moncefem/clinical-trials-ai-2000-2025 huggingface dataset:
Clinical Efficacy of Implementing an AI-Driven Software as a Medical Device (SaMD) for Funduscopy Analysis in Patients With Diabetes Mellitus: A Randomized Controlled Trial Protocol
Trial ID: NCT07378956
Status: RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2026-04-07
Completion date: 2027-08-31
Sponsor: VUNO Inc.
Conditions: Diabetic Retinopathy (DR); Diabete Mellitus; Fundus Photography
Interventions: VUNO Med®-Fundus AI™
Locations: Inha University Hospital
Countries: South Korea
Enrollment: 340
Age range: 19 Years - None
Sex: ALL

Summary:
The objective of this study is to investigate the efficacy of implementing the AI-SaMD(VUNO Med®-Fundus AI™) alongside routine clinical practice for the detection of diabetic retinopathy.

Eligibility criteria:
Inclusion Criteria:

* Adults aged 19 years or older.
* A documented diagnosis of type 2 diabetes mellitus.
* Ability to communicate adequately and provide written informed consent for participation in the study.

Exclusion Criteria:

* A prior diagnosis of diabetic retinopathy at the time of screening.
* A history of ophthalmic surgery within 6 months prior to the screening date.
* A diagnosis of type 1 diabetes mellitus.
* Pregnancy at the time of screening.
* Any condition that, in the opinion of the investigator, would make participation in the study infeasible or inappropriate.

Outcomes:
True Referral Rate
Endometrial Receptivity Prediction During in Vitro Fertilization Using Artificial Intelligence Analysis of Vaginal Ultrasound Images
Trial ID: NCT06717802
Status: RECRUITING
Study type: OBSERVATIONAL
Start date: 2025-06-01
Completion date: 2028-12-31
Sponsor: Gottsegen National Cardiovascular Institute
Collaborators: Dunamenti REK Reprodukcios Kozpont
Conditions: Infertility; Infertility (IVF Patients)
Locations: Dunamenti REK Reprodukcios Kozpont
Countries: Hungary
Enrollment: 1500
Age range: 18 Years - 40 Years
Sex: FEMALE

Summary:
The investigators plan to use artificial intelligence to analyse vaginal ultrasound images of the uterine lining (endometrium) taken during routine IVF treatment, which may predict implantation success during IVF treatment.

Participation in the study is voluntary, involves no additional testing or intervention beyond routine procedures, and consent can be withdrawn verbally or in writing at any time without cause or adverse consequences.

Over a three-year period, the trial is expected to enrol approximately 1,500 patients between the ages of 18 and 40 who are indicated for IVF treatment and who volunteer for treatment.

Patients enrolled in the study will not be required to attend more clinic visits during treatment than they would otherwise have to. During the trial, certain patient-specific data (age, indication for treatment, body mass index), stimulation-specific data (duration of stimulation, type and dose of drug, endometrial thickness), ultrasound scans and outcome-specific data (treatment failure, biochemical pregnancy, clinical pregnancy) will be collected. The data will be stored in a secure database. The data collected during the study will only be accessible to the professionals involved in the study and no information, including personal data, will be disclosed to third parties.

Eligibility criteria:
Inclusion Criteria:

* Female patient 18-40 years, for whom IVF is indicated
* Maximum 3 unsuccessful previous embryo transfers
* Only cycles in which single blastocyst is transferred

Exclusion Criteria:

* Congenital uterine anomalies, fibroids, adenomyosis, Asherman-syndrome or any other conditions resulting in malformation of the uterus
* Presence of hydrosalpinx
* Endometriosis
* Planned freeze-all cycle
* Positive hepatitis B, hepatitis C or HIV screening test

Outcomes:
Clinical pregnancy
Development and Validation of a Multimodal Predictive Recurrence Score for Patients With Clear Cell Renal Cell Carcinoma: a Multicenter Cohort Study
Trial ID: NCT06656039
Status: COMPLETED
Study type: OBSERVATIONAL
Start date: 2024-01-01
Completion date: 2024-10-10
Sponsor: RenJi Hospital
Collaborators: The First Affiliated Hospital of Anhui Medical University; The Fourth Affiliated Hospital of Harbin Medical University; Second Affiliated Hospital of Soochow University; Qianfoshan Hospital; Chang Gung Memorial Hospital
Conditions: Renal Cell Carcinoma, Clear Cell
Locations: Renji Hospital
Countries: China
Enrollment: 1200
Age range: 18 Years - None
Sex: ALL

Summary:
The main goal of this observational study is to construct a predictive recurrence model for renal clear cell carcinoma through an artificial intelligence multimodal algorithm, which will improve the prognosis and survival time of ccRCC patients by helping clinicians to formulate individualised follow-up and to screen for appropriate adjuvant therapy candidates.

Eligibility criteria:
Inclusion Criteria:

* Patients with malignant renal tumours must have postoperative pathological confirmation of renal clear cell carcinoma with pathological TNM stage Ⅰ-Ⅲ;
* Have available preoperative imaging
* Have available post-operative pathological paraffin samples or HE-stained tissue sections
* Must agree to and be able to comply with the study's visit schedule and other requirements as specified in the protocol, including follow-up visits by telephone

Exclusion Criteria:

* The patient's tumour type cannot be determined on the basis of histopathological sections
* Simultaneous combination of primary tumours at other sites;
* No regular follow-up imaging data
* Cases in which other factors led the investigator to believe that enrolment was inappropriate
* Cases that met all the inclusion criteria of the appeal and did not meet all the exclusion criteria were selected for this study

Outcomes:
Disease free survival
What is the Impact of Implementing Pharmaceutical Algorithms in the PharmaClass® Software, on the Handling the Patient's Medication Load, by the Clinical Pharmacist? Analysis of These Impacts Within 2 Geriatric Units of the CHU Brugmann Hospital
Trial ID: NCT05416892
Status: COMPLETED
Study type: OBSERVATIONAL
Start date: 2021-09-14
Completion date: 2022-04-01
Sponsor: Murielle Surquin
Conditions: Pharmacist-Patient Relations
Interventions: Pharmaclass® software
Locations: Brugmann university hospital
Countries: Belgium
Enrollment: 109
Age range: 75 Years - None
Sex: ALL

Summary:
The clinical pharmacists present in the hospitalisation units aim to ensure the daily review of the drug prescriptions of hospitalized patients.

In order to optimize their work, the objective of this study would be to provide them with a clinical decision support tool via artificial intelligence in order to improve the patient's medication management. This study will test the Pharmaclass® software.

Eligibility criteria:
Inclusion Criteria:

* Hospitalized patient entering the SU06 or SU13 geriatrics unit of the Paul Brien site of the CHU Brugmann Hospital between November 16 2021 and April 15, 2022
* Speaking French and/or Dutch
* With chronic renal failure or taking at least one medicine for diabetes, heart, COPD, asthma, high blood pressure, epilepsy, atrial fibrillation, osteoporosis, high cholesterol, pain, parkinsonism, blood clotting, constipation, thyroid, depression, benign prostatic hypertrophy, gastric ulcer, Alzheimer's disease, cirrhosis as well as for electrolyte disorders (hypo or hypernatremia / potassium / calcium/magnesemia/phosphatemia).

Exclusion Criteria:

* Patient who died or was transferred to another care unit during his/her hospitalization

Outcomes:
Time; Dosage compliance; Medication error severity; Geriatrician approval
Efficacy of a Novel Web-based Fatigue and Cognitive Assessment Platform in Detecting Fatigue and Depression
Trial ID: NCT07218263
Status: RECRUITING
Study type: OBSERVATIONAL
Start date: 2025-12-01
Completion date: 2026-05
Sponsor: Brijesh Patel
Collaborators: SmartTec Inc
Conditions: Depression Disorders; Fatigue Symptom; Cardiovascular
Interventions: Participants will complete PHQ-9, FAS, and Okaya assessments.
Locations: Indiana University; Methodist Hospital
Countries: United States; United States
Enrollment: 100
Age range: 18 Years - 99 Years
Sex: ALL

Summary:
This observational study evaluates the accuracy of the Okaya AI platform in detecting fatigue and depression in cardiology patients, comparing its assessments to PHQ-9 and Fatigue Assessment Scale scores.

Eligibility criteria:
Inclusion Criteria:

* Age ≥18, English-speaking, able to consent

Exclusion Criteria:

* Active substance use, nonverbal, cognitive disability, active suicidal/homicidal ideation

Outcomes:
Correlation between Okaya (AI based) score and PHQ-9; Correlation between Okaya (AI) based score and PHQ-9 and FAS; Correlation between Okaya (AI based) score and FAS
[AI-driven Vaccine Communicator: the Impact of a Web-based Psychoeducation Programme with a Motivational AI-based Digital Assistant on Covid-19 Vaccine Hesitancy in Hong Kong's Population
Trial ID: NCT05531058
Status: COMPLETED
Study type: INTERVENTIONAL
Phase: NA
Start date: 2022-10-01
Completion date: 2024-06-01
Sponsor: The Hong Kong Polytechnic University
Conditions: Vaccine Hesitancy; COVID-19
Interventions: AI-driven Vaccine Communicator; Self-learning of COVID-19 vaccine knowledge
Locations: School of Nursing, The Hong Kong Polytechnic Unviersity
Countries: Hong Kong
Enrollment: 168
Age range: 18 Years - None
Sex: ALL

Summary:
Vaccine hesitancy is defined as 'delay in acceptance or refusal of vaccines, despite the availability of vaccine service' and was named one of the top ten global health threats by the World Health Organization in 2019.

Our proposed study will aim to develop and evaluate the effectiveness of a Web-based psychoeducation programme to address Covid-19 vaccine hesitancy, 'AI-driven Vaccine Communicator' (including educational materials, animations of vaccine research and development, and an MI communication skills-based AI, digital assistant).

Our goal is to standardise our intervention so that it can serve as an effective toolkit for clinicians/healthcare providers to increase Hong Kong residents' motivation to vaccinate and to ensure that the programme can be adapted to viral mutations and newly developed vaccines in the medium/long term.

Eligibility criteria:
Inclusion Criteria:

* 18 years or above;
* Hong Kong residents;
* Show vaccine hesitancy (not taking COVID-19 vaccines or receiving involuntary COVID-19 vaccines);
* have internet access
* able to read Chinese or English. Recruitment involved social media promotion and collaborating with community organizations

Exclusion Criteria:

* People with self-reported cognitive impairments or mental disorders that might interfere with their understanding of the intervention content;
* People who currently engaged in another clinical trial in relation to Covid-19 vaccines.

Outcomes:
Vaccine hesitancy at pre-test; Vaccine hesitancy at post-intervention; Vaccine hesitancy at three months follow-up; Vaccine hesitancy at six months follow-up
Confirmatory Clinical Investigation of Electrocardiographic Diagnostic Performance of the Apple Watch Augmented With an Artificial Intelligence Algorithm
Trial ID: NCT05167058
Status: COMPLETED
Study type: OBSERVATIONAL
Start date: 2022-04-21
Completion date: 2023-03-31
Sponsor: Cardiologs Technologies
Conditions: Atrial Fibrillation; Tachycardia; Bradycardia; Premature Supraventricular Beat; Premature Ventricular Contraction
Interventions: Cardiologs Platform
Locations: Hackensack Meridian School of Medicine; The Valley Hospital; Columbia University Medical Center/ NewYork Presbyterian Hospital
Countries: United States; United States; United States
Enrollment: 220
Age range: 18 Years - None
Sex: ALL

Summary:
The SWAF study will compare the performance of a smartwatch combined with Cardiologs Platform algorithm in the detection of Atrial Fibrillation and other arrhythmias with that measured on a manually read 12-lead ECG in subjects hospitalized for cardioversion or AF ablation.

Eligibility criteria:
Inclusion Criteria:

* Subjects over 18, able and willing to participate in the study
* Subjects who are admitted to the hospital for a cardioversion or AF ablation procedure.
* Subjects having read the patient information letter and provided his/her consent to participate in writing, by dating and signing the informed consent prior to any trial-related procedure being conducted

Exclusion Criteria:

* Subjects with paced rhythm or implanted electronic devices
* Pregnant or breast-feeding subjects

Outcomes:
Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting AF (Atrial Fibrillation or Flutter) as identified by the physician on the 12-lead ECG
Superpower Glass Project: A Mobile At-home Intervention for Children With Autism
Trial ID: NCT03569176
Status: COMPLETED
Study type: INTERVENTIONAL
Phase: NA
Start date: 2016-11-01
Completion date: 2018-04-15
Sponsor: Dennis Paul Wall
Conditions: Autism Spectrum Disorder
Interventions: Autism Glass
Enrollment: 74
Age range: 6 Years - 12 Years
Sex: ALL

Summary:
The purpose of this research is to study the effects of a novel artificial intelligence (AI) tool for automatic facial expression recognition that runs on Google Glass through an Android app to deliver social emotion cues to children with autism during social interactions. This novel device will use a camera, microphone, head motion tracker to analyze the behavior of the subject during interactions with other people. The system is designed to give participants non-interruptive social cues in real-time and will record social responses that can later be used to help aid behavioral therapy. It is hypothesized that the system's ability to provide continuous behavioral therapy during social interactions will enable faster gains in social skills.

Eligibility criteria:
Inclusion Criteria:

1. the child has been diagnosed professionally with ASD
2. the child is currently receiving ABA therapy at least twice per week at home.
3. The child's family is willing to drive to Stanford University for up to 4 study appointments.

Exclusion Criteria:

1. The child scores less than 15 on the Social Communication Questionnaire
2. The child's family does not speak English

Outcomes:
Change in Socialization Subscale Scores of the Vineland Adaptive Behavior Scales, 2nd Edition (VABS-II) From Baseline to Week 6.; Change in Parent Rated Social Responsiveness Scale 2 (SRS-2) From Baseline to Week 6; Change in Emotion Guessing Game (EGG) Scores From Baseline to Week 6
Evaluation of the Clinical Performance of an Investigational Real-Time Colorectal Polyp Clinical Decision Support Device (CDSD)
Trial ID: NCT04437615
Status: COMPLETED
Study type: INTERVENTIONAL
Start date: 2020-11-05
Completion date: 2023-03-30
Sponsor: Olympus Corporation of the Americas
Conditions: Polyp; Colorectal; Colonoscopy
Interventions: Colonoscopy; Clinical Decision Support Device
Locations: Borland Groover
Countries: United States
Enrollment: 2379
Age range: 18 Years - None
Sex: ALL

Summary:
The study objective is to establish the efficacy of the colorectal polyp Clinical Decision Support Device (CDSD) in clinical use.

Eligibility criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Willing and able to provide informed consent
* Subjects undergoing colonoscopy

Exclusion Criteria:

* Polyposis syndromes including Familial Adenomatous Polyposis Syndrome
* Inflammatory Bowel Disease
* Hereditary Non Polyposis Colorectal Cancer
* Severe coagulopathy
* Subjects scoring less than 6 on the Boston Bowel Prep Score or scoring less than 2 in any colon segment.
* No diminutive polyps detected during colonoscopy

Outcomes:
Specificity and Sensitivity CDSD-unaided and CDSD-aided Endoscopist Predictions of Diminutive Polyp Histology
Patient-Centered Pain Care Using Artificial Intelligence and Mobile Health Tools
Trial ID: NCT02464449
Status: COMPLETED
Study type: INTERVENTIONAL
Phase: NA
Start date: 2017-07-24
Completion date: 2020-04-30
Sponsor: VA Office of Research and Development
Conditions: Back Pain
Interventions: Behavioral: AI-CBT; Behavioral: Standard Telephone CBT
Locations: VA Connecticut Healthcare System West Haven Campus, West Haven, CT; VA Ann Arbor Healthcare System, Ann Arbor, MI
Countries: United States; United States
Enrollment: 278
Age range: 18 Years - None
Sex: ALL

Summary:
This study will evaluate a new approach for back pain care management using artificial intelligence and evidence-based cognitive behavioral therapy (AI-CBT) so that services automatically adapt to each Veteran's unique needs, achieving outcomes as good as standard care but with less clinician time.

Eligibility criteria:
Inclusion Criteria:

* Back pain-related dx including back and spine conditions and nerve compression and a score of \>=4 (indicating moderate pain) on the 0-10 Numerical Rating Scale on at least two separate outpatient encounters in the past year
* At least 1 outpatient visit in last 12 months
* At least moderate pain-related disability as determined by a score of 5+on the Roland Morris Disability Questionnaire
* At least moderate musculoskeletal pain as indicated by a pain score of \>=4 on the Numeric Rating Scale
* Pain on at least half the days of the prior 6 months as reported on the Chronic Pain item
* Touch-tone cell or land line phone.

Exclusion Criteria:

* COPD requiring oxygen
* Cancer requiring chemotherapy
* Currently receiving CBT
* Suicidality
* Receiving surgical tx related to back pain
* Active psychotic symptoms
* Severe depressive symptoms
* Can't speak English
* Sensory deficits that would impair participation in telephone calls
* Patient not planning to get care at study site
* PCP not affiliated with study site
* Limited life expectancy (COPD requiring oxygen or Cancer requiring chemotherapy
* Active psychotic symptoms, suicidality, severe depressive symptoms (Beck Depression Inventory (BDI) score or 30+)
* Substance use disorder or dependence, active manic episode, or poorly controlled bipolar disorder as identified by MMini International Neuropsychiatric Interview
* Severe depression identified by chart review of diagnoses and mental health treatment notes
* Cognitive impairment defined by a score of \<=5 on the Six-Item screener
* Current CBT or surgical treatment related to back pain.

Outcomes:
Pain-related Disability
Impact of Intensive Oral Hygiene Regimen Based on Individualized Messages and an Intelligent Power-driven Toothbrush on Non-surgical Treatment of Stage II and III Periodontitis: A Randomized, Standard of Care-controlled Trial
Trial ID: NCT05137392
Status: COMPLETED
Study type: INTERVENTIONAL
Phase: NA
Start date: 2022-02-01
Completion date: 2023-10-15
Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Conditions: Periodontitis
Interventions: oral hygiene instruction
Locations: Shanghai PerioImplant Innovation Center, Ninth People Hospital
Countries: China
Enrollment: 100
Age range: 18 Years - None
Sex: ALL

Summary:
Achievement of adequate oral hygiene standards is critical to the successful treatment of gum disease. The improvement of the patient's adherence to good oral hygiene is of great importance to obtain the satisfactory treatment outcomes. However, patients' adherence to a proper daily oral hygiene regimen generally remains poor. New electric artificial intelligence powered toothbrushes are able to precisely sense the location of the brushing being performed by the patient and transmit information to the clinician who is able to analyze the data and provide targeted instructions, if needed. This study evaluates whether a novel oral hygiene instruction regimen can provide some additional benefit for periodontal treatment compared with routine oral hygiene instructions.

Eligibility criteria:
Inclusion Criteria:

* Aged 18 and above
* Generalized Stage II and Stage III periodontitis
* Subjects willing to receive NSPT necessary for the management of periodontitis and to comply with research appointments/schedule
* Use of a compatible Android cell phone with Oral-B 8.5.1 Application

Exclusion Criteria:

* Edentulism
* Presence of any systemic disease that can alter the manifestation/outcome of periodontal treatment
* Pregnancy or intention to become pregnant at any point during the study duration
* Having received antibiotics within the previous 3 months
* Need for antibiotic prophylaxis in the context of dental treatment
* Having received professional periodontal treatment (other than supragingival cleaning) within the previous 12 months
* Presence of xerostomia interfering with saliva sampling
* Participation in another intervention trial
* Inability or unwillingness of individual to give written informed consent.

Outcomes:
changes in probing pocket depth (PPD); changes in proportion of periodontal pocket closure
Total Body Dermoscopic Evaluation of Pregnancy-related Changes in Melanocytic Nevi Using the FotoFinder ATBM Master System and the Impact of Artificial Intelligence Assisted Examinations on the Patients' Skin Cancer Screening Experience: A Prospective Two-arm Controlled Observational Study
Trial ID: NCT05148455
Status: COMPLETED
Study type: OBSERVATIONAL
Start date: 2021-01-15
Completion date: 2022-02-09
Sponsor: University Hospital, Basel, Switzerland
Conditions: Melanocytic Nevi (MN)
Interventions: standard-of-care clinical skin examination; skin assessment with the 2D FotoFinder ATBM master system; data collection by participant questionnaire
Locations: University Hospital Basel, Department of Dermatology
Countries: Switzerland
Enrollment: 50
Age range: 18 Years - 40 Years
Sex: FEMALE

Summary:
This study is

* to analyze whether more changes in melanocytic nevi (MN) occur in women during and after pregnancy compared to non-pregnant women of the same age
* and to analyze psychological effects of total body mapping and dermoscopic examination assisted by artificial intelligence during pregnancy.

Eligibility criteria:
Inclusion Criteria:

* Pregnant female participants beyond the 12th week of pregnancy
* Non-pregnant female participants

Exclusion Criteria:

* Fitzpatrick skin phototypes V and VI
* less than 15 MN (MN with a diameter less than 2mm will not be taken into account)
* insufficient knowledge of project language (German, English, French)
* inability to give consent.

Outcomes:
Change in macroscopic aspect of melanocytic nevi; Change in mole analyzer score with the 2D FotoFinder ATBM master system