cyrilzakka/clinical-trials huggingface dataset:
Effect of Polyphenol Supplementation on Hepatic Steatosis and Vascular Compliance

The main objective is to study the effect of polyphenol supplementation on hepatic steatosis as measured by hepatic ultrasound, hepatic magnetic resonance imaging and on intima-media thickness and vascular elastography in obese adolescents known for hepatic steatosis as diagnosed by liver biopsy

1. Evaluate the feasibility of a larger, open-label, randomized, controlled trial on the effects of polyphenol supplementation:

   Recruitment, compliance to polyphenol supplementation and the visit roadmaps Duration of the radiological exams and participants' satisfaction and point of view on the experience. Test the relevance of using a food diary. Test the effectiveness of the data collection procedure during the visits. Explore the obstacles encountered while performing the radiological exams and the rate of adverse events (AE). Calculate the sample size of the future randomized clinical study
2. Effects of polyphenols IMT and vascular elastography. Anthropometric measurements, insulin resistance, inflammation, lipid/lipoprotein profile, gut microbiome and liver function
3. Evaluated different imaging modality for steatosis Different imaging modalities will be compared between children

Eligibility Criteria:
Inclusion Criteria:

* Aged 12 to 18 years
* BMI percentile \> 85th for age and sex
* Diagnosis of hepatic steatosis on imaging (ultrasound or MR).
* Diagnosis of hepatic steatosis, NASH, or fibrosis on liver biopsy.
* Elevated alanine aminotransferase (ALT) enzyme level.
* Index of hepatic steatosis 8xALT/AST + BMI (+2 for girls) \> 30.

Exclusion Criteria:

* Known chronic systematic diseases
* Any other serious conditions which, according to the doctor's judgment, would prevent compliance and safe participation in the study until completion.

Exclusion criteria to be validated when contacting the participants and their parents/tutors:

* Being pregnant.
* Taking all kinds of prescription or over-the-counter natural health products/natural supplements/vitamins on an ongoing basis or within the next four months, excluding vitamin D.
* Weight loss of 5% to 10% of the usual weight in the last six months before recruitment or weight change of 5% in the last three months.
* Alcohol consumption \> two drinks/day or \> one day/week.
* Known peanut allergy and/or to the medicinal ingredients contained in the active polyphenol supplement: elderberry, haskap, black chokeberry, blueberry, blackcurrant.
* Any contraindications for MRI.
Comparison Between Split Septum and Mechanical Valve Needleless Connector in Preterm Babies

The goal of this clinical trial study is to compare the effectiveness between split septum and mechanical valve needleless connector in very preterm babies (or under 1500 grams)

The main questions it aims to answer are:

* What is the incidence of Central Line-Associated Bloodstream Infections when using a split septum connector?
* What is the incidence of Central Line-Associated Bloodstream Infections when using a mechanical valve connector?
* What is the ratio length of stay between babies with birth weight \< 1500 grams who use split septum connector and mechanical valve?
* What is the ratio incidence of mortality due to sepsis of babies with birth weight \< 1500 grams who use split septum connector and mechanical valve?

Participants will be observed for two weeks after insertion of central line. They will be taken blood sample for culture and sepsis marker panel.

Researchers will compare split septum group and mechanical valve group to see if there is a central line associated bloodstream infections


Eligibility Criteria:
Inclusion Criteria:

* Preterm neonates with gestational age less than and equal to 32 weeks
* Birth weight less than 1500 gram
* Neonates indicated to use central line access
* Parents are willing to participate in this study and has filled and signed the informed consent letter

Exclusion Criteria:

* Neonates who are previously diagnosed as CLABSI
* Neonates who has other focus of infection that are diagnosed before the recruitment
* Suffer from congenital abnormalities
Effects of Exercise in Patients with Lipedema

Lipedema is a chronic progressive disease characterized by symmetrical, disproportionate swelling of subcutaneous adipose tissue, which is common in women and mostly seen in the lower extremities and to a lesser extent in the upper extremities. Healthy lifestyle approaches including exercise treatments are very important for lipedema patients in order to prevent disease progression. The aim of this study is to investigate the effects of exercise on edema, pain, exercise capacity, lower extremity muscle strength and function in lipedema patients. Sociodemographic information of the patients, body composition with Tanita InnerScan BC-601-CG device, clinical information regarding lipedema, type and stage of lipedema, inspection, palpation findings will be recorded. Local tissue water percentage will be assessed using Moisturemeter-d compact (MMDc, Delfin Technologies, Kuopio, Finland) device, circumference measurement using tape, pain intensity with Visual Analog Scale, pain threshold with Baseline brand digital algometer device. Muscle strength will be assessed using K-Force hand dynamometer. Functional exercise capacity will be assessed with the 6-minute walk test (6MWT), and lower extremity dysfunction with the lower extremity functional scale. After the assessments are made, the patients will be randomly divided into 2 groups. The patients in the study group will perform group exercises consisting of warm-up, loading and cool-down periods of 40-50 minutes, 2 days a week for 6 weeks, and strengthening exercises applied to the hip muscles and knee extensors with elastic resistance bands, which are decided according to the level of effort perceived by the patient, 3 sets of 10 repetitions, 2 days a week for 6 weeks. The same assessments will be applied to the patients again at the end of the exercise program. The control group will be re-evaluated after 6 weeks with suggestions regarding lipedema and physical activity level, and the obtained data will be compared.


Eligibility Criteria:
Inclusion Criteria:

* Having a diagnosis of Lipedema,
* Patients with Lipedema stage 1,2 and 3

Exclusion Criteria:

* Individuals with cardiopulmonary, rheumatic or neurological diagnoses that have symptoms severe enough to prevent participation in exercise,
* History of cancer, surgery or trauma that may affect the circulatory system,
* History of liposuction or orthopedic surgery within the last year,
* Individuals who cannot mobilize independently.
SpecTRA; An Observational Study of the Verification of Protein Biomarkers in Transient Ischemic Attack.

A multi-protein test using mass spectrometry (MS) for multiplexed protein quantitation is being developed. This test and the accompanying decision-aid software will provide Transient Ischemic Attack (TIA) results rapidly for a fraction of the price of neuroimaging. With guidance provided by this test, Emergency Department (ED) physicians can manage medical imaging questions such as the use of Computed Tomography Angiography (CTA) prior to ED discharge and appropriate (timely) referral to stroke clinics for consultation and follow-up care. The right patients will receive the right treatment, reduce unwarranted imaging risks and costs, and reduce the burden of stroke.

This study represents an initial Verification study, in which Mass Spectrometry will be used to quantify a large number of blood proteins previously implicated in ACVS and mimic conditions in patients who are consented and enrolled in the Emergency Department within 24 hrs of symptom onset. 560 patients will be enrolled, and grouped into two cohorts (Cohort 1A: 220; and Cohort 1B: 350).

In Cohort 1A, each consented participant provides three blood samples: on arrival, 4-6 hours later, then \~24 hours after that, but no later than 32 hours from symptom onset. In cohort 1b, each patient provides only a single blood sample up to 24 hours from symptom onset.

A positive diffusion-weighted imaging (DWI) signal on Magnetic Resonance Imaging (MRI) or definite ischemia on Computed tomography (CT) or vascular occlusion on CTA will be used as proof of ischemia to classify the clinical phenotype into three groups (see below). A neurologist will adjudicate all cases according to a study defined adjudication protocol.

Eligibility Criteria:
Inclusion Criteria:

1. Age 19 and older
2. Suspected TIA (as per \<4 NIHSS; or ED physician referral to stroke clinic;
3. English speaking or translator available
4. Competent to provide consent and report symptoms
5. Provides at least one blood sample for the study within 24 hours after symptom onset

   * If three blood samples, then the patient is included in the Verification study 1 Cohort A.
   * If one blood sample, then patient is included in the Verification study 1 Cohort B.

Exclusion Criteria:

1. Stroke requiring admission to hospital based on only clinical observations (including CT scan) made before the MRI.
2. Unable to have MRI/CT
3. Subject unable to provide consent.
4. Isolated monocular blindness.
A Survey to Evaluate the Cardiovascular Risk Status of Subjects With Pre-Diabetes in Hong Kong

Hypothesis: A high cardiovascular risk is present in subjects with pre-diabetes in Hong Kong Chinese.

The investigators plan to assess Chinese subjects in Hong Kong who have pre-diabetes (impaired fasting glucose, IFG; or impaired glucose tolerance, IGT) based on oral glucose tolerance test (OGTT) on their cardiovascular risk status such as obesity, hypertension and lipid profile.


Eligibility Criteria:
Inclusion Criteria:

* Hong Kong Chinese with confirmed IFG or IGT by OGTT

Exclusion Criteria:

* Confirmed diabetic patients
Radiofrequency and Cryoablation of the Posterior Wall of the Left Atrium

Atrial fibrillation (AF) is the cause of 20% of strokes, and the risk of stroke in a person suffering from this arrhythmia increases by 5 times. Ischemic stroke in patients with AF is often fatal and, compared with stroke of other etiology, leads to the most pronounced disability and more often recurs. Accordingly, the risk of death in patients with AF-related stroke is 2 times higher, and treatment costs increase 1.5 times.

The main interventional method of treating AF, available in most medical institutions, is the use of radio frequency and/or cryoenergy to eliminate destructive damage to the left atrium (LA).

The aim of this study is to compare two different interventional methods and identify predictors of recurrence in patients with persistent and long-term AF.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years old;
* Atrial fibrillation resistant to antiarrhythmic therapy;
* Persistent and long-persisting form of atrial fibrillation;
* The patient's consent to participate in the study.

Exclusion Criteria:

* Age under 18 and over 80 years old;
* The presence of another cardiac pathology requiring surgical treatment;
* Congenital heart defects;
* Previous "open" cardiac surgery;
* Bone marrow diseases;
* Pathology of the blood coagulation system;
* The left ventricular ejection fraction is less than 40%;
* Moderate to severe renal insufficiency (creatinine clearance \<50 ml/min);
* Drug-resistant hypertension (despite hypotensive therapy);
* Organically altered mitral valve;
* There are reasons to assume that the patient will not show up for subsequent visits (control points of the study) for various reasons;
* The patient's participation in another clinical trial.
Development and Validation of a Daily Pain Catastrophizing Scale

This study sought to develop and validate a brief, daily version of the Pain Catastrophizing Scale.

The Pain Catastrophizing Scale (PCS; 13 items; factors: rumination, helplessness, magnification) (Sullivan 1995) measures trait catastrophizing in the context of actual or anticipated pain. Currently, there is no validated tool for measuring pain catastrophizing at the daily level. Lack of a validated daily measure stands as a barrier for studies that aim to characterize mechanisms of pain treatment and how PC adaptation / change occurs.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or above
2. Chronic pain of any etiology
3. Online access
4. Ability to participate in daily measurements over 14 days

Exclusion Criteria:

1. Lack of ability to answer questionnaires and daily catastrophizing captures, at the discretion of study staff.
Autologous HBV-specific T Cell Receptor Engineered T Cells (TCR-T) in Patients With HBV-related Advanced HCC

Adoptive cell therapy with TCR-T cells targeting HBV antigens represents an innovative opportunity for treatment of HBV-related HCC. SCG101 is a genetically modified autologous TCR-T cell therapy with a natural high-avidity TCR directed towards the HLA-A\*02-restricted HBsAg peptide. This is a phase 1 clinical study of SCG101 alone and with PD-1/PD-L1 checkpoint inhibitors in HBV-related HCC.

This is an open-label, multi-center clinical study to evaluate the safety, tolerability and effectiveness of SCG101, with and without PD-1/PD-L1 checkpoint inhibitors, in patients with HBV-related HCC. Lymphodepleting regimen of cyclophosphamide and fludarabine will be given prior to SCG101 infusion.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed, or imaging diagnosed HCC
2. HLA-A \*02 genotyping
3. HBsAg positive in serum or tumor tissue
4. Have at least one measurable lesion at baseline as per mRECIST and RECIST v1.1 criteria
5. Child-Pugh score ≤ 7
6. ECOG performance status of 0 or 1
7. Life expectancy of 3 months or greater
8. Patient with adequate organ function

Exclusion Criteria:

1. Uncontrolled portal vein or inferior vena cava tumor thrombosis
2. Untreated or active Central nervous system (CNS) metastasis or other clinically significant CNS diseases
3. Active or uncontrollable infections
4. History of organ transplantation
5. Lack of peripheral or central venous access or any condition that would interfere with study drug administration or collection of study sample
6. History of positive results for human immunodeficiency virus (HIV) 1 or 2 or known acquired immunodeficiency syndrome (AIDS)
7. Prior exposure to any cell therapy
8. Other severe medical conditions that may limit subject's participation in this trial
Mazankowski Alberta Heart Institute (MAHI) EchoGo Discovery 1 Protocol

This study aims to compare conventionally acquired Left Ventricle Ejection Fraction (LVEF) and Global Longitudinal Strain (GLS) data to Artificial Intelligence (AI) driven automated processing of 2 dimensional contrast and 2 dimensional non-contrast resting transthoracic echocardiograms for application in the assessment of patients undergoing chemotherapy with cardiotoxic drugs. This is a single-centre retrospective study which utilizes echocardiographic DICOM image and meta-data datasets received from a Canadian site. Data processed using the AI driven automated processing will be compared to conventionally acquired LVEF and GLS measurements and results will be analysed to determine accuracy and precision.


Eligibility Criteria:
Inclusion Criteria:

* Normal EF and no regional wall motion abnormalities prior to starting chemotherapy treatment.
* Follow-up EF measurements available for at least 1 year during the treatment period.
* Follow-up EF measurements for at least 1 year during the treatment period.

Exclusion Criteria:

* Age \< 18 years
* Inadequate image quality (as determined by the Ultromics Operators Quality Control process)
Metabolic Phenotypes and Heterogeneity in Disease Burden Risk in Type 1 Diabetes

This study focuses on individuals with type 1 diabetes (T1D) and seeks to comprehensively study and understand several aspects of T1D including: susceptibility to hypoglycemia (low blood sugar) and improvement in hypoglycemia risk using of advanced diabetes technologies, such as continuous glucose monitoring (CGM); the differences among individuals with T1D in the risk of chronic complications, and minimize the psychosocial impact of T1D.

The study seeks to comprehensively study and understand several aspects of type 1 diabetes (T1D) including: the risk of low blood sugar and how that may be improved with new technologies; the variability (heterogeneity) among individuals in their risk of diabetes complications, and factors that could impact the psychosocial burdens of having T1D. The investigators want to learn of there are patient-specific systemic metabolomic profiles (substances detected in blood or urine) that lower the risk for hypoglycemia. Metabolomic analyses will be used to discover biological markers that could predict who is most likely to get diabetes complications, and how these risks might be changed, for example, by developing treatments targeted specifically to those biological markers. The investigators also plan to describe the relationship between metabolomic profiles, psychosocial states and cognitive function.

Eligibility Criteria:
Inclusion Criteria:

* All participants with type 1 diabetes
* Previous enrollment and participation in the University of Michigan T1D cohorts (Natural History of Myocardial Dysfunction in T1D (HUM00036408); Targeting Inflammation with Salsalate in a T1D(HUM00169353); Preventing Early Renal Loss with Allopurinol in T1D (HUM00080944); and Tissue Specific Metabolic Reprogramming (HUM00060967)).
* Willing and able to participate in the study procedures described in the consent form.
* Willing to sign a written or electronic informed consent, including authorization to release health information.
* Fluent in spoken and written English.
* Willing to carry around their mobile phone/study mobile phone during the 14-day home monitoring period with daily access to cellular or WiFi connectivity.

Exclusion Criteria:

* Any social or medical condition that would, in the opinion of the Principal Investigator (PI), prevent complete participation in the study or would pose significant hazard to the subject's participation.
* Skin conditions or diseases that would interfere with the Continuous Glucose Monitor (CGM) sensor placement or accuracy (such as extensive psoriasis, extensive eczema, scarring, etc.)
* Scheduled X-ray, MRI, CT scan, or high-frequency electrical heat (diathermy) treatment during the period of CGM wear (or any other activity that would necessitate CGM sensor removal) that cannot be scheduled around or accommodated within the study assessment windows.
Deep Sclerectomy Versus Trabeculectomy in Normal Tension Glaucoma

The purpose of this study is to assess whether deep sclerectomy is as effective in lowering intraocular pressure (IOP) as trabeculectomy in patients with normal tension glaucoma.

Subjects with normal tension glaucoma that is unstable with current medication needing filtration surgery are recruited in the study. All patients meeting the inclusion criteria and giving informed consent will be randomized to whether having deep sclerectomy or trabeculectomy.

Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent
* Normal Tension Glaucoma with typical nerve fiber layer defects in red-free photographs and/or optical coherence tomography (OCT) and possible equivalent visual field defects, IOP never more than 21 mmHg, and open anterior chamber angle
* Glaucoma unstable with current medication assessed by a glaucoma specialist

Exclusion Criteria:

* Secondary Glaucoma e.g. due to previous injury or uveitis
* Exfoliation syndrome
* Pigment dispersion syndrome
* Previous transscleral or endoscopic cyclophotocoagulation
* Previous other glaucoma surgery
* Previous retinal detachment
* Previous intraocular surgery like vitrectomy and other retinal surgery
* Wet age-related macular degeneration
* Diabetic retonopathy
* Previous corneal transplant or previous refractive surgery
* Fuchs' dystrophy and other abnormalities compromising corneal clarity like scars
* The patient does not want to participate in the study
* The patient does not speak Finnish, Swedish or English
* Dementia
* Only eye with vision worse than 20/200 or loss of central visual field
Measuring the Range of Cardiac Magnetic Parameters in Healthy Subjects by Magnetocardiogram

A prospective and observational clinical study of measuring the range of cardiac magnetic parameters in healthy people with the magnetocardiogram manufactured by Hangzhou Nuochi Life Science Co., LTD

This study is a prospective and observational study on the collection of cardiac magnetic signals from healthy subjects by magnetocardiogram. It is expected that 412 subjects will be examined by magnetocardiography, and the range of parameters related to magnetocardiography in healthy subjects will be reported.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy people aged 18-70 years old;
2. Subjects receiving physical examination in physical examination institutions, or in other departments other than heart disease (such as orthopedics, gynecology, etc.), or in cardiology department, excluded from coronary heart disease;
3. No history of coronary heart disease;
4. ECG did not indicate myocardial ischemia or infarction;
5. Sinus rhythm without arrhythmia;
6. The subject or the subject's legal representative has been informed of the nature of the study, understands the purpose of the clinical study, voluntarily participates in the study and signs the informed consent.

Exclusion Criteria:

1. Acute coronary syndrome requires emergency PCI treatment, and it is estimated that magnetic cardiogram examination will affect the timing of emergency PCI surgery;
2. Subjects with metal implants in the thoracic cavity (including the heart cavity), such as those who have received pacemaker therapy or cardiac resynchronization therapy (CRT, CRT-D) or implantable cardioverter defibrillator (ICD) implantation, or those who have received metal heart valve implantation;
3. There is hemodynamic instability, which is defined as systolic blood pressure \&lt; 80mmHg, or cardiogenic shock; Or need vasoactive drug therapy; Intra-aortic balloon counterpulsation may be required; Or other hemodynamic support devices; As syndrome;
4. Severe tachycardia (ventricular rate \> 150 beats/min), ventricular flutter, ventricular fibrillation and other malignant arrhythmias;
5. Subjects unable to lie flat (supine position);
6. Subjects with mental illness, unconscious or uncontrollable ability; Or claustrophobic subjects;
7. Other circumstances in which the investigator considers the subject inappropriate for participation in the study