cyrilzakka/clinical-trials huggingface dataset:
Elective Abdominal Aortic Aneurism - Open Versus Endovascular Repair

Abdominal aortic aneurysm (AAA) is a life threatening disease. There is a consensus to propose surgical repair in patients with a reasonable operative risk when the AAA exceeds 5 cm in diameter.

The aim of the study is to compare the mortality and the occurrence of severe general, vascular and local complications in two groups of patients treated by either by open surgery or by EVAR (EndoVascular Aneurysm Repair). The main outcome criteria and the secondary endpoint are respectively the survival without severe complications and minor morbidity.

ACE Trial :Not Worn-Out Aneurism of the Abdominal Aorta Under Renal " Surgery Versus Endoprosthesis Abdominal aortic aneurysm (AAA) is a life threatening disease. There is a consensus to propose surgical repair in patients with a reasonable operative risk when the AAA exceeds 5 cm in diameter.

The aim of the study is to compare the mortality and the occurrence of severe general, vascular and local complications in two groups of patients treated by either by open surgery or by EVAR (EndoVascular Aneurysm Repair). The main outcome criteria and the secondary endpoint are respectively the survival without severe complications and minor morbidity.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 50 years old or more (more than 80 possible depending on physiological age)
* Level 0, 1, or 2 of operative risk
* Abdominal aortic aneurysm with a diameter \> or equal to 50 mm or \> or equal to 40 mm if rapid growing (10 mm or more in a year), or painful, or saccular aneurysms, or aneurisms of common iliac arteries with a diameter equal or superior to 30 mm; or women with a diameter equal to 45 mm;
* Aortic neck superior or equal to 1.5 cm
* No stenosis superior or equal to 75% of the superior mesenteric artery
* Proximal neck angulation inferior to 80°
* Diameter of the iliac arteries compatible with introducer sheath
* Inform consent signed

Exclusion Criteria:

* Aneurysm involving the renal arteries or with the length of the neck less than 1.5 cm
* Thrombus or major calcification in the neck
* Diameter of the iliac arteries not compatible with introducer sheath
* Level 3 of operative risk
* History of major iodine allergy (Quincke oedema, anaphylactic shock)
* Other comorbidity with life expectancy less than 6 months
* Follow up impossible during the trial
* Participation in another trial
* Inform consent not signed
Aspirin in Asymmetrically Intrauterine Growth

Intrauterine growth restriction refers to a fetus that has failed to get a specific measures by a gestational age. Asymmetric type of Intrauterine growth restriction is known by normal sized head with smaller abdomen.It is important to recognize the growth restricted fetuses, because these fetuses may have fetal or neonatal complications.

When blood flow is increased, the oxygen and nutrients will deliver good to the fetus. The role of low-dose aspirin therapy in management of intrauterine growth restriction is controversial. It has been used, in many studies, in prevention of intrauterine growth restriction especially in women at high risk of pre-eclampsia or obstetrical antiphospholipid syndrome.


Eligibility Criteria:
Inclusion Criteria:

* The pregnant women
* 28-30 weeks
* Idiopathic asymmetrically intrauterine growth restriction
* Middle aged women (20-35 years)
* Women with abnormal umbilical artery Doppler flow indices ( \> +2 standard deviation above mean for gestational age)

Exclusion Criteria:

* Women less than 20 and more than 35 years
* hypertensive or diabetic women
* any type of smoking
* multiple pregnancies
* amniotic fluid index \<5 cm
* premature pre-labor rupture of membranes
* abnormal placenta
* any fetal congenital malformations.
* women had absent diastolic flow or reversed flow in umbilical artery at the time of recruitment.
Effect of Tourniquet Application on Postoperative Functional Outcome Following Total Knee Arthroplasty

A pneumatic tourniquet is often used during total knee arthroplasty. However, its effect on postoperative outcomes as soft tissue damage resulting in delayed recovery remains unclear. The purpose of the present study was to compare tourniquet use versus non-tourniquet use during total knee arthroplasty for short-term functional recovery.

In a prospective cohort design, consecutive series of patients who underwent primary unilateral total knee arthroplasty (TKA) in the Bergman Clinic, the Netherlands were investigated. Patients scheduled for primary TKA due to osteoarthritis, age between 50 and 75 years and with Dutch language proficiency were eligible for inclusion. Exclusion criteria were inflammatory arthritis, severe cardiac complaints, severe pulmonary disorders, Body Mass Index (BMI) \>35, severe coagulation disorders or hospitalization in the previous two months before surgery. Each patient included in the study signed informed consent. The research protocol was approved by the Regional Ethics Committee VCMO in Nieuwegein, the Netherlands, registration number W13.022.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled TKA due to osteoarthritis
* Age between 50 and 75 years
* Dutch language proficiency
* Signed informed consent

Exclusion Criteria:

* Inflammatory arthritis
* Severe cardiac complaints
* Severe pulmonary disorders
* Body Mass Index \>35
* Severe coagulation disorders
* Hospitalization in the previous two months before surgery
Telemedicine Interventions for Obstructive Sleep Apnea (OSA)

This project is investigating whether both moderate-intensity physical activity and dietary weight loss will independently reduce sleep apnea symptoms and improve quality of life.

Background/Rationale:

Obstructive sleep apnea/hypopnea (OSAH) is a common chronic disease that is associated with daytime sleepiness, impaired health-related quality of life (QOL), and increased risk of hypertension and cardiovascular disease. The most common treatment is continuous positive airway pressure (CPAP), although adherence to CPAP is poor in more than one-third of patients. Weight loss can clearly lessen the severity of OSAH, but although short-term dietary weight loss can often be achieved it is difficult to maintain. Regular aerobic exercise is associated with a lower prevalence of OSAH in observational studies after adjustment for body habitus, and in two small clinical trials moderate exercise was associated with a substantial decrease in OSAH severity despite little or no weight loss. Demonstrating that dietary weight loss and moderate physical activity, promoted in the home setting, independently improve OSAH severity will have a major impact on the therapeutic approach to OSAH, a disease that is highly prevalent in the VA population.

Objective:

The investigators hypothesize that both moderate-intensity physical activity and dietary weight loss will independently reduce OSAH severity and improve QOL.

Methods:

The proposed study is a randomized clinical trial designed to test the independent effects of the physical activity and diet interventions, with an attention control intervention for subjects not assigned to either active intervention. Subjects will be male and female Veterans with a BMI over 24 kg/m2, with a physician diagnosis of OSAH and apnea-hypopnea index (AHI) \>10/hr. The interventions will last six months.

Eligibility Criteria:
Inclusion Criteria:

* Physician diagnosis of sleep apnea
* Apnea-hypopnea index \>10/hr
* BMI over 24 kg/m2

Exclusion Criteria:

* Angina pectoris
* History of myocardial infarction within 6 months
Lactobacillus Farciminis and Hyperalgesia

We want to analyse a possible effect of o dialy consumption of Lactobacillus farciminis on a hyperalgesia on response to thermal stimulation. A comparaison of results before and after three weeks of treatment will be made.


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* consumption of yogurts
Observational Study on the Efficacy and Tolerance of EYEBRID Lenses

Technical advances in lenses are continuous and materials are improved. We provide a prospective longitudinal observational study evaluating the efficacy and safety of new EyeBrid Excel hybrid lenses (LCS) in the treatment of severe ametropia and for patients with corneal irregularities.

This study should include 60 patients for a period of three months. The aim of this work is to assess the improvement in the best corrected visual acuity and the good tolerance of this lens.


Eligibility Criteria:
Inclusion Criteria:

* o Wear rigid lenses and complain about their lenses (discomfort, loss, poor vision) or

  * Wear rigid lenses and have objective intolerances (damage to surfaces related to rigid lenses) or
  * Are new wearers of lenses and presenting a strong ametropia (Strong myopia from -5.00 to -30.00d, strong hyperopia from + 4.50d to + 30.00d, strong astigmatism from 2.50d to 12.00d), with or without presbyopia (Addition of 0.75d to 3.50d)
* Any patient diagnosed with Keratoconus stages 1 to 3.
* Be affiliated to the social security system

Exclusion Criteria:

* Patient with contraindications to wearing contact lenses
* Pregnant or breastfeeding woman
* Any minor or over 80 years old
* Any infection, inflammation or abnormality of the anterior segments
* Progressive ocular disorder of the anterior segments for which the wearing of contact lenses would be discouraged;
* Use of systemic or ocular treatment products for which the wearing of contact lenses would be discouraged;
* History of any herpetic keratitis;
* History of any refractive surgery or any irregular cornea (except in cases where the contact lenses examined may be worn by a subject with an irregular cornea, suffering from keratoconus or having undergone refractive surgery);
* Slit lamp observations of greater than grade 1 gravity;
* Vascularization of the cornea with a penetration greater than 1 mm;
* Case of pathological dry eye;
* When a subject has participated in a clinical trial on contact lenses or contact lens care products within the past 30 days.
Sprinter Legend Balloon Catheter

Open label, single-arm trial to study the safety and effectiveness of the Sprinter Legend 1.25 mm angioplasty balloon.

The study examines acute outcomes when the Sprinter Legend 1.25mm balloon catheter is used for enlarging coronary luminal diameters during PCI procedures.

Eligibility Criteria:
Inclusion Criteria:

* Patient is greater than18 years of age and able to give informed consent.
* Patient with stenotic lesions in coronary arteries or bypass graft stenosis that are suitable for percutaneous coronary intervention (PCI).
* The patient has single or multiple vessel coronary artery disease and clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, and/or a positive functional study.
* Female patients of childbearing potential must have a negative pregnancy test within seven (7) days before the procedure.
* Patient or patient's legal representative has been informed of the nature of the trial and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective investigational site.
* Patients with symptomatic ischemic heart disease due to stenotic lesions in coronary arteries or bypass graft stenosis that are amenable to percutaneous treatment.

Exclusion Criteria:

* A known hypersensitivity or contraindication to aspirin, heparin, or bivalirudin, anti-platelet medications, or sensitivity to contrast media, which cannot be adequately pre-medicated.
* A serum creatinine level \> 2.0 mg/dl within seven days prior to index procedure.
* Evidence of an acute myocardial infarction within 72 hours of the intended index procedure (defined as: Q wave myocardial infarction or non-Q wave myocardial infarction having creatine kinase myocardial-band isoenzyme (CK-MB) or troponin elevated above the Institution's upper limit of normal).
* During the index procedure, the target lesion requires additional treatment with a cutting balloon, any artherectomy, any laser, thrombectomy, etc.
* History of stroke or transient ischemic attack (TIA) within the prior 6 months.
* Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months.
* History of bleeding diathesis or coagulopathy or will refuse blood transfusions.
A Study to Evaluate the Efficacy and Safety of CREZET Tablet

This observation study is to evaluate blood lipid-lowering effects and liver/renal safety, changes in HbA1c and FPG in patients with dyslipidemia who administered CREZET tablets for 24 weeks.

A subject who is diagnosed with dyslipidemia and scheduled to administer CREZET tablets, will be enrolled in this study based on the doctor's medical decision.

The CREZET Tablet will be administered for 24 weeks, and the data including demographic information, body measurement, vital signs and etc will be collected during the study period.

The data collection point is as follows.

1. Visit 1 (baseline, day 0)
2. Visit 2 (at 12 weeks)
3. Visit 3 (at 24 weeks)

Eligibility Criteria:
Inclusion Criteria:

1. an adult male and female over 19 years of age
2. A patient with dyslipidemia who is scheduled to administer Crezet tablets according to the medical judgment of the investigator based on permission
3. A person who voluntarily participates in the observational study and agrees in writing to comply with the subject's precautions during the study period after hearing and understanding the detailed explanation of the characteristics of the observational study and the drug to be studied

Exclusion Criteria:

1. A person who is prohibited from administering according to the permission of the Crezet definition

   * Patients who overreact to the principal or component of the Crezet definition
   * Patients with active liver disease or patients with persistent high symptoms of serum aminotransferase levels
   * a patient with a muscle disease
   * a patient administered in combination with a cyclosporine-med
   * Patients with severe renal failure (Creatinine Clearance (CLcr) \< 30 mL/min)
   * Women and lactating women who may be pregnant or pregnant
   * Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
2. A person who has a history of taking Crezet tablets within three months of the date of registration
3. A person who is deemed inappropriate to participate in this observational study based on the judgment of investigator.
Microbial Composition of Breast Milk Collected From Healthy Turkish Women

Breast milk is an optimal source of nutrients for newborns as well as a potential source of bacteria for the intestinal microbiota. However, there are limited number of studies evaluating the relationship between maternal nutrition, breast milk and neonatal intestinal microbiota.

The study was conducted on a total of 20 healthy women following at Obstetrics and Gynecology Department of Gülhane Education and Research Hospital in Ankara Health Sciences University. Sociodemographic characteristics, anthropometric measurements, breastfeeding characteristics were evaluated in the third trimester of the women who underwent routine prenatal care. Breast milk samples were obtained at 16.day postpartum during lactation.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Age 19-35 years
* At weeks of 30-36 gestation
* No history of acute or chronic diseases
* Term delivery

Exclusion Criteria:

* Alcohol use
* Smoking
* Gestational diabetes
* Type 1 and 2 diabetes
* Preeclampsia
* Polycystic ovary
* Syndrome
* Thyroid and parathyroid disease
* Metabolic bone or kidney disease
* Abnormal liver function
* Multiple pregnancy
* Premature and postmature labor
* Having chemotherapy
* Taking drugs such as antibiotics and probiotics
AI Evaluation of COVID-19 Sounds (AI-EChOS)

In this study the investigators record sounds of voice, breaths and cough of subjects who tested positive for COVID19. The investigators then feed these sounds into an artificial intelligence and see if it can learn to recognise features to make COVID19 diagnosis from these sounds in order to avoid to use swabs to test the general population.


Eligibility Criteria:
Inclusion Criteria:

* Adults who tested positive for SARS-CoV-2 currently admitted to hospital at the study site
* Adults who tested negative for SARS-CoV-2 and are admitted for any respiratory condition (eg COPD or asthma flare-up, pneumonia..)
* Healthy volunteers

Exclusion Criteria:

* Patients under the age of 18.
* Patients unable to read in Italian.
* Patients unable to give informed consent to participate.
* Patients requiring life support (including, but not limited to, mechanical cardiac support, ventilation, etc.)
* Patients who are pregnant
Pilot Study To Assess CAT-2003 in Patients With Severe Hypertriglyceridemia

The purpose of this study is to determine the safety and efficacy of multiple doses of CAT-2003 in patients with severe hypertriglyceridemia either naive or refractory to current therapy. The study will evaluate effects of CAT-2003 on fasting and postprandial total triglycerides and chylomicron triglyceride levels in patients with severe hypertriglyceridemia.

This is a single-blind study. All patients will receive placebo for a 14 day treatment period and CAT-2003 for a 28 day treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 74 years at Screening
* Severe Hypertriglyceridemia (TG ≥ 500 mg/dL). If on lipid lowering therapy including statins, fibrates, and/or omega-3 fatty acids, stable dose for at least 4 weeks prior to Screening
* Body mass index (BMI) ≤ 45 kg/m2

Exclusion Criteria:

* History of any major cardiovascular event within 6 months of Screening
* Type I diabetes mellitus or use of insulin
* History of pancreatitis
Induction Lorlatinib in Stage III Non-small Cell Lung Cancer

A prospective, single-arm, open-label phase 2 study that evaluates the efficacy and safety of induction Lorlatinib in stage III non-small cell lung cancer and explores the clinical feasibility of dynamic ctDNA and multidisciplinary assessment in guiding local treatments.

Simon two-stage was applied to estimate the required sample size for the study. Overall an estimated 43 patients were required and at least 12 patients achieved pathological complete response would be deemed as positive result. Patients will be provided 3 cycles induction Lorlatinib 100mg and then assessed whether patients would be eligible for radical surgery or local radiotherapy through multidisciplinary evaluation. After local intervention, patients could choose consolidation treatment of Lorlatinib for up to 2 years or adjuvant doublet chemotherapy for up to 4 cycles. Dynamic blood samples will be collected before and after induction Lorlatinib as well as consolidation treatment. The primary endpoints is pCR for patients who received radical surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age :18 Years to 75 Years;
* ECOG physical score 0-2 points; expected survival time ≥ 1 year;
* Pathologically confirmed diagnosis with Stage III NSCLC which harbored ALK fusion detected by next generation sequencing (NGS) or immunohistochemistry (IHC) with or without FISH. Suspected N2 (station 2/4/7) for stage III disease should be confirmed by either mediastinoscopy or EBUS.
* At least one measurable target lesion according to the RECIST 1.1 standard;
* The main organ function meets the following criteria: 1) blood routine: absolute value of neutrophils ≥ 1.5 × 109 / L, platelets ≥ 75 × 109 / L, hemoglobin ≥ 80 g / L; 2) blood biochemistry: total bilirubin ≤ 1.5 times the upper limit of normal value, aspartate aminotransferase and alanine aminotransferase ≤ 2.5 times the upper limit of normal value (if liver metastasis, ≤ upper limit of normal value 5 times), serum creatinine ≤ 1.5 times the upper limit of normal;
* Subjects voluntarily joined the study and signed informed consent, with good compliance to follow-up.

Exclusion Criteria:

* Stage I, stage II and metastatic stage IV NSCLC;
* Histologically confirmed small cell lung cancer (including lung cancer mixed with small cell lung cancer and non-small cell lung cancer);
* Patients who have previously used any other anti-tumor drugs or received surgery/radiotherapy;
* Patients with any underlying disease that investigators consider it may affect patient's prognosis including sever cardiovascular, pulmonary disease or serious infections.
* Clinically obvious gastrointestinal abnormalities, which may affect the intake, transport or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or patients with total gastrectomy;
* Pregnant or lactating women; those who have fertility are unwilling or unable to take effective contraceptive measures;
* Patients with low compliance or willingness to take the drugs and surveillance.
Impact of an Electronic Monitoring Device on Maintaining a Correct Elevation of Head of Bed for Mechanically-ventilated Patients in Intensive Care Unit

Maintaining mechanically-ventilated patients in semi-recumbent position (defined by a head of bed inclination between 30° and 45°) would decrease the risk of pneumopathy occurrence in those patients. However, such a bed inclination frame is still difficult to maintain in day-to-day care.

The aim of the study is to evaluate the impact of an electronic monitoring device on the proportion of time spent per day in semi-recumbent position, as defined by a head of bed inclination between 40° and 50°, in mechanically-ventilated patients.

Maintaining semi-recumbent position (defined by a head of bed inclination between 40° and 50°) is an international guidance to prevent ventilator-associated pneumopathy which is the main nosocomial infection in intensive care unit. However, maintaining such an inclination has been shown to be difficult in day-to-day care.

This could be improved by using an assistance device that would measure inclination of the head of bed in real time and trigger an alarm when the value order is not reached, hence allowing a quick readjustment if necessary.

The investigators want to evaluate en electronic monitoring device (EMD) that is removable and adjustable to all beds, which would allow a whole intensive care unit to be fully equipped at low cost.

Hypothesis : using an EMD could improve the proportion of time spent per day in semi-recumbent position (defined by a head of bed inclination between 40° and 50°) in mechanically-ventilated patients.

Primary objective : to evaluate the impact of an EMD with alarm on the proportion of time spent per day in semi-recumbent position, as defined by a head of bed inclination between 40° and 50°, in mechanically-ventilated patients.

Secondary objectives :

* to evaluate the impact of the EMD on the head of bed inclination overall mean
* to evaluate the impact of the EMD on the proportion of time spent per day with a head of bed inclination superior to 30°
* to evaluate the impact of the EMD on the proportion of time spent per day with a head of bed inclination between 30° and 45°
* to study factors associated to a head of bed inclination inferior to 30° for more than 12hrs per 24hrs

Eligibility Criteria:
Inclusion Criteria:

* patient with invasive mechanical ventilation
* expected mechanical ventilation duration for more than 48h after inclusion
* signature of an informed consent by a relative
* patient affiliated to a social security scheme (beneficiary or assignee)

Exclusion Criteria:

* age\<18 years old
* mechanical ventilation with tracheotomy
* contraindication to semirecumbent position (e.g., spinal cord injury, important sacral bedsore, counterpulsation balloon, femoral cannulation for extracorporeal circulation) or expected indication to another position within the following 48 h after inclusion (e.g., ventral decubitus for hypoxemia pulmonary pathology)
* SAPS II score \> 65 at the admission (moribund patients)