cyrilzakka/clinical-trials huggingface dataset:
Pulmonary Microbiota and ARDS Mortality

Acute respiratory distress syndrome (ARDS) is due to diffuse and severe lung inflammation. Despite intensive research, few therapeutics have emerged and treatment is still mostly symptomatic. As lung microbiota seems to be associated with lung inflammation in numerous chronic respiratory diseases, this study aims to analyse the correlation between lung microbiota and mortality.

ARDS is caused by diffuse intense lun inflammation. Its mortality rate is still about 40%. Despite decades of research, few therapeutics have emerged. Treatment is based on the treatment of ARDS cause, if possible and on protective ventilation, curare use and prone position. For more severe cases, nitric monoxide inhalation and extra-corporeal membrane oxygenation can be considered. Nevertheless, no treatment specifically addresses lung inflammation. Lung microbiota has been shown to be associated with lung inflammation in asthma, chronic obstructive disease and cystic fibrosis. Lung microbiota also plays a role in lung immunity. Regarding specifically ARDS, one study correlated lung microbiota with the occurrence of non-infectious ARDS in trauma patients. Thi study therefore aims to analyse the correlation between lung microbiota at admission to ICU for ARDS with mortality.

Eligibility Criteria:
Inclusion Criteria:

* Patient above 18 year-old admitted to intensive care unit
* ARDS according to Berlin criteria
* Needing oro-tracheal intubation for mechanical ventilation
* Within the first 48 hours of ARDS evolution

Exclusion Criteria:

* Guardianship or curatorship
* Prisoners
* No health insurance
* No legal representative
The Concomitant Cryomaze Procedure Using Nitreous Oxide Cryoprobe: Comparison With Argon Based Cryoprobe

The aim of this study is compare the surgical convenience and early and long-term outcomes of cryomaze procedure using nitrous oxide with using Argon gas.

The investigators will analyze the pathologic findings of atrial tissue after cryoablation using two probes and early and long-term outcomes with Holter monitoring. Atrial fibrillation burden 3 months and 1 year postoperatively and atrial activity will be checked.

The investigators have used the Medtronic ATS cryoprobe (Argon based) since 2009 for cryomaze procedure for treatment of atrial fibrillation combined with valvular heart disease.

However, sometimes, it was inconvenient due to excess flexibility, wide lesion related to excess low temperature and time-consuming detachment from atrium after cryoablation. The investigators introduced Atricure cryoprobe (Nitreos Oxide based) in hope of overcoming these shortcomings of ATS probes last year.

Up to date, the investigators have been satisfactory in terms of the surgical convenience. On the other hand, we have the questionability of transmural lesion of Atricure probe because of the higher temperature of Atricure probe compared with ATS probe.

The aim of this study is compare the surgical convenience and early and long-term outcomes of cryomaze procedure using nitrous oxide with using Argon gas.

The investigators will analyze the pathologic findings of atrial tissue after cryoablation using two probes and early and long-term outcomes with Holter monitoring. Atrial fibrillation burden 3 months and 1 year postoperatively and atrial activity will be checked.

Eligibility Criteria:
Inclusion Criteria:

* requiring concomitant maze operation with valve surgery (persistent atrial fibrillation)
* between 18 and 75 years old

Exclusion Criteria:

* previous cardiac surgery
* Behcet disease
* Takayasu's arteritis
* Infective endocarditis
* Congenital heart disease
* left atrial size over 80mm
* moderate or greater functional tricuspid regurgitation
A Randomized Control Trial of a Simulation-based Curriculum to Enhance Skills in Colonoscopy

Colonoscopy is a commonly used medical procedure. Medical and surgical residents learning colonoscopy typically learn the procedure experientially but simulation based teaching is increasingly being integrated into training programs. The optimal manner to teach colonoscopy on virtual-reality simulators is uncertain. We aim to test a curriculum in simulation-based colonoscopy with self-directed learning on simulators.


Eligibility Criteria:
Inclusion Criteria:

* Trainee endoscopists from the gastroenterology and general surgery programs at the University of Toronto

Exclusion Criteria:

* Greater than 20 colonoscopies performed
The Effect of Pre-exercise Feeding on Bone Turnover Biomarkers

Osteoporosis is a major contributor to loss of independence due to bone fractures and resulting hospital treatments lead to significant morbidity. While pharmacological treatments can reduce consequences of osteoporosis, there is a pressing need for non-pharmacological interventions to improve bone health across the life-course and to reduce likelihood of age-related bone disease.

This study will allow us to determine whether synergistic potentiating effects on bone metabolism are observed in humans in relation to the timing of food ingestion and what recommendations can be made to people with respect to food ingestion and exercise to obtain the maximal bone benefits from aerobic exercise. Furthermore, if we can identify interventions that potentiate bone's response to aerobic exercise in younger adults, then such interventions may have the ability to maximise bone mass in younger adults so that with ageing, the additional bone mineral density and improved bone microarchitecture would extend the time before osteoporotic "fracture thresholds" are reached. Therefore, understanding the bone metabolic response to exercise following fasting and feeding in younger adults is important.


Eligibility Criteria:
Inclusion Criteria:

* Male (females excluded to remove the interplay between menstrual cycle and bone turnover)
* Caucasian ethnicity
* Aged 28 ± 4 years
* Are physically active (meet the UK guidelines for physical activity of at least 150 minutes moderate intensity activity and/or at least 75 minutes of vigorous intensity activity per week)
* Otherwise, healthy, able and willing to participate and provide written informed consent

Exclusion Criteria:

* Current smokers
* Excessive alcohol consumption (max 15 alcohol units/week)
* Any musculoskeletal injury/disabilities
* Any conditions known to affect bone metabolism (e.g. uncontrolled hyper-/hypothyroidism, hyperparathyroidism, hypo-/hypercalcaemia) or malabsorption syndromes (e.g. Crohn's disease, coeliac disease or inflammatory bowel disease).
* Taking any medication known to affect bone metabolism (such as glucocorticoids or bisphosphonates)
* Positive Covid-19 test within the last 8 weeks
* Suffered a fracture in the previous 12 months
* Sedentary status (see physical activity inclusion criteria above)
* Have been told by medical professionals that they should not take part in moderate to high intensity exercise
* Should not be a professional athlete or take part in significant competitive recreational activity (takes no more than 4 structured exercise sessions per week on average)
* History of diagnosed eating disorders
THE TRAVEL II TRIAL: Transcatheter Right Atrial-ventricular Valve rEplacement With LuX-Valve Via Jugular Vein

The trial aims to evaluate the safety and effectiveness of LuX-Valve transcatheter tricuspid valve and delivery system via jugular vein which are intended to use in symptomatic patients with severe tricuspid regurgitation and high surgical risk.

The TRAVEL II study is a prospective multi-center single-arm trial for transcatheter tricuspid valve replacement with LuX-Valve via jugular vein. A series of physical, imaging and laboratory exams will be performed to determine whether a subject has severe tricuspid regurgitation with high surgical risk. Subjects who meet the criteria will then receive LuX-Valve implantation via jugular vein if an informed consent is obtained.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 50 years at time of consent.
2. Subjects or subject's legal representative has been informed of the nature of the study and provided written informed consent.
3. The site heart team confirmed the subject is at high risk for tricuspid valve surgery (euroSCORE II ≥ 7.0%) and the subject will get benefit from the intervention.
4. Subjects must guarantee they won't participate in any other clinical trial for a period of one year after the intervention.
5. Subjects are with New York Heart Association (NYHA) Functional Class III or IV.
6. Subjects are with normal left heart function (EF ≥ 50%).
7. No indications for left-sided or pulmonary valve intervention.
8. Subjects must have severe or greater tricuspid regurgitation ( the vena contracta (VC) width ≥ 7 mm or the effective regurgitant orifice area (EROA) ≥ 40 mm2), which confirmed by the Echocardiography Core Lab (ECL) via transthoracic echocardiogram (TTE).

Exclusion Criteria:

1. Subjects with pulmonary hypertension (systolic pressure ≥ 55mmHg determined by right heart catheterization).
2. Subjects with previous transcatheter or surgical tricuspid valve procedure.
3. Subjects with tricuspid stenosis or other anatomy disorders that unsuitable for the procedure.
4. Subjects with depressed right heart function (tricuspid annular plane systolic excursion (TAPSE) \< 10mm or right ventricle fractional area change (FAC) \< 20%).
5. Subjects with aortic stenosis (mean ΔP≥ 40mmHg or aortic valve area ≤ 1 cm2), aortic regurgitation (≥ 3+), mitral stenosis (mitral valve area ≤1.5 cm2) or mitral regurgitation (≥ 3+).
6. Subjects with active endocarditis or other infectious diseases.
7. Subjects with untreated severe coronary artery disease.
8. Subjects with percutaneous coronary intervention, cerebrovascular accident or surgical intervention within 3 months of the date of the procedure.
9. Subjects with coagulation disorders.
10. Subjects with known allergy, hypersensitivity or contraindication to the material or drugs used in the procedure.
11. Subjects with cognitive disorders that can not cooperate the study or follow-up.
12. Subjects with less than 12 months life expectancy because of non-cardiac conditions.
Errors in the Use of Turbuhaler and Spiromax Devices Patients With Asthma

The aim of the study is to evaluate the errors that may occur during inhalation of two devices in patients with asthma, as well as to study whether it relates to the degree of control of patient symptoms and the degree of compliance of medication symptoms. Finally, we also want to study the degree of patient satisfaction with each of the inhalers studied


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of asthma with treatment indication with CI + LABA according to GINA 2015 guide and in dry powder device.
* Over 18 years.
* Patient in stable phase without having had exacerbations in the 3 months previous to the Inclusion in the study

Exclusion Criteria:

* Presence of relevant respiratory disease other than asthma (including COPD).
* Refusal to participate in the study and sign informed consent or inability to To give informed consent.
* Patients who have previously been treated with inhaled dust devices dry.
A Study of Trilaciclib Combined With mFOLFIRINOX in the Treatment of Patients With Advanced Pancreatic Cancer

To observe the incidence of chemotherapy-induced myelosuppression and the safety of Trilaciclib combined with mFOLFIRINOX in patients with advanced pancreatic cancer receiving first-line treatment.

This study was a single-arm, exploratory clinical study. Patients with advanced pancreatic cancer were screened and enrolled according to the inclusion and exclusion criteria described in the study protocol. Informed consent was signed after full communication. Patients with advanced pancreatic cancer who received first-line treatment were treated with Trilaciclib +mFOLFIRINOX. The incidence of chemotherapy-induced myelosuppression was used as the primary endpoint to observe whether Trilaciclib could reduce the occurrence or degree of chemotherapy-induced myelosuppression.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years
* ECOG score 0 or 1
* Expected survival≥12 weeks
* Patients with histologically or cytologically confirmed pancreatic cancer
* Have not received any antineoplastic therapy prior to treatment
* Major organ functions within 7 days prior to treatment shall meet the following criteria: a. Neutrophil count ≥1.5×109 /L； b. Hemoglobin ≥10g/dL； c. Platelet count ≥100×109 /L
* Biochemical examination shall meet the following standards: a、Total bilirubin(TBIL)≤1.5times the upper limit of normal value(ULN); b、ALT and AST≤1.5×ULN ; c、creatinine clearance(CCr)≥60ml/min
* Patients of reproductive age(including female and male patients'female companions)must use effective birth control measures
* Subjects voluntarily joined the study and signed an informed consent form(ICF)
* It is expected that the patient has good compliance and can follow up the efficacy and adverse reactions according to the protocol requirements

Exclusion Criteria:

* Had received systemic antineoplastic therapy
* Pregnant and lactating women. Women of childbearing age had to test a negative pregnancy test within 7 days before enrollment
* Substance abuse, clinical or psychological or social factors that may interfere with informed consent or the conduct of the study
Proparacaine and Mydriatic Eye Drops

In this study, we will be evaluating whether premedication with an anesthetic eye drops leads to a decreased sensation of pain when given dilating eye drops prior to eye examinations to evaluate for retinopathy of prematurity in neonatal intensive care unit (NICU) infants.

A. Randomization of subjects: Infants will be randomized to receive Proparacaine versus no intervention based on computerized randomization performed by our statistician. Due to the lack of a placebo group, practitioners present at the time of examination will not able to be blinded to group assignment. Each infant will only be enrolled for one examination.

B. Monitor setup/application: The Central Nervous System (CNS) Neonatal Neurological Monitor (Moberg Research) will be used to videotape each patient encounter and record vital sign information during the study period. The CNS monitor will record physiologic variables indirectly via cables attached to the bedside monitor. Before scheduled eye drop administration takes place, the appropriate connections between the bedside monitor and CNS monitor will be made in order to continuously record heart rate, respiratory rate, pulse oximetry, and blood pressure. A video camera attached to the CNS monitor will also be positioned to capture the subjects' facial activity and gross body movements. The monitor will be set up with enough time prior to eye drop administration such that baseline data can be collected before any intervention is performed. In addition, a video recording of the method of eyedrop administration will be assessed. The monitor will remain in place up to 5 minutes after completion of eye drop administration.

C. Eye drop administration: The CNS Monitor will be in place at least 3 minutes prior to administration of any eye drops to record baseline data on the infant. One drop of Proparacaine anesthetic ophthalmic solution will be applied to each eye of infants randomized to receive Proparacaine prior to the mydriatic eye drops. At least 30 seconds and no longer than 5 minutes after administration of Proparacaine, the mydriatic eye drops will be given as per routine standard practice for ophthalmologic examinations in the NICU.

Eligibility Criteria:
Inclusion Criteria:

* Infants admitted to the Pennsylvania Hospital NICU who require an ophthalmologic examination.

Exclusion Criteria:

* Infants with congenital anomalies, seizures, or other neurologic conditions or malformations that may alter the pain response
* Infants with corneal abrasions, corneal ulcers or other relative or absolute contraindications to proparacaine administration
Glucose Monitor Accuracy Investigation (Ⅱ)

According to Section 7.3 and Section 7.4, ISO 15197(2003), it adopts the whole blood of fingertips as samples to evaluate the accuracy of portable BGM.

The clinical medical technologists collected blood samples from 319 volunteers including 90 diabetics and 229 healthy people. The range of the blood glucose concentration was from 30.2mg/dL to 577.5mg/dL. The result of clinic evaluation shows that the accuracy of BGM matches the requirement of ISO15197(2003).

Eligibility Criteria:
Inclusion Criteria:

* volunteers with diabetes and non-diabets

Exclusion Criteria:

* hypertension,fever,AIDS,hemophilia
I am Protecting my Child From the Sun Program

This study aimed to examine the effect of the "I Am Protecting My Child from the Sun" program, based on social cognitive theory, on parents' sun-protection product use and sun avoidance behaviors. The "I Am Protecting My Child from the Sun" program, based on Social Cognitive Theory, and the sending of short reminder messages had positive effects on the parents' behaviors related to protecting themselves and their children from the sun.

This study aimed to examine the effect of the "I Am Protecting My Child from the Sun" program, based on social cognitive theory, on parents' sun-protection product use and sun avoidance behaviors. Organized as a randomized controlled experimental study conducted on three groups with a pre- and post-test follow-up design, the study was carried out in Manavgat between April 2018 and October 2018 and included the participation of 185 parents, of which 63 were in the education group, 62 were in the education+SMS group, and 60 were in the control group. The parents in the intervention group were administered the "I Am Protecting My Child from the Sun" program for a period of six weeks, while the education+SMS group, in addition to the program, also received a total of 25 short text messages twice a week. Data were collected using the Parent Information Form, Skin Cancer Risk Perception Form, Skin Cancer and Sun Knowledge Scale, Parental Self-Efficacy Scale, Parental Sun Protection Scales, and Parent Behaviors Regarding Protecting Themselves and Their Children from The Sun Question Form.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the research
* Being least literate
* No communication problems in terms of hearing, seeing and understanding
* Being a mobile phone user to receive text messages sent by the researcher
* Living in the same home with the child
* Joining both parents or one of the parents
* No possibility of leaving the region during the research

Exclusion Criteria:

* Skin cancer diagnosis / history
* Having a family history of skin cancer
Confirmation of Correct Tracheal Tube Placement in Newborn Infants - a Randomized Control Trial

Most premature babies have difficulty breathing at birth and need help (resuscitation). The treatment for this is to gently inflate their lungs with a resuscitation device and a facemask. To gently inflate an infant's lungs the clinical team places a breathing tube in the windpipe and blow air into your baby's lung (puffs). With the first puffs the clinical team checks if the breathing tube is correctly placed within the windpipe. The investigators routinely use a detector which checks for exhaled carbon dioxide or the graphical display of waves forms of the infants breathing to check that the breathing tube position. However, the investigators do not know which one (exhaled carbon dioxide or the graphical display of waves forms) is better to check that the breathing tube position is correct and therefore the investigators would like to study them. The purpose of this study is to compare exhaled carbon dioxide detectors (ECO2 group) with the graphical display of waves forms (flow waves group) to provide us with information on how the investigators can help babies who struggle with breathing at birth.


Eligibility Criteria:
Inclusion Criteria:

* All infants (term and preterm) born at The Royal Alexandra Hospital who require endotracheal intubation in the delivery room or neonatal intensive care unit will be recorded.

Exclusion Criteria:

* Infants will also be excluded if their parents refuse to give consent to this study.
Elucidation of Sensory Characteristics and Food Preferences in the Elderly

Malnutrition is a frequent problem in persons older than 65 years: the prevalence of malnutrition can reach 25 to 29% in persons living at home who require help, figures vary between 19 and 38% for those living in institutions, and finally, the prevalence of malnutrition in hospitalized elderly patients can reach 30 to 90%. A few studies have attempted to explain modifications in attitudes, behaviour, the frequency of meals or nutritional status in the elderly by a fall in chemosensory sensitivity The aim of this project is to test the hypothesis that perhaps it is not as much the capacity to perceive a smell or a taste that affects eating behaviour in the elderly as their ability to distinguish between smells or tastes on the one hand (perceptual processing), and their ability to correctly interpret a chemosensory signal on the other (cognitive processing).


Eligibility Criteria:
Inclusion Criteria:

* Persons older than 65 years.
* Persons with diabetes, heart disease or hypertension stabilized by a treatment.
* Persons cognitively able to carry out the tests and fill in the questionnaires (Folstein test between 22 and 30).

Exclusion Criteria:

* Any person suffering from an acute disease at the time of the test.
* Any person presenting any allergy whatsoever (food, mites, pollen...).
* Any person suffering from asthma or severe respiratory disorders (lung cancer, tracheotomy...).
* Any person presenting anosmia (total loss of olfaction) from birth or following physical trauma (head injury) or due to disease (severe rhinitis).
* Persons with diabetes, heart disease or hypertension not stabilized by treatment.
* Any person presenting life expectancy of less than 6 months.