cyrilzakka/clinical-trials huggingface dataset:
A Study of JNJ-77242113 Following Oral Administration in Healthy Chinese Adult Participants

The purpose of the study is to assess what drug does to body when healthy Chinese participants receive single oral dose of JNJ-77242113.


Eligibility Criteria:
Inclusion Criteria:

* Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. If there are any abnormalities, they must be consistent with the underlying illness in the study population or considered not clinically relevant and this determination must be recorded in the participant's source documents and initialed by the investigator
* Body mass index (BMI; weight kilograms \[kg\] per height \[meter\^2\]) between 18.0 and 27.9 kilograms per meter\^2 (kg/m2) (inclusive), and body weight not less than 50.0 kg at screening
* A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) at screening and on Day -1
* Blood pressure (after the participant is supine for 5 minutes) between 90 (inclusive) and 140 millimeters of mercury (mmHg) (exclusive) systolic, and no higher than 90 mm Hg diastolic
* Must be a nonsmoker or habitually smokes no more than 5 cigarettes or equivalent of e-cigarettes, or 2 cigars, or 2 pipes of tobacco per day for at least 6 months before study drug administration

Exclusion Criteria:

* History of surgical resection of the stomach, small or large intestine (excluding appendectomy, cholecystectomy, or resection of benign polyps)
* History of use of medications such as nonsteroidal anti-inflammatory drugs (NSAIDS) or aspirin within 28 days prior to screening or planned use during the study
* Clinically significant infection within 30 days prior to screening or any serious infection within 6 months prior to screening requiring intravenous antimicrobial therapy
* Known allergies, hypersensitivity, or intolerance to JNJ-77242113 or its excipients
* History of severe allergic or anaphylactic reactions
Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation

This is an international observational study in patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism.


Eligibility Criteria:
Inclusion Criteria:

* Female and male patients ≥ 18 years of age with a diagnosis of non-valvular atrial fibrillation who start treatment with rivaroxaban to prevent stroke or non-CNS (Central Nervous System) systemic embolism, and who consent to participate in the study
Safety, Tolerability, and Pharmacokinetics of BGB-23339 in Healthy Japanese and Caucasian Subjects

This study is designed to evaluate the influence of ethnic factors on the safety, tolerability, and pharmacokinetics (PK) of BGB-23339 after multiple dosing under fasting condition in healthy Japanese and Caucasian participants.

The study comprises 2 parts: Part A is a randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety, tolerability, and PK profile of BGB-23339 in healthy Japanese subjects. Part B is a randomized, double-blind, placebo-controlled, multiple-dose study to evaluate the safety, tolerability, and PK profile of BGB-23339 in healthy Caucasian subjects.

Eligibility Criteria:
Inclusion Criteria:

Each subject must meet all of the following inclusion criteria to be considered eligible for participation in this study:

1. Signed informed consent form (ICF) and able to comply with study requirements
2. Healthy Japanese or Caucasian men and/or women of no childbearing potential aged ≥ 18 years and ≤ 55 years on the day of signing the ICF (or the legal age of consent), and to be specific:

   1. For Part A only: Eligible Japanese subjects should have both biological parents and 4 biological grandparents of Japanese descent, and their 4 biological grandparents must be born in Japan.
   2. For Part B only: Eligible Caucasian subjects should 1) have both biological parents and 4 biological grandparents of Caucasian descent, and 2) be matched by body weight (± 20% body weight \[kg\]), height (± 15% height \[centimeter (cm)\]) and sex to each Japanese subject receiving the highest dose level planned in Part A.
3. Subjects are in good general health as determined by the investigator or medically qualified designee, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from this study:

Medical Conditions

1. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study drug; or interfering with the interpretation of data
2. Active herpes infection, including herpes simplex 1 and 2 and herpes zoster (demonstrated on physical examination and/or medical history ≤ 2 months before randomization)
3. Any malignancies within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
4. Positive HBV, HCV and HIV test
5. History or risk for tuberculosis (TB)
HLT Meridian Valve CE Mark Trial

To evaluate the safety and performance of the HLT System in patients with symptomatic heart disease due to severe aortic stenosis who are judged by the Heart Team to be at Intermediate or High Risk for aortic valve replacement surgery.

Prospective, non-randomized, single arm, multi-center CE Mark trial.

Eligibility Criteria:
Inclusion Criteria:

* Echocardiographic or hemodynamic based evidence of severe aortic stenosis with one of the following:

  1. Aortic valve area ≤ 1.0 cm\^2 or 0.6 cm\^2/m\^2
  2. Mean aortic valve gradient ≥ 40 mmHg
  3. Peak aortic valve velocity ≥ 4 m/sec
* Symptoms due to severe aortic stenosis resulting in one of the following:

  1. NYHA Functional Classification of II or greater
  2. Presence of angina
  3. Presence of syncope
* Documented aortic valve annular size of ≥ 24 and ≤ 26 mm (associated perimeter range is 76-81mm or associated area range of 453-530 mm2) by the MSCT Core Lab assessment of pre-procedure imaging.
* Patient is considered intermediate or high risk to undergo surgical aortic valve replacement with one of the following:

  1. Intermediate Surgical Risk: STS-PROM score of ≥ 3% to 8%
  2. High Surgical Risk: STS-PROM score of ≥ 8%
  3. Documented heart team agreement of risk for surgical aortic valve replacement (SAVR) due to other factors not captured by risk-scores (i.e. frailty or comorbidities)
* Geographically available, willing to comply with follow up and able to provide written informed consent

Exclusion Criteria:

* Patients with a coronary height of \<10mm, or otherwise determined to be at high risk for coronary obstruction
* Patients with low flow/low gradient aortic stenosis
* Patients with significant annular or LVOT calcification that could compromise procedural success
* Pre-existing prosthetic heart valve in any position, or prosthetic ring
* Severe aortic, mitral or tricuspid valve regurgitation
* Untreated clinically significant coronary artery disease requiring revascularization
* Unfavorable peripheral vascular anatomy or disease (e.g. severe obstructive calcification or severe tortuosity) that would preclude passage of 18 Fr catheters from the femoral arterial access to the aorta as evidenced by peripheral MSCT
* Need for emergent surgery or intervention other than the investigational procedure
Natural History Study of Infants With Adrenal Masses Found on Prenatal and/or Neonatal Imaging

This natural history study is collecting health information about infants with adrenal masses found on prenatal and/or neonatal imaging. Gathering information over time from imaging and laboratory tests of infants with adrenal masses may help doctors learn more about the disease and plan the best treatment.

PRIMARY OBJECTIVE:

I. Determine whether nonoperative management of infants with adrenal masses found on prenatal and/or neonatal imaging results in a 3-year survival rate of 95%.

SECONDARY OBJECTIVES:

I. Estimate the percentage of these patients who are spared surgical resection. II. Evaluate the natural history and histology of perinatal adrenal masses. III. Evaluate the tumor biology and histology of prenatal and neonatal neuroblastomas.

IV. Determine the tumor characteristics that are associated with a need for resection.

OUTLINE:

Patients undergo an abdominal CT or MRI scan on weeks 0, 6, and 42 and an abdominal sonogram on weeks 0, 3, 6, 12, 18, 30, 42, 66, and 90. Urinary catecholamine levels are also measured on the same weeks as the abdominal sonogram. Patients with an increase in tumor volume or catecholamine levels undergo sonographic evaluation and urine catecholamine sampling every 3 weeks until stabilization. Patients with a continued increase in catecholamine levels or a 50% increase in tumor volume undergo surgical resection off protocol therapy.

After a patient goes off-observation, they will be monitored every six months for two years, and annually thereafter.

Eligibility Criteria:
Inclusion Criteria:

* Sonographically identified adrenal mass meeting one of the following criteria:

  * No greater than 16 mL in volume, if solid
  * No greater than 65 mL if at least 25% cystic and does not cross the midline
* Disease limited to the adrenal gland

  * No evidence of positive contralateral or ipsilateral lymph nodes or other spread outside the adrenal gland by CT scan or MRI
  * No evidence of disease outside the adrenal gland by MIBG scan
  * Negative for tumor cells by bone marrow biopsy, if performed
* No more than 6 months of age on the date the mass is first identified
* No prior chemotherapy
* No prior abdominal surgery
Simulating Psychotherapeutic Sessions With Generative Artificial Intelligence

The study assesses the potential of using computational models, specifically large language models, to simulate psychotherapeutic sessions, aiming to improve therapy outcomes and advance therapist training through innovative technology.

Health research has evolved significantly, increasingly incorporating computational models that improve our understanding and effectiveness of medical interventions. This shift from traditional to computational methods represents a major advancement in medical research, offering a more sustainable and innovative approach for conceptual advances and therapeutic discovery. In silico models, based on scientific simulation, use computational algorithms to mimic real-world systems or processes. This virtual environment allows researchers to explore phenomena impractical, unethical, dangerous, expensive, or impossible to study otherwise.

Psychotherapy is widely acknowledged as a primary treatment for a variety of mental health conditions, from depression and anxiety to personality disorders, offering significant pathways to recovery and improved quality of life. Yet current methods have shown limited effectiveness, prompting a need for innovative research approaches. In silico psychotherapy research leverages computational simulations, large language models (LLMs), and generative artificial intelligence to explore and refine psychotherapeutic interventions. By simulating human-like conversations, this approach provides insights into therapy dynamics and holds promise for revolutionizing therapist training and expanding treatment techniques.

This study aims to establish a proof-of-concept for simulating psychotherapeutic sessions using LLMs, focusing specifically on motivational interviewing. It involves the simulation of 512 psychotherapy sessions using LLMs as well as 8 real-world psychotherapy transcripts. By modeling human interactions, the study seeks to enhance healthcare delivery, therapist training, and personalized psychotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Simulation of psychotherapy sessions of conversations between an adult person presenting with a mental or behavioral health problem and a psychotherapist using large language models and 8 real-world transcripts

Exclusion Criteria:

* Simulation protocols with severe simulation errors
Spinal Muscular Atrophy and Cardiac Autonomic Function

Respiratory dysfunction is the major cause of morbidity and mortality in patients with spinal muscular atrophy (SMA). Air stacking is a clearance airway technique frequently used but its effects on cardiac autonomic function in patients with spinal muscle atrophy is not clear.

Objective: To evaluate the acute effect of air stacking and posture on cardiac autonomic function in patients with spinal muscular atrophy types II and III.

Methods: Patients with spinal muscle atrophy type II and III will be recruited. Electrocardiogram signals will be recorded for analyses of heart rate variability during air stacking in supine and sitting position.

Background: Respiratory dysfunction is the major cause of morbidity and mortality in patients with spinal muscular atrophy. Air stacking is a clearance airway technique frequently used but its effects on cardiac autonomic function in patients with spinal muscle atrophy is not clear.

Objective: To evaluate the acute effect of air stacking and posture on cardiac autonomic function in patients with spinal muscular atrophy types II and III.

Methods: Patients with spinal muscle atrophy type II and III will be recruited. Electrocardiogram signals will be recorded for analyses of heart rate variability during air stacking in supine and sitting position. Data will collected before, during and after air stacking and will be compared using Anova Repeated Measures or Kruskal-Wallis Anova on Ranks, followed by Tukey test. The relationship between heart rate variability indexes and age will be evaluated by Pearson correlation. Significant level will be set at 5%.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of SMA types II and III,
* absence of acute respiratory disease in the last two weeks,
* agreement to participate in the study,
* according written informed consent and
* at least 5 years old.

Exclusion Criteria:

* respiratory disease in the last two weeks
Changes in Intravenous Anesthetic Drug Dosage in Insomnia Patients Undergoing Digestive Endoscopy

To compare the dosage requirement of intravenous anesthetics during digestive endoscopy between patients with insomnia and those with normal sleep pattern.

The investigators aim to investigate whether intravenous anesthetic drug dosage requirement is increased in patients with insomnia undergoing digestive endoscopy compared with normal sleep patterns.

Eligibility Criteria:
Inclusion Criteria:

* Patients with insomnia:

  1. Age of 18 - 64 years;
  2. ASA physical status of I - II;
  3. BMI of 15 - 30;
  4. Scheduled for digestive endoscopy under intravenous anesthesia;
  5. Positive screening results according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for insomnia disorder;
  6. 8-item Sleep Condition Indicator (SCI; score 0-4; range 0-32, higher score means better sleep) scored 16 or less;
* Patients with normal sleep:

  1. Age of 18 - 64 years;
  2. ASA physical status of I - II;
  3. BMI of 15 - 30;
  4. Scheduled for digestive endoscopy under intravenous anesthesia;
  5. No history or evidence of insomnia.

Exclusion Criteria:

* 1. Associated with any neurological disease; 2. Daily alcohol consumption; 3. Any contraindication to intravenous anesthetic drug, such as hypotension or shock; 4. History of allergy to any drug used in the study; 5. Pregnancy or breastfeeding; 6. Patients with sleep apnea syndrome; 7. acute upper respiratory infection; 8. Patients with psychological diseases who report suicidal thoughts; 9. Patients who need to work or take care of children/elderly people frequently at night.
Upper Versus Lower Limb Exercises on Intermittent Claudication in Diabetic Patients

Sixty patients with intermittent claudication and type 2 diabetes mellitus. Their age will ranged from 45-55 years old. They recruited from internal department at Damanhour Medical National Institute (DMNI), Damanhour, Beheira Governorate, Egypt. Patients randomly assigned into three equal groups:

Group (A):

Upper limb exercises group consist of 20 patients. They received arm cranking exercise three times per week for three consecutive months plus routine physiotherapy program.

Group (B):

Lower limb exercises group consist of 20 patients. They received bicycling exercise three times per week for three consecutive months plus routine physiotherapy program.

Group (C):

The control group consisted of 20 patients. They received only routine physiotherapy program.

1. Subjects:

   Sixty patients with intermittent claudication and type 2 diabetes mellitus. Their age ranged from 45-55 years old. They recruited from internal department at Damanhour Medical National Institute (DMNI), Damanhour, Beheira Governorate, Egypt. Patients randomly assigned into three equal groups:

   Group (A):

   Upper limb exercises group consist of 20 patients. They received arm cranking exercise three times per week for three consecutive months plus routine physiotherapy program.

   Group (B):

   Lower limb exercises group consist of 20 patients. They received bicycling exercise three times per week for three consecutive months plus routine physiotherapy program.

   Group (C):

   The control group consisted of 20 patients. They received only routine physiotherapy program.
2. Equipment:

Measurement equipment:

1. The Treadmill:

   All patients were tested Maximum walking distance and Pain free walking distance by walking in the treadmill.
2. Ankle/brachial indices (ABI) Doppler Ultrasound Machine
3. All patients were tested HbA1C before and after the treatment in medical analysis lab department at Damanhour Medical National Institute (DMNI).

Therapeutic equipment:

1. The arm crank ergometer
2. bicycle ergometer

Eligibility Criteria:
Inclusion Criteria:

* Sixty patients with type 2 diabetes mellitus and intermittent claudication.
* Patients with diabetes at least 5 years.
* Both genders were included.
* Their age will be ranged from 45-55 years old.
* Patients referred from physician of internal medicine diagnosed as controlled type 2 diabetes (HbA1c 7-7.5%) for the previous 3 months.
* Their body mass index will be ranged from 25.0 to 34.9 kg/m2.

Exclusion Criteria:

* Pregnant women.
* Malignancy.
* Other medical conditions such as uncontrolled hypertension and osteoporosis.
* Past medical history included conditions that may influence the provision of physiotherapy interventions such as (severe asthma, chronic airflow limitation, bronchiectasis, ankylosing spondylitis or lumbar disc prolapse).
A Two-part Single and Multiple Dose Study to Assess the Safety , Pharmacokinetics and Effects of AZD3293 in Healthy Japanese Young and Elderly Volunteers

This study consists of two parts, ie, single dose part with young healthy subjects (Part 1) and single and multiple dose part with elderly healthy subjects (Part 2), to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD3293 following single and multiple ascending dose administration to healthy subjects.

This is a Phase I, randomised, double-blind, placebo-controlled, single centre study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD3293 following single and multiple ascending dose administration to healthy subjects. This study consists of two parts, ie, single dose part with young healthy subjects (Part 1) and single and multiple dose part with elderly healthy subjects (Part 2). The study design allows a gradual escalation of dosage levels between sequential cohorts with safety monitoring to ensure the safety of the healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Japanese elderly and young males and females (of non-childbearing potential)
* Body mass index (BMI) between 17 and 27 kg/m2 and weigh at least 40 kg and no more than 100 kg

Exclusion Criteria:

* Psychiatric disease/condition, GI, renal, hepatic, cardiovascular, psychiatric, or retinal diseases or disorders
* Use of antipsychotic drugs , or chronic use of antidepressant or anxiolytic drugs.
* Frequent use (more than 2 days per week during the last 12 weeks) of tobacco or other nicotine products.
* Neurological disease, including seizures, recent memory impairment, or clinically significant head injury.
A Botanical Skin Care Regimen on Mild to Moderate Acne and the Microbiome

The purpose of this study is to analyze changes in acne and changes in the gut and skin microbiome with the use of a multi-step botanical skin care regimen in those with mild to moderate acne.


Eligibility Criteria:
Inclusion Criteria:

* Subjects 15 years of age until 45 years of age.
* The presence of mild to moderate acne based on investigator global assessment.

Exclusion Criteria:

* The presence of severe acne as noted by the investigator global assessment.
* Those with a nut allergy.
* Those who are unwilling to discontinue oral probiotic-based supplementation to meet the washout criteria prior to enrolling.
* Those who are unwilling to discontinue topical antibiotics and topical benzoyl peroxide to meet the washout criteria prior to enrolling.
* Individuals who are unwilling to discontinue vitamin E containing supplements during the washout and intervention.
* Individuals who have been on an oral antibiotic for acne within the previous 1 month.
* Individuals who are pregnant or breastfeeding.
* Individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study.
* Oral supplementation that has nuts in it.
* Use of isotretinoin within the three months prior to joining the study.
* Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years.
Functional and Non-Functional CSF Shunt Flow Measured with a Second-Generation Wireless Thermal Device

This study compares the performance of two generations of non-invasive cerebrospinal fluid (CSF) shunt flow assessment devices. Measurements of known non-functional and functional implanted shunts will assess the diagnostic non-inferiority of the second-generation device to the first-generation device.


Eligibility Criteria:
Inclusion Criteria:

1. At least one existing ventricular CSF shunt, functional or non-functional (including an adjustable valve set to "virtual off," ligated shunt, uncorrected distal catheter disconnection or fracture, distal catheter fragment left in place during shunt surgery, or indication that the shunt is otherwise non-functional), with a region of overlying intact skin appropriate in size for application of the study device
2. If more than one distal shunt catheter is present, at least one distal shunt catheter is at least 2 cm away from any other distal shunt catheter in the device measurement region
3. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
4. Signed medical records release by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
5. Verbal assent by minors 7 years of age and older who are able to understand the study and communicate their decision

Exclusion Criteria:

1. Presence of an interfering open wound or edema in the FlowSense device measurement area
2. Patient-reported history of adverse skin reactions to adhesives
3. Previous participation in a Rhaeos clinical study in which FlowSense device measurement data were acquired
4. New or worsening symptoms of a possible shunt malfunction in the prior 7 days
5. Use of the study device would interfere with standard patient care, or emergency surgery that cannot be delayed, or participation in the study will interfere with, or be detrimental to, administration of optimal healthcare to the subject
6. Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study