ClinicalTrials.gov

Tracking AI in medicine — clinical trials

From the U.S. NIH clinical-trial registry ClinicalTrials.gov, clinical trials of AI (artificial intelligence / machine learning) in medicine and diagnostics, organized with conditions, sponsor, and status. This site is not an official U.S. government website.

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Notable AI medical trials explained with key points, FAQs, and sources.

Recruiting Genetic Conditions

AI medical trial: a natural-history study collecting medical data on genetic conditions to build "advanced data analytics" (AI) tools (NHGRI observational study) — a clinical trial (ClinicalTrials.gov)

National Human Genome Research Institute (NHGRI)

A natural-history (observational) study collecting medical and genetic data from people with (or suspected to have) genetic conditions, and their relatives. The data aims to help develop advanced data-analytics tools for better analyzing and understanding genetic data.

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Recruiting High-risk Cardiac Patients

Medical-AI trial: real-world registry of the Willem AI-based ECG platform (high-risk cardiac patients, large-scale observational) (NCT07333547)

Idoven 1903 S.L.

A large-scale registry study collecting real-world performance of Willem (Idoven), a platform that interprets ECGs automatically with AI. It evaluates the performance of Willem in detecting cardiac abnormalities on the ECGs of high-risk cardiac patients admitted to cardiovascular units. Single-group observational; retrospective + prospective; target 200,000; recruiting.

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Recruiting Antenatal Care / Maternal Health

Medical-AI trial: AI-assisted "blind-sweep" obstetric ultrasound by non-specialists — antenatal screening in rural DR Congo (SPAQ E-con AI) (NCT07677670)

SOIK Corporation Sarl

A multicenter prospective study evaluating the diagnostic accuracy and implementation feasibility of an AI-assisted blind-sweep obstetric ultrasound (SPAQ E-con AI), operated by trained non-specialist health workers, for antenatal screening in rural Democratic Republic of the Congo. Primary outcomes are gestational-age mean absolute error (trimesters 2 and 3) and AI confidence calibration. Target ~1,430 (IRB ceiling 3,000). Recruiting.

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Completed Pneumothorax / Pulmonary Nodule, Solitary

AI medical trial: "Carebot AI CXR" reads chest X-rays vs. radiologists (completed)

Carebot s.r.o.

A multi-reader retrospective study evaluating how accurately the AI chest X-ray tool "Carebot AI CXR" (a deep-learning automated detection system) detects findings such as pneumothorax, pulmonary nodules, atelectasis, cardiomegaly, and pleural effusion compared with individual radiologists. Completed with 956 cases.

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Active, not recruiting Uterine Cancer / Rectal Cancer

Medical-AI trial: protecting the ovaries with AI adaptive radiotherapy (OvAR-Y) — pelvic cancer in young women and oncofertility (in-silico) (NCT06904365)

Washington University School of Medicine

An observational study using in-silico (computer simulation on real data) to test the feasibility of ovarian-sparing adaptive radiotherapy for women under 50 who need pelvic radiation for cancers such as uterine and rectal. It addresses the unmet need to reduce the risk of premature ovarian failure. 10 cases.

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Recruiting Diagnostic Imaging / Eye Tracking

Medical-AI trial: when should AI advice appear? eye-tracking of visual search, diagnosis, and trust in chest X-ray reading (human-AI interaction) (NCT07675694)

University Hospitals, Leicester

A within-subject interventional study using eye-tracking to examine whether showing AI advice before or after a clinician first reviews a chest X-ray changes visual search, reading time, diagnostic decisions, confidence, and trust in AI. Healthcare professionals complete two reading sessions. 24 participants.

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Active, not recruiting Anemia (Diagnosis) / Anemia

Medical-AI trial: smartphone photo of the inner eyelid + AI to detect anemia non-invasively (NiADA / AnemiAI) vs. blood draw (3,000 participants) (NCT07678762)

Fabio Biscegli Jatene

A multicenter prospective study evaluating the diagnostic accuracy of NiADA, an app that photographs the lower eyelid conjunctiva with a smartphone and uses AI to estimate hemoglobin and detect anemia non-invasively, compared with the standard venous blood draw. Sensitivity and specificity are the primary endpoints. Target 3,000.

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Recruiting Basal Cell Carcinoma

Medical-AI trial: predicting high/low risk and subtype of basal cell carcinoma from dermoscopy images with a CNN — compared with dermatologists (NCT07677124)

Istanbul Training and Research Hospital

A retrospective observational study evaluating whether a convolutional neural network (CNN) can classify basal cell carcinoma (BCC) as low- or high-risk and predict its histopathological subtype from clinical and dermoscopy images, and compares the model with dermatologists. Histopathology is the reference. Target 2,500; recruiting.

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Recruiting Weaning From Mechanical Ventilation in Care Unit

Medical-AI trial: predicting the success of a spontaneous breathing trial with machine learning — ICU ventilator weaning from biosignals and biomarkers (NCT05886803)

Centre Hospitalier Universitaire de Nice

An observational study of whether machine learning can predict, from biosignals and biomarkers, the success of the spontaneous breathing trial (SBT) used to test weaning from a ventilator in the ICU. Weaning takes up much of an ICU stay, and the first attempt reportedly fails in about 20%. Target 500; recruiting.

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Recruiting Coronary Artery Disease

Medical-AI trial: intravascular-ultrasound (IVUS)-based AI to improve outcomes after coronary stenting (INNOVATE-PCI) (NCT05807841)

Asan Medical Center

A prospective, multicenter observational study validating, in real practice, the diagnostic performance and clinical impact of machine-learning models based on coronary angiography and intravascular ultrasound (IVUS) during percutaneous coronary intervention (PCI, stenting). The primary outcomes are target-vessel failure (TVF) related to the treated (culprit) and untreated (nonculprit) lesions. 3,000 patients; recruiting.

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Recruiting Periapical Diseases

Medical-AI trial: detecting periapical lesions from dental panoramic images with AI — catching easily missed root-tip lesions (CBCT reference) (NCT05888935)

Centre Hospitalier Régional Metz-Thionville

An observational study evaluating whether AI can detect periapical lesions (at the tip of a tooth root) from low-dose dental panoramic X-rays. Panoramic is a first-line examination, but detection rates for these lesions are low (20–36%), and cone-beam CT (CBCT) is used as the reference. The primary outcome is the performance of the AI software. 2,000 patients; recruiting.

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Recruiting Gynecologic Cancer / Hereditary Cancer Syndrome

Medical-AI trial: a chatbot to bring hereditary-cancer genetic testing to an underserved population — reducing health inequity (NCT05562778)

Weill Medical College of Cornell University

An interventional study comparing a chatbot that uses AI and natural language processing against usual care, to see whether it can raise the rate of recommending genetic testing among patients at elevated risk of a familial cancer syndrome, in an all-Medicaid gynecology clinic. It also evaluates drivers of inequity in access to testing. The primary outcome is the proportion recommended for genetic testing. 150 patients; recruiting.

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Recruiting Colorectal Cancer (CRC) / Adenomatous Polyposis

Medical-AI trial: can AI-assisted colonoscopy increase detection of adenomas (precancerous lesions)? vs. standard (randomized controlled trial) (NCT07066046)

Instituto do Cancer do Estado de São Paulo

A randomized controlled trial (RCT) evaluating whether AI-assisted colonoscopy raises the adenoma detection rate (ADR) and improves the accuracy of characterizing colorectal lesions (telling benign from malignant), compared with standard colonoscopy. The primary outcome is the proportion of patients with at least one histologically confirmed adenoma (AI vs. control). Target 1,000; recruiting.

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Active, not recruiting Ovarian Cancer

Medical-AI trial: AI ultrasound screening for ovarian cancer in postmenopausal women — a field with no effective screening (ASTOM) (NCT07660718)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

A single-center prospective observational pilot applying AI to ultrasound screening for ovarian cancer in postmenopausal women, a higher-risk group where early diagnosis remains a major challenge because no effective screening exists. Conducted at a gynecologic-oncology unit in Bologna, Italy. The primary outcome is the predictive performance of an integrated model discriminating ovarian-lesion risk categories. 100 patients.

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Recruiting Membranous Nephropathy

Medical-AI trial: personalizing rituximab dosing with AI — optimizing treatment in membranous nephropathy (a leading cause of nephrotic syndrome) (NCT06341205)

Centre Hospitalier Universitaire de Nice

An interventional study of an AI-based protocol to personalize rituximab dosing in membranous nephropathy, an autoimmune kidney disease. Since up to 40% of patients do not respond to a first course, it aims to optimize dosing. The primary outcome is clinical remission (complete or partial) six months after starting rituximab. 120 patients; recruiting.

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Active, not recruiting Intracranial Aneurysm

Medical-AI trial: detecting brain aneurysms from head MRI (TOF-MRA) with AI (RDX-Aneurysm) — testing performance against misses (NCT07655635)

Taipei Medical University Shuang Ho Hospital

A retrospective, multicenter, case-control study evaluating the standalone performance of RDX-Aneurysm, a computer-assisted detection software, in finding and marking saccular intracranial (brain) aneurysms on adult head time-of-flight MR angiography (TOF-MRA). About 550 exams: ~250 positive with a confirmed aneurysm 3 mm or larger and ~300 negative. The primary outcome is lesion-level sensitivity for saccular aneurysms 3 mm or greater.

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Recruiting Opioid Overdose / Opioid Use

Medical-AI trial: predicting overdose risk with machine learning and nudging safer prescribing in the EHR — curbing opioid overdose (cluster-randomized) (NCT06806163)

University of Pittsburgh

A cluster-randomized trial of a clinician-targeted behavioral nudge in the electronic health record (EHR) for patients flagged by a machine-learning model as at elevated risk of opioid overdose. It compares a risk flag alone, a flag plus nudges, and usual care. The primary outcome is a prescribing-practices composite score. 1,350 patients; recruiting.

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Active, not recruiting Patient Understanding of Ultrasound Reports

Medical-AI trial: using a large language model to simplify ultrasound reports and improve patient understanding — vs. standard reports (NCT07647536)

Lu Wang

A multicenter, patient-blinded controlled evaluation of whether expert-reviewed, AI (large language model)-simplified ultrasound reports improve patient- or guardian-reported understanding and reading experience versus standard reports. The simplified report is a patient-facing aid only; it does not replace the standard clinical report. The primary outcome is a text-comprehension composite score. 660 participants.

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Recruiting Breast Cancer

Medical-AI trial: catching breast cancer opportunistically on chest CT with AI — compared with mammography and MRI (NCT07557654)

Fudan University

An observational study evaluating the feasibility and effectiveness of using non-contrast chest CT, taken for other reasons, for opportunistic breast-cancer screening with AI, and comparing its diagnostic performance with mammography and/or breast MRI. The primary outcome is the screening performance of chest CT for breast-cancer detection versus mammography/MRI. 5,000 patients; recruiting.

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Recruiting Respiratory Infections in Children

Medical-AI trial: AI lung auscultation to curb antibiotic overuse in children (BLAAAST) — tackling antibiotic resistance (rural Bangladesh, RCT) (NCT07362433)

Johns Hopkins University

Most lower-respiratory infections in young children are self-limiting viruses, yet antibiotics are often used. In rural Bangladesh, this randomized controlled trial tests whether AI-based lung auscultation (a digital stethoscope) can safely reduce unnecessary antibiotics without increasing treatment failure. The aim is antibiotic stewardship and stemming global antibiotic resistance (AMR). The primary outcome is treatment failure. 2,500 children; recruiting.

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Completed Artifical Intelligence / Preoperative Evaluation

Medical-AI trial: agreement between ChatGPT-5 and anesthesiologists on preoperative risk class (ASA-PS) — preoperative triage (NCT07459491)

Damla Kaytancı Özçelik

An observational study in adults scheduled for elective surgery comparing the agreement between the ASA-PS physical-status class assigned by anesthesiologists and the one generated by ChatGPT-5 from the same anonymized information. It also explores differences in lab recommendations and links to perioperative red-blood-cell (transfusion) use. 703 patients; completed.

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Completed Preclinical Dental Education

Medical-AI trial: AI feedback vs. instructor feedback in dental education (preclinical simulation lab) (NCT07682116)

Seda Nur Karakaş

An interventional study in a preclinical restorative-dentistry lab, where third-year dental students practicing restorations on simulated teeth received either AI-generated feedback or human-instructor feedback, comparing effects on practical performance, in-the-moment (state) anxiety, and student perception. 140 participants; completed.

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Completed MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)

Medical-AI trial: deep learning on repeated blood tests to catch liver fibrosis early (NIMIT-AI) — triage in fatty liver disease (MASLD) (NCT07675525)

Siriraj Hospital

An observational study of NIMIT-AI, which reads the trajectory of repeated blood tests with deep learning to identify liver scarring (fibrosis) early in fatty liver disease (MASLD), compared with the current FIB-4 score. Validated on patients seen at Siriraj Hospital in Bangkok in 2018–2022. Completed.

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Completed Acetabular Fractures / Pelvic Injury

Medical-AI trial: can ChatGPT classify acetabular (pelvic) fractures? compared with orthopedic residents (multimodal LLM, 184 cases) (NCT07673991)

Ankara City Hospital Bilkent

A retrospective observational study evaluating the diagnostic reliability of the multimodal AI model ChatGPT-4o in Letournel-Judet classification of acetabular fractures from pelvic radiographs (Judet views), compared with two fourth-year orthopedic residents and a reference standard from CT and intraoperative findings. 184 cases. Completed.

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Completed Glioma / Glioma (Diagnosis)

Medical-AI trial: non-invasive AI detection of IDH-wildtype glioblastoma from MRI (GliomaAI-GBM, brain tumor, 1,372 public scans) (NCT07673692)

Deep Learning Institute of Radiological Sciences

An observational study evaluating whether an AI system, GliomaAI-GBM, can identify the molecular subtype IDH-wildtype glioblastoma from routine MRI. It uses 1,372 fully anonymized scans from 13 institutions in the Cancer Imaging Archive (TCIA) and measures accuracy, sensitivity, specificity, and area under the ROC curve. Completed.

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Completed Burnout, Healthcare Workers / Clinical Workflow Optimization

Medical-AI trial: easing the documentation burden with AI (Evidently) — a randomized test against clinician burnout (NCT07498582)

University of North Carolina, Chapel Hill

A randomized evaluation of whether outpatient specialists can spend less time and effort reviewing and documenting care by receiving AI-made summaries of existing medical-record information. It looks at effects on clinician workload, time in the electronic health record (EHR), and documentation experience. The primary outcome is the change in clinician cognitive load. 128 clinicians; completed.

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Completed DaTSCAN SPECT Scans

Medical-AI trial: classifying parkinsonian syndromes from brain imaging (DaTSCAN SPECT) with machine learning — aiding a hard diagnosis (NCT05080296)

Central Hospital, Nancy, France

An observational study evaluating whether machine learning can distinguish healthy people from Parkinson disease, and idiopathic PD from atypical parkinsonian syndromes, using morphological features from DaTSCAN (ioflupane) SPECT scans of dopamine nerves. Diagnosis of PD relies mainly on clinical observation and can be challenging. The primary outcome is algorithm accuracy. 1,664 cases; completed.

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Completed Electrocardiogram / Mortality Risk Prediction

Medical-AI trial: AI predicts one-year mortality risk from the ECG — a Software as a Medical Device validated on 462,000 records (NCT07659262)

National Defense Medical Center, Taiwan

A study validating a Software as a Medical Device (the Chang Gung ECG Mortality Risk Prediction Software) that analyzes a standard 10-second, 12-lead resting ECG with AI to predict the probability of cardiac-related death within one year, in a multicenter retrospective cohort. Notably, it predicts from the ECG alone without relying on blood tests. The primary outcome is area under the ROC curve (AUC). 461,982 records. Completed.

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Completed Diabetes Type 2

Medical-AI trial: AI-driven insulin dose adjustment vs. clinicians — glycemic control in type 2 diabetes on general wards (multicenter RCT) (NCT06319300)

Shanghai Zhongshan Hospital

A multicenter, single-blind, randomized controlled trial in type 2 diabetes patients on general wards who need subcutaneous insulin, comparing a group whose insulin doses are adjusted by an AI system against a group adjusted by clinicians, on glycemic control and adverse-event risk. The primary outcome is time in target range (3.9–10.0 mmol/L). About 142 patients; completed.

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Completed Asthma in Children / Artificial Intelligence

Medical-AI trial: a human support robot to help teach children about asthma (AIR) — evaluating design and usability (NCT07387718)

University of Miami

A prevention study evaluating the design and usability of a new asthma-education protocol delivered with a Human Support Robot for children with asthma. The primary outcomes are feasibility (enrollment rate, completion rate, session length, number of technical issues) and the acceptability of the robot-supported education. 98 participants; completed.

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Completed Psychotic Disorders / Prevention

Medical-AI trial: using AI to gauge psychosis risk early and act ahead — staged diagnosis and risk-adapted treatment (pronia.ai) (NCT05813080)

Heinrich-Heine University, Duesseldorf

A multicenter randomized controlled trial in people at increased clinical risk for psychosis, comparing an arm with AI-staged early diagnostics and risk-adapted treatment (RAB) against treatment-as-usual (TAU). The primary outcome uses the Structured Interview for Psychosis-Risk Syndromes (SIPS). 260 patients; completed.

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Enrolling by invitation Emerging Infectious Diseases / COVID-19

Medical-AI trial: an international consensus on AI-enabled emergency research for emerging infectious diseases — risk perception to decision-making (NCT07678619)

Peking University

A study to build an international consensus on an AI system that supports emergency clinical research for emerging and re-emerging infectious diseases such as COVID-19, mpox, and dengue, which spread fast and carry high uncertainty. It targets the full chain of risk perception, situational assessment, intelligent decision-making, and comprehensive evaluation. 780 participants.

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Enrolling by invitation Congenital Heart Disease (CHD)

Medical-AI trial: detecting congenital heart disease from heart sounds recorded on a smartphone mic — assessing an algorithm (ausculto) (NCT07376785)

The University of Hong Kong

An observational study assessing ausculto, a set of computer algorithms that analyze heart sounds recorded from a smartphone built-in microphone for abnormal sounds, to tell murmurs of congenital heart disease from normal sounds and innocent murmurs. Recorded sounds are manually annotated to build a database for future AI training and testing. 220 participants; by invitation.

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Enrolling by invitation Snake Bite

Medical-AI trial: identifying snake species with AI to aid snakebite treatment — a deep-learning system tested in emergency care (64-class classification) (NCT07658885)

Second Affiliated Hospital, School of Medicine, Zhejiang University

A multicenter prospective observational study that develops and validates a deep-learning AI system to identify snake species and evaluates its clinical usefulness in real emergency snakebite care. Across 10 institutions in Zhejiang, China, it tests whether the system can accurately identify indigenous biting species and improve the accuracy and efficiency of clinician species judgment. 64-class classification plus venomous/non-venomous discrimination. 400 cases.

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Enrolling by invitation Severe Mental Illness

Medical-AI trial: how do people with mental illness use AI chatbots for mental health? a survey of use, expectations, and concerns (NCT07658547)

Medizinische Hochschule Brandenburg Theodor Fontane

An online observational survey of how adults in psychiatric or psychotherapeutic treatment use, perceive, and evaluate generative-AI chatbots for mental-health purposes, asking about usage patterns, expectations, experiences, perceived benefits, barriers, and concerns. The primary outcome is the percentage who have used generative AI for mental-health issues. 150 participants.

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Enrolling by invitation Esophageal Cancer

Observational study testing the clinical utility of an AI large language model for esophageal cancer screening, diagnosis, treatment and prognosis — a clinical trial (ClinicalTrials.gov)

The First Affiliated Hospital of Henan University of Science and Technology

An observational study using de-identified data from patients in routine esophageal cancer care to test whether an AI large language model can improve early detection, diagnostic accuracy, treatment personalization and prognosis prediction versus standard care over three years.

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Not yet recruiting Rare Disorders / Rare Diseases

Medical-AI trial: a large language model to help diagnose rare diseases — can it shorten the diagnostic odyssey? (cluster-randomized) (NCT07650799)

Peking Union Medical College Hospital

A multicenter, prospective, cluster-randomized, parallel-controlled real-world trial of whether a rare-disease diagnostic large language model (LLM) can improve diagnostic quality, efficiency, and health-economic outcomes for physicians managing patients with suspected rare or diagnostically unresolved disease. Primary outcomes are top-3 candidate diagnostic accuracy and rare genetic-disease diagnostic yield. 1,055 patients.

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Not yet recruiting Glaucoma

Medical-AI trial: finding early glaucoma from fundus photos with AI (GlaukomAI) — preventing blindness and cutting waits (NCT07668193)

Fondazione G.B. Bietti, IRCCS

A study evaluating whether the AI software GlaukomAI can detect glaucoma, a leading cause of irreversible blindness, at an early stage from fundus (back-of-eye) photographs. Current diagnosis needs multiple specialist visits and tests, causing long waits and delays. At an eye institute in Rome, Italy, Phase 1 uses 100 glaucoma and 100 healthy controls to assess accuracy (sensitivity and specificity). 1,200 patients; two phases.

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Not yet recruiting Deglutition Disorders / Dysphagia

Medical-AI trial: an AI app to make eating safer for older adults with swallowing difficulty (dysphagia) — sticking to the prescribed texture (RCT) (NCT07654088)

KAM Chi Shan Anna

Swallowing difficulty (dysphagia), common in older adults, risks choking, pneumonia, and poor nutrition. Preparing food and drink at the correct modified texture at home is hard. This randomized controlled trial tests whether an AI smartphone app can help community-dwelling older adults eat more safely. The primary outcome is the proportion of meals adhering to the prescribed texture level. 332 participants.

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Not yet recruiting Cardiac Amyloidosis / Heart Failure With Preserved Ejection Fraction (HFPEF)

AI medical trial: AI echocardiography to detect cardiac amyloidosis — a clinical trial (ClinicalTrials.gov)

Germans Trias i Pujol Hospital

A prospective study testing whether AI applied to echocardiography images can pick up patients with findings suggestive of cardiac amyloidosis (especially the ATTR type) — a condition easily missed. The AI flags are checked against confirmatory methods: bone-tracer SPECT, cardiac MRI, and blood tests.

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Latest (original, AI-in-medicine)

Recent clinical trials

Recently updated AI-in-medicine trials (original titles). Each links to the official ClinicalTrials.gov page.

Source: ClinicalTrials.gov (U.S. NIH/NLM, public domain). This site does not provide medical advice. Verify the latest and exact details with the official source. This site is not endorsed or certified by the NIH/NLM.

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