cyrilzakka/clinical-trials huggingface dataset:
Testing the Effectiveness of AI Chatbots to Improve Public Knowledge and Attitudes Towards Depression

The purpose of this randomized controlled trial (RCT) is to find out whether using AI Chatbots can help the public better understand depression, reduce negative attitudes towards it, and encourage more people to seek help when needed. The study will also explore whether the Chatbot can help individuals feel more confident in supporting others who might be experiencing depression.

Participants will be randomly assigned to either:

1. AI-PsyTeacher Group: Participants interact with the AI psychology teacher "Liran" to complete three progressive tasks (identifying depression symptoms, learning coping strategies, and understanding prevention). This group assesses the independent role of AI in mental health education.
2. AI-Integrated Intervention Group: Participants first learn with the AI psychology teacher "Liran" and then interact with the AI-simulated depressed patient "Beibei" to complete three tasks (identifying issues, teaching coping strategies, and creating a prevention plan). This group examines the combined effect of AI teaching and patient simulation.
3. Traditional Psychoeducation Group (Control): Participants gain depression-related knowledge by reading traditional educational materials and watching a first-person experience video. This group serves as the control to compare AI interventions.

Primary outcomes include changes in depression literacy, attitudes toward depression, help-seeking intentions, and confidence in helping others. The study aims to determine whether AI-driven interactive learning can improve public understanding and support for mental health.


Eligibility Criteria:
Inclusion Criteria:

1. Adults aged 18 to 65.
2. General population, non-clinical individuals.
3. No history of diagnosed mental disorders or current mental health diagnosis.
4. Ability to complete AI interactions and related tasks via the internet or mobile devices.
5. Native Chinese speakers.
6. Willingness to participate in the study and sign an informed consent form.

Exclusion Criteria:

1. History of mental disorders or self-reported current mental health issues.
2. Currently undergoing psychological counseling.
3. Inability to use mobile or internet devices properly.
Migraine Prophylaxis With Clopidogrel Trial

The underlying mechanisms of association between the right-to-left shunts (RLS) and migraine may concern with platelet aggregation and paradoxical embolization. The aim of the study is to evaluate the prophylactic effectiveness of clopidogrel for migraineurs with RLS.

Many studies have shown an increased prevalence of right-to-left shunts in migraineurs. The underlying mechanisms of association between the right-to-left shunts (RLS) and migraine may concern with platelet aggregation and paradoxical embolization. In the present study, migraineurs without taking prophylactic medicines regularly will be given only clopidogrel 75 mg daily for three months. Migraineurs who are unresponsive to at least two commonly applied preventive medications, clopidogrel 75 mg daily will be added to his/her existing prophylactic migraine regimen for three months. Patients will be followed up at the third month and the sixth month for headache frequency, attack duration of headache, migraine disability assessment scale（MIDAS）scores, headache impact test（HIT-6）scores and visual analogue scale（VAS）scores. Investigators will evaluate the changes of these measurements between baseline and the follow-up time. The aim of the study is to evaluate the prophylactic effectiveness of clopidogrel for migraineurs with RLS.

Eligibility Criteria:
Inclusion Criteria:

* migraine with or without aura diagnosed by a neurologist according to the criteria of the International Headache Society (3nd edition)
* experience a minimum of two migraine attacks per month in a 3-month baseline phase
* without regular use of prophylactic treatments or unresponsive to two and more commonly applied preventive medications
* the presence of RLS confirmed by contrast-enhanced transcranial Doppler
* no positive findings in cranial CT and MRI

Exclusion Criteria:

* other types of headaches
* systemic chronic diseases, cerebrovascular disease, abnormal platelet or liver function
* history of head injury
* other contraindications to clopidogrel treatment
Efficacy Study of Pneumococcal Vaccination in Crohn's Disease

A growing number of patients with Crohn's disease are treated with immunosuppressive agents, such as anti-tumor necrosis factor blockers and immunomodulators. Several recent studies have indicated that immunosuppressive treatment may impair the immunological response to pneumococcal vaccination in patients with inflammatory bowel disease (Crohn's disease and Ulcerative colitis). One of weaknesses in the previous studies did not focus on specific disease, such as Crohn's disease. In addition, predictive factors affecting impaired response following pneumococcal vaccination have not clearly evaluated in patients with Crohn's disease. In this study, patients with Crohn's disease will be assessed for serological response to pneumococcal vaccination. Further, potential predictive factors that impact on vaccination outcomes and adverse events related to vaccination will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18
* Informed consent
* Patients who had a definitive diagnosis of Crohn's disease for more than 6 months (documented by the standard clinical, radiographic, endoscopic, and histopathologic criteria)

Exclusion Criteria:

* Hypersensitivity to any component of the pneumococcal vaccine
* Known allergy to pneumococcal vaccination
* Patients who treated with glucocorticoids (prednisolone \> 20 mg/day equivalent for 2 weeks or more, and within 3 months of stopping
* Patients who inoculate another vaccine in the past 4 weeks
* Significant protein calorie malnutrition
* Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, infectious, neurologic or cerebral disease
* Any condition which, in the opinion of the Investigator, places the patient at unacceptable risk if he/she were to participate in the study
Effect of Metformin as add-on Therapy on Glycemic Control and Other Outcomes in Type 1 Diabetes

Aim Evidence of a possible connection between gut microbiota and several physiological processes linked to type 1 diabetes is increasing. However, the effect of multistrain probiotics in people with type 1 diabetes remains unclear. This study investigated the effect of metformin as add-on therapy on glycemic control and other diabetes-related outcomes in people with type 1 diabetes.

Design An open-label, add-on, self-control clinical trial. Setting Diabetes clinic of a teaching hospital in Shenzhen China Participants A total of 20 participants with type 1 diabetes, aged 18-60 years, will be recruited and treated with metformin as add-on therapy with insulin for 12 weeks.

Outcomes Primary outcomes were glycemic control related parameters, and secondary outcomes were anthropomorphic variables, lipid profile, blood pressure and high-sensitivity C-reactive protein. The gut microbiota profile will be analyzed before and after intervention .

Eligibility Criteria:
Inclusion Criteria:

type 1 diabetes patients age 18-60years old 18 Kg/m2≤BMI≤30Kg/m2 ketonuria (-)；

Exclusion Criteria:

pregnancy lactation having other severe chronic illnesses taking other anti-diabetic drugs
Characterizing Outcomes and Real-World Experience of Cardiac Physiologic Pacing (The CORE-CPP Study)

The purpose of this study is to use real-world evidence to validate that conduction system pacing (CSP), delivered via a Medtronic 3830 catheter-delivered lead and a Medtronic dual-chamber transvenous pacemaker, is a safe and effective alternative to biventricular pacing (BVP) in patients indicated for cardiac resynchronization therapy (CRT) to deliver cardiac physiologic pacing (CPP), as documented in the clinical literature.


Eligibility Criteria:
Inclusion Criteria:

Dual-chamber CSP cohort:

* Medicare beneficiaries implanted with a Medtronic dual-chamber transvenous pacemaker on or after the study start date.
* Lead type and placement data indicating CSP.
* An indication for CRT.

BVP comparator cohort:

* Medicare beneficiaries implanted with a Medtronic biventricular pacemaker (CRT-P) on or after the study start date.

Exclusion Criteria:

Dual-chamber CSP cohort:

* Evidence of a prior CIED device.
* Less than 12 months continuous enrollment in Medicare Part A and Part B prior to implant date.
* Non-Medtronic pacemaker (unable to link to Medtronic device registration data).
* Missing lead type or placement data.
* Lead type and placement data indicating non-CSP placement.

BVP comparator cohort:

* Evidence of a prior CIED device.
* Less than 12 months continuous enrollment in Medicare Part A and Part B prior to implant date.
* Non-Medtronic pacemaker (unable to link to Medtronic device registration data).
* Missing lead type or placement data.
Exercise and Cardiac Measures in Dialysis Patients

Background: The impact of the known non-invasive cardiac indices for identification of hemodialysis (HD) patients at high-risk for sudden cardiac death (SCD) has not been evaluated.

Patients: Fifty-nine HD patients were randomized into 2 groups. Thirty of them (group A-aged 54.6±8.9 years) participated in a supervised training program with stationary bicycles during their HD sessions (3/weekly) for 10 months, while the rest (group B-aged 53.2±6.1 years) remained untrained and were used as controls.

Study hypothesis: Exercise training will affect most of the non-invasive cardiac markers of SCD and the total score positively.

Method: At entry, as well as at the end of the study all subjects underwent a cardiopulmonary exercise testing (estimation of aerobic capacity-VO2peak), an echocardiographic study (LV ejection fraction -LVEF evaluation), an ambulatory 24-hour Holter monitoring for cardiac autonomic nervous system activity evaluation by time- and frequency- domain heart rate variability (HRV) calculation (measurement of SDNN, mean RR and low to high frequency ratio-LF/HF), a signal-averaged ECG (late potentials-LP documentation) and a submaximal exercise test for microvolt-T-wave alternans (TWA) detection.

The identification of patients on hemodialysis (HD) at increased cardiac risk with powerful screening tests and the reduction of factors, which increase the probability of malignant arrhythmias are important for primary prevention of sudden cardiac death (SCD).

Study Design: randomized and controlled clinical trial. Setting \& Participants: Fifty-nine HD patients were randomized into exercise training group (group A-30 patients) and controls (group B-29 patients).

Intervention: Group A participated in a 10-month supervised exercise training program during the HD sessions (3/weekly).

Outcomes: The effects of exercise on the score of the non-invasive cardiac markers for SCD risk stratification and on the occurrence of each variable separately. Statistical analysis included a two-group comparison of change scores and an analysis of covariance adjusting for baseline.

Measurements: At entry and the end of the study, in all participants aerobic capacity (VO2peak) and left ventricular ejection fraction (LVEF) were estimated, late potentials and T-wave alternans were detected and heart rate variability was calculated. Specifically, from the 24-h Holter monitoring the standard deviation of all the normal R-R intervals (SDNN), the mean R-R intervals (mean RR), the low (LF) and high (HF) frequency components of the autoregressive power spectrum of the NN intervals and their ratio (LF/HF) were recorded.

Eligibility Criteria:
Inclusion Criteria:

* on HD for at least 6 months
* in sinus rhythm
* able to reach a sufficient workload during ergometry

Exclusion Criteria:

* with bundle branch block
* unstable hypertension
* diabetes mellitus
* severe congestive heart failure
* recent myocardial infarction
* unstable angina
Ammonia Metabolism Assessed by Ammonia Infusion

The present study will develop a method to assess ammonia metabolism by ammonia infusion and investigate ammonia production and clearance in healthy individuals and in patients with liver cirrhosis.


Eligibility Criteria:
Inclusion Criteria - Healthy controls:

* Alcohol \< 40g/day
* BMI \< 30
* Diseased or medicated

Inclusion Criteria - Patients with cirrhosis:

* Child-Pugh A or B cirrhosis
* BMI \< 30

Exclusion Criteria:

* Child-Pugh score C
* Kidney failure (eGFR \< 60 mL/min/1.73m2)
* Overt hepatic encephalopathy or more than one previous 1 episode of overt hepatic encephalopathy
* Acute bacterial infection
* Cancer
* Diabetes
* Ammonia-targeted treatment of hepatic encephalopathy other than lactulose (including Rifaximin and branched-chain amino acids)
Tailored Messaging to Reduce Sodium Intake

The proposed study will determine the effectiveness of a mobile application location-based tailored notification message system in helping hypertensive patients reduce dietary sodium intake and feel more confident in following a low sodium diet.

People with high blood pressure often get advice to lower their salt or sodium intake. High dietary sodium intake is linked to high blood pressure, stroke, heart failure and kidney disease. U.S. federal guidelines advocate daily sodium intake of less than 2,300 milligrams (mg). The estimated average sodium intake for Americans is 3,400 mg per day. In recent years, consumption of processed and restaurant foods has substantially increased. More than 75% of sodium in the average U.S. diet now comes from these sources.

The mobile application will deliver tailored messages based on the user's location and previously identified high-sodium food items that they commonly consume.

This 8-week research study at Visit 1 or baseline will consent and randomize 50 eligible adults with high blood pressure to use the mobile application daily or to follow their usual eating pattern with no access to the application.

All participants will be asked to complete four surveys at baseline and Week 8: Block Food Frequency Questionnaire, Block Sodium Screener, Self-care Confidence in following a Low Sodium Diet and the Automated Self-administered 24-Hour Dietary Recall survey. All participants will be asked to provide a baseline and end of study 24-hour urine collection, regularly provide home blood pressure measurements and urine dipstick tests every two weeks.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age
* Hypertension
* Use of anti-hypertensive therapy for at least 3 months, with stable anti-hypertensive therapy (medication type and dose) for at least 2 weeks
* Daily sodium intake of \>2,000 mg with sodium to kcal ratio \> 1, estimated via Food Frequency Questionnaire
* Ownership and use of an Apple iPhone

Exclusion Criteria:

* Chronic Kidney Disease
* Heart Failure
* Systolic Blood Pressure \>180 mm Hg
* Diastolic Blood Pressure \>110 mm Hg
* Use of a loop diuretic or corticosteroid
* Insulin dependent diabetes mellitus
Comparison of Devices Evaluating Fractional Flow Reserve in Coronary Arteries

The aim of the study is to compare different devices available to measure fractional flow reserve (FFR) in coronary arteries.

The decision to perform a percutaneous coronary intervention (PCI) is usually based on angiographic results alone. Angiography can be used for the visual evaluation of the inner diameter of a vessel. Visual evaluation is limited by inter-individual variability.

Fractional flow reserve provides a functional evaluation, by measuring the pressure decline caused by a vessel narrowing.

The original studies validating the use of FFR were conducted with only one device (St-Jude Medical®). Recently, new FFR devices have been commercialized but have not yet been compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized at Caen University Hospital for coronary angiography
* Coronary stenosis needing FFR evaluation according to recommendations
* More than 18 years old
* Clinically stable
* De novo coronary stenosis
* Affiliated to social security
* Informed consent signed

Exclusion Criteria:

* Unstable patients defined by acute coronary syndrome \< 7 days
* Contre-indication to adenosine administration (asthma, allergy, high grade atrio-ventricular bloc without pace maker)
* History of coronary artery bypass
* intra-stent restenosis
* Patient not capable of understanding the study
* Informed consent not signed
Incentives for Postnatal Care Demand

The purpose of this study is to identify the causal impact of performance-based monetary incentives in increasing postnatal care (PNC) referrals by traditional birth attendants (TBAs), via a randomized controlled trial (RCT).


Eligibility Criteria:
Inclusion Criteria:

* community-based providers of antenatal and/or delivery care, and who are non-formally trained
* must be resident within the community
* must not plan to relocate over the intervention duration
* identified in partnership with community leadership
* be willing to participate fully in the study, including having their clients contacted for verification

Exclusion Criteria:

* plan to relocate over the intervention duration
* refusal to provide informed consent for the entire study protocol including agreeing to have their delivery clients contacted for verification
Feasibility of Home-based Measurement of Walking Capacity Using Global Positioning System in Peripheral Artery Disease

The purpose of this study is to assess the feasibility of home-based measurement of walking capacity in peripheral arterial disease (PAD) patients, uing the Global Positioning System (GPS). This study should state if the GPS technique could be used in clinical routine in order to assess walking capacity in PAD patients. Patients will be assessed a first time (test 1) and six months later (test 2).

The measurement of walking capacity in PAD patients is an important step in the management of such patients. The gold standard method to assess this walking capacity is the measurement of the maximal walking distance on a treadmill. However, treadmill measurement are not readily accessible and the relationship with free-living walking capacity is, although not well known, weak. A novel approach was developed using a Global Positioning System in order to assess community-based walking capacity. This method showed interesting results, validating the technique, but was limited to one laboratory and to the place where the measurements were performed. The next step is therefore to assess the feasibility of home-based measurement of walking capacity using the GPS technique, through a multicenter study regrouping university hospitals, independent vascular specialists (angiologists) and private clinic(s).

Eligibility Criteria:
Inclusion Criteria:

* ABI \< 0.90 or patients with vascular history (surgery, endovascular treatment) and having vascular type claudication
* Older than 18 years
* Vascular-type claudication (defined by the Leriche classification and the Edimbourg questionnaire criterion)
* Informed consent of the patient

Non-Inclusion Criteria:

* No informed consent of the patient
* Exercise (walking) limitation other than vascular explained limitation
* Critical limb ischemia (Leriche stage 3 or 4)
* Major cardiovascular events in the last 3 months
* Pregnant woman
* Patient unable to understand the protocol of the study

Exclusion Criteria:

* Withdrawal of the informed consent of the patient following the inclusion period
* Emergence of a non-inclusion criteria during the inclusion period
* Patient with a GPS maximal walking distance \> 2000 meters following the first evaluation (can not be considered as having a major walking limitation)
Evaluation of Multi-Cancer Early Detection Testing in a High-Risk Military Population: The Sentinel Study

The purpose of this research study is to evaluate the possible benefits of an investigational, but commercially available Galleri multi-cancer early detection (MCED) blood test which is designed to detect many types of cancer early in veterans who have served in the military in active duty.

The name of the screening blood test being studied is:

-GRAIL Galleri MCED test

This research study aims to assess the performance of the Galleri multi-cancer early detection (MCED) screening test in a military population and to compare the number and types of cancers diagnosed using MCED testing versus standard of care. This research study will give doctors and participants results of Galleri® blood tests which is designed to detect many types of cancer.

The research study procedures including screening for eligibility, blood draws, questionnaires, and clinic visits.

Participation in this research study is expected to last for up to 1 year.

It is expected that about 1,500 people will take part in this research study.

The Department of Defense (DoD) is funding this study.

Eligibility Criteria:
Inclusion Criteria:

* Active-duty or National Guard/Reserves military service for eight or more years
* Age ≥ 45
* Received care at a VA facility within past 5 years
* Able to sign informed consent
* Willingness to travel to Dana-Farber Cancer Institute in Boston, MA, for diagnostic testing if screening test indicates possible malignancy

Exclusion Criteria:

* Individuals diagnosed with invasive malignancy within 3 years of enrollment (non- melanoma skin cancer is acceptable)
* Individuals with evidence of symptomatic or active cancer requiring therapeutic intervention at the time of participation (hormone therapy for breast/prostate cancer is acceptable)
* Individuals in the process of being evaluated for a clinical suspicion of cancer
Memory and Attention in Healthy Children

This project studies memory and attention in healthy children aged from 5 to 17 years. The processes investigated are short term memory (auditory and visual) and attention.

To characterize these processes involved in childhood, neuropsychological and neurophysiological assessments will be performed (using Electro-encephalography measures, behavioural responses and questionnaires).


Eligibility Criteria:
Inclusion Criteria:

* Normal or corrected vision
* No neurological and psychiatric antecedent.
* No neuro-developmental disorder (dysphasia, dyslexia, dyspraxia, attention deficit disorder...)
* Motivation to participate to the study
* Signed parental informed consent authorizing their child to participate to the study

Exclusion Criteria:

* Children educated in a specialized institution.
* Subjects diagnosed with a neurological, psychiatric or neuro-developmental disorder
* Subjects with hearing loss
* Subjects with a visual impairment that cannot be corrected
* Subjects with an organic or chronic disease that can affect cognitive functions.
* Subjects who do not benefit from social security.
Microbiome Composition Changes on 4 Week Gluten-free Diet Challenge

Changes in the gut microbiomes of healthy volunteers who followed a gluten-free diet (GFD) for four weeks were studied. Per participant, nine stool samples were collected: one at baseline, four during the GFD period, and four when they returned to their habitual diet. Microbiome profiles were determined using 16S rRNA sequencing and the samples were next processed for taxonomic and imputed functional composition. Additionally, participants kept a 3-day food diary and six gut health-related biomarkers were measured.


Eligibility Criteria:
Inclusion Criteria:

* healthy participants aged \>=16

Exclusion Criteria:

* Known gastrointestinal disorder
* Known food intolerance