moncefem/clinical-trials-ai-2000-2025 huggingface dataset:
Polish Registry of Percutaneous Coronary Intervention for Chronic Total Occlusions (POL-CTO Registry)
Trial ID: NCT07330622
Status: RECRUITING
Study type: OBSERVATIONAL
Start date: 2025-05-21
Completion date: 2026-06
Sponsor: National Institute of Cardiology, Warsaw, Poland
Collaborators: Polish Cardiac Society
Conditions: Coronary Occlusion; Percutaneous Coronary Intervention
Locations: Medical University of Białystok; Szpital Zachodni; Specialist Hospital in Inowrocław; Medical University of Silesia; Institute of Cardiology; St. John Paul II Hospital; Copper Health Centre Inc.; 1st Military Clinical Hospital; Hospital of the Ministry of the Interior and Administration; University of Applied Science in Nowy Sącz; Masovian Specialist Hospital; Poznań University of Medical Sciences; Samodzielny Publiczny Zakład Opieki Zdrowotnej w Puławach; Specialistic Hospital; The Ministry of Internal Affairs and Administration Hospital; Military Institute of Medicine - National Research Institute; National Institute of Cardiology; The Doctor Sokolowski Hospital; Military Hospital in Wrocław; University Hospital in Wroclaw; Provincial Hospital in Łomża
Countries: Poland; Poland; Poland; Poland; Poland; Poland; Poland; Poland; Poland; Poland; Poland; Poland; Poland; Poland; Poland; Poland; Poland; Poland; Poland; Poland; Poland
Enrollment: 1000
Age range: 18 Years - None
Sex: ALL

Summary:
The goal of this observational study is to evaluate the safety, efficacy, and clinical outcomes of percutaneous coronary intervention (PCI) for chronic total occlusions (CTO) in patients treated in contemporary clinical practice in Poland.

The main questions it aims to answer are:

* What are the rates of procedural success and periprocedural complications of CTO PCI in routine clinical practice?
* How do CTO PCI strategies and techniques, intravascular imaging, different treatment strategies, and mechanical circulatory support affect clinical outcomes?
* How do clinical outcomes differ among different patient subgroups?
* Can artificial intelligence-based analysis predict clinical and quality-of-life outcomes after CTO PCI?

Patients undergoing CTO PCI as part of their standard medical care will be prospectively enrolled in a national, multicenter registry, with clinical, procedural, and follow-up data collected to evaluate real-world outcomes.

Eligibility criteria:
Inclusion Criteria:

* Patients undergoing CTO PCI based on clinical grounds

Exclusion Criteria:

* Age \<18 years
* Patient's refusal to participate in the registry

Outcomes:
Technical success
A Single-center Study of an AI-assisted Endoscopy Report System In Improving Reporting Quality
Trial ID: NCT05479253
Status: UNKNOWN
Study type: INTERVENTIONAL
Phase: NA
Start date: 2021-11-01
Completion date: 2022-12-01
Sponsor: Renmin Hospital of Wuhan University
Conditions: Artificial Intelligence; Endoscopy
Interventions: Artificial intelligence assistant system
Locations: Renmin Hospital of Wuhan University
Countries: China
Enrollment: 10
Age range: 18 Years - 70 Years
Sex: ALL

Summary:
In this study, we proposed a prospective study about the effectiveness of artificial intelligence system for endoscopy report quality in endoscopists. The subjects would be divided into two groups. For the collected endoscopic videos, group A would complete the endoscopy report with the assistance of the artificial intelligence system. The artificial intelligence assistant system can automatically capture images, prompt abnormal lesions and the parts covered by the examination (the upper gastrointestinal tract is divided into 26 parts). Group B would complete the endoscopy report without special prompts. After a period of forgetting, the two groups switched, that is, group A without AI assistance and group B with AI assistance to complete the endoscopy report. Then, the completeness of the report lesion, the accuracy of the lesion location, the completeness of the lesion and the standard part in the captured images, and so on were compared with or without AI assistance.

Eligibility criteria:
Inclusion Criteria:

1. Males or females who are over 18 years old;
2. After qualified medical education and obtained the Certificate of Chinese medical practitioner;

Exclusion Criteria:

1. Doctors without qualified medical education and didn't obtaine the Certificate of Chinese medical practitioner;
2. The researcher believes that the subjects are not suitable for participating in clinical trials.

Outcomes:
Integrity of report lesion; Accuracy of lesion location; Integrity of lesion in captured images; Integrity of standard part in captured images
Ticino Artificial InTelligence integrAtioN for Occlusion Myocardial Infarction
Trial ID: NCT07077057
Status: RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2025-08-23
Completion date: 2027-09
Sponsor: Cardiocentro Ticino
Conditions: Myocardial Infarction (MI); Acute Coronary Syndrome (ACS)
Interventions: AI-assisted ECG interpretation (PMcardio)
Locations: Cardiocentro Ticino Institute
Countries: Switzerland
Enrollment: 500
Age range: 18 Years - None
Sex: ALL

Summary:
The goal of this clinical trial is to evaluate whether an artificial intelligence (AI)-based ECG interpretation tool improves the early diagnosis and treatment of occlusion myocardial infarction (OMI) in adults presenting with suspected acute coronary syndrome (ACS) who do not meet traditional ST-elevation myocardial infarction (STEMI) criteria.

The main questions it aims to answer are:

1. Does AI-assisted ECG interpretation enable more timely identification and treatment of OMI, as defined by earlier initiation of coronary intervention?
2. Does AI-assisted diagnosis reduce infarct size, measured by peak high-sensitivity troponin T (hsTnT) levels?

Researchers will compare AI-assisted ECG interpretation to standard care to determine if the AI tool improves clinical outcomes and care timelines.

Participants will:

1. Present with symptoms suggestive of ACS but without clear STEMI criteria
2. Be randomized 1:1 to either AI-assisted or standard ECG interpretation
3. Undergo follow-up assessments for cardiovascular outcomes, including 30-day death, time to treatment of total coronary occlusion, and peak hsTnT levels

Eligibility criteria:
Inclusion Criteria:

1. Symptoms suspected of ongoing acute myocardial ischemia: Patients presenting with symptoms such as chest pain, dyspnoea, sweating, nausea or vomiting, pain radiating to the shoulder/arm/jaw/back, fatigue, or light-headedness
2. Age: Patients aged 18 years or older.
3. Informed Consent: Patients able to provide informed consent

Exclusion Criteria:

1. Clear diagnosis of ST-segment elevation MI (STEMI) according to managing physicians.
2. Pregnancy or Lactation.
3. Legally incompetent to provide informed consent.
4. Symptoms onset\>24 hrs prior to clinical presentation.

Outcomes:
Hierarchical primary endpoint
The Role of Generative Artificial Intelligence Supported Morphological Analysis on Problem Solving Skills and Creative Thinking Disposition of Nursing Students: A Randomized Controlled Trial
Trial ID: NCT07018973
Status: COMPLETED
Study type: INTERVENTIONAL
Phase: NA
Start date: 2025-06-12
Completion date: 2025-06-13
Sponsor: Gazi University
Conditions: Generative Artificial Intelligence; Creative Thinking; Problem Solving; Morphological Analysis and Classification; Nursing; Student
Interventions: GAISMA; Control
Locations: Gazi University Faculty of Nursing
Countries: Turkey (Türkiye)
Enrollment: 113
Age range: None - None
Sex: ALL

Summary:
It will be conducted as a two-group, pretest-posttest, randomized controlled study to determine the effect of generative artificial intelligence-supported morphological analysis on nursing students' problem solving skills and creative thinking tendencies. This study will be conducted with third year students who enrolled in Gazi University Faculty of Health Sciences, Department of Nursing, HEM 312 Critical Thinking in Nursing course for the first time in the spring semester of the 2024-2025 academic year and agreed to participate in the study. Data will be collected using the "Inclusion Form", "Descriptive Characteristics Form", "Marmara Creative Thinking Dispositions Scale", "Problem Solving Skills Scale for Adults" and "Morphological Analysis and Generative Artificial Intelligence Application Opinion Form". Students who meet the inclusion criteria will be randomized into intervention and control groups according to the midterm exam results of the course. At the end of the intervention, post-tests (Marmara Creative Thinking Dispositions Scale and Problem Solving Skills Scale for Adults) will be administered. The control group will be allowed to use the generative artificial intelligence after completing the post-tests. When the application is completed, students will be given an opinion form and their opinions will be taken. The data of the intervention and control groups will be analyzed with SPSS in computer environment.

Eligibility criteria:
Inclusion Criteria:

* Volunteering to participate in the research
* Taking HEM 312 Critical Thinking in Nursing course for the first time

Exclusion Criteria:

* Not attending more than 30% of HEM 312 Critical Thinking in Nursing course
* To have received a training on Morphological Analysis

Outcomes:
Marmara Creative Thinking Dispositions Scale; Problem Solving Skills Scale for Adults
The Combined Usage of Clinical Physical Finding With Simple Triage and Rapid Treatment (START), Modified Early Warning Score(MEWS)and Quick Sequential Organ Failure Assessment(qSOFA) in Management of COVID 19 Patients
Trial ID: NCT06528119
Status: COMPLETED
Study type: OBSERVATIONAL
Start date: 2020-09-30
Completion date: 2024-07-20
Sponsor: St. Martin De Porress Hospital
Conditions: COVID-19 Pandemic
Interventions: COVID 19 pandemic
Locations: St. Martin De Porres Hospital
Countries: Taiwan
Enrollment: 10000
Age range: None - None
Sex: ALL

Summary:
Physiological indicators such as blood pressure, heart rate, respiratory rate, and consciousness status of COVID-19 patients are used to apply the START (simple triage and rapid treatment, START), Modified Early Warning Score (MEWS), and quick Sequential Organ Failure Assessment (qSOFA) as tools for assessing clinical symptom tracking, deterioration, and subsequent improvement in COVID-19 patients. In response to the need for scarce manpower when a large number of emergency patients appear, a simple and easy-to-operate assessment method is adopted for mild patients, and artificial intelligence technology can be further used to assist in the assessment for early response and medication.

Eligibility criteria:
Inclusion Criteria:

* a group of hospitalized COVID 19 patients were treated in the hospital between March 2020 and Sep.2022

Exclusion Criteria: Exclude patients who lack information in their medical records and incomplete clinical data.

\-

Outcomes:
COVID 19 pandemic
Analytical Performance Study of the Handheld Device Single-Molecule with a Large Transistor (SiMoT) for the Near-patient Testing of Biological Samples
Trial ID: NCT06518967
Status: ACTIVE_NOT_RECRUITING
Study type: OBSERVATIONAL
Start date: 2024-07-16
Completion date: 2025-05-31
Sponsor: Centro di Innovazione Regionale in Single Molecule Digital Assay
Conditions: Non-interventional Analytical Performance Study on Left-over Samples
Interventions: analytical performance study
Locations: IRCCS Istituto Tumori Giovanni Paolo II, Gynecological Oncologic Clinic
Countries: Italy
Enrollment: 50
Age range: 18 Years - None
Sex: ALL

Summary:
Advanced and performing technologies able to analyze specific biomarkers for the diagnosis, prognosis and prediction as well as for the monitoring, the personalized care and the evaluation of the therapeutic response to pathologies, is currently considered extremely relevant. Such technologies work only if molecular markers specific for a given pathology have been already validated. This approach is considered of strategic importance for the health and well-being of citizens as well as for the sustainability of public spending. Often, however, the analysis of the markers is carried out on tissues or fluids of the organs involved, being hence quite invasive procedures. In this scenario, it is strategic to develop devices and platforms that allow the analysis of markers in a minimally invasive or non-invasive way, through the analysis of peripheral biological fluids, such as blood or urine. The goal is to provide clinicians with the attacker's advantage against a plethora of progressive diseases by mass-screening individuals who are affected by a disease long before symptoms appear or to allow the identification of those patients who have a high probability of recurring or responding to target-oriented pharmacological approaches. This study pertains to the definition of the analytical performance of the Single-Sensor Single-Molecule with a large Transistor (SiMoT) device. In the context of the present performance study, the IVD SiMoT system will be equipped with an accessory-cartridge developed and produced without any diagnostic purpose but only to verify the analytical performance of the SiMoT system, in the detection of exogenous biochemical molecules suitably selected to act as markers of interest.

Eligibility criteria:
Inclusion Criteria:

* Informed Consent and personal data handling consent signed by the subject;
* \> 18 years of age
* presence of neoplastic or suspected neoplastic pathology at the time of sample collection

Exclusion Criteria:

* \< 18 years of age
* Participation in a clinical trial with an investigational drug or a medical device within the 30 days preceding and during the present investigation.

Outcomes:
To evaluate the analytical performance in plasma, serum, and urine samples supplemented with non-endogenous molecules (three proteins and two nucleotide sequences) of the SiMoT handheld device
A Case-control Study of Phenotype and Multi-omics Analysis of Children With Congenital Diarrhea and Enteropathy in China
Trial ID: NCT06356545
Status: RECRUITING
Study type: OBSERVATIONAL
Start date: 2024-04-15
Completion date: 2026-10
Sponsor: Children's Hospital of Fudan University
Conditions: Diarrhea Infantile
Locations: Yanqiu Wang
Countries: China
Enrollment: 60
Age range: 1 Month - 3 Years
Sex: ALL

Summary:
This study will establish a clinical cohort of children with congenital diarrhea and enteropathy (CODE), mine biomarkers of CODE through multi-omics technology and construct a clinical risk prediction model.

Eligibility criteria:
Inclusion Criteria:

* Patients with chronic diarrhea lasting greater than 2 months or greater than 1 month in patients younger than 2 months of age
* Patients with consent from parents or legal guardians

Exclusion Criteria:

* Chronic diarrhea caused by specific infections, i.e. CMV, Clostridioides difficile
* Chronic diarrhea with necrotizing enterocolitis, short bowel syndrome
* Functional diarrhea
* Patients with poor compliance

Outcomes:
Clinical phenotype of congenital diarrhea and enteropathy in China
CT-based Radiomics Predicts Occult LNM and Uncovers Immune Microenvironment of Head and Neck Cancer
Trial ID: NCT06757530
Status: COMPLETED
Study type: OBSERVATIONAL
Start date: 2024-11-27
Completion date: 2025-04-15
Sponsor: First Affiliated Hospital of Chongqing Medical University
Collaborators: Zigong The Fourth People's Hospital
Conditions: HNSCC
Interventions: AI
Locations: The First Affiliated Hospital of Chongqing Medical University
Countries: China
Enrollment: 700
Age range: 18 Years - 89 Years
Sex: ALL

Summary:
Occult lymph node metastasis (LNM) remains one of the most critical and challenging aspects of managing head and neck squamous cell carcinoma (HNSCC). Defined as the presence of metastatic disease in lymph nodes that are clinically undetectable through routine imaging or physical examination, occult LNM has profound implications for treatment planning, prognosis, and overall patient management. In HNSCC, accurate detection and prediction of occult LNM are crucial as they significantly influence decisions regarding the extent of neck dissection, the need for adjuvant therapies, and the overall therapeutic strategy. Undiagnosed or underestimated LNM can result in inadequate treatment, increasing the risk of locoregional recurrence and poor survival outcomes.

Eligibility criteria:
Inclusion Criteria:

1. Availability of complete clinical data;
2. Diagnosis of laryngeal squamous cell carcinoma confirmed by surgery or biopsy;
3. CT contrast-enhanced examination performed within two weeks prior to surgery.
4. All patients underwent neck lymph node dissection surgery.

Exclusion Criteria:

1. Patients who received other treatments before surgery;
2. CT images with significant artifacts;
3. Patients with tumor recurrence.

Outcomes:
AUC
The Long-term Effect of Artificial Intelligence-assisted Colonoscopy on Risk of Metachronous Advanced Colonic Lesion
Trial ID: NCT07467928
Status: RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2025-07-01
Completion date: 2028-02-28
Sponsor: The University of Hong Kong
Conditions: Colonic Polyps; Artifical Intelligence; Advanced Metachonous Colonic Lesion
Interventions: Suveillance colonoscopy
Locations: Queen Mary Hospital
Countries: Hong Kong
Enrollment: 404
Age range: 18 Years - None
Sex: ALL

Summary:
The goal of this prospective study is to to evaluate the prevalence of metachronous advanced colonic lesions in subsequent surveillance colonoscopies in patients who had previously undergone AI-assisted colonoscopy to conventional colonoscopy examinations.

The main question it aims to answer is whether employing AI-assisted colonoscopy can decrease the likelihood of metachronous advanced colonic lesions during subsequent surveillance colonoscopies.

Researchers will compare patient who undergo conventional colonoscopy in previous colonoscopy to see if AI-assisted colonoscopy can decrease the likelihood of metachronous advanced colonic lesions during subsequent surveillance colonoscopies. Participants will undergo surveillance colonoscopy to assess the presence of metachronous advanced colonic lesion

Eligibility criteria:
Inclusion Criteria:

* Eligible participants are those who were previously enrolled and completed our randomized controlled trial comparing AI-assisted and conventional colonoscopy

Exclusion Criteria:

* In addition to the baseline exclusion criteria of the index trial, patients who were found to have inflammatory bowel disease, colorectal cancer and underwent bowel resection would be excluded. Similar to index trial, patients who have developed severe comorbid illnesses that make surveillance colonoscopy and polypectomy unsafe, or become unable to provide informed consent for trial participation would also be excluded

Index trial: Lui TK, Lam CP, To EW, Ko MK, Tsui VWM, Liu KS, et al. Endocuff With or Without Artificial Intelligence-Assisted Colonoscopy in Detection of Colorectal Adenoma: A Randomized Colonoscopy Trial. Am J Gastroenterol. 2024;119(7):1318-25

Outcomes:
the cumulative risk of metachronous advanced colonic lesions
Prediction of Pre-existing Lower Extremity Injuries Using Lower Limb-worn Inertial Measurement Units
Trial ID: NCT07289828
Status: COMPLETED
Study type: OBSERVATIONAL
Start date: 2024-01-29
Completion date: 2024-06-04
Sponsor: Technical University of Munich
Conditions: Lower Extremity Injuries
Interventions: IMU Data collection; Questionnaire
Locations: TUM University Hospital
Countries: Germany
Enrollment: 108
Age range: 18 Years - 60 Years
Sex: ALL

Summary:
This study analyses questionnaires and inertial sensor data from 108 sports science students regarding previous lower extremity injuries, sports activity, and preventive measures, combined with the prospective development of an AI-based prediction algorithm.

Inertial sensor data were collected during walking and running on a standard 400 m track, with sensors placed on the thighs and ankles, and heart rate recorded via smartwatch. Participants also completed questionnaires on previous injuries, comorbidities, sports activity, and prevention.

The aim is to use the anonymized data to identify gait and running patterns associated with prior knee and ankle injuries using AI analysis, and to correlate these findings with sports activity and preventive measures.

Hypothesis: Prior lower extremity injuries leave specific gait and running patterns detectable by inertial sensors and AI-based analysis.

Eligibility criteria:
Inclusion Criteria:

* Subjectively healthy participants
* Age: \>18 years and under 60 years
* German language skills sufficient to follow the exercise instructions and complete the questionnaires

Exclusion Criteria:

* Age \<18 years or \>60 years
* Recent injuries and trauma to the lower extremities (less than 6 months ago)
* Acute malignant disease
* Acute inflammatory disease
* Lack of German language skills
* Lack of cardiopulmonary endurance for testing

Outcomes:
IMU data
A Prospective, Multicenter, Open-label, Randomized, Comparative Clinical Trial to Verify the Effectiveness, Safety, and Cost-effectiveness of AI-Gatekeeper, a Multimodal AI Software, in Assisting the Screening of Coronary Artery Stenosis
Trial ID: NCT06178900
Status: COMPLETED
Study type: INTERVENTIONAL
Phase: NA
Start date: 2024-03-01
Completion date: 2025-02-28
Sponsor: INFINITT Healthcare
Collaborators: Korea Medical Device Development Fund
Conditions: Coronary Artery Disease; Diagnosis
Interventions: Assisted by the AI-Gatekeeper software group
Locations: Soonchunhyang University Bucheon Hospital; Seoul National University Bundang Hospital; Yongin Severance Hospitall, Yonsei University College of Medicine; Catholic Kwandong University International St. Mary's Hospital; Hanyang University Seoul Hospital
Countries: South Korea; South Korea; South Korea; South Korea; South Korea
Enrollment: 450
Age range: 19 Years - 80 Years
Sex: ALL

Summary:
The purpose of this study is to determine the efficacy, safety, and cost-effectiveness of AI-Gatekeeper software to assist clinicians in the diagnosis of coronary artery disease by predicting coronary artery stenosis (≥50%) from a multimodal AI technology that integrates clinical risk factors and baseline blood tests, including chest X-ray, electrocardiogram, and echocardiogram, in patients with suspected coronary artery disease (coronary stenosis).

Eligibility criteria:
Inclusion Criteria:

* A patient with symptoms such as chest pain suggestive of coronary artery disease, who underwent routine evaluations including blood tests, electrocardiogram, chest X-ray, and echocardiography
* Low to Intermediate risk of pretest probabilities of obstructive CAD
* Voluntarily agreed to participate in this clinical trial and signed the written consent form

Exclusion Criteria:

* Acute chest pain (in patients who have not been ruled out for ACS)
* Previously diagnosed and treated coronary artery disease (myocardial infarction, PCI, CABG)
* Patients with a life expectancy of less than 2 years due to conditions other than heart disease
* Those who have not consented to the protocol
* Participated in a drug or medical device clinical trial within the last 3 months
* Pregnant or lactating women
* Allergic to iodine preparations
* Serum creatine level greater than 1.5 mg/dL or eGFR less than 30 mL/min
* Baseline irregular and uncontrolled heart rhythm
* Heart rate greater than 100 beats/minute
* Systolic blood pressure of 90 mm Hg or less
* Contraindications to beta blockers or nitroglycerin
* Patients with complex congenital heart disease
* Body mass index greater than or equal to 35

Outcomes:
MACE (major adverse cardiovascular events); Unnecessary utilization of advanced cardiac imaging