cyrilzakka/clinical-trials huggingface dataset:
Scientific Rationale and Design for a Prospective Study to Codify Coronary Lesions Based on Fluid Mechanics and Acoustic Mechanisms

From January 2020 to June 2025, patients coming to the cardiac catheterization laboratories (CCL) for out-patient coronary angiography with diagnosis of unstable angina were screened for inclusion. Patients were included in the study if they had previously undergone one or more coronary angiograms, allowing for a longitudinal comparison of dynamic flow and phenomena between the two or more angiograms.

Patients with history of prior percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG) were excluded. The aortic stenosis patients were also excluded if they had end-stage disease with survival time \<6 months or if they had other severe hemodynamic disturbances such as hypotension from non-cardiac problems (sepsis, bleeding, etc).

Eligibility Criteria:
Inclusion Criteria: Patients were included in the study if they had one or two lesions in coronary angiograms. -

Exclusion Criteria: Patients with history of prior percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG) were excluded.

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Efficacy and Safety of Lucerastat Oral Monotherapy in Adult Subjects With Fabry Disease

This study aimed to determine the efficacy and safety of lucerastat oral monotherapy in adult subjects with Fabry disease.

The primary objective of this prospective, multicenter, double-blind, randomized, placebo-controlled, parallel group, Phase 3 study is to determine the effect of oral lucerastat monotherapy on neuropathic pain in subjects with Fabry disease (FD) through daily collection of patient-reported outcomes with an electronic diary.

Eligibility Criteria:
Inclusion Criteria:

1. Signed and dated ICF prior to any study-mandated procedure;
2. Male or female adult subjects;
3. FD diagnosis confirmed with local genetic test results;
4. Fabry-associated neuropathic pain, as defined by the subject, in the last 3 months prior to screening;
5. Enzyme replacement therapy (ERT) status:

   1. Subject never treated with ERT; or
   2. Subject has not received ERT for at least 6 months prior to screening; or
   3. Subject treated with ERT since at least 12 months at the time of the screening visit, and agreeing to stop ERT for approximately 8 months.
6. A woman of childbearing potential is eligible only under certain conditions, e.g. taking contraceptive measures.
7. Subjects with moderate or severe neuropathic pain during the screening period.

Exclusion Criteria:

1. Pregnant, planning to be become pregnant, or lactating subject.
2. Severe renal insufficiency (eGFR \< 30 mL/min/1.73 m2) at screening.
3. Subject on regular dialysis for the treatment of chronic kidney disease.
4. Known and documented transient ischemic attack, stroke, unstable angina, or myocardial infarction within 6 months prior to screening.
5. Clinically significant unstable cardiac disease (e.g. uncontrolled symptomatic arrhythmia, congestive heart failure NYHA class III or IV).
6. Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results.
The Sleep in Pregnancy Study

Sleep disordered breathing (SDB) insidiously worsens metabolic function, heightens insulin resistance (IR), and in pregnancy is thought to precipitate gestational diabetes, preterm birth, growth restriction, gestational hypertension, and preeclampsia. Despite the fact that sleep disturbances are common during pregnancy, SDB remains under-recognized, under-diagnosed, and poorly understood, particularly in pregnancies affected by obesity. Sixty percent of pregnancies are now affected by obesity, yet the relationship between SDB, patterns of glycemia, and insulin resistance (IR) in obese pregnant women is a neglected area with major therapeutic implications to improve maternal and infant health. Using a prospective design in which diet and gestational age are highly controlled, the investigators propose to measure SDB (apneas/hypopneas) in obese pregnant women using an ambulatory sleep monitoring system. In parallel, robust patterns of glycemia will be measured with a continuous glucose monitoring system (CGMS), followed by a 75g oral glucose tolerance test to measure insulin action. The investigators global hypothesis is that worse SDB in part accounts for higher 24-hour patterns of glycemia in obese normal glucose tolerant (NGT) pregnant women in their 3rd trimester. The Investigators will test the hypothesis that: 1) In obese NGT pregnant women at 32-34 weeks gestation on a controlled eucaloric diet, higher apnea hypopnea index (AHI) will be positively associated with 24-hour glycemia measured by a CGMS and that, 2) Higher AHI in obese NGT pregnant women at 32-34 weeks gestation on a eucaloric controlled diet will be associated with higher insulin resistance measured by a 75g oral glucose tolerance test (Matsuda Model). Early identification and treatment has the potential to decrease long-term maternal cardiovascular morbidity and mortality.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women:

  1. Between the ages of 20-39 yrs,
  2. At 32-34 weeks gestation,
  3. Who have a BMI of ≥30 to ≤40 kg/m2,
  4. Who have a singleton pregnancy, and
  5. Who have a normal glucose tolerance test on entrance to the study.

Exclusion Criteria:

* Pregnant Women:

  1. Who have a diagnosis of diabetes (GDM, type 1 or type 2),
  2. Who are using beta blockers/glucocorticoids.
  3. Who have other children who are ≤2 yrs old (due to risk of disrupted sleep),
  4. With diagnosed sleep disorders (e.g. OSA, insomnia, restless leg syndrome),
  5. Who work night or rotating shifts,
  6. Who report use of sleep medications will be excluded,
  7. With diagnosed pulmonary or cardiovascular disease
  8. Who do not speak English.
LIRA-ADD2SGLT2i - Liraglutide Versus Placebo as add-on to SGLT2 Inhibitors.

The trial is conducted in Asia, Europe, North America and South America. The aim of the study is to compare the effect of liraglutide 1.8 mg/day versus placebo as add-on to an SGLT2 inhibitor with or without metformin on glycaemic control in subjects with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
* Male or female, age 18 years or older at the time of signing informed consent.
* Diagnosed with type 2 diabetes mellitus.
* HbA1c of 7.0-9.5% (53-80 mmol/mol) (both inclusive).
* Stable dose of an SGLT-2 inhibitor as monotherapy or in combination (including fixed-dose drug combination) with a stable dose of metformin (1500 mg or more, or maximum tolerated dose) for at least 90 days prior to the day of screening. All medications in compliance with current local label.
* Body mass index of 20 kg/m\^2 or above.

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice).
* History of diabetic ketoacidosis while being treated with SGLT2 inhibitors.
* Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of less than 60 mL/min/1.73m\^2 as defined by Kidney Disease Improving Global Outcomes (KDIGO) classification using isotope dilution mass spectrometry (IDMS) for serum creatinine measured at screening.
* Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term insulin treatment for a maximum of 14 days during the 90 days prior to screening is allowed.
* Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. Family is defined as a first degree relative.
* History or presence of pancreatitis (acute or chronic).
* Impaired liver function, defined as ALT 2.5 or more times upper normal limit at screening.
* Subjects presently classified as being in New York Heart Association (NYHA) Class IV.
Exploring the Optimal Concentration of Lidocaine Test Dose for Labor Analgesia

This study aims to compare the analgesia effects and side effects of different concentrations of test dose lidocaine (1.5% lidocaine 3 ml, 1.0% lidocaine 5 ml, 0.5% lidocaine 10 ml) in labor analgesia, so as to provide a scientific basis for the clinic al practice of labor analgesia.

Epidural analgesia is the most effective and widely used analgesic method for relieving labor pain in clinical practice. However, inadvertent insertion of an epidural catheter into a blood vessel or subarachnoid space may result in local anesthesia or total spinal anesthesia, which can be life-threatening. Therefore, a low-concentration, low-volume dose of local anesthetic is usually injected as a test dose before injecting a large dose of local anesthetic through the epidural catheter to ensure that the catheter is within the epidural space. At present, the guidelines recommend 3 ml of 1.5% lidocaine as the test dose, but in clinical practice and the study of Chen et al., it was found that the test dose of 1.5% lidocaine 3ml still has a high incidence of lower limb motor block of 57.1%, which affects maternal activity and labor progression. In addition, Liu Henry et al. found that the incidence of 0.5% lidocaine 10 ml test dose-induced motor block was 0%, and the analgesic effect could be quickly achieved. Therefore, it is uncertain which concentration of lidocaine has the fastest onset of analgesia and the fewest side effects in labor analgesia. Therefore, this study aims to compare the effects of different concentrations of lidocaine (1.5% lidocaine 3 ml, 1.0% lidocaine 5 ml, 0.5% lidocaine 10 ml) in labor analgesia, so as to provide a scientific basis for the clinical practice of labor analgesia.

Eligibility Criteria:
Inclusion Criteria:

1. Singleton primipara
2. Aged 20-40 years
3. Pre-assessed as eligible for vaginal delivery
4. Height between 155-170 cm, BMI between 18.5-35 kg/m²
5. Cervical dilation between 2-6 cm
6. No significant history of cardiopulmonary disease
7. No history of surgical trauma
8. American Society of Anesthesiologists (ASA) Grades I-III
9. Patients are willing to participate and be able to understand and sign an informed consent form

Exclusion Criteria:

1. Contraindications for spinal anesthesia, such as coagulopathy or ongoing anticoagulant therapy, infection at the puncture site, bacteremia, epidural abscess, increased intracranial pressure, severe hypovolemia
2. Physical or mental disabilities, such as scoliosis and depression, alcohol or drug abuse
3. Major organ diseases, such as hyperthyroidism, cardiopulmonary diseases, diabetes treated with insulin, and neuromuscular diseases
4. Numerical Pain Rating Scale (NPRS) \< 5
5. Refusal to participate in the study
Strong Connections

The purpose of this study is to compare two talking forms of therapy designed to help reduce depressive symptoms in teenagers: Interpersonal Psychotherapy for Adolescents and Treatment as Usual.

Interpersonal Psychotherapy for Adolescents (IPT-A) is a manualized short-term therapeutic intervention that has been shown to be efficacious in a number of randomized control trials for adolescent depression. The primary aim of the present study is to evaluate the feasibility of incorporating Interpersonal Psychotherapy for Adolescents (IPT-A) into routine psychotherapeutic treatment at Strong Behavioral Health: Child and Adolescent Outpatient. The second aim of the present investigation is to examine changes in adolescent symptomatology, interpersonal functioning, perceived stress, and social support throughout the course of treatment. The third aim of the present study is to compare the effectiveness of IPT-A versus treatment as usual (TAU) at reducing depressive symptoms among adolescents.

Eligibility Criteria:
Inclusion Criteria:

* age 12-18
* scoring in the clinically elevated range for depression using the Beck Depression Inventory for Youth

Exclusion Criteria:

* currently psychotic
* do not speak English
* currently participating in another form of mental health treatment
* considered to need inpatient hospitalization
* IQ less than 70
Satiety Effects on the Neural Valuation of Food

Using fMRI, this study will explore the neural correlates of satiety when individuals make decisions about food. The investigators will also examine individual differences in satiety effects.


Eligibility Criteria:
Inclusion Criteria:

* Chinese ethnicity
* 21 to 45 years old
* English as first language
* Right-handed
* Have normal eyesight, or have long-sightedness or myopia within +8.0 to -8.0 diopters (unless corrected by contact lenses)
* Weigh less than 100kg with an abdominal circumference of less than 120cm
* Non-smoker, or only smoke occasionally (less than 5 sticks a week)
* Consume less than 2 units (200 mg) of caffeine a day
* Consume less than 21 units of alcohol per week (e.g. 500ml 5% beer = 2.5 units, 250ml 14% wine = 3.5 unit)
* Habitually sleep before 1am and wake before 9am

Exclusion Criteria:

* On a restrictive diet (e.g., vegetarian/vegan diet)
* History of food allergies
* History of psychiatric or neurological disorders
* History of chronic medical illness
* Metal implants in or on the body (e.g. braces, dental retainers, pacemakers)
* Shift worker
* Claustrophobic
* High astigmatism (high = \>2.00 diopters)
* Colour-blind
Three Different Laparoscopic Approaches for Ovarian Endometrioma and the Effect on Ovarian Reserve

Is ovarian reserve and fecundity rate higher with laparoscopic ovarian aspiration rather than laparoscopic ovarian cystectomy and laparoscopic ovarian de-roofing in infertile woman with ovarian endometrioma or not?

Primary objective:

To assess antral follicular count before and after treatment of endometriotic cyst either by aspiration, stripping, de-roofing and bed cauterization.

Secondary objectives To assess anti mullerian hormone level, follicle stimulating hormone level ,Doppler blood flow before and after treatment of endometriotic cyst either by aspiration, stripping, de-roofing and bed cauterization.

Eligibility Criteria:
Inclusion Criteria:

* Infertile woman aged 18-35 years old.
* Endometriotic ovarian cyst with size less than or equal 5 cm.

Exclusion Criteria:

* Other than included criteria.
Efficacy of RAD001/Everolimus in Autism and NeuroPsychological Deficits in Children With Tuberous Sclerosis Complex

Tuberous sclerosis complex (TSC) is a genetic disease that leads to mental retardation in over 50% of patients, and to learning problems, behavioral problems, autism and epilepsy in up to 90% of patients. The underlying deficit of TSC, loss of inhibition of the mammalian target of rapamycin (mTOR) protein due to dysfunction of the tuberin/hamartin protein complex, can be rescued by everolimus. Everolimus has been registered as treatment for renal cell carcinoma and giant cell astrocytoma (SEGA). Evidence in human and animal studies suggests that mTOR inhibitors improve learning and development in patients with TSC.

Randomized double-blind placebo controlled intervention study in children with TSC between age 4 and 15 years with an intelligence quotient (IQ) estimated \<80 and/or special schooling and/or autism spectrum disorder and/or learning disability requiring remedial teaching.

Patients are randomised to receive everolimus or placebo during a period of 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Children with a definite diagnosis of TSC between 4 and 15 years.
* With an IQ estimated \<80 and/or special schooling and/or autism spectrum disorder and/or learning disability requiring remedial teaching.
* Written informed consent by parents/care-takers, and the patient if he or she is 12 years or older and cognitively able to consent.
* In girls after menarche, appropriate contraception must be used or abstinence practiced.

Exclusion Criteria:

* Hepatic dysfunction
* Surgery \<6wk
* Current infection at time of inclusion
* Developmental age estimated below 3.5 years
* Intractable epilepsy with more than 1 seizure/week
* Inability to comply with the treatment protocol
* Additional diseases or disorders that may influence the endpoints, including:

  * SEGA requiring treatment
  * Uncontrolled diabetes mellitus
  * Known impaired lung function
* Allergy for any of the components of the study medication
* Prior treatment with mTOR inhibitors
* HIV seropositivity
* Bleeding diathesis or oral anti-vitamin K medication
* Serum creatinine \> 1.5 x ULN
* Uncontrolled hyperlipidemia (fasting serum cholesterol \> 7.75 mmol/L, fasting serum triglycerides \> 2.5 x ULN)
* Use of investigational drug within 30 days prior to inclusion
* History of myocardial infarction, angina or stroke related to atherosclerosis, organ transplantation, malignancy in the past 2 years
* Pregnancy or breastfeeding
* Children at risk for Hepatitis B (HB), unless hepatitis B serology is normal. Risk groups are children who have lived in Asia, Africa, Central and South America, Eastern Europe, Spain, Portugal, and Greece, children with known or suspected past or current hepatitis B infection, current or prior IV illicit drug use, current or prior dialysis, household contact with hepatitis B infected patient(s), current or prior high-risk sexual activity, body piercing or tattoos, mother known to have hepatitis B history. If vaccinated, presence of HBs Ab is normal.
* Known or suspected hepatitis C infection, unless hepatitis C serology is normal.
A Study of LY3305677 in Healthy Participants

The purpose of this study is to evaluate the safety of LY3305677 and any side effects that might be associated with it.

This study will also look at how much LY3305677 gets into the blood stream, how long it takes the body to remove it.

This study involves a single dose of LY3305677 administered by subcutaneous injection (SC).

Participation in this study is expected to last up to 16 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy as determined by medical history and physical examination
* Male participants: will agree to use a reliable method of birth control and will not donate sperm during the study and for at least 3 months following the last dose of the investigational product
* Female participants: women not of child-bearing potential due to surgical sterilization confirmed by medical history or menopause
* First generation Japanese participants or non-Japanese participants
* Have a body weight of more than 50 kilograms (kg)

Exclusion Criteria:

* Have participated within the last 3 months in a clinical trial involving an investigational product
* Have known allergies to glucagon-like peptide-1 (GLP-1) analogs, or any components of the formulation, or history of significant atopy
* Have an abnormality in the 12-lead electrocardiogram (ECG) at screening and/or Day -1
* Have undergone any form of bariatric surgery
* Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis
* Have a history of acute or chronic pancreatitis or elevation in serum lipase and/or amylase
* Show evidence of human immunodeficiency virus (HIV) or Hepatitis B or C
* Have used or intend to use medications that promote weight loss
* Have donated blood of more than 500 milliliter (mL) within the last month
* Currently smoke more than 10 cigarettes per day
Effects of High Protein Intake With Intense Exercise and Energy Deficit

A four week intervention will take place with the participants. They will undergo 6 days a week of high intensity training. They will also be at a 40% energy deficiency. One group will have a normal intake of protein, 1.2g/kg, while the other will have 2.4g/kg. It is our thesis that the participants with the higher protein will retain more lean mass.


Eligibility Criteria:
Inclusion Criteria:

* 18-30 males
* Healthy

Exclusion Criteria:

* more than 15% body fat
* 35-50ml/kg/min VO2
* BMI grater than 27
Fractional Flow Reserve Versus Angiography for Guiding Selective Percutaneous Coronary Intervention in ST-segment Elevation Myocardial Infarction

To assess the outcomes of patients with ST-segment elevation myocardial infarction (STEMI) assigned to fractional flow reserve (FFR) and angiography-guided selective percutaneous coronary intervention (PCI).

The investigators retrospectively collect STEMI patients received selective PCI from Jan 2012 to Dec 2015. Clinical follow-up is performed from the date of FFR assessment to Dec 2016 or death, which is up to 5 years. The primary endpoint is major adverse cardiac events, composite of cardiac death, reinfarction and unplanned hospitalization due to cardiovascular reasons. The primary endpoints are cardiac death, reinfarction and unplanned hospitalization due to cardiovascular reasons. All deaths are considered cardiovascular unless an unequivocal noncardiac cause could be established. Reinfarction is defined as myocardial infarction after the PCI procedure. Unplanned hospitalization will be present only if the patient is hospitalized unexpectedly because of persisting or increasing complaints of angina, ventricular arrhythmias and heart failure. All patients were received FFR-guided PCI or angiography-guided PCI before enrollment, and the investigators do not assign specific interventions to the subjects during the study. So this study might be considered to be observational.

Eligibility Criteria:
Inclusion Criteria:

* age\>18 years
* documented acute ST-segment elevation myocardial infarction
* onset of symptom \>6 days before percutaneous coronary intervention
* eligible for PCI

Exclusion Criteria:

* cardiogenic shock or hemodynamic instability
* highly tortuous or calcified arteries
* infarct related artery with a diameter \< 2.5mm
* a life expectancy\< 2 years
* intolerance to anti-platelet drugs
* left main disease (≥ 50% stenosis)
* contraindication to adenosine
* hypertrophic cardiomyopathy