cyrilzakka/clinical-trials huggingface dataset:
Sleep-disordered Breathing and Neurocognitive Assessment in Children and Young Adults

One of main problems in the management of sleep-disordered breathing (SDB) in children and young adults is their screening, and the absence or the weak correlation between clinical symptoms and polysomnography (PSG). It may be useful to use additional measures together with PSG to improve the detection and characterization of respiratory events during sleep and/or correlation with clinical signs of SDB.

The primary objective of the study is to determine whether psychological and neuropsychological test scores correlate with diagnostic PSG results.

One of main problems in the management of sleep-disordered breathing (SDB) in children and young adults is their screening, and the absence or the weak correlation between clinical symptoms and polysomnography (PSG). It may be useful to use additional measures together with PSG to improve the detection and characterization of respiratory events during sleep and/or correlation with clinical signs of SDB.

In addition, the clinical impact of SDB and the benefit of treatment are still not clear in children and young adults, including neurocognitive and developmental perspective.

Finally, the validation of simplified tools could optimize and simplify the detection of SDB in children and young adults.

Patients scheduled to perform a diagnostic PSG for routine clinical care will have additional recordings and questionnaires as part of the study.

The primary objective of the study is to determine whether psychological and neuropsychological test scores correlate with diagnostic PSG results.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 1 to 20 years with a suspicion of SDB or a high-risk of SDB due to their pathology and hospitalized at Necker Hospital for a sleep study
* Written informed consent

Exclusion Criteria:

* No social insurance
* Significant psychomotor retardation
* Cooperation not possible
* Significant agitation
* Acute condition and/or temporary drug treatments that may interfere with the results of PSG (upper or lower airway infection)
* Patient under guardianship/curatorship
Combined Spinal-Epidural Versus Traditional Labor Epidural

The purpose of this study to compare the use of spinal-epidural versus traditional labor epidural on maternal and fetal effects. The hope is to determine the safest and most effective epidural method of relieving pain during labor.

Combined spinal-epidural anesthesia (CSE) was developed to allow excellent pain control for the pregnant woman who arrives in advanced labor and does not have much time for the anesthetic to have its effect. This has been extended recently to women in all stages of labor because of its rapid and excellent control of pain. Recent case series comparing CSE with traditional epidural have shown a slight difference in the rate of hypotension and fetal bradycardia, with the CSE technique having a higher rate of both of these side effects. This study will compare the two techniques in a prospective, randomized method.

The aim is to compare the maternal and fetal effects of two neuraxial block techniques for pain control during labor, to document blood pressure changes in upper and lower extremities pre- and post- block placement, and to document side effects (e.g. pruritus) and patient satisfaction with both techniques.

Eligibility Criteria:
Inclusion Criteria:

* Patient is able to read, understand and voluntarily sign the approved informed consent form (ICF) prior to any study- specific procedure;
* Must be between 18 to 50 years of age.
* Must be carrying a singleton fetus at term.
* Must have less than a body mass index of 40.
* Must be in labor, or is having a medical induction of labor.

Exclusion Criteria:

* Patient who has chronic renal disease, pre-existing hypertension, or pre-eclampsia.
* Patient who is undergoing an elective cesarean delivery
* Patient who has a presence of non-reassuring fetal status
* Patient who has an abnormal or non-reassuring fetal heart rate (FHR) pattern
The Effects of Individualised Short-term Sleep Restriction on Tactical Performance

The goal was to evaluate the influence that chronic sleep restriction may have on football players tactical performance during small-sided games. By using a relative sleep restriction (i.e., by reducing the normal sleep duration by 15%) instead of an absolute sleep restriction (e.g., 3-4 hours), different sleep schedules were applied, according to the players individual sleep profile. It was hypothesized that the player's performance would be impaired, particularly their tactical behaviors when performing a 4x4 small-sided game format.

An impairment on cognitive and physical performance is commonly suggested in literature. However, there is a lack of information regarding sport-specific parameters. Thus, the present study aimed to examine whether chronic sleep restriction during 9 consecutive days impairs the tactical performance of football players during small-sided games (SSGs). A total of sixteen national level male football players wore wrist actigraphy units during night sleep throughout the study. Players were randomized into two groups: intervention (IG), and control (CG). The first four days corresponded to a familiarization period, where players were informed about the study procedures and started using wrist actigraphy. Throughout the next seven consecutive days, the characterization phase of sleep players profile (i.e., baseline) was collected and analyzed. Then, players entered the intervention phase, where the IG slept 15% less than routine. During this 9-days period, players performed a 4x4 SSGs in two moments (moment 1 and moment 2) with a week interval. The SSGs were recorded using a video camera and subsequently analyzed using the Game Performance Assessment Instrument.

Eligibility Criteria:
Inclusion Criteria:

* Soccer players classified as Tier 3, corresponding to the National Level in accordance to McKay et al. (2022), as they represented the under-19 team playing in the Portuguese National Championship 1st Division.

Exclusion Criteria:

* 1) players with previously identified sleep disorders;
* 2) players with injuries that prevented them from playing SSGs.
Study of the Cellular Diffusion of Tacrolimus Across the Membrane of Mononuclear Cells

Pharmacokinetics of tacrolimus are highly variable and may result in graft rejection (underdosing) or toxicity (overdosing).

The risk of transplant rejection and the toxicity of tacrolimus can be reduced by pharmacological therapeutic monitoring of the molecule, based on the measurement of residual blood concentrations. Nevertheless, some patients are victims of rejections or toxic signs even though their blood concentrations are in the therapeutic target.

The aim of the study is to describe the pharmacokinetics of tacrolimus diffusion in mononuclear cells as well as the kinetics of effect of the drug on its target protein

Factors responsible for pharmacokinetic variability of tacrolimus are multiple: compliance, diet, drug interactions and also genetic polymorphism of cytochrome P450 3A5 (CYP 3A5) and efflux protein ABCB1 (P-glycoprotein, P-gp).

The mechanism of action of tacrolimus is based on inhibition of calcineurin in T cells. Therefore, tacrolimus intra-lymphocyte concentration may be a finer marker of the risk of transplant rejection or toxicity. The degree of inhibition of calcineurin in the T lymphocyte could also be a pharmacodynamic marker more relevant than the blood concentration. The hypothesis that the ABCB1 efflux pump is the main factor limiting the diffusion of tacrolimus into mononuclear cells is advanced.

The diffusion of tacrolimus into mononuclear cells and the impact of the ABCB1 efflux pump on this diffusion have not been studied to date. The effect kinetics of the drug on calcineurin in mononuclear cells is also unknown.

The aim of the study is to describe the pharmacokinetics of tacrolimus diffusion in mononuclear cells as well as the kinetics of effect of the drug on its target protein: calcineurin in the presence or absence of an efflux pump inhibitor ABCB1 at room temperature and at 4 ° C (in order to inhibit all transport proteins) from blood obtained from 18 patients undergoing bleeding as part of maintenance treatment for hemochromatosis.

Eligibility Criteria:
Inclusion Criteria:

* adult (age \> 18 years old);
* phlebotomy as part of the maintenance treatment of hemochromatosis;
* having received the information on the protocol and not having indicated his opposition to participate;
* not receiving immunosuppressive therapy;
* not receiving drug treatment that can induce or inhibit the protein ABCB1 (Rifampicin, Carbamazepine, Phenobarbital, Phenytoin, Efavirenz, Amiodarone, azole antifungals, calcium channel blockers).

Exclusion Criteria:

* participation in another protocol whose procedures are incompatible with the realization of the study;
* adults who are subject to legal protection (protection of justice, guardianship) and persons deprived of their liberty;
* pregnant women.
Self-myofascial Release in Hemophilic Ankle Arthropathy

Introduction: Hemophilic ankle arthropathy is manifested by degenerative functional alterations (deficit of muscle strength, mobility and proprioception) (intra-articular alterations) and chronic pain. Myofascial release techniques are used to treat soft tissue adhesions, relieve pain and reduce tissue sensitivity.

Design. A randomized clinical trial. Aimed: To evaluate the safety and effectiveness of a protocol by self-myofascial release with Foam Roller applied in patients with hemophilic ankle arthropathy.

Patients: 70 patients with ankle arthropathy will be recruited for inclusion in the study. Patients will be recruited in 5 centers, from different regions of Spain.

Intervention: Each session will last approximately 15 minutes, with five physiotherapy sessions per week for a period of 3 months. Patients will be evaluated at baseline, after the intervention, and after a follow-up period of 3 months. The treatment program includes 11 exercises that must be administered bilaterally. A mobile application will be developed where each patient will be able to observe the exercises to be carried out.

Measuring instruments and study variables: digital goniometer (ankle range of motion); visual analog scale and pressure algometer (joint pain); Haemophilia Joint Health Score (joint status); dynamometer assess (muscle strength); 6-Minute Walking test (functionality of lower limbs); Mobile device (Activity record); Finger-floor test (muscle flexibility). At the same time, the study will allow to determine joint bleeding caused by applied physiotherapy treatment.

Expected results: To demonstrate the safety of this Physiotherapy technique in patients with hemophilia. Likewise, an improvement in ankle pain, functionality and joint motion is expected.


Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years old
* Patients with a medical diagnosis of hemophilia A or B.
* Patients with a severe phenotype of hemophilia (\<1% FVIII/FIX).
* Patients with a medical diagnosis of hemophilic ankle arthropathy and more than 3 points on the Hemophilia Joint Health Score.
* Nno scheduled orthopedic surgeries during the study phase.
* Signing the informed consent document.

Exclusion Criteria:

* Patients with ankle hemarthrosis in the month before the beginning of the study.
* Patients unable to walk even with technical aids.
* Patients with hemophilic elbow arthropathy that prevented the performance of the exercises.

  * Patients failing to complete at least 80% of the sessions scheduled in the intervention
Nebulized Midazolam, Dexmedetomidine, and Their Combination in Sedation of Preschoolers Undergoing Dental Treatment

The aim of the study is to evaluate the effect of nebulized Midazolam, Dexmedetomidine, and their combination as procedural, moderate sedative agents in preschoolers undergoing dental treatment.

Dental anxiety and fear related behaviors are global problems in Pediatric Dentistry. Preschoolers represent a dental behavior management problem and there is always a debate over the best behavioral management technique for preschoolers undergoing dental treatment. Moderate sedation is considered as an acceptable option.

Children who need treatment under local anesthesia, for thirty minutes will be included in the study. A total of 72 uncooperative pediatric dental patients, of age range 4-6 years, will be selected from the Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, Egypt. The participants will be randomly allocated into 3 groups that will undergo a procedural sedation session via a nebulizer. Children of group I will receive nebulized solution of 0.5 mg/kg Midazolam, Group II will receive nebulized solution of 5µg/kg Dexmedetomidine, and Group III will receive a nebulized solution of 0.3 mg/kg Midazolam and 3µg/kg Dexmedetomidine respectively.

Eligibility Criteria:
Inclusion Criteria:

* Age range 4-6 years
* Frankl scale score 2.
* ASA I or II physical status.
* Dental intervention under local anesthesia not requiring more than 30 minutes.
* No previous dental experience.
* Parent/guardian"s written consent.

Exclusion Criteria:

* Dental treatment indicated under general anesthesia.
* Presence of facial deformities.
* History of neurological or cognitive alterations.
* Mouth breathers.
Effect Of GW501516X On How The Heart Obtains And Uses Energy

The purpose of this study is to determine the effect of a 4-week treatment period with GW501516X on how the heart obtains and uses energy. The energy of the heart will be measured by Magnetic Resonance Imaging (MRI). This study will also measure a number of other potential markers of drug activity, including levels of certain lipids (fats) and proteins in your blood. The data from this study may help researchers better understand the actions of this drug in the body and if this drug may be useful to treat patients with heart disease.


Eligibility Criteria:
Inclusion criteria:

* Non-smoking.
* Body Mass Index of greater than 27 and less than 32 and who weigh 120 kg (264 lbs) or less and have a waist circumference of greater than 95 cm (37.5 inches).

Exclusion criteria:

* History of muscle disease, coagulation disorders, heart disease or abnormal heart rhythm (or a family history of early coronary artery disease).
* Documented diabetes, hypoglycemia, thyroid disfunction or adrenal disorder.
Comparison of MEOPA + Paracetamol Versus Morphine Treatment in Acute Coronary Syndrome Analgesia.

In the management of acute coronary syndromes with ST-segment elevation (STEMI), early analgesia reduces the effects of hyperadrenalism which increases the size of myocardial infarction. In order to reduce pain intensity, the recommendations advocate emergency use of morphine. In STEMI patients, other analgesic treatments could provide analgesia that is at least as effective as morphine. The equimolar oxygen/nitrous oxide mixture (MEOPA) is widely used in emergency medicine and has minor secondary effects that are very rapidly reversible when inhalation is discontinued. Used in association with paracetamol, it could be an at least equally effective alternative to the use of morphine.

The investigators wish to compare the use of morphine according to current recommendations with the use of MEOPA associated with intravenous paracetamol in the management of patients with STEMI. The investigators hypothesize that the association of MEOPA and paracetamol, which is easy to use in a pre-hospital setting, will give patients pain relief as effectively as morphine.

This alternative treatment would avoid the use of morphine, whose potentially damaging consequences on myocardial function have been suggested by experimental studies and by an observational study. The physician of the mobile emergency team (SMUR) verifies the inclusion and non- inclusion criteria for the study. The patient must present STEMI defined in accordance with the recommendations and chest pain of intensity ≥ 4 on the NRS. The specific treatment for STEMI will be given before inclusion in the study, with the exception of analgesic treatment. In particular, inclusion in the study must not delay the initiation of strategies of recanalization and reperfusion.

The SMUR physician in charge of the patient will administer the treatment defined by randomization.

After 30 minutes, the patient will be managed in accordance with the recommendations and will be hospitalized, generally in a cardiology intensive care unit. At one month, the clinical research technician will record the patient's vital status and collect the patient's hospital records.

Eligibility Criteria:
Inclusion Criteria:

* Patient with STEMI \< 12 h treated before hospital admission and pain ≥ 4 on the numerical rating scale.

Exclusion Criteria:

* Acute severe hemodynamic, respiratory or neurological failure
* Heart failure: Killip class III and IV
* Known allergy to morphine or nitrous oxide
* Patient who has already received morphine or MEOPA before the arrival of the hospital team during the 4 hours preceding the pre-hospital intervention
* Contraindications to nitrous oxide
* Patient unable to assess pain intensity on the numerical rating scale
* Patient under legal guardianship
* Pregnancy
* Patient transported by air ambulance
Coenzyme Q10 in Relation of the Lipid Peroxidation, Antioxidant Enzyme Activities in Coronary Artery Disease Patients

Coenzyme Q10 (Ubiquinone) is recognized as an endogenous fat-soluble antioxidant in the mitochondrial membrane and considered as a preventive factor for coronary artery disease (CAD). However, the relationships between coenzyme Q10 and the prevention of the risk of CAD are still inconsistent. The purposes of this study are to investigate the relation of coenzyme Q10 concentration with the blood lipid levels, plasma homocysteine, the markers of lipid peroxidation (TBARS, ox-LDL),antioxidant enzymes activities (catalase, glutathione peroxidase, superoxide dismutase)and to examine the association with the risk of CAD.The CAD patients is identified by cardiac catheterization as having at least 50% stenosis of one major coronary artery (n = 100). The second year is a double-blind, placebo-controlled intervention study. CAD subjects (n = 60) are randomly assign to one of the three groups (coenzyme Q10 supplements 60 mg/d, 150 mg/d, and placebo groups, n = 20/group). Intervention is going to administration for three months. The third year is a case-control study. The control group （n = 100） is comprised of healthy individuals with normal blood biochemical values, and match by age and gender with the first year CAD subjects (case group). Fasting blood samples will be obtain to determine the concentration of coenzyme Q10, homocysteine, the markers of lipid peroxidation,antioxidant enzymes activities. The differences between case and control groups will be compared by using Student's t-test. Conditional logistical regression model will be performed to calculate the odds ratio for CAD based on coenzyme Q10 level. Hopefully, the results of this study could provide the information to what has been know in CAD subjects. We expect coenzyme Q10 could be a preventive supplement to reduce the risk of CAD.


Eligibility Criteria:
Inclusion Criteria:

* CAD patients is identified by cardiac catheterization as having at least 50% stenosis of one major coronary artery

Exclusion Criteria:

* age \< 18 years old
* pregnancy women
* taking lowering lipid drug (Statin)
CYP2C19 Gene Alteration and Thienopyridine Resistance in Percutaneous Coronary Intervention Study

Dual antiplatelet therapy with aspirin and thienopyridines decreases the rate of stent thrombosis in patients undergoing percutaneous coronary intervention (PCI). However, despite intensified antiplatelet treatment, some of the patients undergoing PCI develop thrombotic stent occlusion, suggesting incomplete platelet inhibition due to thienopyridine resistance. The present study is designed in order to clarify the influence of CYP2C19 genetic polymorphism on the several biomarkers for platelet activation in Japanese patients treated with thienopyridines undergoing elective PCI.

We enrolled patients with stable effort angina who received dual-antiplatelet therapy with both aspirin (100mg) and clopidogrel (75mg). We performed PCI 12-24 hours after 300mg loading dose of clopidogrel, or at least 7 days of 75mg clopidogrel treatment after 300mg initial loading dose. We examined platelet adhesiveness, plasma biomarkers for platelet activation such as plasma VWF and ADAMTS13, CD40L, P-Selectin levels, and ADP-induced platelet aggregation using Light transmittance aggregometry (LTA) and VerifyNow P2Y12 assay system in those patients. We also analyzed the CYP2C19 genetic polymorphism to examine the influence of this genetic variation on the several biomarkers for platelet activation.

Eligibility Criteria:
Inclusion Criteria:

* The stable effort angina patients
* More than 20 years old
* Undergoing elective PCI treated with aspirin and clopidogrel

Exclusion Criteria:

* Patients treated with the following medical therapy (ie. Warfarin, Steroid, thrombolytic drug, Ticlopidine, Sarpogrelate hydrochloride or Cilostazol)
* Patients with the following diseases (deep vein thrombosis, atrial fibrillation, collagen disease, infection, liver or renal dysfunction, malignant diseases)
Nebulized Ceftazidime and Amikacin in Ventilator Associated Pneumonia

Pseudomonas aeruginosa is one of the major causative microorganisms of ventilator-associated pneumonia often resistant to antibiotics. In experimental models, nebulization of antibiotics delivers high lung tissue concentrations of antibiotics in infected lungs and increases lung bacterial killing. The aim of the study is to assess the efficiency of nebulized ceftazidime and amikacin in the treatment of pneumonia caused by Pseudomonas aeruginosa in ventilated patients.


Eligibility Criteria:
Inclusion Criteria:

* Male or female \>18 years old, ventilator associated pneumonia caused by pseudomonas aeruginosa
* Written informed consent provided by the relatives

Exclusion Criteria:

* Pseudomonas aeruginosa resistant to ceftazidime and amikacin
* Pseudomonas aeruginosa pneumonia associated with other infections requiring intravenous treatment
* Severe septic shock and severe hypoxemia
* Allergy to ceftazidime or amikacin