moncefem/clinical-trials-ai-2000-2025 huggingface dataset:
Construction and Evaluation of an Intelligent Decision System for Reperfusion Therapy in Acute Ischemic Stroke
Trial ID: NCT07316049
Status: NOT_YET_RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2025-12-15
Completion date: 2027-02-28
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions: Acute Ischemic Stroke
Interventions: LingBao System; Standard Care
Enrollment: 3000
Age range: 18 Years - None
Sex: ALL

Summary:
This multicenter, cluster-randomized controlled trial will evaluate the effectiveness and safety of the LingBao System, an AI-enabled clinical decision support platform for reperfusion therapy in acute ischemic stroke (AIS). Twenty certified stroke centers will be randomized 1:1 to LingBao-assisted care or standard care. Consecutive patients aged 18 years or older who present within 24 hours of symptom onset or last-known-well and are evaluated for intravenous thrombolysis and/or endovascular therapy will be prospectively enrolled.

At intervention sites, clinicians may use the LingBao System during their routine workflows. The platform integrates routinely available clinical and imaging data, automatically estimates onset-to-treatment windows, screens contraindications, and provides evidence-based, guideline-concordant recommendations for reperfusion therapy; all treatment decisions remain at physician discretion.

The primary endpoint is the 90-day modified Rankin Scale (mRS) score analyzed by ordinal shift. Secondary endpoints include workflow metrics (door-to-needle time and door-to-puncture time), reperfusion treatment rates, early neurological improvement, symptomatic intracranial hemorrhage, and mortality.

The study plans to include approximately 20 centers (about 150 patients per center), accounting for intracluster correlation. The findings will provide real-world evidence on the clinical value of AI-assisted decision support for reperfusion therapy in AIS and inform broader implementation of intelligent stroke management systems.

Eligibility criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Clinical diagnosis of acute ischemic stroke (AIS).
* Presentation within 24 hours of symptom onset or last-known-well.
* Evaluated for reperfusion therapy (intravenous thrombolysis and/or endovascular treatment).
* Admission to one of the participating certified stroke centers.
* Availability of required clinical and imaging data for system evaluation and outcome assessment.

Exclusion Criteria:

* Absence of key clinical or imaging data necessary for analysis.
* Patients not undergoing reperfusion assessment or outside the pre-defined workflow.
* Prior participation in LingBao pilot testing or other AI-based decision support trials within the past 6 months.
* Explicit refusal of data use or withdrawal of consent (if applicable).

Outcomes:
Functional outcome at 90 days assessed by the modified Rankin Scale (mRS)
Abridge AI Pilot Test
Trial ID: NCT06778148
Status: ACTIVE_NOT_RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2025-01-13
Completion date: 2025-12-31
Sponsor: University of Colorado, Denver
Conditions: Clinician Experience; Clinician Burnout
Interventions: Ambient AI for clinician documentation
Locations: UCHealth
Countries: United States
Enrollment: 232
Age range: None - None
Sex: ALL

Summary:
We are piloting a new technology (Abridge) that uses artificial intelligence to listen to clinician-patient office visits and then document the interaction in the electronic health record.

Eligibility criteria:
Inclusion Criteria:

-clinician (physician, advance practice professional, or licensed mental health professional) employed by UCHealth

* See clinic patients at least three half-day sessions per week. (Half-day sessions seeing or supervising patients with residents and fellows will NOT count toward the weekly total. Half-day sessions seeing patients with a medical student CAN count toward the weekly total, however, Abridge can only capture conversations where you are physically present with patients.)
* Own an iOS smartphone and be willing to download and use the Epic Haiku smartphone app during clinic visits

Exclusion Criteria:

* Trainees including residents and fellows
* PT/OT, ED, maternal/fetal, pediatric, dental, eye specialties

Outcomes:
Burnout - High emotional exhaustion; Burnout - High depersonalization; Burnout - emotional exhaustion and depersonalization; Time in notes per appointment; Adoption
A Liquid Biopsy Assay For The Non-Invasive Early Detection of Advanced Adenomas and Colorectal Cancer
Trial ID: NCT06342440
Status: RECRUITING
Study type: OBSERVATIONAL
Start date: 2020-03-15
Completion date: 2026-06-18
Sponsor: City of Hope Medical Center
Conditions: Colorectal Cancer; Colorectal Neoplasms; Colorectal Polyp; Colorectal Adenocarcinoma; Colorectal Disorders; Colorectal Dysplasia; Colorectal Cancer Stage I; Colorectal Cancer Stage II; Colorectal Cancer Stage III; Colorectal Cancer Stage IV; Colorectal Neoplasms Malignant; Colorectal Serrated Adenocarcinoma; Colorectal Adenoma With Severe Dysplasia; Colorectal Adenoma With Mild Dysplasia; Colorectal Adenoma With Moderate Dysplasia; Colorectal Adenoma and Carcinoma 1; Colorectal Adenomatous Polyp; Colorectal Adenocarcinoma Metastatic in the Liver
Interventions: DENEB
Locations: City of Hope Medical Center; University of California San Diego; The First Affiliated Hospital of Dalian Medical University; IRCCS San Raffaele; Mie University; Barcelona University
Countries: United States; United States; China; Italy; Japan; Spain
Enrollment: 2000
Age range: 18 Years - None
Sex: ALL

Summary:
This study aims to develop a highly sensitive, specific, and cost-effective blood assay for early detection of colorectal adenomas and cancer, using advanced machine learning and state-of-the-art biological analyses.

Eligibility criteria:
Inclusion Criteria:

* All individuals included in the study need to have had a colonoscopy at the time of blood sampling.
* Received standard diagnostic and staging (as necessary) procedures as per local guidelines, and at least one sample was drawn before receiving any curative-intent treatment.
* Received standard pathological and endoscopic diagnosis and assessment for cohort assignment.

Exclusion Criteria:

* Hereditary colorectal cancer syndromes (identified through genetic testing).
* Inflammatory bowel diseases.
* Lack of written informed consent.

Outcomes:
Sensitivity
Artificial Intelligence to Assess the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
Trial ID: NCT04941560
Status: COMPLETED
Study type: OBSERVATIONAL
Start date: 2021-09-06
Completion date: 2023-02-10
Sponsor: China National Center for Cardiovascular Diseases
Conditions: Coronary Artery Disease
Interventions: No intervention
Locations: Fuwai hospital
Countries: China
Enrollment: 460
Age range: 18 Years - None
Sex: ALL

Summary:
The purposes of this study are 1) to explore the association between multi-dimension facial characteristics and the increased risk of coronary artery diseases (CAD); 2) to evaluate the diagnostic efficacy of multi-dimension appearance factors for coronary artery diseases.

Eligibility criteria:
Inclusion Criteria:

* Undergoing coronary angiography or coronary computer tomography angiography
* Written informed consent

Exclusion Criteria:

* Prior percutaneous coronary intervention (PCI)
* Prior coronary artery bypass graft (CABG)
* Screening coronary artery disease before treating other heart diseases
* Without blood biochemistry outcome
* With artificially facial alteration (i.e. cosmetic surgery, facial trauma or make-up)
* Other situations which make patients fail to be photographed

Outcomes:
Area under receiver operating curve (AUC)
Risk Prediction Model in Patients With Suspected Coronary Artery Disease Based on Contemporary Stress Echocardiography Data Using Artificial Intelligence
Trial ID: NCT07432620
Status: ACTIVE_NOT_RECRUITING
Study type: OBSERVATIONAL
Start date: 2019-06-07
Completion date: 2028-10
Sponsor: Milton Keynes University Hospital NHS Foundation Trust
Conditions: Coronary Artery Disease; Chest Pain; Myocardial Ischemia; Angina Pectoris; Myocardial Infarction (MI)
Interventions: Dobutamine Stress Echocardiography
Locations: Milton Keynes University Hospital
Countries: United Kingdom
Enrollment: 2281
Age range: 18 Years - None
Sex: ALL

Summary:
The goal of this observational study is to learn whether combining stress echocardiography (stress echo) results with routine clinical information can better predict important heart outcomes in adults (18+) with chest pain who were assessed for suspected coronary artery disease.

The main questions it aims to answer are:

Can an artificial intelligence / machine learning model using stress echo findings plus clinical factors (such as blood pressure, diabetes, smoking, other health conditions, medications, and body measurements) predict major heart-related events (such as heart attack, stroke, death related to heart disease, or the need for coronary procedures) more accurately than stress echo results alone?

Can the model help identify which patients are most likely to benefit from further invasive assessment and possible coronary revascularisation (for example, a stent or bypass surgery)?

Which combination of stress echo measurements and clinical factors contributes most to risk prediction?

Participants will:

Not be asked to attend extra visits or have additional tests for this study.

Have their existing stress echo reports and routinely collected hospital record data analysed (approximately 3,000 people who previously had dobutamine stress echo at Milton Keynes University Hospital).

In some cases, if outcomes are not fully available from hospital records, the research team may check additional sources (such as GP records, or contacting the patient if appropriate) to confirm whether a major heart-related event occurred.

Eligibility criteria:
Inclusion Criteria:

* Age 18 years or older at the time of the index stress echocardiography.
* Referred for pharmacological (dobutamine) stress echocardiography at Milton Keynes University Hospital for assessment of suspected coronary artery disease / chest pain.
* Stress echocardiography report available in the hospital dataset for data extraction and conversion into a structured database.

Exclusion Criteria:

* Age under 18 years at the time of the index stress echocardiography.
* No available/usable stress echocardiography report for extraction into the study database.
* Unable to link the record to follow-up outcome information using routine hospital systems (with attempted supplementary checks where needed).
* Patients who have registered a National Data Opt-out and are therefore not eligible for use of their confidential patient information for research/secondary purposes in this study.

Outcomes:
Major adverse cardiovascular events (MACE) - composite
Preclinical Development of a 3D Bili-MRI Reconstruction Tool and an Artificial Intelligence Algorithm to Assist Endoscopists in Performing Endoscopic Retrograde Cholangiopancreatography (ERCP) : MAAGIE
Trial ID: NCT07401485
Status: NOT_YET_RECRUITING
Study type: OBSERVATIONAL
Start date: 2026-03-02
Completion date: 2026-07-02
Sponsor: Assistance Publique - Hôpitaux de Paris
Conditions: Patients With Biliary Stricture Treated During ERCP With Available MRCP and Abdominal CT Scan
Interventions: retrospective study based on data already collected during routine care (no intervention)
Locations: Service Endoscopie digestive, Saint Antoine APHP
Countries: France
Enrollment: 100
Age range: 18 Years - None
Sex: ALL

Summary:
ERCP is a complex interventional endoscopic procedure based on 2D visualization of the biliary tract. 3D modeling and AI are promising solutions to improve navigation and safety during ERCP.

The MAAGIE project was designed to create one of these innovative solutions and received ANR funding in 2024. It includes several Work Packages, among which the first WP involves creating a database from imaging data of the biliary tract already collected during clinical care.

The main objective of our study will be to develop and validate a tool that enables 3-dimensional modeling of the biliary tract from preoperative MRCP and abdominal CT scan sequences, allowing better visualization and understanding of patients' biliary anatomy before and during ERCP.

Eligibility criteria:
Inclusion Criteria:

* Patients aged 18 years or older.
* Patients treated by ERCP in the endoscopy unit of Saint Antoine Hospital or Henri Mondor Hospital for a biliary condition related to a biliary stricture (benign or malignant).
* Patients who underwent an MRCP and an abdominal CT scan in the imaging department of Saint Antoine Hospital or Henri Mondor Hospital as part of their clinical care.

Exclusion Criteria:

-Patients who oppose the reuse of their clinical data for research after receiving the information letter.

Outcomes:
medical softaware and/or solution to guide stent placement in complex hilar biliary stricture
Telemedicine System and Intelligent Monitoring System Construction of Pediatric Asthma Based on the Electronic Stethoscope
Trial ID: NCT05659225
Status: UNKNOWN
Study type: INTERVENTIONAL
Phase: NA
Start date: 2023-01-01
Completion date: 2025-12-31
Sponsor: Shanghai Children's Medical Center
Conditions: Asthma
Interventions: Electronic Stethoscope; Standard treatment according to GINA(2019)
Locations: Shanghai Children's Medical Center
Countries: China
Enrollment: 208
Age range: 3 Years - 6 Years
Sex: ALL

Summary:
The purpose of this study is to retrofit the existing electronic stethoscope, improve the quality and efficiency of signal acquisition and the intelligent degree of information processing, decrease the manual action of electronic stethoscopes implemented by parents of asthma children, simplify the process of data transfer and the user's operational cost using signal processing, artificial intelligence technology, thus decreasing the feedback cycle between patients and clinicians. Eventually, we will construct an intelligent monitoring system based on the modified electronic stethoscope and explore the interactive remote management approaches on children's asthma at the same time, thus achieving revolutionized remote management of asthma.

Eligibility criteria:
Inclusion Criteria:

1. Diagnosed as asthma according to "Guideline for the diagnosis and optimal management of asthma in children" in the respiratory clinic of Shanghai Children's Medical Center from January 2023 to January 2025
2. Out-patient, female or male, 3 years old≤ age \< 6 years old
3. long-term maintenance therapy with inhaled glucocorticoids or concomitant leukotriene receptor antagonists
4. Equipped with a household atomizer or spacer, it can afford the inhalation therapy of short-acting β2 receptor agonists (SABA) at home
5. The subjects or subjects' caregiver must have a smart phone with Android or Harmony system at their disposal
6. The guardian agrees to participate in the study and signs the informed consent form

Exclusion Criteria:

1. Acute exacerbation of asthma 30 days before enrollment (receive short-term prednisone treatment, emergency department visit or hospitalization due to acute asthma attacks)
2. Other chronic lung diseases, cardiovascular diseases, blood system diseases, immunodeficiency diseases, neurological diseases, genetic or chromosomal abnormalities and other underlying diseases
3. Patients or their caregivers can't complete the collection of breath sound

Outcomes:
visits of asthma-related unplanned emergency department
Diagnostic Accuracy, Usability, Patient Compliance, and System Reliability of the AK+ Guard™ ECG Application for Hyperkalemia Prediction in Ambulatory Chronic Kidney Disease Patients (Outpatient and Remote Monitoring Arms)
Trial ID: NCT07210021
Status: RECRUITING
Study type: OBSERVATIONAL
Start date: 2025-10-14
Completion date: 2025-11-28
Sponsor: AccurKardia, Inc.
Conditions: Hyperkalemia; Chronic Kidney Disease (Stage 3-4)
Interventions: AK+ Guard™ ECG Application
Locations: Central Jersey Kidney Care - Hypertension & Nephrology Associates
Countries: United States
Enrollment: 50
Age range: 22 Years - None
Sex: ALL

Summary:
The goal of this observational pilot study is to evaluate the investigational AK+ Guard™ software as a medical device (SaMD) for detection of moderate to severe hyperkalemia (serum potassium (K+) ≥ 6.5 mmol/L) in adults with chronic kidney disease (CKD).

Study objectives are:

* Arm 2A (Outpatient Diagnostic Accuracy): To generate a preliminary, real-world signal of the diagnostic performance of AK+ Guard™ when used in an ambulatory CKD cohort for identifying clinically significant hyperkalemia episodes (serum K+ ≥ 6.5 mmol/L) at the time of an outpatient laboratory draw.
* Arm 2B (Remote Patient Monitoring): To assess participant compliance, usability, and end-to-end system reliability of AK+ Guard™ when deployed for daily remote monitoring of CKD patients outside the clinical environment for up to four weeks.

Eligibility criteria:
Inclusion Criteria:

(Arm 2A - Outpatient Diagnostic Accuracy)

* Age 22 years or older
* CKD stages III-IV managed at Central Jersey Kidney Care outpatient clinic
* Scheduled outpatient serum potassium laboratory test
* On RAASi therapy or documented hyperkalemia (K+ ≥ 5.5 mmol/L) within the past 12 months
* Able to provide written informed consent

(Arm 2B - Remote Patient Monitoring)

* Completion of Arm 2A visit
* Owns an iPhone compatible with the study application

Exclusion Criteria (Both arms):

* Age 21 years or younger
* Pacemaker or implantable cardioverter defibrillator
* Pre existing Left Bundle Branch Block (LBBB), Right Bundle Branch Block (RBBB), Intraventricular Conduction Delay (IVCD), or clinically significant hypocalcemia
* Potassium lowering treatment administered before Lead I ECG acquisition
* Trauma, acute events, or active interventions altering potassium homeostasis
* Physical limitation precluding ECG acquisition

Outcomes:
Arm 2A: Sensitivity and specificity of AK+ Guard™ for detecting serum potassium greater than or equal to 6.5 mmol/L; Arm 2B: (a) Daily compliance rate (proportion of completed ECGs out of scheduled ECGs); Arm 2B: (b) Mean System Usability Scale (SUS) score; Arm 2B: (c) Net Promoter Score (NPS)
Influence Of Age And Radiograph Presentation on C-Shaped Canal Morphology In Mandibular Second Molar By Using CBCT Analysis
Trial ID: NCT04817852
Status: UNKNOWN
Study type: INTERVENTIONAL
Phase: NA
Start date: 2021-02-01
Completion date: 2023-02-01
Sponsor: CSI College of Dental Sciences and Research, Madurai
Conditions: Decayed Teeth
Interventions: CBCT data of c-shaped canal in mandibular second molar.
Locations: CSI College of Dental Sciences And Research
Countries: India
Enrollment: 180
Age range: 13 Years - 70 Years
Sex: ALL

Summary:
CBCT Data Of C-Shaped Canal In Mandibular Second Molar Will Be Assessed For Age.

Eligibility criteria:
Inclusion Criteria:

* In lower second molar with C-shaped canal.

Exclusion Criteria:

* Patient not willing for CBCT.

Outcomes:
Morphological variation in root canal anatomy of c shaped canal in mandibular second molar will be assessed for 180 participants by using cone beam computed tomography
Real Life AI in Polyp Detection
Trial ID: NCT04335318
Status: COMPLETED
Study type: INTERVENTIONAL
Phase: NA
Start date: 2020-05-01
Completion date: 2020-10-01
Sponsor: Wuerzburg University Hospital
Conditions: Colonic Polyp
Interventions: AI-assisted colonoscopy
Locations: Universitätsklinikum Würzburg
Countries: Germany
Enrollment: 230
Age range: 18 Years - None
Sex: ALL

Summary:
The objective of this study is to compare the polyp detection rate (PDR) of endoscopists unaware of a commercially available artificial intelligence (AI) device for polyp detection during colonoscopy and the PDR of endoscopists with the aid of such a device. Moreover, an extensive characterization of the performance of this device will be done.

Eligibility criteria:
Inclusion Criteria:

* Colonoscopies for Polyp detection

Exclusion Criteria:

* Colonoscopies for Inflammatory Bowel Disease (IBD).
* Colonoscopies for work up of an active bleeding

Outcomes:
Polyp detection rate comparison; Mean withdrawal time comparison
Clinical and Radiographic Outcomes of Computer Guided Immediate Implant Placement Utilizing Artificial Intelligence Assisted Socket Shield Approach: Randomized Clinical Trial
Trial ID: NCT06299449
Status: COMPLETED
Study type: INTERVENTIONAL
Phase: NA
Start date: 2024-03-05
Completion date: 2026-05-06
Sponsor: Kafrelsheikh University
Conditions: Implant Complication; Dental Implant Failed
Interventions: free-hand socket shield; AI/guided socket shield
Locations: faculty of dentistry, kafrelsheikh University
Countries: Egypt
Enrollment: 22
Age range: 19 Years - 40 Years
Sex: ALL

Summary:
Aim of the current randomized clinical trial is to evaluate and compare the effectiveness of computer-guided immediate implant placement performed simultaneously with artificial intelligence assisted socket shield technique versus conventional approach.

Eligibility criteria:
Inclusion Criteria:

* above the age of 18years
* presence of non-restorable maxillary anterior tooth
* had intact socket walls following tooth extraction
* the gingival biotype was thick.

Exclusion Criteria:

* history of systemic condition
* history of using bisphosphonates or other drugs that might impact bone turnover
* a history of smoking during the previous five years,
* a history of any acute infections at the surgical site,
* teeth having root resorptions

Outcomes:
Stability Quotient of dental implant; pink esthetic score; Midfacial Mucosal Alterations; facial marginal bone level
Developing a Nationwide Registry to Track Longitudinal Clinical Outcomes of Corneal Surgery and Disease
Trial ID: NCT06101017
Status: COMPLETED
Study type: OBSERVATIONAL
Start date: 2023-10-12
Completion date: 2024-08-15
Sponsor: Nitin Vaswani
Conditions: Corneal Disease; Endothelial Corneal Dystrophy; Corneal Transplant Failure; Corneal Transplant Rejection
Interventions: Optical Coherence Tomography
Locations: Keratoplasty Alliance International
Countries: United States
Enrollment: 19
Age range: 18 Years - None
Sex: ALL

Summary:
The goal is to develop a nationwide registry to track longitudinal clinical outcomes of and store imaging data related to numerous corneal conditions. There are two main objectives including the establishment of the first nationwide corneal transplant registry in the United States to include information related to the donor tissue, recipient, surgical procedure, and long-term clinical outcomes. Ultimately, this prospective data collection will allow us to determine prognostic factors for successful corneal transplantation and create an algorithm to guide clinical practice based on real world outcomes. The second objective is to collect and create a database of historical, de-identified optical coherence topography (OCT) and corneal topography images to ultimately develop artificial intelligence (AI) based diagnostic and prognostic algorithms for corneal disease and surgery.

Eligibility criteria:
Inclusion Criteria:

* All subjects with corneal disease or undergoing corneal transplantation (either penetrating keratoplasty, endothelial keratoplasty \[including DSAEK and DMEK\], or anterior lamellar keratoplasty are eligible to be included in this study. Imaging studies performed pre-operatively, up until 1 year prior to surgery will be collected. Studies may include the following:
* OCT
* Corneal topography
* Specular biomicroscopy
* In vivo confocal biomicroscopy

Exclusion Criteria:

* Any criteria that does not meet the inclusion criteria above.

Outcomes:
Corneal thickness measurement from OCT images; Reflectivity measurement from OCT images; Segmentation measurement from OCT images