cyrilzakka/clinical-trials huggingface dataset:
The AI-CAC Model for Subclinical Atherosclerosis Detection on Chest X-ray

The AI-CAC model is an artificial intelligence system capable of assessing the presence of subclinical atherosclerosis on a simple chest radiograph. The present study will provide prospective validation of its diagnostic performance in a primary prevention population with a clinical indication for coronary artery calcium (CAC) testing.

The AI-CAC-PVS project is a prospective, multicenter, single-arm clinical study, with enrollment at 5 Radiology Units in Piedmont (Italy). Consecutive individuals without prior reported cardiovascular events referred for a non-contrast chest CT for the assessment of coronary artery calcium (CAC) score for cardiovascular risk stratification purposes will be considered for inclusion in the study. Individuals who agree to participate in the study will undergo a standard chest radiograph, as the only deviation from clinical practice. The CAC score will be calculated on chest CT scans according to international standards, and the result will be provided to the patient. Any subsequent changes in behavioral habits, lipid-lowering, antiplatelet, antihypertensive, and antidiabetic therapies prescribed by the attending physician will be collected in a dedicated dataset, along with the occurrence of cardiovascular events at the last available follow-up.

The AI-CAC model will be applied to the chest radiograph, yielding an AI-CAC value as output. The patient, radiologist, and attending physician will not be informed of the AI-CAC value until the end of the study.

The primary outcome will be the accuracy of the AI-CAC model to detect the presence of subclinical atherosclerosis on chest x-ray as compared to the CT scan (i.e. CAC \>0). The ability to predict clinical outcomes at follow-up (ASCVD, atherosclerotic cardiovascular disease events comprising myocardial infarction, ischemic stroke, coronary revascularization and cardiovascular death) will be assessed as exploratory secondary outcome.

Eligibility Criteria:
Inclusion Criteria:

* Consent to participate in the study
* Age between 40 and 75 years
* Clinical indication from the treating physician to undergo chest CT for CAC score evaluation

Exclusion Criteria:

* Prior cardiovascular events (myocardial infarction, coronary revascularization, transient ischemic attack, stroke, symptomatic peripheral vascular disease, arterial revascularization of peripheral districts)
* Cancer or other chronic diseases with an estimated prognosis of less than five years
* Technical contraindications to the execution of chest CT with electrocardiographic gating (highly penetrant atrial fibrillation, frequent ventricular extrasystoles)
The Effect of Almond and Extra Virgin Olive Oils on Maintaining Skin Integrity in Neonates

This study aimed to evaluate the effects of extra virgin olive and almond oils on maintaining skin integrity in neonates admitted to the neonatal intensive care unit.

Interventional research with two parallel groups and no control group

The study was conducted in the Neonatal intensive care unit (NICU) of a training and research hospital.The total number of infants admitted to the NICU was 28. Each nurse is responsible for the care of 3 or 4 newborn babies.

Skin are routines in the NICU: A skin condition assessment score is routinely performed every day (09.00 am) in all infants and moisturizing products are used for their skin care. Therefore, there was no control group in the study.

Extra virgin olive oil and almond oil are among the skin care products used in the clinic routines. Therefore, the effects of the currently used oils were compared in the study

Eligibility Criteria:
Inclusion Criteria:

* Neonates who were born at 37-42 weeks of gestation, were planned to be hospitalized in the NICU for at least 5 days, had a post-natal age of 0-72 hours, and were received written and verbal consent from parents were included in the study.

Exclusion Criteria:

* ; Neonates who were discharged before 5 days and required phototherapy were excluded from the study.
Postoperative Results of Incisional Endometriosis

The primary aim is to determine the endometriotic foci formed in the incision line after surgical operations, and the medical treatment approach is the primary objective. Medical treatment was initiated and the patients who did not benefit from the treatment would be operated and postoperative pain scores would be compared with the medical treatment. It will be tried to determine which treatment is more effective in pain control.

In addition to removing the symptoms and providing therapeutic methods in patients, it is aimed to help in differential diagnosis of dermatological diseases and malignancy and thus to prevent anxiety in patients. It is also aimed to evaluate the pathology results in the most appropriate way to eliminate the symptoms (severe pain, bleeding, etc.) that occur in accordance with the menstrual cycle every month.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have undergone surgery previously and who have an incision in the abdominal region and who applied with a complaint of mass in the incision and who were primarily considered endometrial focus in the diagnosis,
* Patients who were diagnosed with endometriotic foci in the incision line and used medical treatment for a while, but who did not benefit because of surgical excision.

Exclusion Criteria:

* Dermatologically diagnosed patients
* Follow-up patients with malignancy diagnosis
* Patients who have responded to medical treatment
A Clinical Study of the Value of Circulating Free Methylated EBV DNA in Extranodal NK/T Cell Lymphoma

This study is a prospective, multicenter, open-label, single-arm clinical study. This study plans to enroll 72 newly diagnosed ENKTCL patients. The enrollment was completed in 2 years, and the follow-up was terminated in 4 years. To observe the accuracy of circulating free methylated EBV DNA in predicting 2-year PFS rate, 2-year OS rate, and CR rate in newly diagnosed ENKTCL patients; and to clarify the prognostic stratification ability of PINK-cpgE compared with PINK-E


Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed ENKTCL confirmed by pathological tissue, the diagnostic criteria refer to the 2016 WHO diagnostic criteria
* Sign written informed consent and be able to comply with the visits and related procedures specified in the protocol

Exclusion Criteria:

* The investigator believes that the subjects may have other factors that may affect the efficacy or safety evaluation of this study
Sleep Health Enhancement in Midlife Adults

Despite the strong links between sleep and AD, a sleep health enhancement has yet to be targeted in mid-life adults (45-64 years old) to delay or prevent AD. An intervention aimed at enhancing sleep health is a critical opportunity for primary prevention to potentially delay the onset of AD. The objective of the proposed study is to develop and assess the feasibility, acceptability, and treatment effect of a comprehensive sleep health intervention (SHI) on improving sleep health in mid-life adults


Eligibility Criteria:
Inclusion Criteria:

* 45-64 years old
* ≤ 7 on the RU-SATED self-report questionnaire
* MMSE ≥25 and AD8 \<3

Exclusion Criteria:

* Known untreated sleep disorder (such as sleep apnea or restless leg syndrome)
* \>3 on the STOP BANG indicating increased risk of sleep apnea
* Increased risk of restless legs syndrome on RLS-Diagnosis Index
* Evidence of circadian rhythm sleep-wake disorder
* Evidence of parasomnia
* Regular use (\>2x/week) of prescription or over-the-counter medications to improve sleep
* Score of ≥15 on the Patient Health Questionnaire (PHQ-9) indicating severe depression or endorsement of any suicidal ideation (answer 1, 2 or 3 on #9 of the PHQ-9)
* Score of ≥10 on the Generalized Anxiety Disorder (GAD-7) indicating moderate to severe anxiety
* Self-report of current or history (up to 2 years) of drug or alcohol abuse based on the DSM-5-TR criteria
* History of nervous system disorder such as stroke or Parkinson's disease
* Severe mental illness such as schizophrenia or bipolar disorder
* Current or history (within 5 years) of shift work including hours of midnight-4am
* Is currently receiving a behavioral sleep health intervention
Safety and Pharmacokinetic Comparison of Exforge® and G-0081 in Healthy Male Volunteers

This study investigates safety and pharmacokinetic comparison of G-0081, a combination tablet of amlodipine and valsartan (test formulation), and Exforge®, a combination tablet of amlodipine and valsartan (reference formulation) for single dose in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers between the ages of 20 and 50 and within 20% of their ideal body weight, without congenital abnormality or chronic disease

Exclusion Criteria:

* History of cardiovascular, pulmonary, renal, endogenous, gastrointestinal, hematologic, neurologic or hemorrhagic disease;
* Clinically significant findings on routine laboratory (hematology, serum chemistry and urinalysis) or ECG tests;
* Use of prescription drugs in the 14 days immediately prior to starting the study that had the potential to interact with the study medication;
* Use of any substance that could induce or inhibit drug metabolism enzymes
18F-FLT-PET in Breast Cancer (MK-0000-139)

This study correlated changes from baseline in Ki-67, an immunohistochemical marker of cell proliferation, with changes from baseline in tumor uptake of 3'-deoxy-3'\[18F\]-fluorothymidine (18F-FLT) following the first cycle of treatment with standard of care neo-adjuvant therapy in participants with breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Has newly-diagnosed stage IIB/IIIA/IIIB locally advanced breast cancer
* Is eligible for pre-operative (neo-adjuvant) chemotherapy

Exclusion Criteria:

* Has a contraindication to magnetic resonance imaging (MRI)
* Any condition that would limit ability to undergo MRI or PET scans
* Is a nursing mother
* Has moderate to end-stage renal disease and is not on dialysis or has renal failure on chronic dialysis
Clinical Cardiac Rehabilitation Registry Study

Establish an electronic cardiac rehabilitation patient registration system and clinical database, carry out prospective cohort follow-up and observation of cardiovascular disease (CVD) patients receiving cardiac rehabilitation in inpatients and outpatients, collect risk factors, diagnosis and treatment status, rehabilitation diagnosis and treatment, clinical outcomes and follow-up results, and establish a short-term and long-term follow-up mechanism.

Establish an electronic cardiac rehabilitation patient registration system and clinical database, carry out prospective cohort follow-up and observation of cardiovascular disease (CVD) patients receiving cardiac rehabilitation in inpatients and outpatients, collect risk factors, diagnosis and treatment status, rehabilitation diagnosis and treatment, clinical outcomes and follow-up results, and establish a short-term and long-term follow-up mechanism. Through the real world clinical practice data of cardiac rehabilitation of CVD patients, describe the population and disease characteristics of cardiac rehabilitation patients, the provision of cardiac rehabilitation services and the influencing factors; Analyze and study the key technologies of clinical cardiac rehabilitation, evaluate the implementation quality of cardiac rehabilitation, improve the clinical pathway of cardiac rehabilitation, and optimize the service process.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age and older.
2. Patients receiving inpatient cardiac rehabilitation, and/or participating in outpatient cardiac rehabilitation.
3. All cases selected were in New York Heart Association (NYHA) cardiac function class II and below.
4. Normal troponin.
5. Patients with some ability to communicate and understand.
6. have signed an informed consent form. -

Exclusion Criteria:

1. Subjects who are participating in clinical trials of other drugs or devices.
2. Patients with NYHA cardiac function class III or higher.
3. Mentally impaired, or unable to communicate effectively with investigators.
4. Refusal to sign the informed consent form.
Safety & Immunogenicity Study of Meningococcal Vaccine GSK134612 Given With Priorix-Tetra™ to 12-23 Month-Old Children

The purpose of this study is to demonstrate, in 12-23 month old children, the non-inferiority of the meningococcal vaccine 134612 given with Priorix-Tetra.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Open multicentre study with 4 treatment groups. Two groups will receive the 134612 vaccine with Priorix-Tetra either at the same or different visits followed by a second Priorix-Tetra vaccination at 84 days.

Two control groups will receive Priorix-Tetra and Meningitec at different visits followed by a second Priorix-Tetra vaccination at 84 days.

For all subjects, two blood samples will be taken: prior to and 42 days after the first vaccination. In a subset (30% of subjects in Groups A en C) from selected study centres: additional sample 42 days after second Priorix-Tetra dose.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
* A male or female between, and including, 12 and 23 months of age at the time of the vaccination.
* Written informed consent obtained from the parent or guardian of the subject.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.
* Previously completed routine childhood vaccinations to the best of parents' or legal guardians' knowledge.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
* Planned administration/ administration of a vaccine not foreseen by the study protocol within one month before and 42 days after the first dose of vaccine(s).
* Previous vaccination with meningococcal vaccine of serogroup A, C W and/or Y.
* History of meningococcal disease.
* Previous vaccination against measles, mumps, rubella, and/or varicella.
* History of measles, mumps, rubella and/or varicella.
* Known exposure to measles, mumps, rubella, varicella or zoster within 30 days prior to vaccination.
* Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including neomycin.
* Major congenital defects or serious chronic illness.
* Acute disease at the time of enrolment.
* Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
Comparative Analysis Between Sleeve Gastrectomy and Roux-en Y Gastric Bypass in Bariatric Operation

Prospective, double-arm, multi-center cohort study on obese patients, for laparoscopic sleeve gastrectomy versus Roux-en Y gastric bypass

This is prospective cohort study. Total 400 obese patients will be enrolled(Sleeve gastrectomy 200 patients, Roux-en-Y gastric bypass 200)

The principal investigator or another clinical investigator in charge will individually inform the patients about the study, before operation at out patient clinic. At that time patient is selected to either sleeve gastrectomy group or Roux-en-Y gastric bypass group. All investigator report to clinical research center about patients BMI and operation method.

About 30-35 obesity patients will be enrolled according to their BMI status. Patients' BMI status is classified into several parts by 2.5 gap started from 27.5.

All patients will undergo periodically anthropometry, laboratory tests, bioelectrical impedance analysis, gastrofiberscopy, polysomnography and abdomen CT before and after surgery.

Patients with hypertension will undergo echocardiography. Patients with polycystic ovary syndrome will be checked hormonal study. Patients with type 2 diabetes mellitus will be performed 75g oral glucose tolerance test test.

Surgical complication include wound morbidities, gastrointestinal leakage or fistula, postoperative bleeding, intra-abdominal abscess, stricture , adhesive ileus, reflux esophagitis, marginal ulceration, dumping syndrome and internal hernia.

Systemic complication which is not associated with the operation field include ling morbidities, heart morbidities, urinary morbidities and others.

Hospital mortality is defined as postoperative death form any cause within 30 days after operation.

All patients will be followed up post operative 1 month, 3 month, 6 month, 12 month, 18 month, 24 month.

All patients' liver tissue, visceral fat and subcutaneous fat will be harvested during operation.

All patients' blood sample will be collected at out patient clinic visit. All patients' urine and face will be collected at out patient clinic visit and will be analyzed to evaluate microbial change throughout pre and post operation period.

Eligibility Criteria:
Inclusion Criteria:

* obesity patients(BMI over 35)
* morbid obesity patients(BMI over 30) with cardiovascular disease, hypertension, hyperlipidemia, type 2 diabetes mellitus, obstructive sleep apnea
* type 2 diabetes mellitus obesity patients(BMI over 27.5) who were treated medical therapy or HbA1C level over 7%

Exclusion Criteria:

* Patients who underwent previously bariatric operation
* Patients who were diagnosed malignant disease patients within 5 years
* Patients who were involved with other clinical trial within 3 months
* Patients who are risky to conduct general anesthesia for operation
Optimizing Individual Health Care for Young People With Gender Incongruence

This observational study focuses on evaluating the effect of the current health care program for Danish children and adolescents with gender incongruence, which was established in January 2016. Somatic outcome parameters include growth, bone health, body composition, metabolic parameters, hormone levels and concurrent diseases. Psychosocial parameters include the trajectory of gender incongruence development, mental health, i.e. autism spectrum disorders, behavioural problems, self-harm, suicidal ideation and psychiatric diagnoses, and social context, i.e. family demographics, education, minority stress.

This study aims to:

1. Characterise the psychosocial profile of all children and adolescents referred for treatment, as well as the history of gender identity development and treatment trajectories.
2. Systematically evaluate biological parameters before and during hormonal treatment with gonadotropin-releasing hormone (GnRH) analogues and cross-sex hormones, and to establish a biobank for those in hormone treatment.

The investigators hypothesise that intervention with counselling and hormonal treatment is safe and has a positive impact on psychosocial well-being of transgender youngsters. The overall aim is to provide data for improving future family counselling, clinical care, patient satisfaction, patient safety and ultimately quality-of-life.


Eligibility Criteria:
Inclusion Criteria:

* Accepted referral to the gender identity service.

Exclusion Criteria:

* None.
Renal Outcomes in the Early Use of Vasopressin in the Treatment of Septic Shock

The aim of the present study is to verify whether the earlier association of vasopressin and norepinephrine, in patients in septic shock, determines variations in terms of use of renal function replacement techniques in the first 7 days of hospitalization in Intensive Care, compared to patients in whom vasopressin is added only when norepinephrine reaches a higher dose.

The aim of the present study is to verify whether the earlier association of vasopressin and norepinephrine, in patients in septic shock, determines variations in terms of use of renal function replacement techniques in the first 7 days of hospitalization in Intensive Care, compared to patients in whom vasopressin is added only when norepinephrine reaches a higher dose. The study is aimed at patients admitted to the ICU with a diagnosis of septic shock on admission or in the first 24 hours of admission.

Patients will be divided and randomized in a 1:1 ratio through a computer-generated scheme, when the dose of norepinephrine administered is ≥ 0.25 mcg/kg/min, into the following groups:

* Group A: when the norepinephrine dosage is equal to or greater than 0.25 mcg/kg/min in the absence of adequate MAP (Mean arterial pressure \>65 mmhg), vasopressin infusion will be associated with the standard dosage of 0.3UI/min.
* Group B (control): the infusion of vasopressin at a dosage of 0.3 IU/min will be associated if norepinephrine exceeds the dosage of 0.5 mcg/kg/min in the absence of adequate MAP.

Eligibility Criteria:
Inclusion Criteria:

* patients suffering from septic shock hospitalized in an intensive setting
* patients over 18 years and under 80 years of age
* patients within 24 hours of clinical diagnosis, and requiring, in this time window, a norepinephrine dosage equal to or greater than 0.25 mcg/kg/min according to the patient's ideal weight (IBW)
* patients capable of expressing informed consent to treatment.

Exclusion Criteria:

* patients in the absence of consent to participate in the study and to the processing of personal and particular data;
* patients under 18 years of age or over 80 years of age;
* patients who died within the first 24 hours of admission to the ICU;
* patients requiring a norepinephrine dosage lower than 0.25 mcg/kg/min in the first 24 hours of hospitalization in the ICU;
* patients with recent acute coronary syndrome (within the previous 7 days);
* patients with allergy/intolerance to the drugs used in the study or to any component of the study drug including excipients;
* pregnant patients;
* breastfeeding individuals;
* patients who need to start renal replacement treatment within 24 hours of admission to the ICU for dialysis emergencies that cannot be deferred;
* patients with a history of end-stage renal failure or already undergoing dialysis treatment (CKD stages 4 and 5, with glomerular filtration \< 30 ml/min);
* single kidney patients;
* patients with bilateral renal hypoplasia;
* patients undergoing kidney transplant;
* patients undergoing haemoperfusion with an adsorbent cartridge for bacterial endotoxin.