cyrilzakka/clinical-trials huggingface dataset:
Study of the Impact of Changes in Carbonemia on Microcirculation in Patients Achieving a Test Hypercapnia

The microcirculatory alterations is common in circulatory failure, especially during sepsis. The severity of these changes and their sustainability are responsible of multi organ failure and ultimately death. The optimization of microcirculatory flow could be a central objective of the management of patients hospitalized in intensive care.

Microcirculation includes all blood vessels of a diameter smaller than 100 micrometer. It represents the largest heat exchange surface of the body and is involved in tissue oxygenation. Microcirculatory flow is conditioned by the macrocirculation (heart rate and blood pressure) and the state of the microcirculation (thrombosis, vasoconstriction ...). The role of the CO2 in regulating microcirculatory flow is little studied. A recent work of our team and the oldest work in the literature lead to believe that CO2 has a specific role in modulating microcirculatory flow. No study to date precisely studied the impact of changes in the microcirculatory flow carbonemia .

The hypocapnia test is carried out in a standardized manner by inhalation of a mixture enriched in CO2 7% allows a significant increase in carbonemia. Hypocapnia will in turn obtained by a calibrated voluntary hyperventilation test.

Direct visualization of microcirculation by confocal microscopy is now considered the gold standard for exploring the microcirculation.


Eligibility Criteria:
Inclusion Criteria:

* patients from achieving hypercapnia test the CHU of Saint-Etienne
* non smoking
* non diabetic
* affiliated with or entitled to a social security system
* Written consent

Exclusion Criteria:

* subjects not performing the test hypercapnia in full
* patients with dermatological pathology at the study area
* patient with Raynaud's syndrome
* Patients with known bleeding disorders
* refusal to consent
Dapagliflozin in Type 2 Diabetes Mellitus Patients (T2DM) With Nonalcoholic Fatty Liver Disease (NAFLD)

The aim of this study is to evaluate the effect of dapagliflozin on liver function of patient with NAFLD and T2DM.

1. Ethical committee approval will be obtained from Ethics committee of Faculty of Pharmacy, Damanhour University.
2. Ethical committee approval will be obtained from Ethics committee of General Organization for Teaching Hospitals and Institutes.
3. About 50 patients who are candidate to detect the hepato-protective effect of Dapagliflozin on non- alcoholic fatty disease, will be recruited from Alexandria Teaching Hospital (EL-Mery), General Organization for Teaching Hospitals and Institutes.
4. All participants should agree to take part in this clinical study and will provide informed consent.
5. Demographic data; age (year), sex (female/male), weight (kg), height (cm), BMI (kg/m2) will be collected.
6. Venous blood samples (5 ml will be collected by a sterile syringe then placed in a suitable sterile tube to be centrifuged, the serum will be reserved and stored at -80°C until the analysis) before, and after receiving medication (Dapagliflozin).
7. Measuring outcome:

   1. The biochemical tests will be done on the patients are alanine aminotransferase (ALT), aspartate aminotransferase (AST), homeostasis model assessment of insulin resistance (HOMA-IR), Hemoglobin A1C (HbA1C), Low-density lipoproteins (LDL), High-density lipoproteins (HDL), Triglycerides (TG), liver fibrosis score, and complete blood count (CBC).
   2. The molecular tests will be done on the patient are soluble vascular cell adhesion molecule-1 (Svcam-1), adipocytes (e.g. adiponectin, leptin).
8. The ultrasound screening will be done at first examination.
9. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
10. Results, conclusion, discussion and recommendations will be given.

Eligibility Criteria:
Inclusion Criteria:

1. Type 2 diabetes mellitus patients.
2. HbA1C \< 8.5.
3. Patients were They were having fatty liver changes on abdominal ultrasound and mild to moderate elevation of serum liver enzymes.
4. BMI more than 30

Exclusion Criteria:

1. Patients with a history of alcohol, smoking, uncontrolled diabetes.
2. (HbA1c \> 9.0).
3. Pregnancy.
4. Lactation.
5. Hemochromatosis.
6. Thyroid disorders.
7. Renal dysfunction.
8. Cardiac problem.
9. Chronic liver and decompensated liver disease in the form of hepatitis B and C.
Promoting Physical Activity Among Patients With Type 2 Diabetes

The purpose of this study is to determine the effects of a tailored, print-based physical activity intervention for patients diagnosed with type 2 diabetes.

Given the growing rates of type 2 diabetes and the documented benefits of physical activity in the treatment of this illness, further research is needed to examine methods of targeting this patient group to achieve improvements in physical activity behavior. The primary aim of this planning grant is to implement a pilot study examining the feasibility and efficacy of an individually-targeted, theoretically-based physical activity intervention for patients with type 2 diabetes. The physical activity intervention is compared to usual care, and the primary outcome is weekly physical activity at a one-month follow-up. These pilot data would demonstrate the feasibility of partnering with a community agency for participant recruitment and program implementation, as well as the potential efficacy of this intervention to promote physical activity in this high-risk population.

Eligibility Criteria:
Inclusion Criteria:

* adults diagnosed with type 2 diabetes
* current patients referred to diabetes center

Exclusion Criteria:

* medical contra-indication to moderate-intensity physical activity
Clinical Effect of MiboFlo in Dry Eye Patients

The aim of this prospective study is to compare the changes between the patients receiving traditional treatment and the patients with MiBoFlo, evaluating the effectiveness of MiBoFlo.

The MiBoFlo Thermoflo uses a proprietary thermoelectric heat pump to help meibum maximize liquefaction, improving the preservation and function of the tear film's evaporative component. It supplies continuous controlled heat to the outer skin of the eyelids, absorbing deep into the tissue and breaks down the hardened oils in the meibomian glands. We are trying to find a effective, safe and economical therapy for dry eye patients.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age of older;
* Meet the diagnostic criteria for dry eye developed by DEWS II: OSDI score≥15 points, TBUT≤10 minutes;
* Meet the signs of meibomian gland dysfunction

Exclusion Criteria:

* Had skin allergies or inflammation;
* Had active ocular infection or inflammation;
* Had history of ocular surgery, eyelid surgery or neurological paralysis within 6 months;
* Had history of systemic disease affecting ocular surface function, such as Stevens-Johnson syndrome, Sjögren syndrome etc.
Smoking Status and Body Image in Oral Cancer Patients

Primary Objectives:

1. To characterize smoking behaviors and body image in patients with oral cavity cancer prior to and following surgical procedures.
2. To examine the relationship between smoking status and body image in this sample of head and neck cancer patients.
3. To examine the influence of smoking status and body image on quality of life outcomes.

If you agree to take part in this study, researchers will first perform a test to check the level of carbon monoxide (CO) in your blood. To do this test, you will be asked to blow into a cardboard tube attached to a machine. You will then be asked to fill out some questionnaires and complete a one-on-one interview. All of these things combined will take about an hour to complete. You will be asked basic questions such as your age, education level, and smoking history. You will also be asked questions about your mood, quality of life, and how you feel about your appearance.

If you do not have surgery, your participation in this study will end after this visit. If you have surgery, you will be asked to come back for 2 more study visits, 1 month and 6 months after your surgery. During these evaluations, you will be asked once again to blow into the cardboard tube, fill out questionnaires, and a complete a one-on-one interview. Each visit will last about an hour. You will again be asked questions about your smoking behaviors, mood, quality of life, and how you feel about your appearance. Your participation in this study will be finished after the 6-month evaluation.

This is an investigational study. About 75 people will take part in this research study. All will be enrolled at M. D. Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Able to provide written informed consent to participate
3. Diagnosis of head and neck malignancy involving an oral cavity site without previous treatment
4. Current treatment plan includes surgical intervention
5. English speaking

Exclusion Criteria:

1. Previous treatment for malignancy in the head and neck region
2. Significant preexisting facial disfigurement from a previous trauma or congenital defect
3. Diagnosis of a serious mental illness involving formal thought disorder (e.g., Schizophrenia) documented in medical record.
Characterization of Myocardial Blood Flow During Heat Exposure

The purpose of this study is to determine the increase in myocardial blood flow during heat exposure and how this response is affected by age and coronary artery disease.

As a result of climate change, heat waves are more frequent and of longer duration. These heat waves are associated with a higher risk of hospitalization and mortality in vulnerable populations such as people with cardiovascular disease or cardiovascular risk factors. It has been hypothesized that this observation may be explained by the cardiovascular demands imposed by heat exposure.

Heat exposure requires increased cardiac work that may place individuals with cardiovascular disease at risk of ischemic events if the metabolic demand is not compensated by adequate blood supply. However, the extent to which cardiac work increases during heat exposure remains unknown. The aim of this study is to test the hypothesis that heat exposure increases myocardial blood flow and that this increase is affected by age and coronary artery disease.

Eligibility Criteria:
Inclusion Criteria for Healthy Participants:

* Age between 18-40 years or 60-80 years
* Non-smoker (≥1 year)
* Non-diabetic
* Normal kidney function
* Body Mass Index \<30 kg/m2
* Resting blood pressure \<140/\<90 mmHg
* Resting heart rate \<100 bpm

Inclusion Criteria for Participants with Coronary Artery Disease:

* Age between 60-80 years old
* History of angiographic coronary disease (≥70% arterial diameter narrowing of at least one major epicardial coronary artery) and/or prior coronary revascularization and/or documented prior acute coronary syndrome and/or perfusion defect during stress testing
* Stable medications (≥4 weeks) prior to enrollment

Exclusion Criteria for Healthy Participants:

* Diagnosis of heart, vascular, respiratory, neurological or metabolic disease and/or a prescription of medication for the treatment of these diseases
* Pregnancy or lactation
* Dyslipidemia not controlled by medication

Exclusion Criteria for Participants with Coronary Artery Disease:

* Recent hospitalization (\<3 months) related to coronary artery disease
* Unstable angina (\<3 months)
* Recent coronary artery bypass surgery (\<3 months)
* Left branch block
* Ejection fraction \<40% and/or clinical signs of heart failure
* Severe valvular heart disease
* Hypertension not controlled by medication
* Diabetes not controlled by medication and/or serious complications related to diabetes
Observational Study in Infants Who Are Prescribed Treatment With Keppra® (Levetiracetam) Oral Solution

The purpose of this observational study is to broaden the knowledge of the known safety and efficacy profile of Keppra® (Levetiracetam) oral solution in epileptic infants younger than 12 months when treated according to routine clinical practice. Their data will be collected until they reach the age of 13 months.

This non-interventional sentinel sites post-authorization safety study (PASS) aims to collect additional data on use of Keppra® (Levetiracetam) oral solution in clinical practice, and on efficacy and safety of Keppra® (Levetiracetam) in infants younger than12 months. Epileptic patients between the age of 1 month and 11 months inclusive can be invited for participation to the non-interventional sentinel sites PASS, after the physician has decided to initiate therapy with Keppra® (Levetiracetam) oral solution (100 mg/ml bottle) and patient has so far been treated with Keppra® (Levetiracetam) for no longer than 10 days. The patients will be followed and their data will be collected until they reach the age of 13 months.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of epilepsy
* being treated with Keppra® Oral Solution
* aged between 1 month and 11 months inclusive at study baseline

Exclusion Criteria:

* none
Phase III Confirmatory Study of DE-089 Ophthalmic Solution in Patients With Dry Eye

To investigate that the efficacy of 3% DE-089 ophthalmic solution (one drop at a time, 6 times daily, 4 weeks topical administration), in comparison to 0.1% sodium hyaluronate ophthalmic solution (0.1% HA) (one drop at a time, 6 times daily, 4 weeks topical administration), is at least non-inferior in the change in fluorescein staining score, and is superior in the change in Rose bengal score, in a multicenter, double-masked, parallel-group comparison study. Safety profile will likewise be compared.


Eligibility Criteria:
Inclusion Criteria:

* Those who show:

  * Keratoconjunctival disorder confirmed with vital dye staining
  * Abnormal Schirmer score results

Exclusion Criteria:

* Eye disease that needs therapy other than that for dry eye
* Those who need to wear contact lenses during the clinical study
Real Time Evaluation of Dynamic Changes of the Lungs During Respiratory Support of VLBW Neonates Using EIT

Electric Impedance Tomography (EIT) is a lung monitoring technique based on the injection of small currents and voltage measurements using electrodes on the skin surface generating cross-sectional images representing impedance change in a slice of the thorax. It is a real time, radiation free, non-invasive and portable. Neonatal respiratory distress syndrome (RDS) is a respiratory disorder resulting from immaturity of the lung structure and lack of surfactant. It is one the most common conditions in premature infants. Many of these infants require either invasive or non-invasive respiratory support. The goal of the study is to investigate the dynamic changes in pulmonary aeration during assisted breathing in very low birthweight preterm infants using pulmonary electrical impedance tomography. Currently most widely used methods to assess respiratory lung function are either invasive and/or indirect (ABG, pulse oximetry, transcutaneous pCO2 measurement), lacks temporal resolution (lung ultrasound) or emit ionizing radiation (CT). EIT provides information on regional lung aeration without the aforementioned shortcomings.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age \<32 weeks OR birthweight \<1500 g.
* Need of respiratory therapy (invasive or non-invasive)
* Parental consent.

Exclusion Criteria:

* patient does not meet all of the above listed inclusion criteria
* patients with a pacemaker
* patients with skin damage/abrasions at the EIT device belt area
* newborns with significant thoracic deformity
Effectiveness of Repeated Amiodarone Dosing Regimen Versus Standard Dosing Regimen in Atrial Fibrillation Patient With Rapid Ventricular Response

The goal of this clinical trial is to compare in atrial fibrillation patient with rapid ventricular response. The main question it aims to answer are Effectiveness of Repeated Amiodarone dosing regimen versus standard dosing regimen in Atrial fibrillation patient with rapid ventricular response Participants will receive Amiodarone iv treatment with different regimen

* Repeated dosing regimen
* Standard dosing regimen


Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years old
* Atrial fibrillation with rapid ventricular response patient (ventricular rate \> 110)

Exclusion Criteria:

* Baseline EKG Corrected QT interval (QTc) \< 500 msec
* History of pulmonary fibrosis
* History of Cirrhosis
* Cardiac Index \<2.2 L/min/m2 or Cardiogenic shock
* Unstable arrhythmia
* Receive amiodarone within 3 months prior to present illness
* Pregnancy
* Amiodarone or Iodine allergy
Diaphragmmatic Muscle Strength and Balance in Women With Dysmenorhea

Analysis of stabilometric and respiratory variables in patients with dysmenorrhea during the first day of the menstrual cycle and any other day outside the cycle.

Sociodemographic variables such as age, height, body mass index.

Respiratory variables such as maximum inspiratory pressure (MIP), MIP reference %, and MIP predictive value.

Stabilometric variables we will measure the balance in condition of eyes open and eyes closed bipodal support and eyes open in monopodal support

Eligibility Criteria:
Inclusion Criteria:

* Adult women with primary dysmenorrhea.
* Not having had any type of childbirth (natural, caesarean section, etc).
* Not be positive in COVID. Antigen test in the last 24 hours or negative PCR in the last 48 hours.

Exclusion Criteria:

* Receive medical treatment during research.
* Have any orthopedic, neurological or systemic disease diagnosed other than primary dysmenorrhea.
* Be in follow-up with any medical treatment that does not be primary dysmenorrhea
* Women with a history of trauma or surgical treatment who involve the musculoskeletal system in the last year.
* Use of analgesics in the last 48 hours.
* Consumption of alcohol in the last 24 hours.
* Have a history or suspicion of pregnancy.
The OSIRIS ECPR Trial

The OSIRIS trial is an investigator-initiated, multicenter, multinational, open-label, randomized controlled trial with a 2:1 concealed allocation of refractory out-of-hospital cardiac arrest (OHCA) patients to the extracorporeal cardiopulmonary resuscitation (ECPR) based approach versus the conventional cardiopulmonary resuscitation (CCPR) approach.

ECPR for OHCA is a resource-intensive method and poses significant challenges for both prehospital and hospital systems. Recent meta-analyses have highlighted persisting uncertainties regarding the routine use of ECPR strategy for OHCA, emphasizing the need for further research.

The refractory OHCA trial is a multicenter, multinational, open-label, randomized trial with a 2:1 concealed allocation of refractory OHCA patients to ECPR-based approach versus CCPR approach.

ECPR-based approach is defined as advanced cardiac life support (ACLS) per current guidelines with aim to proceed to in-hospital or out-of-hospital veno-arterial extracorporeal membrane oxygenation (V-A ECMO) if (return of spontaneous circulation) ROSC is not achieved before the cannulation.

CCPR is defined as conventional ACLS per current guidelines without mechanical circulatory support (MCS) use until sustained ROSC is achieved or the patient pronounced dead.

This study was designed to test the hypothesis that invasive, ECPR-based approach when compared to CCPR:

1. increases survival in selected adults with refractory OHCA.
2. and can be successfully implemented in different cities and countries.

The study will include adults 18-70 years of age suffering refractory OHCA of presumed cardiac cause. Refractory OHCA is characterized as either 3 unsuccessful defibrillations in ongoing shockable rhythms or 10 minutes of ACLS without ROSC in the case of a non-shockable rhythm following the first or second defibrillation.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 and ≤ 70 years presumed or known
2. Witnessed OHCA
3. Bystander CPR provided
4. Presumed cardiac or unknown cause
5. An initial documented shockable rhythm of VF (ventricular fibrillation) or pulseless VT (ventricular tachycardia)
6. Minimum of ≥ 10 min of ACLS without ROSC or at least ≥ 3 defibrillations in ongoing VF/pulseless VT
7. Body morphology able to accommodate a mechanical chest compression device
8. ECPR team and intensive care unit (ICU) capacity in the receiving center available
9. Estimated transfer time from the scene to the hospital ≤ 30 minutes or to the scene ≤ 30 minutes
10. Eligible for intensive care without restrictions or limitations

Exclusion Criteria:

1. ACLS ≥ 30 minutes before randomization
2. Known limitations in care or a Do Not Attempt to Resuscitate (DNAR) order
3. Known severe disease making 90-day survival unlikely
4. Known bleeding diathesis or acute or recent intracranial bleeding
5. Known, obvious or suspected pregnancy
6. Known pre-arrest severe cognitive dysfunction (mRS ≥ 4)
7. Known hypothermia as a cause of cardiac arrest
Evaluation of the Effect of the BOAT® Structured Prevention Program on Violence in Middle Schools

Violence has major consequences for the health and development of children and teenagers, even though it is commonplace, particularly in secondary schools. The team at the Centre Ressources pour les Intervenants auprès d'Auteurs de Violences Sexuelles Languedoc-Roussillon (CRIAVS-LR, CHU Montpellier) has created a BOite A ouTils to prevent sexual and gender-based violence: the BOAT, for professionals working with children and teenagers aged between 5 and 18. Structured around 5 themes and 4 age groups, the BOAT is very easy to use. The 134 intervention sheets have been validated and designed to target a risk factor (to be reduced) or a protective factor (to be developed) so that children do not become perpetrators or victims of violence.

The study will involve 60 middle school (10 middle school REP/REP+ in six academies) over four consecutive school years between 2023 and 2027, the first year being devoted to preparing the study with the establishment. The research project is coordinated by the Montpellier University Hospital, and regulatory approvals have been sought from the relevant authorities.

Eligibility Criteria:
Inclusion Criteria:

* Middle school students: students enrolled in a middle school included in the study, enrolled in the fourth or ninth grade and randomly selected to participate in the research. The age of a fourth or ninth grader is between 13 and 17.

  * Educational team: professionals and teachers working in a middle school participating in the research (included in the study).

Exclusion Criteria:

* Schoolchildren: opposition to participation in the search by the child's parents (or one of the 2 parents with parental authority) and/or opposition by the child.
* Educational team: opposition to participation in the search.
* Person unable to speak French
* Person unable to understand the nature, purpose and methodology of the study
NVP-1805 Compared to Coadministration of NVP-1805-R1 With NVP-1805-R2 in Healthy Adult Volunteers (BE)

The purpose of this study is to compare the pharmacokinetics of NVP-1805 and coadministration of NVP-1805-R1 with NVP-1805-R2

Evaluate pharmacokinetics and safety of NVP-1805 compared to coadministration of NVP-1805-R1 with NVP-1805-R2

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult subjects who signed informed consent
* BMI of \>18.0 kg/m2 and \<30.0 kg/m2 subject, weight more than 50kg(45 kg or more for woman)

Exclusion Criteria:

* Subjects participated in another clinical trial within 6 months prior to administration of the study drug
* Inadequate subject for the clinical trial by the investigator's decision
* Subjects participated in another clinical trial within 6 months prior to administration of the study drug