cyrilzakka/clinical-trials huggingface dataset:
Decision Support Following Genetic Testing for Breast-Ovarian Cancer Susceptibility

This non-therapeutic trial is for women who have received results of genetic testing for BRCA1/2 mutations. The trial compares decision support tools designed to facilitate informed decision making regarding risk management following testing to usual care. The researchers will test separate decision support tools for women who receive positive test results and women who receive negative/inconclusive test results. Among women who receive a positive test result, an interactive decision support intervention will be compared to a print intervention. Among women who receive an inconclusive result, an interactive intervention will be compared to usual care.


Eligibility Criteria:
Inclusion Criteria:

* Undergo BRCA1/2 genetic counseling and testing at one of four study sites
* Receive positive or uninformative test results
* English speaking

Exclusion Criteria:

* Newly diagnosed breast cancer patients who have not yet initiated definitive breast cancer treatment
* Previous bilateral mastectomy
A Study of an Automated Insulin Delivery System in Adult Participants With Type 1 Diabetes Mellitus

The purpose of this study is to evaluate whether an Automated Insulin Delivery (AID) System is safe to use and functions as intended with personalized basal insulin rates and when basal insulin rates are increased.


Eligibility Criteria:
Inclusion Criteria:

* Participants with T1DM for at least 2 years and who have used an insulin delivery system with any rapid-acting insulin analog for the preceding 6 months
* Have a body mass index of 18.5 to 37 kilogram per meter squared
* Have a hemoglobin A1c level ≥6.0% and ≤9.0%

Exclusion Criteria:

* Have known allergies or history of hypersensitivity to insulin lispro
* Have had an episode of severe hypoglycemia within the past 6 months
* Have had more than 1 episode of diabetic ketoacidosis in the past 6 months
Effect of Inhalation Sedation Compared With Propofol on the Sepsis-related Acute Respiratory Distress Syndrome Course

Investigation of effect of inhalation sedation by administration of Sevoflurane compared with Propofol on the moderate acute respiratory distress syndrome course in mechanically ventilated patients with sepsis.


Eligibility Criteria:
Inclusion Criteria:

* sepsis
* ARDS
* P/F Ratio 100-250
* start of mechanical ventilation

Exclusion Criteria:

* pregnancy
* concomitant oncological disease
* prior psychological impairment
Dose-finding Study With ACT-132577 (Aprocitentan) in Participants With Essential Hypertension

The main objective will be to evaluate the dose-response of ACT-132577 (aprocitentan) on diastolic blood pressure (DBP) in participants with grade 1 or 2 essential hypertension.

Secondary objectives will be to evaluate the dose-response of ACT-132577 on: systolic blood pressure (SBP); control and response rate of blood pressure; 24-hour ambulatory blood pressure monitoring (ABPM) and to evaluate the safety and tolerability of a once daily oral regimen of 4 doses of ACT-132577.

Participation in the study is planned to last up to 18 weeks. A single-blind placebo run-in period of 4 to 6 weeks after which participants will be randomized into a double-blind treatment period of 8 weeks and a washout and follow-up period ending with an end-of-study visit approximately 12 weeks after randomization.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent prior to any study-mandated procedure
* No contra-indication to stop (according to label) anti-hypertensive treatment(s) at screening
* Mild-to-moderate essential hypertension with or without ongoing anti-hypertensive treatment(s):

  -- Mean (of 5 measurements) sitting diastolic blood pressure (SiDBP) ≥ 90 to \< 110 mmHg measured by office blood pressure measurements (OBPM).
* Women of childbearing potential must have a negative pregnancy test and use of reliable methods of contraception

Exclusion Criteria:

* Severe hypertension (grade 3): mean sitting systolic/diastolic BP (SiSBP/SiDBP; measured by OBPM) ≥ 180/110 mmHg, respectively.
* Secondary hypertension
* Known hypertensive retinopathy greater than Keith-Wagener Grade 2
* Myocardial infarction, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft within 12 months prior to randomization
* Unstable angina within 6 months prior to randomization
* Heart failure New York Heart Association class III and IV
* Valvular defects (such as severe aortic or mitral valve disease) and/or hemodynamically relevant rhythm disturbances
* Clinical evidence of cerebrovascular insufficiency or a cerebrovascular accident within 6 months prior to randomization.
* Subjects working night shifts
* Body mass index \< 20 kg/m2 or \> 40 kg/m2
* Treatment with any medication which may affect BP (e.g., treatment of psychiatric diseases, ophthalmic preparations)
* Treatment with strong cytochrome P450 3A4 (CYP3A4) isoenzyme inhibitors or inducers
* Treatment with guanethidine and/or mineralocorticoid receptor antagonists within 1 month prior to Screening (Visit 1)
* Treatment with another investigational treatment within 1 month prior to Screening (Visit 1)
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
Real-time Automated Program for IDentification of VT Origin

RAPID-VT Pilot is a single centre prospective cohort pilot study to assess the feasibility, safety and efficacy of catheter ablation of ventricular tachycardia (VT) guided by a novel real-time software to localize the origin of VT during the ablation procedure.

Consecutive patients with ischemic heart disease and clinical indication of VT ablation will undergo baseline clinical evaluation, echocardiography and cardiac CT imaging using a contrast-enhanced cardiac-gated method with a 64-section scanner. Trans-axial CT images comprising the whole heart volume will be exported in DICOM format. CT image processing will be performed and will be used to delineate the LV endocardial and/or epicardial geometries. These data will be imported into the RAPID-VT software and the 3D-electranatomical mapping system for image integration.

During the VT ablation procedure, VT(s) induction will be performed. The VT(s) 12-lead ECG will be acquired by the RAPID-VT software and will be localized to the scar margin using the RAPID-VT software. Catheter ablation will be attempted at software-determined sites.

Post procedure, patient will be followed up for a minimum of 6 months. That will include Remote ICD follow-up and telephone study visits. Follow-up at 6 months will include a clinic visit for assessment of heart failure status, ECG, ICD interrogation and changes in antiarrhythmic drug therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be eligible for inclusion if they fulfilled VANISH inclusion criteria by having both of:

  1. Prior myocardial infarction (pathological Q waves or imaging evidence of regional myocardial akinesis/thinning in the absence of a non-ischemic cause)38 and
  2. One of the following VT events within the last 6 months while on Amiodarone or another class III or class I antiarrhythmic drug:

A: Sustained monomorphic VT documented on 12-lead ECG or rhythm strip requiring termination by pharmacologic means or DC cardioversion, B: ≥3 episodes of symptomatic VT treated with anti-tachycardia pacing (ATP), C: ≥1 appropriate ICD shocks, D: ≥3 VT episodes within 24 hours, separated by ≥ 5 minutes, E: sustained VT below detection rate of an ICD

Exclusion Criteria:

* Patients will be excluded from the trial if they:

  1. Are unable or unwilling to provide informed consent.
  2. Have active ischemia or another reversible cause of VT (e.g. drug-induced arrhythmia), or had recent acute coronary syndrome requiring revascularization.
  3. Are antiarrhythmic drug-naïve.
  4. Are known to have protruding left ventricular thrombus or mechanical aortic and mitral valves.
  5. Have had a prior catheter ablation procedure for VT.
  6. Are in renal failure (Creatinine clearance \<15 mL/min)
  7. Have NYHA Functional class IV heart failure or CCS Functional class IV angina.
  8. Have had recent ST elevation myocardial infarction (\< 1 month).
  9. Are pregnant or have a systemic illness likely to limit survival to \<1 year.
A Phase IV Study of the Onset and Maintenance of the Antiplatelet Effect of Ticagrelor Compared With Clopidogrel in Chinese Patients With ACS

The purpose of this study is to test the hypothesis that the onset of the antiplatelet effect of ticagrelor is more rapid and greater than clopidogrel in Chinese patients with ACS.


Eligibility Criteria:
Inclusion Criteria:

* 1. Provision of informed consent prior to any study specific procedures
* 2. Female or male aged at least 18 years
* 3. Females of child-bearing potential must have a negative urine pregnancy test at enrolment and be willing to use reliable contraception
* 4. Index event of non-ST or ST segment elevation ACS.

Exclusion Criteria:

* 1.Contraindication or other reason that clopidogrel or ticagrelor should not be administered (eg, hypersensitivity, active bleeding, moderate or severe liver disease, history of previous intracranial bleed, GI bleed within the past 6 months, major surgery within 30 days)
* 2. Oral anticoagulation therapy or GP IIb/IIIa receptor antagonists therapy within 30 days prior to randomisation or cannot be stopped
* 3. Ticagrelor or clopidogrel or other P2Y12 inhibitors within 14 days prior to randomisation
* 4. Requires dialysis
* 5. Nonselective non-steroidal anti-inflammatory drugs (NSAIDs) and prostacyclins (PGI2) therapy that cannot be stopped
Effect of Intravenous Magnesium on Postoperative Sore Throat After Thyroidectomy

The primary purpose of this study is to investigate the effect of intravenous magnesium on postoperative throat pain after thyroidectomy.

The secondary purpose of this study is to investigate the effect of intravenous magnesium on total dose of fentanyl in recovery room after thyroidectomy.


Eligibility Criteria:
Inclusion Criteria:

* Thyroidectomy

Exclusion Criteria:

* Allergy to magnesium
* Chronic pain
* Chronic opioid use
* Chronic NSAID use
* Renal dysfunction
* Liver dysfunction
* Cardiac arrythmia
* Seizure
Four Locator Attachment Mandibular Overdentures

. There is little information on the degree of crestal bone loss around 4 inter-foraminal implant-retained mandibular overdentures (OVDs) and the amount of bone remodelling on the anterior maxilla and posterior mandibule on long-term function, particularly with different distributions.

Numerous studies confirm the successful use of implants to retain prostheses in the edentulous atrophic mandible. It has been recommended by some authors that clinicians should use 3 or 4 implants in situations that require increased retention, such as high muscle attachment or prominent mylohyoid ridge. LOCATOR attachment as a retentive component has several advantages over other systems, Such as: dual retention through both external and internal mating surfaces, a self-aligning feature which is helpful in guiding patients when placing their denture. There is little information on the degree of crestal bone loss around 4 inter-foraminal implant-retained mandibular overdentures (OVDs) and the amount of bone remodelling on the anterior maxilla and posterior mandibule on long-term function, particularly with different distributions.

Eligibility Criteria:
Inclusion Criteria:

* Patients with 4 implants in the inter-foraminal region.
* Patients treated by staff and students in the Master's program in Prosthodontics Department according to the following criteria:
* Edentulous maxilla and mandible for at least 1 year.
* Problems with retention and stability of the mandibular denture.
* Mandibular bone height between 15 and 25 mm.

Exclusion Criteria:

* Patients with relative contraindications, such as
* A history of para functional habits.
* Smokers more than 10 cigarettes per day.
* alcoholism.
* Patients with a history of radiation therapy in the head and neck region . • Patients within intravenous administrated bisphosphonates., chemotherapy, and mental disorders that could jeopardies their co-operation.
Awareness Training in Children With Autism Spectrum Disorder.

The proposed protocol aims to facilitate awareness and understanding of autism spectrum disorder among children aged 8 to 14 with an IQ between 85 and 115. Conducted once a week for 60 minutes, the protocol encompasses two initial group sessions followed by 5 group meetings, introducing activities to foster self-awareness, cognitive understanding, and an inclusive environment. Subsequently, the protocol advances to 12 individual sessions focused on emotional well-being and self-awareness, integrating Oculus technology and chest sensors for heart rate monitoring. Initiating the intervention, individual family meetings are scheduled to outline intervention goals and phases. The initial group sessions focus on social bonding, cognitive understanding, and creating an accepting atmosphere among participants. Utilizing activities addressing neurodiversity awareness and technological tools like tablets, the sessions encourage discussions on individual differences and sensitivities. The subsequent individual sessions are structured to explore personal values, identify inner critical voices, and develop emotional awareness through exercises exploring emotions and physical sensations. Progressively, the intervention introduces mindfulness, guiding participants to acknowledge emotions as normal and encouraging alignment of daily actions with personal values. Following this, sessions center on building observational skills, recognizing past behaviors, and fostering strengths tied to values. Participants are encouraged to distinguish between their critical "consultant" and the value-driven "explorer," fostering personal growth and reflection. The protocol's later stages delve into identifying personal strengths linked to core values and exploring value-driven goals. Visual exercises, metaphors, and flexible self-views are emphasized, promoting adaptability and self-evolution. The protocol concludes by advocating a flexible self-view, embracing change, and connecting oneself to ever-evolving metaphors like "a cup with changing contents" or "the ever-changing sky." These sessions culminate with visual relaxation facilitated through Oculus technology while simultaneously monitoring participants' heart rates using chest sensors. This comprehensive approach integrates technological tools with emotional and cognitive exercises, providing a multifaceted framework to enhance self-awareness and promote acceptance within the context of neurodiversity.


Eligibility Criteria:
Inclusion Criteria:

* 85\<IQ\<115

Exclusion Criteria:

* presence of other medical disorders
The Acute Effect of Mango Intake (Mangifera Indica L.) on Blood Pressure and Blood Glucose

In the current proposal the investigators seek to evaluate the acute effects of mango intake on blood pressure, blood glucose and insulin in postmenopausal women between 50 and 70 years old.

Cardiovascular disease (CVD) is the leading cause of mortality in the U.S, and aging is the largest risk factor for vascular diseases. Both male and female adults have increased risk for CVD as they age. For postmenopausal women, this risk is particularly elevated due to the loss of the protective effect of estrogen. It is evident that nutrition plays a crucial role in prevention of chronic diseases such as heart disease, stroke and cancer. Scientific evidence shows that high intake of plant-based food lowers the risk of CVD and many other chronic diseases.

Polyphenolic compounds in fruits and nuts have been the focus of extensive research regarding their potential to reduce risk for a number of chronic diseases. However, fruits and nuts vary largely in the type and amounts of phytonutrients they provide. Mango (Mangifera Idica L.), a commonly cultivated fruit worldwide, is rich in polyphenolic compounds such as gallic acid, mangiferin, quercetin glycosides, ferulic acid, and hydroxybenzoic acid. Many of those bioactive compounds have been found to have anti-diabetic and anti-inflammatory effects in cell models. For instance, mangiferin has been proved to effectively reducing glucose-induced endoplasmic reticulum stress by inhibiting IREα phosphorylation and ROS production in endothelial cells. However, it is unknown if the phytonutrients in mango will demonstrate a similar impact in humans. Therefore, the overall objective of this study is to investigate the effects of acute mango intake on blood pressure and blood glucose.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal female: 50-70 years
* Women: lack of menses for at least one year and FSH 23-116.3 mlU/mL
* Subject is willing and able to comply with the study protocols.
* Subject is willing participate in all study procedures
* BMI 25.0 - 40 kg/m2
* Weight ≥ 110 pounds

Exclusion Criteria:

* BMI ≥ 40 kg/m2
* Dislike or allergy for mango
* Self-reported use of daily anticoagulation agents including aspirin, NSAIDs
* Vegan, Vegetarians, food faddists or those consuming a non-traditional diet
* Alcohol consumption \> 3 drinks/week (i.e. 1 bottle of beer, 1 glass of wine, and 1 shot of hard liquor)
* Fruit consumption ≥ 2 cups/day
* Vegetable consumption ≥ 3 cups/day for females
* Fatty Fish ≥ 3 times/week
* Coffee/tea ≥ 3 cups/day
* Dark chocolate ≥ 3 oz/day
* Self-reported restriction of physical activity due to a chronic health condition
* Self-reported chronic/routine high intensity exercise
* Self-reported diabetes
* Blood pressure ≥ 140/90 mm Hg
* Self-reported renal or liver disease
* Self-reported heart disease, which includes cardiovascular events and Stroke
* Abnormal Liver, CBC or Chemistry panels (laboratory values outside the reference range) if determined to be clinically significant by the study physician.
* Self-reported cancer within past 5 years
* Self-reported malabsorption
USG Vs Palpation for Cricothyroid Membrane Determination

Emergency cricothyroidotomy is a very important technique to ensure airway safety in acute situations. Problem in identifying the cricothyroid membrane is a major contributor to high failure, as the most common complication during cricothyrotomy is the misplacement of the cannula. The success rate of emergency airway access performed by anesthesiologists and emergency medicine specialists was found to be low due to the low frequency of the procedure. The aim in this study is to compare the palpation method with the ultrasonugraphy (USG)-based method in determining the cricothyroid membrane. The hypothesis is that USG is more successful than palpation in identifying the cricothyroid membrane. In addition, the relationship between difficult intubation and measurements such as the cricothyroid membrane length, the cricoid cartilage and the skin distance, the distance between the cricoid cartilage and the second tracheal ring will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anaesthesiologists (ASA) I and II physical status
* Elective pediatric surgery
* Patients going to be intubated

Exclusion Criteria:

* ASA III or above physical status
* Emergency surgery
* Patients having tracheostomy
* Patients going to have laryngeal mask
The Effect of Acute Exogenous Oral Ketone Supplementation on Immune Cells Function and Immune Cells Histone Β-hydroxybutyrylation

To conduct a single-arm pilot study to determine how acute ingestion of an exogenous ketone monoester supplement alters the histone lysine β-hydroxybutyrylation and immune function in healthy human monocytes and lymphocytes.


Eligibility Criteria:
Inclusion Criteria:

* Over the age of 19
* Able to fast overnight

Exclusion Criteria:

* Being a competitive endurance athlete.
* Following a ketogenic diet, low-calorie diet, periodic fasting regimen, or regularly consuming ketogenic supplements.
* Being unable to travel to and from the university
* Being pregnant.
* Having been diagnosed with a chronic disorder of glucose or fat metabolism, including type 2 diabetes, chronic pancreatitis, or gallbladder disease
* Being unable to read or communicate in English.
Efficacy of AI EF Screening by Using Smartphone Application Recorded PLAX View Cardiac Ultrasound Video Clips

Assessing the Efficacy of Artificial Intelligence in Left Ventricular Function Screening Using Parasternal Long Axis View Cardiac Ultrasound Video Clips

ABSTRACT BACKGROUND: Echocardiography serves as a fundamental diagnostic procedure for managing heart failure patients. Data from Thailand's Ministry of Public Health reveals that there is a substantial patient population, with over 100,000 admissions annually due to this condition. Nevertheless, the widespread implementation of echocardiography in this patient group remains challenging, primarily due to limitations in specialist resources, particularly in rural community hospitals. Although modern community hospitals are equipped with ultrasound machines capable of basic cardiac assessment (e.g., parasternal long axis view), the demand for expert cardiologists remains a formidable obstacle to achieving comprehensive diagnostic capabilities. Leveraging the capabilities of Artificial Intelligence (AI) technology, proficient in the accurate prediction and processing of diverse healthcare data types, offers a promising for addressing this prevailing issue. This study is designed to assess the effectiveness of AI in evaluating cardiac performance from parasternal long axis view ultrasound video clips obtained via the smartphone application.

OBJECTIVES: To evaluate the effectiveness of artificial intelligence in screening cardiac function from parasternal long axis view cardiac ultrasound video clips obtained through the smartphone application.

METHODS: The investigators built the smartphone application to collect parasternal long axis view video clips and used artificial intelligence "Easy EF" to evaluate cardiac function. All samples that were evaluated for LVEF by certified cardiologists, 70% of all clips were used to train AI, while the remaining 30% of clips were used to test if AI could process the results correctly. Artificial intelligence aims to classify cardiac function into three groups: Reduced EF, Mildly Reduced EF, and Preserved LV.

Eligibility Criteria:
Inclusion Criteria:

* Shot 5 second VDO clip of Parasternal long axis heart ultrasound recorded by smartphone Application "Easy EF" without patient identification with result of Ejection fraction that performed by certify cardiologist approved result

Exclusion Criteria:

* Incomplete VDO clip (too much shaking, too shot recording)
* Lighting was inappropriate
* Inappropriate ultrasound framing
* arrhythmia (atrial fibrillation)