cyrilzakka/clinical-trials huggingface dataset:
Cyclosporine in Acute Myocardial Infarction Complicated by Cardiogenic Shock

The size of the acute myocardial infarction (AMI) is related to ischemia and injury induced by tissue reperfusion. These reperfusion's injuries can be reduced by injection of cyclosporin A (CsA) at the time of reperfusion. This post-conditioning reduces the final infarct size 20 to 40%. This has been demonstrated in STEMI patients non-complicated by cardiogenic shock. Early revascularization in the AMI complicated by cardiogenic shock improves short-term and long term survival by reducing the size of the myocardial infarction. The hypothesis of this study is that the administration of Cyclosporin A to these patients, in addition to mechanical reperfusion, is likely to reduce the severity of the multi-organ failure associated with the cardiogenic shock and improve clinical outcome.


Eligibility Criteria:
Inclusion Criteria:

* Patients ( male or female), aged over 18, without any legal protection measure
* Having a health coverage
* Presenting within 12 hours of the onset of chest pain, with a ST segment elevation or non ST elevation and for whom the clinical decision was made to treat with percutaneous coronary intervention (PCI) primary or rescue
* Occlusion of culprit coronary artery (TIMI flow grade = 0 or 1) at the time of admission in the catheterism laboratory
* Patient presenting a cardiogenic shock defined by a SBP\<90mmhg for a period over 30 minutes and do not answering to a test of vascular charge associated with signs peripheral hypoperfusion (cold extremities, cyanosis, oliguria with urine output \<50 ml/h or alteration of higher mental functions).
* Clear information is delivered to the patient or a legal representative if present and preliminary oral consent obtained, followed by obtaining written consent signed as soon as possible, in accordance with ICH.

NB: Patients undergoing either primary PCI or rescue PCI are eligible for the study.

Patients with previous AMI, PCI or coronary artery bypass surgery (CABG) are eligible for the study.

Exclusion Criteria:

* TIMI flow grade \>1
* Patients in cardiac arrest
* Patients with mechanical complication of myocardial infarction at admission (septal, broken pillar cracking or myocardial rupture, tamponade).
* Patients with other causes of hemodynamic shock: hemorrhagic, septic or anaphylactic.
* Patients with known hypersensitivity to cyclosporine, hypersensitivity to egg, peanut or Soya-bean proteins
* Renal insufficiency (either known creatinine clearance \< 30 ml/min/1.73m² or current medical care for severe renal insufficiency)
* Patients treated with any compound containing Hypericum perforatum (St. John's Wort) or Stiripentol or Aliskiren or Bosentan or Rosuvastatine
* Female patients currently pregnant or women of childbearing age who were not using contraception (oral diagnosis).
* Patients with any disorder associated with immunological dysfunction more recently than 6 months prior to presentation, cancer, lymphoma, known positive serology for HIV, or hepatitis
* Participation to another clinical trial
Diuretic Efficacy of Dexamethasone in Heart Failure

The purpose of this study is to determine whether glucocorticoids have potent diuretic effects in patients with congestive heart failure.

Glucocorticoids are known to have pronounced physiological effects in the kidney. Conventional teaching dictates that it should be used with caution in patients with congestive heart failure due to its fluid and sodium retention effects. Surprisingly, despite the widespread prevalence of this belief within the medical community, there are few data to support it. In fact, several small animal studies have documented its striking diuretic effects due to increased renal plasma flow and glomerular filtration rate without changes in the glomerular filtration fraction. We design this study to determine whether glucocorticoids have a potent diuretic effect in patients with heart failure.

Eligibility Criteria:
Inclusion Criteria:

* Congestive heart failure patients due to any cause
* Patients with normal cortical function
* Congestive heart failure patients who are on diuretic therapy
* Clinically stable and body weight maintained the same for at least 3 days without signs of fluid retention

Exclusion Criteria:

* Patient refusal
* Signs of infection
Pain Relief for OsteoArthritis Through Combined Treatment (PROACT)

This mechanistic clinical trial proposes to test whether a five-day course of mindfulness meditation training (MMT) and tDCS, and their combination, can enhance pain modulatory balance and pain-related brain function, reduce clinical pain, among African Americans and non-Hispanic whites with knee osteoarthritis (OA). This approach will provide evidence that targeting stress and pain-related brain function will reduce OA-related pain and ethnic group differences therein.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral or bilateral symptomatic knee OA based on American College of Rheumatology Clinical criteria
* Participant reports primary ethnic/race group as either African American or non-Hispanic white

Exclusion Criteria:

* Actively symptomatic systemic rheumatic disease/condition (e.g. rheumatoid arthritis, systemic lupus erythematosus), or fibromyalgia that results in pain outside the knee that is equal to or worse than the participant's knee pain.
* A history of clinically significant surgery to the index knee.
* Daily use of opioids. We will exclude patients using opioids daily as both continued use and temporary withdrawal from these medications this could affect pain perception and response to interventions. Other medications being used will be recorded and controlled in statistical analyses as needed.
* Use of some centrally acting sodium channel blockers, calcium channel blockers and NMDA receptor antagonists, because some of these medications can block tDCS effects. Other medications can potentially influence response to tDCS (e.g. SSRIs, beta-blockers); therefore, consistent with recent recommendations (2), we will assess use of these medications and include them as covariates in our statistical models.
* Uncontrolled hypertension (i.e. SBP/DBP of \> 150/95) or unstable or activity limiting cardiovascular or peripheral arterial disease. These exclusions are in place primarily for safety reasons, because the cold pressor task represents a cardiovascular challenge. However, uncontrolled hypertension can also affect pain perception, which is another reason for excluding these individuals.
* Neurological disease (e.g. Parkinson's, multiple sclerosis, epilepsy) or evidence of previous brain injury, including stroke and traumatic brain injury.
* Serious psychiatric disorder requiring hospitalization within the past 12 months or characterized by active suicidal ideation.
* Current substance use disorder or history of hospitalization for treatment of substance use disorder.
* Diminished cognitive function that would interfere with understanding of study procedures.
Safety and Efficacy of SIMBRINZA® BID as an Adjunctive to DUOTRAV®

The purpose of this study is to evaluate the additive intraocular pressure (IOP) lowering effect of Brinzolamide 1%/Brimonidine 0.2% (SIMBRINZA®) dosed twice daily (BID) when added to Travoprost 0.004%/Timolol 0.5% (DUOTRAV®) in subjects with open-angle glaucoma or ocular hypertension.

This study is divided into 2 sequential phases for a total of 5 visits. Phase I of the study is the open-labeled Screening/Eligibility Phase, which includes a Screening Visit followed by 2 Eligibility Visits. Phase II of the study is the randomized, double-masked Treatment Phase, which includes 2 on-therapy visits: Visit 4 (at Week 2) and Visit 5 (Week 6, Exit Visit).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of open-angle glaucoma (including pseudoexfoliation or pigment dispersion glaucoma) or ocular hypertension.
* Currently on treatment with Travoprost 0.004%/Timolol 0.5% prescribed as approved in the country, on morning or evening dosing for at least 28 days prior to screening, and in the opinion of the Investigator may benefit from further IOP lowering.
* Mean IOP measurements at both the Eligibility 1 and Eligibility 2 visits, in at least 1 eye (the same eye(s) ≥ 19 and ≤ 28 mmHg at 09:00 while on a Travoprost 0.004%/ Timolol 0.5% solution.
* Able to understand and sign an informed consent form that has been approved by an Institutional Review Board/Ethics Committee.
* Willing and able to attend all study visits.

Exclusion Criteria:

* Women of childbearing potential: not postmenopausal for at least 1 year or less than 6 weeks since sterilization, currently pregnant; have a positive result on the urine pregnancy test at Screening; intend to become pregnant during the study period; breast-feeding; or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
* Mean IOP \> 28 mmHg at any time point in either eye during the Screening/Eligibility Phase.
* Any form of glaucoma other than open-angle glaucoma or ocular hypertension.
* Severe central visual field loss in either eye.
* Chronic, recurrent or severe inflammatory eye disease in either eye.
* Ocular trauma in either eye within the past 6 months prior to the Screening visit.
* Ocular infection or ocular inflammation in either eye within the past 3 months prior to the Screening visit.
* Retinal degeneration, diabetic retinopathy, or retinal detachment in either eye.
* Best-corrected visual acuity score worse than 55 ETDRS letters (equivalent to approximately 20/80 Snellen, 0.60 logMAR or 0.25 decimal) in either eye.
* Other ocular pathology (including severe dry eye) in either eye that may, in the opinion of the Investigator, preclude the safe administration of any study medication.
* Intraocular surgery in either eye within the past 6 months prior to the Screening visit.
* Ocular laser surgery in either eye within the past 3 months prior to the Screening visit.
* Any other condition including severe illness which would make the subject, in the opinion of the Investigator, unsuitable for the study.
* Asthma, history of asthma, or severe chronic obstructive pulmonary disease.
Active Induction of Labor in Pregnancies Complicated With Oligohydramnios at Term

The purpose of this study is to evaluate the risk of cesarean delivery in pregnancies complicated with isolated oligohydramnios managed by induction of labor. This prospective case-control study was conducted in Hamıdıye Sisli Etfal Teaching and Research Hospital between January 2013 and June 2014. 159 women with isolated oligohydramnios and 165 women with postdate pregnancies who met the inclusion criteria underwent induction of labor with dinoprostone or oxytocin. The rate and the indications of C/S deliveries were compared between two groups.

The study was designed as a prospective study. The rates of cesarean section and maternal/fetal outcomes had been compared between pregnancies complicated with isolated oligohydramnios at term and postdate pregnancies. All patients with isolated oligohydramnios were term (37-40 weeks' gestation according to accurate last menstrual period and first trimester sonographic examination). Oligohydramnios was defined as an amniotic fluid index \< 5 cm. The control group consisted of prolonged pregnancies in the absence of spontaneous labor and oligohydramnios. Prolonged pregnancy is diagnosed if 41 gestational weeks are completed according to accurate date of last menstrual period and first trimester ultrasound. All patients who accepted to join the study gave informed consent. All patients had a complete physical and obstetrical examination. Vital signs were recorded at regular intervals. The primary outcome measure was defined as cesarean section rates in pregnancies complicated with isolated oligohydramnios managed by induction of labor.

Eligibility Criteria:
Inclusion Criteria:

* term isolated oligohydramnios
* postdate pregnancies
* vertex presentation
* singleton pregnancies
* primigravid and multigravid women

Exclusion Criteria:

* women with presence of any chronic disease
* maternal condition complicating the pregnancy
Evaluation of the Impact of Rotating Posterior and Transverse Presentations At 2 Hours of Full Dilation

During labor, 20% of fetuses present in a posterior or transverse position. Among them, 90% rotate spontaneously during labor. For the remaining 10%, maintaining a posterior or transverse position leads to longer labor, increased instrumental deliveries, more cesarean sections, and more severe perineal tears. Obstetricians can intervene by manually rotating the fetus to an anterior position. Several studies have shown the benefits of this technique, but they were all conducted at full dilation or one hour after full dilation. This timing does not allow enough time for the fetus to rotate spontaneously. Additionally, manual rotation can be poorly tolerated by the patient, especially if pain management is insufficient.

Our study aims to demonstrate the benefits of manual rotation two hours after full dilation. This delay allows 90% of fetuses to rotate spontaneously, and it could help harmonize obstetrical practices.


Eligibility Criteria:
Inclusion Criteria:

* - Patient delivering at Hospices Civils de Lyon (XR, HFME, LS?)
* Low-pitched voice agreement
* Mobile fetal cephalic presentation
* Transverse or posterior presentation confirmed by ultrasound
* 2 hours of complete dilation
* Agreement for 3 hours by OB-GYN
* Normal fetal heart rate
* Epidural anesthesia in place
* Bladder catheterized

Exclusion Criteria:

* - Multiparous uterus with scars
* Breech presentation
* Fetus \> 5000 g
* Patient refusal
* Inadequate analgesia
* Fetal hypoxia
Macrophage Markers, Soluble CD163 (sCD163) and Soluble CD206 (sCD206) in Paracetamol Overdose

Paracetamol (PCM) is a widely used over-the-counter analgesic, and overdose with PCM is a condition regularly seen in everyday clinical practice. Identification of the patients with early signs of liver injury that may develop into acute liver failure is important. Previous research has shown that macrophages play a role in the development of liver damage in PCM-induced acute liver failure, making macrophage markers interesting possible biomarkers of this condition. In the present study, the investigators aimed to investigate the extent and timing of macrophage activation in PCM-induced liver injury by measuring levels of macrophage markers sCD163 and sCD206 in patients admitted with PCM overdose. The investigators also hoped to find out whether these markers are valuable as prognostic markers of severe outcome in these patients.

Furthermore the investigators examined the possible effect of antidote treatment with N-acetylcysteine on activation and function of macrophages by administering NAC to healthy subjects and measuring levels of sCD163 and sCD206 prior to and after completion of treatment.

The part of the study concerning the patients with PCM overdose was strictly observational with measurement of macrophage markers and no other intervention than the NAC treatment administered in the setting of management of the participants PCM overdose according to best clinical practice.

The interventional part of the study which is submitted for registration here concerns only healthy controls who were exposed to NAC treatment in order to assess the direct effects of NAC on macrophages. The participants received NAC treatment according to the same protocol as the PCM overdosed patients, and macrophage activation markers were measured prior to and after 16 hours of NAC treatment. Thus, the involvement of the participants in the study was limited to the 16 hours of NAC treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 75

Exclusion Criteria:

* A history of previous illness
Using Artificial Intelligence for the Detection of Respiratory Diseases Associated With Pollution

Generating a picture at the city level, through geospatial and temporal grouping a lung diseases associated or exacerbated by pollution (COPD, AB and neoplasm pulmonary or pleural) and correlating this data with pollution data.

Development of an accurate and prognostic HRCT imaging diagnostic tool, computer assisted in the mentioned pathology, by generating an algorithm capable of to detect early the follow-up tomographic imaging lesions, as well as to evaluate objective their speed of evolution.

Validation of the proposed algorithm by comparison with medical diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be diagnosed with COPD and/or asthma and/or pulmonary neoplasm and/or secondary pulmonary, pleural or mediastinal determinations, suspected or confirmed, according to ICD-10.
* Patients will be included regardless of the type of hospitalization, continuous or day.
* The existence of freely expressed consent, carried out according to Ethics standards professional (from the observation sheet).

For stage 2

* The use of HRCT images, in DICOM format, with a maximum cup thickness of 1.5 mm and with an average of 250 cups; no image acquisition errors;
* Imaging monitoring at a time interval;.
* Respiratory function evaluation data available: spirometry +/- the factor of gaseous diffusion (DLco);

Exclusion Criteria:

For both stages:

- Patients who do not have a stable real domicile (eg social cases) or are not from the Timis county

For stage 2

* Patients who do not have HRCT images available or cannot be followed.
* Patients who have insufficient quality HRCT images.
* Patients who have a history of lung surgery.
* Patients who have a history of allergies to contrast agents used in imaging HRCT.
Norwegian Birch Rust Allergy Study

This study investigates whether spores from birch rust fungi (Melampsoridium Betulinum = MB) may be the eliciting allergen in patients with seasonal airway allergy during autumn in North Norway. Patients with suspected allergy to MB are compared with non-allergic controls using data about allergic disease and daily allergic symptoms during autumn. Potential variations in allergic symptoms during season will be compared with spread of MB spores. Sensitation to MB and MB allergy are to be tested with skin prick test (SPT), measurements of spesific immunglobulin E (IgE) in serum, passive basophil activation test (pBAT) and nasal provocation test (NPT)

Symptoms of seasonal airway allergy most commonly take place during spring and summertime, normally attributed to pollen from birch or grass. However, some patients in the clinic have experienced and reported typical airway allergy symptoms during autumn, when there is no spread of pollen. The patients report symptoms of allergic rhino-conjunctivitis and/or asthma, and some also tells about worsening in eczema/skin affections.

Birch rust is a disease on birch trees caused by the fungus Melampsoridium Betulinum (MB), and apparently MB spreads in largest amounts in August and September - especially in North Norway.

This study aims to investigate if MB is an allergen causing seasonal airway allergy during autumn in Norway. Both type and severity of symptoms of MB allergy are to be investigated, and also the association between spread of MB spores and symptoms of airway allergy. During the study period there are to be developed MB extracts for skin prick test (SPT), serum specific IgE (sIgE), nasal provocation test (NPT) and passive basophil activation test (BAT), and sensitivity and specificity of SPT, sIgE and BAT will be calculated in comparison to NPT as a gold standard test for allergic rhinitis caused by MB.

Eligibility Criteria:
Inclusion Criteria:

* Self-reported symptoms of allergic rhinitis, conjunctivitis, allergic asthma and/or exacerbation of eczema in the period from August to October.

Exclusion Criteria:

* Perennial airway allergy without worsening of symptoms during autumn.
* Too long or inadequate distance from home to hospital/testcenter.
* More than 14 days of absence from Northern Norway during symptomregistration autumn 2022 (August 15 - September 30, 2022).
* Diseases with persistent manifestations that can interfere or be confused with airway allergic symptoms.
* Treatment with immunosuppressive drugs.
An Efficacy and Safety Study of SRM003 in the Treatment of Subjects Undergoing Creation of an Arteriovenous Fistula to Facilitate Hemodialysis Access

A study to evaluate the efficacy of SRM003 treatment versus participating sites' standard practice treatment in improving the rate of AVF maturation and use in subjects with end-stage renal disease undergoing surgery for creation of an AVF to facilitate hemodialysis access.

It is hypothesized that when placed outside the blood vessel, the seeded SRM003 gelatin matrix containing endothelial cells can provide a continuous supply of multiple growth regulatory compounds to the underlying cells within the blood vessel, while being protected from the effects of blood flow in the vessel(s) or complications resulting from being in direct contact with the point of injury.


Eligibility Criteria:
Inclusion Criteria:

1. Subject must be 18 years of age or older at the time of signing and dating informed consent (no upper age limit), can be male or female.
2. Subject who is of child bearing potential must agree to use adequate contraception for 6 months after randomization.
3. Subject must be currently undergoing hemodialysis or anticipating the start of hemodialysis and must require a new permanent, suitable access for the AVF creation in the upper extremity.
4. Subject must have a life expectancy of at least 26 weeks after randomization.
5. Subject must be able to understand and be willing to complete all study requirements.

Exclusion Criteria:

1. Subject is currently on an active organ transplant list from a deceased donor or is undergoing assessment and expects to be placed on the active organ or bone marrow transplant list within the next 26 weeks from surgery, or expects to receive a living donor organ or bone marrow within the next 26 weeks and is unwilling to change transplant list status to "hold" for 3 months after randomization.
2. Subject has had more than 1 access placement surgery (defined as a new access, not a revision) in the target limb.
3. Subject has medical conditions and diseases that may cause non-compliance with the protocol
4. Subject has a known allergy to bovine/porcine products or collagen/gelatin products.
5. Subject has a history of intravenous drug use within 6 months prior to screening
6. Subject is morbidly obese, defined as having a body mass index \>40.
7. Pregnant or nursing woman, or plans to become pregnant during the study.