moncefem/clinical-trials-ai-2000-2025 huggingface dataset:
PolyDeep Advance 3: Randomized Clinical Trial Comparing High Definition Colonoscopy With PolyDeep Assisted High Definition Colonoscopy.
Trial ID: NCT05513261
Status: COMPLETED
Study type: INTERVENTIONAL
Phase: NA
Start date: 2023-11-17
Completion date: 2024-05-14
Sponsor: Fundacin Biomedica Galicia Sur
Collaborators: Ministerio de Ciencia e Innovación, Spain; Ministry of Work and Welfare - Xunta de Galicia; Asociación Española de Gastroenterología; European Regional Development Fund
Conditions: Colorectal Cancer
Interventions: High definition colonoscopy (standard colonoscopy) in Adenoma Detection Rate; PolyDeep assisted high definition colonoscopy (CAD system) in Adenoma Detection Rate
Locations: Complexo Hospitalario Universitario de Ourense; Hospital de Montecelo; Hospital Álvaro Cunqueiro (Vigo)
Countries: Spain; Spain; Spain
Enrollment: 857
Age range: 40 Years - 79 Years
Sex: ALL

Summary:
This study is a clinical validation of PolyDeep, a computer-aided polyp detection (CADe) and characterization (CADx) system. PolyDeep Advance 3 is a multicentric randomized clinical trial comparing high definition colonoscopy with PolyDeep assisted high definition colonoscopy. The hypothesis of the study is that the PolyDeep assisted colonoscopy increases the Adenoma Detection Rate (ADR).

Eligibility criteria:
Inclusion Criteria:

* First diagnostic colonoscopy performed after a positive fecal immunochemical test performed within the CRC screening program.
* Surveillance after resection of colorectal adenomas
* Acceptance after reading the information sheet and signing informed consent.

Exclusion Criteria:

* Colonoscopies with insufficient intestinal cleansing (Boston Bowel Preparation Scale \<6 or \<2 in any of the evaluated segments).
* Incomplete colonoscopy without cecal intubation.
* Previous CRC
* Previous colonic resection.
* Hereditary CRC syndromes
* Serrated polyposis syndrome

Outcomes:
Adenoma Detection Rate (ADR)
Observational Pilot Study on the Use of the HERO Health Monitoring System for the Detection of Vital Signs, Emotional States, and Body Postures
Trial ID: NCT07248969
Status: ACTIVE_NOT_RECRUITING
Study type: OBSERVATIONAL
Start date: 2024-04-01
Completion date: 2025-12-31
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions: Cardiovascular
Locations: Giovanni Tinelli
Countries: Italy
Enrollment: 100
Age range: 18 Years - None
Sex: ALL

Summary:
New technologies offer significant opportunities to enhance the quality and intensity of care services, amplifying the ability to respond to patient needs through contactless solutions that also contribute to the humanization of care. Their application in patient monitoring can enable continuous observation, even in the absence of physically present staff, for a larger number of non-critical patients (thus reducing the risk of adverse events), and facilitate timely interventions when needed-aligned with the logic of Anglo-Saxon models based on Early Warning Systems.

The general objective of this study is to conduct a pilot clinical trial of a specific solution based on Artificial Intelligence and Computer Vision, the HERO Health Monitoring (HHM) system, capable of detecting vital signs (heart rate, respiratory rate, blood oxygen saturation, and blood pressure), body posture, movements, and patients' emotional states-such as expressions of pain-using simple video devices.

The study aims, in particular, to measure the concordance of the system's vital sign measurements with standard (telemetric) systems, and to assess the added value of combining these measurements with the additional information provided by HHM regarding posture, movement, and emotional state analysis-once their agreement has been verified against patient-reported outcomes collected via self-assessment questionnaires.

This is an observational study involving the HERO Health Monitoring medical device, for which the certification process is expected to be completed through the present study.

Eligibility criteria:
Inclusion Criteria

* Age over 18 years
* Signed informed consent

Exclusion Criteria

* Age under 18 years
* Ongoing pregnancy
* Refusal to sign informed consent

Outcomes:
Level of agreement between heart rate (measured as beats per minute) collected via HHM (Home Health Monitoring) system and those obtained from standard telemetry monitoring, measured using Intraclass Correlation Coefficient
Monocentric Prospective Randomized Study on the Influence of On-screen Use of a Virtual 3-dimensional Liver Model Reconstructed From CT Data on Spatial Perception During Laparoscopy on the Liver Phantom.
Trial ID: NCT05389241
Status: UNKNOWN
Study type: INTERVENTIONAL
Phase: NA
Start date: 2022-09-01
Completion date: 2024-03-01
Sponsor: Universitätsklinikum Köln
Conditions: Laparoscopy; Augmented Reality; Orientation, Spatial; Liver
Interventions: Method A; Method B
Locations: University of Cologne, Department of General, Visceral and Cancer Surgery
Countries: Germany
Enrollment: 72
Age range: 18 Years - None
Sex: ALL

Summary:
Procedure preparation and accurate knowledge of the specific anatomy is an integral part of performing minimally invasive procedures. Due to the complexity with high variability and the non-visibility of the vascular structures, the liver poses a particular challenge.

Therefore medical students and experienced surgeons will receive standardized, structured training on liver anatomy, the use of laparoscopic ultrasound and the application and use of CT data sets and the virtual 3D liver model. This training will be evaluated by questionnaires. Both groups then carry out a series of localization exercises on an artificial liver phantom: tumor imitations, which are displayed in the image(3D virtaul mdoel or 2D-CT-Data-Set), have to be found in the liver phantom laparoscopically using ultrasound.

In each round, different scenarios are worked on, once without and then with the support of the virtual 3D liver model. The virtual 3D model can be displayed directly on the laparoscopic monitor using a display software specially developed for the trial and can be manipulated by the subjects.

The aim of the study is to provide evidence that the availability and use of a virtual 3D model (augmented reality) leads to a significantly improved spatial perception of the subjects during laparoscopy of the liver. In addition, the subjectively perceived cognitive load of the subjects during the test run with and without the support of the virtual 3D model is surveyed and the learning success is evaluated.

Eligibility criteria:
Inclusion Criteria:

* medical student of University of Cologne OR medical doctor in a surgical specialty
* informed consent signed

Exclusion Criteria:

* known and not correctable deficit of stereoscopic view
* for medical students: experience with laparoscopy or laparoscopy simulators

Outcomes:
Number of correctly identified targets; Time required
Adherence Promotion with Person-centered Technology (APPT): Promoting Adherence to Cognitive Intervention
Trial ID: NCT05016856
Status: COMPLETED
Study type: INTERVENTIONAL
Phase: NA
Start date: 2022-11-07
Completion date: 2025-01-01
Sponsor: Florida State University
Conditions: Adherence, Treatment
Interventions: Adherence Promotion With Person-centered Technology (APPT) System; Standard Reminder System (Active Control)
Locations: Department of Psychology, Florida State University
Countries: United States
Enrollment: 190
Age range: 65 Years - None
Sex: ALL

Summary:
This study will examine whether among older adults an adaptive and personalized reminder system can better support adherence to home-based cognitive training over typical reminder systems.

Eligibility criteria:
Inclusion Criteria:

* 65 years of age or older
* normal or corrected to normal visual acuity
* must pass a dementia screening

Exclusion Criteria:

* Parkinson's, Alzheimer's disease, or any other neurodegenerative disease
* terminal illness
* blindness or deafness
* severe motor impairment
* not living in the Tallahassee area for the entire 6 month study period
* unable to read at or above 6th grade level

Outcomes:
Adherence (session number); Adherence (session length); Adherence (holidays)
Investigation of Hemodynamics and Radiomics Based on High Resolution Magnetic Resonance Imaging for Predicting the Outcomes of Intracranial Dissecting Aneurysm
Trial ID: NCT07335029
Status: ACTIVE_NOT_RECRUITING
Study type: OBSERVATIONAL
Start date: 2023-01-01
Completion date: 2027-12-31
Sponsor: Beijing Neurosurgical Institute
Conditions: Cerebrovascular Disease; Intracranial Aneurysm; Intracranial Arterial Dissection
Locations: Beijing Tiantan Hospital, Capital Medical University
Countries: China
Enrollment: 208
Age range: 18 Years - 80 Years
Sex: ALL

Summary:
This study aims to conduct a comprehensive analysis by integrating clinical factors, aneurysm morphological characteristics, and factors reflecting pathophysiological processes (such as hemodynamic and radiomics features), in order to explore the hemodynamic mechanisms associated with the progression of intracranial dissecting aneurysms. Furthermore, artificial intelligence algorithms will be employed to develop and validate an intelligent risk prediction model for the progression and outcomes of intracranial dissecting aneurysms.

Eligibility criteria:
Inclusion Criteria:

1. Intracranial dissecting aneurysm clearly diagnosed by DSA and high-resolution MRI imaging (according to the imaging diagnostic criteria proposed in the Chinese Expert Consensus on Imaging Diagnosis of Intracranial Arterial Dissection)
2. patients managed with conservative treatment and follow-up
3. patients who agree and sign a written informed consent form

Exclusion Criteria:

1. Arteritis, fibromuscular dysplasia, iatrogenic or traumatic pseudoaneurysms
2. Contraindications to MRI examination (such as claustrophobia or metallic implants), or contraindications to cerebral angiography (such as iodine contrast allergy)
3. Dissecting aneurysms extending from the extracranial segment to the intracranial segment, or cases with concomitant intracranial atherosclerotic plaques in the affected vessels
4. Patients who refuse MRI examination
5. Patients with severe comorbid diseases and an expected survival time of less than 2 years due to these conditions
6. Patients without follow-up HR-MRI imaging for any reason

Outcomes:
Progression of intracranial dissecting aneurysms
Smart Technology Platform for Socio-emotional Development and Health Promotion: Implementation and Validation of a Serious Game in Adolescentes With DM1
Trial ID: NCT06331429
Status: COMPLETED
Study type: INTERVENTIONAL
Phase: NA
Start date: 2024-07-22
Completion date: 2025-03-31
Sponsor: University of Valencia
Collaborators: Universitat Politècnica de València
Conditions: Type 1 Diabetes; Adolescent Development
Interventions: EmoTiCare
Locations: Universitat de València
Countries: Spain
Enrollment: 200
Age range: 12 Years - 16 Years
Sex: ALL

Summary:
The intervention program targets adolescents with chronic Type 1 Diabetes Mellitus. Given the critical developmental stage and life transitions, necessitating robust personal resources, psychological support becomes imperative. To foster socioemotional skills and overall well-being, particularly crucial for averting future emotional issues and promoting a healthier, more fulfilling life, this support is especially vital for those dealing with chronic illnesses. Such conditions pose a risk for psychological problems, potentially complicating treatment and prognosis. Presently, digital and technological platforms are integrating psychological interventions for patients with chronic diseases, showcasing an innovative approach to address psychological challenges.

The platform integrates new technologies for assessment and intervention. Ecological Momentary Assessment enables real-time evaluation, with data transferred to the technological platform. Artificial intelligence personalizes interventions based on participants' socio-demographic characteristics and assessment results. Ecological Momentary Intervention is employed for in-context treatments in participants' daily lives and natural environments. A serious game method, proven effective in various interventions, is used to engage adolescents and young people intrinsically. The game encompasses six main areas aligning with theoretical models, facilitating the development of socio-emotional competencies, and promoting physical and psychological health. It addresses different aspects of psychological and subjective well-being, reinforcing resources needed to navigate vital changes in these developmental stages, especially when living with a chronic illness.

Eligibility criteria:
Inclusion Criteria:

* Diagnosis of Diabetes mellitus type 1 (6 months from diagnosis)
* Informed consent by parents/guardians and participants

Exclusion Criteria:

* Diagnosis other than type 1 diabetes mellitus
* No access to internet or new technologies
* Not speaking Spanish

Outcomes:
Change Quality of Life (Baseline-Pre-Post); Change Emotional and Behavioral Problems (Baseline-Pre-Post); Change Emotional Competences (Baseline-Pre-Post); Change Self-concept (Baseline-Pre-Post); Change Coping (Baseline-Pre-Post); Change Social Skills (Baseline-Pre-Post)
Measuring Motor Symptoms in Clinical Conditions OR Objective Measures to Monitor the Progression of Motor Symptoms of Clinical Conditions
Trial ID: NCT07582653
Status: ENROLLING_BY_INVITATION
Study type: OBSERVATIONAL
Start date: 2026-02-01
Completion date: 2026-05-31
Sponsor: University of Exeter
Collaborators: Oxford Brookes University
Conditions: Multiple Sclerosis
Locations: University of Exeter Engineering Research Centre
Countries: United Kingdom
Enrollment: 10
Age range: 18 Years - 80 Years
Sex: ALL

Summary:
Multiple Sclerosis (MS) is a condition that affects the brain and spinal cord, leading to problems with movement, balance, and vision. This project will validate innovative tools developed for monitoring MS progression using advanced movement analysis and retinal imaging technologies. Two computer vision-based applications, Digi Motion and Digi Balance, will measure range of motion, centre of mass, balance, and stability. In parallel, a model will be trained to analyse eye images using Optical Coherence Tomography (OCT)-a non-invasive technique that captures detailed views of retinal structures, including the retinal nerve fibre layer (RNFL), ganglion cell-inner plexiform layer (GC-IPL), and macular thickness, which are key biomarkers of MS-related neuroaxonal loss.

These tools will be evaluated in people with MS, comparing results with traditional clinical assessments to determine reliability and validity. By integrating movement and retinal biomarkers, this approach aims to create a comprehensive and personalised method for tracking disease progression.

Eligibility criteria:
Inclusion Criteria:

* condition has been stable over a period of a month
* can walk at least 10 metres independently with or without their walking aids

Exclusion Criteria:

* pregnancy
* allergic to adhesive materials
* a condition that precludes safe participation in the assessment as indicated by the referring clinician
* insufficient mental capacity to consent

Outcomes:
Agreement and reliability between DigiBalance quantitative physical function metrics and standard clinical assessments
Efficiency of Sonic Activation During Root Canal Treatment of Primary Molars on Postoperative Pain and Facial Expressions of Children Using Artificial Intelligence
Trial ID: NCT07138937
Status: COMPLETED
Study type: INTERVENTIONAL
Phase: NA
Start date: 2024-08-01
Completion date: 2025-03-01
Sponsor: Suez Canal University
Conditions: Root Canal Treatment in Children Primary Molars; Postoperative Pain; Facial Expressions; Facial Emotions; Artificial Intelligence Mobile Application; Sonic Activation
Interventions: Root canal treatment in primary molars with irreversible pulpitis; EDDY system for sonic activation of irrigation; side-vented needle
Locations: Faculty of Dentistry Suez Canal University
Countries: Egypt
Enrollment: 30
Age range: 5 Years - 8 Years
Sex: ALL

Summary:
This study was conducted to evaluate the efficiency of sonic activation of 5%sodium hypochlorite during root canal treatment of primary molars on postoperative pain and facial expressions. In addition to comparing between the Five-face pain scale and AI Emotion Detector mobile application in postoperative pain assessment.

Eligibility criteria:
Inclusion Criteria:

1. Children's age range 5-8 years. Boys and girls will be included.
2. Children with positive or definitely positive behavior on the Frankl's behavior rating scale (rating 3 or 4 on the scale).
3. Children with at least one primary molar with irreversible pulpitis and symptomatic apical periodontitis confirmed using periapical radiographs, percussion, and cold test.
4. Children having teeth with two-thirds of each root remaining.
5. Children with a moderate to very severe (2-4) pain score according to five-face pain scale in only one tooth within the 24-h period before the procedure.
6. Children with no allergy to Ibuprofen.

Exclusion Criteria:

1. Teeth with pathological root resorption.
2. Teeth with mobility greater than 1st-degree mobility.
3. Children who received analgesics and/or antibiotics in the last 12 h before root canal treatment

Outcomes:
Five-Face Pain Scale Score; facial expressions analysis
A Multi-center Observational Clinical Study Observing the Differences of Tongue Images Between Patients With Malignant Tumors and Healthy People
Trial ID: NCT04793672
Status: COMPLETED
Study type: OBSERVATIONAL
Start date: 2020-05-01
Completion date: 2023-12-01
Sponsor: Zhejiang Cancer Hospital
Collaborators: Sichuan Cancer Hospital and Research Institute; Zhejiang Hospital of TCM; Wenzhou Medical University; Fujian Cancer Hospital; RenJi Hospital; Zhejiang Provincial Tongde Hospital; Kecheng District People's Hospital; Yueyang Central Hospital; Shandong Cancer Hospital and Institute; Shanxi Province Cancer Hospital; Liaoning Cancer Hospital & Institute; Harbin Cancer Hospital; Yuhang District People's Hospital; Hainan Cancer Hospital; Zigong Fourth People's Hospital; Henan University of Science and Technology
Conditions: Malignant Tumor
Interventions: Tongue images, coating on the tongue and clinical data of patients with malignant tumors and healthy people will be collected.
Locations: Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital); Zhejiang Cancer Hospital
Countries: China; China
Enrollment: 4100
Age range: 18 Years - 80 Years
Sex: ALL

Summary:
The tongue images of malignant tumors and corresponding healthy people will be collected to establish the tongue image database. Deep learning will be carried out by computer and artificial intelligence to construct the early screening, diagnosis, prognosis and prognosis model of various malignant tumors based on tongue image for the diagnosis and treatment of malignant tumors.

Eligibility criteria:
Inclusion Criteria:

* 18≤age≤80
* Histologically or cytologically confirmed malignant tumor
* No prior chemotherapy, radiotherapy, biotherapy, immunotherapy or other anti-tumor treatment for malignant tumor
* Subject volunteers to join the study, Signs informed consent, has good compliance and can cooperate with follow-up

Exclusion Criteria:

* Two or more kinds of malignant tumors at the same time
* Malignant tumor that has been treated by chemotherapy, radiotherapy, biotherapy, immunotherapy or other anti-tumor therapy
* Subjects who had other factors that might force them to terminate the research ahead of time, such as the development of other severe disease (including mental disease) that required combined treatment, seriously abnormal laboratory examination value, and family or social factors that might affect the subject safety or experimental data collection, as judged by the researchers

Outcomes:
The differences of tongue images between patients with malignant tumors and healthy people.; Overall Survival (OS)
Predicting Neoadjuvant Chemoradiotherapy Response by Radiomics-based Artificial Intelligence System in Locally Advanced Rectal Cancer: A Multicenter, Prospective and Observational Clinical Study
Trial ID: NCT04273477
Status: UNKNOWN
Study type: OBSERVATIONAL
Start date: 2020-01-10
Completion date: 2020-12
Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Collaborators: The Third Affiliated Hospital of Kunming Medical College.; Sir Run Run Shaw Hospital
Conditions: Rectal Cancer
Locations: the Sixth Affiliated Hospital of Sun Yat-sen University; The Third Affiliated Hospital of Kunming Medical College; Sir Run Run Shaw Hospital
Countries: China; China; China
Enrollment: 100
Age range: 18 Years - 75 Years
Sex: ALL

Summary:
In this study, investigators utilize a radiomics prediction model to predict the tumor response to neoadjuvant chemoradiotherapy (nCRT) before the nCRT is administered for patients with locally advanced rectal cancer (LARC). Previously, the radiomics prediction model has been constructed based on the radiomics features extracted from pretreatment Magnetic Resonance Imaging (MRI) in the training set, and optimized in the external validation set. The predictive power of this radiomics prediction model to discriminate the pathologic complete response (pCR) patients from non-pCR individuals, will be further verified in this prospective, multicenter clinical study.

Eligibility criteria:
Inclusion Criteria:

* pathologically diagnosed as rectal adenocarcinoma
* defined as clinical II-III staging (≥T3, and/or positive nodal status) without distant metastasis by enhanced Magnetic Resonance Imaging (MRI)
* intending to receive or undergoing neoadjuvant concurrent chemoradiotherapy (5-fluorouracil based chemotherapy, given orally or intravenously; Intensity-Modulated Radiotherapy or Volume-Modulated Radiotherapy delivered at 50 gray (Gy) in gross tumor volume (GTV) and 45 Gy in clinical target volume (CTV) by 25 fractions)
* intending to receive total mesorectum excision (TME) surgery after neoadjuvant therapy (not completed at the enrollment), and adjuvant chemotherapy
* MRI (high-solution T2-weighted imaging, contrast-enhanced T1-weighted imaging, and diffusion-weighted imaging are required) examination is completed before the neoadjuvant chemoradiotherapy

Exclusion Criteria:

* with history of other cancer
* insufficient imaging quality of MRI to delineate tumor volume or obtain measurements (e.g., lack of sequence, motion artifacts)
* incomplete neoadjuvant chemoradiotherapy
* no surgery after neoadjuvant chemoradiotherapy resulting in lack of pathologic assessment of tumor response
* tumor recurrence or distant metastasis during neoadjuvant chemoradiotherapy

Outcomes:
The prediction accuracy of the radiomics prediction model