potential to revolutionize perioperative fluid management by offering a rapid, non-invasive, and accurate tool for objective volume status assessment, ultimately guiding personalized therapy and improving patient outcomes.

AI-Orchestrated Workflow Versus Consultant Ophthalmologist for Refractive Surgery and Keratoconus Diagnosis (AEYE Trial)

Background and Rationale: Laser vision correction procedures, such as LASIK (Laser-Assisted In Situ Keratomileusis), PRK (Photorefractive Keratectomy), and SMILE (Small Incision Lenticule Extraction), are highly effective but require careful preoperative screening to ensure safety. One of the most critical aspects of screening is identifying keratoconus and other corneal ectatic disorders-conditions that cause progressive thinning and bulging of the cornea, often contraindicating surgery. Early detection is essential to avoid vision-threatening complications. Despite advanced corneal imaging tools such as Scheimpflug tomography and anterior segment optical coherence tomography (AS-OCT), accurate diagnosis-particularly in borderline or early-stage cases-remains challenging and subject to variability in human interpretation. Artificial intelligence (AI) offers the potential to improve diagnostic precision, reduce oversight, and standardize surgical planning. Purpose of the Study: This study evaluates the performance of AEYE (Automated Evaluation for Your Eye), a multi-agent AI system designed to support ophthalmologists in diagnosing keratoconus and determining refractive surgery eligibility. AEYE simulates the clinical workflow of an anterior segment specialist by orchestrating three specialized agents: History \& Risk Agent: Reviews patient history and extracts risk factors. Imaging Agent: Analyzes corneal tomography, AS-OCT, and epithelial mapping scans. Surgical Decision Agent: Integrates all findings, assigns a diagnosis, and recommends appropriate treatment options, including surgical eligibility or corneal cross-linking (CXL). Study Design: The study includes 50 real-world patient cases, both retrospective (from 2020 onward) and prospective, who were evaluated for refractive surgery or keratoconus. Each case is analyzed independently by AEYE and a consultant ophthalmologist (blinded to AI output), using the same multimodal clinical and imaging data. Diagnostic accuracy, agreement in surgical recommendations, and workflow efficiency are assessed. Anticipated Impact: By comparing AI-derived decisions with expert clinical judgment, this study aims to validate whether structured AI workflows like AEYE can serve as reliable, safe, and explainable decision support tools. If successful, AEYE may offer a scalable solution to reduce diagnostic variability and enhance the safety and consistency of refractive surgery screening.

Cardiovascular Complications in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation.

Allogeneic hematopoietic stem cell transplantation (HSCT) represents a major therapeutic strategy for malignant hematologic diseases, with the number of procedures steadily increasing in France each year. Conditioning and maintenance regimens carry a risk of both short- and long-term cardiotoxicity, leading to serious cardiovascular events including acute coronary syndrome (ACS), cardiac dysfunction, arrhythmias, pulmonary hypertension, and pericardial effusion. The pathophysiology of cardiotoxicity in HSCT patients remains poorly understood. It is therefore crucial to investigate underlying mechanisms and identify predictive factors of cardiotoxicity in order to provide appropriate cardiological follow-up and management. Current European Society of Cardiology guidelines recommend routine monitoring of HSCT patients with echocardiography and cardiac biomarkers (NT-proBNP, troponin), although these recommendations are based on small-scale studies. The cardiodepressor factor DPP3 has shown promising results in cardio-oncology, with a causal role in anthracycline-induced cardiac dysfunction. Its role in HSCT-related cardiotoxicity requires further evaluation. This multicenter study of HSCT recipients will be a valuable resource, enabling a better understanding of the pathophysiology of cardiotoxicity and prognosis. It will highlight imaging (echocardiography, calcium score, supra-aortic Doppler), electrocardiographic, and biological markers (including DPP3) associated with prognosis.

Prognotic Role of CMR in Takotsubo Syndrome

The primary objective of this observational registry is to develop a comprehensive clinical and imaging score (incorporating echocardiography and cardiac magnetic resonance data) that enhances risk stratification for patients with Takotsubo syndrome. The secondary objectives of this registry are as follows: Investigate the diagnostic value of cardiac magnetic resonance parameters in predicting in-hospital and long-term outcomes in patients with Takotsubo syndrome. Compare the proposed risk stratification score for patients with Takotsubo syndrome with previously existing scores. Investigate the contribution of machine learning models in predicting in-hospital and long-term outcomes compared to standard clinical scores. The design and rationale of this registry are available at 10.1097/RTI.0000000000000709

Detection of Keratoconus Progression Using Machine Learning

Keratoconus (KC) is a bilateral ocular disease characterized by progressive thinning and steepening of the cornea, usually in its inferotemporal region. The disease often occurs asymmetrically as one eye is more severely affected by the condition. The changes underlying KC lead to the generation of irregular astigmatism resulting in diminished visual acuity of the patients and can even lead to axial corneal scarring in advanced stages. The disease usually occurs in the second or third decade of life, but can develop at any age. KC is a complex condition involving environmental factors such as age, eye rubbing, contact lens use, atopy, sun exposure, hormones, toxins, as well as a genetic component. However, how these factors contribute to the disease is still unknown and intraindividual differences might exist. KC can be categorized into different forms based on the stage of the disease. In clinical KC, there are both topographic and slit lamp findings of the disease. The importance of corneal epithelial imaging in the diagnosis of keratoconus has been further demonstrated in several clinical studies. As new anterior segment optical coherence tomography (AS-OCT) devices provide more detailed measurements for instance of the corneal epithelium. This layer could therefore be an interesting marker for the prediction of KC progression and contribute to earlier diagnosis as well as better outcome of the disease. The aim of this retrospective study is therefore to determine whether different topographical and volumetric data, for instance epithelial thickness maps (ETM), can be reliably used to predict the progression of KC using a machine learning algorithm.

Home Sleep Therapy for Older Adults With MCI

The goal of this clinical trial is to learn about the ability of non-invasive brain stimulation during sleep to enhance people's deep sleep and its potential benefit on memory in people with mild cognitive impairment via home use sleep therapy device (SleepWISP) as well as learn about biomarkers associated with Alzheimer disease (AD). The clinical trial aims to answer the following main questions: 1. Whether the non-invasive transcranial electrical stimulation (TES) delivered by SleepWISP could provide short-term enhancement of deep sleep in a single night in the target population. 2. Whether TES delivered by SleepWISP could enhance deep sleep over multiple nights in the target population. 3. Whether enhance on deep sleep could improve memory performance in the target population. Participants will be asked to wear non-invasive and painless devices that record their brain activity during sleep along with an actigraphy watch that measures their movement throughout the day. In addition, blood samples or nasal swab assays will be collected from participants multiple times during the study.

Artificial Intelligence for Automated Clinical Data Exploration From Electronic Medical Records (CardioMining-AI)

The purpose of this study is to highlight the usefulness of artificial intelligence and machine learning to develop computer algorithms that will achieve with great reliability, speed and accuracy the automatic extraction and processing of large volumes of raw and unstructured clinical data from electronic medical files.

Use of Machine-learning Algorithms, Biomarkers and Measures of Quality of Life to Personalize Medical Management of Liver and Heart Transplant Recipients

This is an observational, low risk tissue based, non-pharmacological, retrospective-prospective study for adults heart and liver transplant patients, related to IRCCS Azienda Ospedaliero-Universitaria di Bologna (IRCCS AOUBO). This clinical study is part of the national multicentric project DARE. The project has the wide overarching aim to develop digital solutions for personalized healthcare.

Accuracy of an Artificial Intelligence-assisted Diagnostic System for Caries Diagnosis: a Prospective Multicenter Clinical Study

This clinical trial was designed as a prospective, multicenter, multi-reader multi-case (MRMC), superiority, parallel-controlled study. Participants who met the trial criteria and signed the informed consent form were enrolled. The trial group involved diagnoses of caries on panoramic radiographs using an artificial intelligence-assisted diagnostic system, while the control group involved diagnoses made by dental practitioners specializing in operative dentistry and endodontics with five years of experience, who interpreted oral panoramic radiographs to determine the presence and severity of caries.

Using Machine Learning to Detect Risky Behavior in Psychiatric Clinics

The aim of this study is to ensure the safety of patients in a psychiatric clinic and to detect risky behaviors by using machine learning method. Risky behaviors are defined as behaviors that are personally, socially and developmentally undesirable and endanger life and health.Patient safety and maintaining a safe environment are among the primary duties of healthcare professionals. Suicide is the most important evidence-based risk factor, especially among individuals with psychiatric illnesses, and is one of the most important factors that threaten patient safety. At the end of this study, it is aimed to detect risky behaviors of patients before they harm themselves and to enable healthcare professionals to make early intervention for these behaviors, thus supporting a safe treatment environment, with the computer system that has been trained with the machine learning model installed in the clinics.