moncefem/clinical-trials-ai-2000-2025 huggingface dataset:
Evaluation of an AI-based Informational Assistant for Automated Point-of-care Documentation and Protocol Retrieval in the Intensive Care Unit
Trial ID: NCT07493616
Status: NOT_YET_RECRUITING
Study type: OBSERVATIONAL
Start date: 2026-07-01
Completion date: 2026-12-01
Sponsor: Willemijn Berkhout
Conditions: Artificial Intelligence; Usability
Enrollment: 25
Age range: None - None
Sex: ALL

Summary:
Clinical rounds in the intensive care unit (ICU) involve substantial manual documentation. Retrieving the correct protocol text and structuring notes at the bedside is time-consuming and may contribute to variation in documentation quality. Modern artificial intelligence (AI) can help structure existing information and automate protocol look-ups within a restricted, manually selected document set.

The tool evaluated in this study acts as an AI-based informational assistant for clinicians. It (1) pre-populates a standardized physical-exam and daily-rounds format, (2) prepares a concise ICU course/overview using predefined formatting, and (3) retrieves relevant passages from protocols to enable rapid consistency checks by the clinician.

The AI-based informational assistant does not provide treatment recommendations or patient-specific advice; all outputs require clinician verification and clinical responsibility remains with the physician.

Eligibility criteria:
Inclusion Criteria:

* ICU physician (nurse practicioner, resident, or staff intensivist) at the Erasmus MC.
* Signed informed-consent for study participation.

Exclusion Criteria:

\- Physicians not expected to work on the ICU during the study period will not be approached.

Outcomes:
Implementation outcomes acceptability, appropriateness, and feasibility
Validity and Reliability of Artificial Intelligence-Assisted Posture Applicatıon in Young Adults
Trial ID: NCT06785792
Status: RECRUITING
Study type: OBSERVATIONAL
Start date: 2024-09-15
Completion date: 2025-04-02
Sponsor: Izmir Democracy University
Conditions: Postural; Defect
Locations: Izmir Democracy University
Countries: Turkey (Türkiye)
Enrollment: 27
Age range: 18 Years - 39 Years
Sex: ALL

Summary:
Posture is defined as the situation in which each part of the body is properly positioned in the adjacent segment and is in the most ideal position in proportion to the whole body. Posture requires the appropriateness of joint combinations and positions during movement. With the development of technology, various phone and computer-aided applications are used both in the correction and evaluation of posture. It is thought that posture disorders may cause various pathological problems in the future and may lead to functional limitations in the individual. With the developing technology, there are a limited number of studies on the validity and reliability of phone and computer-aided applications in every field of health. The aim of this study is to perform the validity and reliability study of a sensorless objective application integrated with artificial intelligence used in posture evaluation with the developing technology.

Eligibility criteria:
Inclusion Criteria:

* Young adult individuals between the ages of 18-39
* Individuals who volunteer to participate in the study
* Individuals who are Turkish citizens, reside in Turkey and have been in Turkey for at least 1 month before and during the study period
* Individuals who can communicate in written and verbal Turkish

Exclusion Criteria:

* Individuals with any physical or mental disability and/or cognitive impairment
* Pregnant women
* Individuals with orthopedic, neurological, vestibular diseases that may affect walking and balance functions
* Individuals with neuromuscular system diseases or diseases that will prevent postural control measurements (vertigo, neuropathy, etc.) or those using medication

Outcomes:
Posture Evaluation System (Fizyosoft™ Becure Posture System)
An Observational, Prospective, Non-randomized Multi-centre Cohort Feasibility Study of the Hypotension Prediction Index (HPI) in Patients Undergoing Lung Resections With the Use of One-lung Ventilation.
Trial ID: NCT06202638
Status: RECRUITING
Study type: OBSERVATIONAL
Start date: 2023-11-11
Completion date: 2025-12-31
Sponsor: John Paul II Hospital, Krakow
Conditions: Intraoperative Hypotension
Interventions: HemoSphere monitor with Acumen Hypotension Prediction Index Software
Locations: Faculty of Medicine, NKUA Attikon University Hospital; St. John Paul II Hospital in Krakow; Department of Anesthesiology and Intensive Therapy; Department of Pain Research and Treatment, Faculty of Medical Sciences Zabrze
Countries: Greece; Poland; Poland
Enrollment: 60
Age range: 18 Years - None
Sex: ALL

Summary:
Perioperative hypotension is a risk factor for perioperative complications. Advances in machine learning and artificial intelligence have produced an algorithm that predicts the occurrence of hypotension episodes by analyzing an arterial pressure waveform. This technology has not been validated in thoracic surgical patients undergoing lung resections with the use of one-lung ventilation (OLV). We planned an observational, prospective multi-centre cohort validation study of the Hypotension Prediction Index (HPI) in patients undergoing lung resection procedures with the use of one-lung ventilation and a lung-protective strategy.

Eligibility criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status II to IV;
* Planned invasive blood pressure monitoring during general anesthesia expected to last more than 2 hours and planned overnight hospitalization.
* Procedures: video-assist thoracoscopic (VATS)-lobectomy, open-thoracotomy lobectomy, pneumonectomy.
* Adults over 18 years old.

Exclusion Criteria:

* Urgent/emergency procedures.
* Patients with known clinically important intracardiac shunts.
* Moderate to severe valvular disease.
* Preoperative symptomatic arrhythmias including AF.
* Congestive heart failure with LV ejection fraction less than 35%.
* Refusal of participation

Outcomes:
Positive predictive value
Effect of Two Colonoscopy AI Systems for Colon Polyp Detection According to the False Positive Rates of the Systems: A Single-center Prospective Study
Trial ID: NCT05089071
Status: COMPLETED
Study type: INTERVENTIONAL
Phase: NA
Start date: 2021-11-01
Completion date: 2022-12-31
Sponsor: Seoul National University Hospital
Collaborators: Seoul National University
Conditions: Adenoma; Colonoscopy; Sessile Serrated Adenoma
Interventions: Assist by artificial intelligence system for colon polyp detection
Locations: Healthcare System Gangnam Center, Seoul National University Hospital
Countries: South Korea
Enrollment: 3046
Age range: 45 Years - 100 Years
Sex: ALL

Summary:
Computer-aided detection (CADe) systems have been actively researched for polyp detection in colonoscopy. The investigators aim to identify the effect of two CADe systems according to the system performance on false positive rate

Eligibility criteria:
Inclusion Criteria:

patient for screening or surveillance colonoscopy patients agreed with participating in the study

Exclusion Criteria:

patients who do not agree with participating in the study patients with a history of colon resection patients with a history of inflammatory bowel resection patients with poor bowel preparation

Outcomes:
Adenoma detection rate; Sessile serrated lesion detection rate
Analysis of Patterns of Recurrence in Head and Neck Cancer Using Clinicopathomic Markers
Trial ID: NCT04086849
Status: COMPLETED
Study type: OBSERVATIONAL
Start date: 2019-07-30
Completion date: 2021-04-05
Sponsor: Sunnybrook Health Sciences Centre
Conditions: Head and Neck Neoplasm; Squamous Cell Carcinoma of Head and Neck
Interventions: Radiomic, pathomic, and clinical markers
Locations: Sunnybrook Health Sciences Centre
Countries: Canada
Enrollment: 450
Age range: 18 Years - None
Sex: ALL

Summary:
Here, the investigators will develop a clinicopathomic assay from biomarkers obtained from digital pathologies of resected whole-mount oral cavity and oropharyngeal squamous cell carcinoma (OCSCC and OPSCC) specimens with the goal of administering personalized novel image-guided therapies immediately after primary surgical management in OCSCC and OPSCC patients. The primary aim is to determine the association between clinicopathomic biomarkers and LRR. The secondary aim is to develop a clinicopathomic risk score (assay) such that a decision-support tool can be used by physicians for measuring the benefit of additional therapies (i.e. conventional chemotherapy +/- radiation or administering dose-escalated chemoradiation) in the adjuvant setting to reduce LRR rates.

Eligibility criteria:
Inclusion Criteria:

* Participants must be men and women age 18+
* Confirmed diagnosis of oral cavity or oropharyngeal squamous cell carcinoma
* Participants must have received or will undergo surgery to excise the primary oropharyngeal tumor.

Exclusion Criteria:

* Participants who had other primary cancers prior to oral cavity or oropharyngeal cancer

Outcomes:
Time to locoregional recurrence
A Cohort Study on Treating Primary Nocturnal Enuresis by Regulating Central-Peripheral Circadian Rhythm
Trial ID: NCT07003126
Status: NOT_YET_RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2025-07-01
Completion date: 2028-06-01
Sponsor: Shanghai Children's Medical Center
Conditions: Primary Nocturnal Enuresis
Interventions: Circadian Rhythm Intervention Combined with Bladder Training; Bladder Training (basic treatment for enuresis)
Locations: Shanghai children's medical center
Countries: China
Enrollment: 200
Age range: 5 Years - 15 Years
Sex: ALL

Summary:
Primary nocturnal enuresis (PNE), a prevalent pediatric disorder, suffers from therapeutic limitations characterized by low efficacy and high relapse rates. Targeting its core pathophysiology could significantly improve treatment outcomes. Growing evidence implicates circadian dysregulation in PNE pathogenesis. Our preliminary fMRI cohort identified abnormal functional connectivity between the suprachiasmatic nucleus (SCN, the central circadian pacemaker) and superior temporal gyrus in PNE patients, with clinical data confirming circadian realignment correlates with symptom remission. Small-scale pilot studies and clinical observations indicate that modulating central and peripheral circadian rhythms significantly alleviates PNE symptoms. This study will establish a circadian-focused PNE cohort to quantify therapeutic efficacy and elucidate underlying mechanisms, ultimately driving the development of mechanism-based therapies for PNE.

Eligibility criteria:
Inclusion Criteria:

1. Diagnosis according to the ICCS criteria:

   At least one episode of involuntary nighttime urination per month for more than 3 months.

   No abnormalities in routine urinalysis. No period of bedwetting-free days lasting more than 6 months, except for organic diseases.
2. Age: 5 to 15 years (inclusive), regardless of gender.
3. Right-handedness (as assessed by the Annett Hand Preference Questionnaire)

Exclusion Criteria:

1. Secondary nocturnal enuresis;
2. History of head trauma, neurological disorders, psychosurgery, or major physical conditions (including autism spectrum disorder, epilepsy, cerebral palsy);
3. Contraindications to fMRI.
4. Note: Mild comorbidities commonly associated with primary nocturnal enuresis (e.g., ADHD) are permitted but must be included as covariates in statistical analyses.

Outcomes:
Enuresis Improvement Rate
Mechanism and Predictors of Cardiotoxicity After Prostate Cancer Treatment: A Parallel Cohort and Randomized Trial Comparing Radiation Alone, Radiation Plus Leuprolide, and Radiation Plus Relugolix
Trial ID: NCT05320406
Status: ACTIVE_NOT_RECRUITING
Study type: INTERVENTIONAL
Phase: PHASE2
Start date: 2022-06-06
Completion date: 2026-10-30
Sponsor: Emory University
Collaborators: National Cancer Institute (NCI); Prostate Cancer Foundation
Conditions: Biochemically Recurrent Prostate Carcinoma; Localized Prostate Carcinoma; Stage I Prostate Cancer AJCC v8; Stage II Prostate Cancer AJCC v8; Stage IIA Prostate Cancer AJCC v8; Stage IIB Prostate Cancer AJCC v8; Stage IIC Prostate Cancer AJCC v8; Stage III Prostate Cancer AJCC v8; Stage IIIA Prostate Cancer AJCC v8; Stage IIIB Prostate Cancer AJCC v8; Stage IIIC Prostate Cancer AJCC v8
Interventions: Radiation therapy; Leuprolide; Relugolix
Locations: Emory Proton Therapy Center; Emory University Hospital Midtown; Emory University/Winship Cancer Institute; Emory Saint Joseph's Hospital
Countries: United States; United States; United States; United States
Enrollment: 94
Age range: 18 Years - None
Sex: MALE

Summary:
This clinical trial investigates the impact of prostate cancer treatment, specifically androgen deprivation therapy (ADT), on the heart and coronary vessels among men with localized, non-metastatic prostate cancer undergoing definitive radiation therapy and concomitant ADT. Recently, cardiovascular toxicity from hormone therapy that is routinely used for prostate cancer (e.g. leuprolide) has emerged as a concern, yet studies identifying who is at risk and the mechanism of cardiac damage are lacking. Additionally, a new hormone therapy drug, relugolix, has recently been Food and Drug Administration (FDA)-approved and may reduce toxicity to the heart. This trial intends to investigate the mechanism of cardiovascular toxicity from ADT, investigate the mechanism by which relugolix reduces cardiovascular toxicity, and identify predictive biomarkers to improve individualized risk-assessment for cardiovascular toxicity from ADT.

Eligibility criteria:
Inclusion Criteria:

* Men \>= 18 years old
* Non-metastatic prostate cancer
* Non-metastatic, biochemically recurrent prostate cancer
* Plan to undergo curative-intent pelvic radiation therapy with or without ADT

Exclusion Criteria:

* Metastatic prostate cancer requiring \> 24 months of ADT
* Prior exposure to androgen deprivation therapy
* Prior exposure to chemotherapy or immunotherapy
* History of cardiac bypass surgery or percutaneous coronary intervention

Outcomes:
Total Coronary Plaque Volume in Major Coronary Arteries (i.e. Left Anterior Descending, Left Circumflex, Right Major Coronary Arteries)
Early Diagnosis of Pancreatic Cancer Via Deciphering Multi-modal Immunological Signatures
Trial ID: NCT06495749
Status: NOT_YET_RECRUITING
Study type: OBSERVATIONAL
Start date: 2024-08-01
Completion date: 2027-12-31
Sponsor: Zhejiang University
Collaborators: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences; Nanjing Medical University
Conditions: Pancreatic Cancer Resectable
Locations: First Affiliated Hospital, Medical College of Zhejiang University; the First Affiliated Hospital, School of Medicine, Zhejiang University
Countries: China; China
Enrollment: 3000
Age range: None - None
Sex: ALL

Summary:
Prospective inclusion of 1000 patients with pancreatic cancer (early-stage pancreatic cancer accounts for approximately 75% of cases), 1000 patients with benign pancreatic diseases, and 1000 healthy individuals as controls. Peripheral blood samples were collected from newly diagnosed pancreatic cancer patients and healthy individuals. Using techniques such as plasma TCR/BCR-seq, CyTOF, and plasma proteomics, multi-modal individual immune characteristics were obtained and analyzed along with clinical information. An artificial intelligence predictive model was built based on these multi-modal individual immune characteristics to establish an early screening technique for pancreatic cancer. The sensitivity and specificity of this artificial intelligence model for early pancreatic cancer diagnosis were evaluated using an external multicenter sample test set.

Eligibility criteria:
Inclusion Criteria:

* Sign the informed consent form;
* Initial diagnosis as patients with pancreatic cancer, patients with benign pancreatic lesions, or healthy controls.

Exclusion Criteria:

* History of other malignancies;
* Presence of organ dysfunction;
* Concurrent immunodeficiency syndrome, active tuberculosis, HIV infection, etc.;
* Allogeneic transplantation requiring immunosuppressive therapy;
* Poor follow-up compliance.

Outcomes:
Peripheral blood mononuclear cell; Peripheral blood mononuclear cell; Peripheral blood mononuclear cell; Peripheral blood mononuclear cell; Peripheral blood mononuclear cell; Peripheral blood mononuclear cell; CT; MRI
Collecting Real-world Data on Endoscopic and Histopathological Outcomes of Screening and Surveillance Colonoscopies for the Development of a CAD (Computer Aided Detection) System: A Prospective, Multicenter, Post-market Investigation
Trial ID: NCT05869838
Status: COMPLETED
Study type: OBSERVATIONAL
Start date: 2024-03-12
Completion date: 2025-10-30
Sponsor: Olympus Europe SE & Co. KG
Conditions: Colonic Polyp
Interventions: Colonoscopy
Locations: End- und Dickdarmzentrum Hannover; Hospital Universitario Ramón y Cajal
Countries: Germany; Spain
Enrollment: 600
Age range: 18 Years - None
Sex: ALL

Summary:
The objective of this study is to collect colonoscopy data for use in the development and testing of artificial intelligence (AI) devices for colonoscopies.

Eligibility criteria:
Inclusion Criteria:

* Patients aged 18 years or older
* Patients who have signed a written consent form from their voluntary decision after receiving thorough explanation on this study and fully understanding the explanation prior to participation in the study
* Patients who plan to receive colonoscopy procedure and meet any of the following conditions: Colon cancer screening, post-polypectomy surveillance, patients who are advised by a physician to take a colonoscopy exam

Exclusion Criteria:

* Patients for whom endoscopic submucosal dissection is planned
* Patients for whom polypectomy is difficult to perform due to antithrombotic therapy received etc.
* Patients who have to receive an urgent colonoscopy procedure
* Patients who underwent total colectomy of the large intestine
* Patients who are judged by a physician to be contraindicated for colonoscopy procedures
* Patients who have participated in another clinical study within the last 30 days

Outcomes:
Videos and still images of the colonoscopy
Urine Proteomic Precision Diagnosis Model for Early Stage Lung Cancer
Trial ID: NCT06733311
Status: UNKNOWN
Study type: OBSERVATIONAL
Start date: 2024-03-01
Completion date: 2024-12-31
Sponsor: Beijing Chao Yang Hospital
Conditions: Early-Stage Lung Cancer; NSCLC; Pulmonary Nodule
Locations: Beijing Chao-Yang Hospital, Capital Medical University
Countries: China
Enrollment: 480
Age range: 18 Years - 75 Years
Sex: ALL

Summary:
Brief Summary:

The goal of this observational study is to develop a non-invasive urine proteomic diagnostic model to improve early-stage lung cancer detection. The study aims to answer the following main questions:

Can urine proteomics reliably differentiate early-stage lung cancer from benign conditions? How does the diagnostic model compare to current clinical and imaging methods in accuracy?

Participants will:

Provide preoperative urine samples. Undergo proteomic analysis of urine samples. Have clinical, imaging, and proteomic data integrated into an AI-assisted diagnostic model.

The study will evaluate the sensitivity and specificity of this innovative diagnostic approach.

Eligibility criteria:
Inclusion Criteria:

1. Male or female participants aged 18 to 75 years.
2. Diagnosed or highly suspected early-stage (I-IIIA, non-N2) non-small cell lung 3.cancer (NSCLC) based on imaging or clinical assessment.

4.No prior anti-cancer treatment, including surgery, chemotherapy, radiotherapy, targeted therapy, or immunotherapy.

5.Able to provide informed consent and willing to comply with the study protocol, including urine sample collection before surgery.

6.Diagnosis confirmed within 42 days post-imaging or preoperative assessment through biopsy or surgical specimen.

Exclusion Criteria:

1. History of any cancer treatment prior to study enrollment.
2. Presence of metastatic disease (N2 or more advanced staging).
3. Severe comorbid conditions or organ dysfunctions (e.g., renal failure) that could affect urine sample quality or interpretation.
4. Pregnancy or lactation.
5. Participation in another clinical study that could interfere with the outcomes of this study.
6. Inability to comply with the study protocol, including language barriers or cognitive impairments.

Outcomes:
Prediction Accuracy of Diagnostic Models
Registry Study for the Evaluation of High-risk Cardiac Patients by WILLEM AI-based ECG Platform
Trial ID: NCT07333547
Status: RECRUITING
Study type: OBSERVATIONAL
Start date: 2026-02-03
Completion date: 2036-01
Sponsor: Idoven 1903 S.L.
Conditions: High-risk Cardiac Patients
Interventions: Willem AI ECG assessment
Locations: Vanderbilt University Medical Center; La Paz University Hospital; Puerta de Hierro University Hospital; Murcia University
Countries: United States; Spain; Spain; Spain
Enrollment: 200000
Age range: 18 Years - None
Sex: ALL

Summary:
The WILLEM Registry is a large-scale, single-group, observational, registry study to collect continuous clinical evidence of Willem in real-world settings. Cardiovascular diseases are a major problem for public health and healthcare systems. Electrocardiograms (ECGs) are simple tests which increase diagnostic performance and early detection of cardiovascular diseases. However, its interpretation is complex, time consuming for cardiology experts, and entails high costs for healthcare systems. Willem allows AI-based automatic interpretation and its performance has been examined in previous clinical trials, but additional clinical evidence is needed for its integration in real-world clinical settings. This study will collect clinical evidence of Willem performance to detect cardiac abnormalities in ECGs from high-risk cardiac patients admitted to cardiovascular units.

Eligibility criteria:
Inclusion Criteria:

* EC/IRB approval of ICF waiver prior to recruitment; otherwise, signed informed consent form by subject and investigator
* Age \> 18 years-old, with no upper limit
* Subjects undergoing standard of care electrocardiogram (ECG) of any duration from any hardware device
* All available, but at least one, legible ECG tracings in raw data format (e.g. DICOM, XML, EDF, JSON, HL7, SCP, WFDB, CSV, etc.)
* Available subject clinical data associated with the ECG
* For 12-lead ECGs, a minimum length of 10 seconds at a minimum sample frequency of 250 Hz
* For ECGs from Holters, wearables, patches, insertable cardiac monitors, telemetries, etc., a minimum length of 30 seconds at a minimum sample frequency of 200 Hz with a lead I / II or its MCL-DII lead approximation
* For prospective eligibility only:
* Signed informed consent form, unless previously waived by the EC/IRB
* Site technical viability for ECG and subject clinical data transfer (e.g. end-to-end integration following interoperability standards such as FHIR, HL7 or DICOM)

Exclusion Criteria:

* Unavailable or suboptimal quality of the raw data from the ECG signal
* Age \< 18 years-old

Outcomes:
Primary endpoint analysis: Willem performance