cyrilzakka/clinical-trials huggingface dataset:
Neuroprotection Impact of Cyclosporin A in Cerebral Infarction

The main objective of this study is to determine whether a single injection of CsA after intravenous thrombolysis can significantly decreased the volume of cerebral infarction at day 30 ± 15 assessed with Flair MRI.

Secondary objectives are to determine whether a single injection of CsA after intravenous thrombolysis is safe and effective regarding to death and disability.


Eligibility Criteria:
Inclusion Criteria:

* Patients age ≥ 18 years and \<85 years
* Male or female,
* Patients with cerebral infarction of less than 4:30H,
* NIHSS score between 6 and 18
* Identification of a carotid artery occlusion in the territory in MRI
* Consent of participation signed by the patient or, if it is unable to give the family or someone you trust if it is present.
* Patient beneficiary of a social security system.

Exclusion Criteria:

* Known hypersensitivity to cyclosporin A or castor oil, polyoxyethylene
* Patient in St. John's wort, stiripentol, bosentan or rosuvastatin
* History of immunosuppression recent (\<6 months): cancer, lymphoma, positive serology for HIV, hepatitis, ...
* Known hepatic (prothrombin time \<50%)
* Patients treated with sulfonylureas or nicorandil
* Patients treated with dopamine, adrenaline, noradrenaline or isoprenalin
* Uncontrolled hypertension defined as systolic blood pressure greater than 185mm Hg and a diastolic pressure above 110 mmHg,
* Cardiogenic shock defined by systolic blood pressure below 80 mm Hg
* Contraindication to thrombolysis: History of AIC in the three months history of intracranial hemorrhage, neoplasm, subarachnoid hemorrhage, arteriovenous malformation
* Presumption of septic embolism or aortic dissection or pericardial effusion.
* Recent biopsy or surgery within 3 months
* Head injury less than 3 months
* Known bleeding diathesis, taking anticoagulants with INR\> 1.2
* Hypoglycemia (blood glucose below 0.5 mmol / l)
* Known renal, creatinine greater than 130 Mu / L
* Recent Lumbar puncture \<7days
* Conditions prior psychiatric or neurological deficit does not allow objective analysis of disability
* History of ischemic stroke or hemorrhagic
* History of epilepsy and taking antiepileptic
* Exclusion criteria Imaging
* Structured hypodensity scanner compatible with recent ischemic stroke
* Hematoma
* Other lesions (tumor or inflammatory cerebral venous thrombosis)
* The scanner Contraindications: allergy to iodine or major renal creatinine\> 130μl or MRI referred to above
* Women of childbearing age, pregnant or not recognized effective contraception
* Patients in the measure of legal protection.
Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease (Phase 2, Therapeutic Exploratory Study)

The purpose of this study is to determine the efficacy and safety of DWP14012 compared to esomeprazole in the treatment of erosive gastroesophageal reflux disease classified as Los Angeles(LA) classification grades A to D.


Eligibility Criteria:
Inclusion Criteria:

* Adults between 20 and 75 years old based on the date of written agreement
* Those who have been diagnosed with erosive gastroesophageal reflux disease(EGRD) of LA Grade A-D on the upper gastrointestinal endoscopy
* Those who experienced symptoms of heartburn or acid reflux within the last 7 days

Exclusion Criteria:

* Those who have undergone gastric acid suppression or gastric, esophageal surgery
* Those who with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease
Study of Cellutome System for Treatment of Individual Lesions in EB Pts

Few but persistent wounds often remain even after successful hematopoietic cell transplantation for systemic genodermatosis epidermolysis bullosa (EB). The investigators propose local wound therapy using epidermal skin grafting from the same donor that provided the hematopoietic graft, or from the same EB individual with a mosaic (naturally gene corrected) skin. In both cases permissive immune system and skin chimerism is expected to enable long-term epidermal engraftment and wound healing. The investigators will use FDA approved vacuum device (CelluTome®, Regulation number 878.4820) that enables scar-free harvesting of epidermis and its transfer on a non-adherent silicone dressing (Adaptic) to the recipient as a wound dressing.


Eligibility Criteria:
Inclusion Criteria:

Patient (Recipient)

* Diagnosis of Dystrophic Epidermolysis Bullosa (DEB) or Junctional Epidermolysis Bullosa (JEB) with at least one wound, visibly free from infection (or previously treated) and meets the eligibility for Arm A or Arm B based on the skin graft source:
* Cell harvest from previous hematopoietic cell transplantation (HCT) donor (Arm A) - not applicable if Arm B

  * At least 6 months after hematopoietic cell transplantation with donor chimerism

    * Peripheral blood donor chimerism should be measured within 21 days of grafting and be \>/= 5% and stable. Stability of chimerism will be determined by the protocol team and based on 3 peripheral blood chimerism values at least 1 month apart.
  * No history of pre-BMT autoimmune cytopenias
  * Off immune suppressive therapy
  * Original transplant donor is available and willing to be the epidermis donor
* Self-donation (Arm B) - not applicable if Arm A

  * Proven somatic reversion
  * Site for skin grafting free of cellulitis and any other clinically evident abnormalities
  * Meets donor eligibility
* Insurance pre-authorization for procedure, if applicable
* Voluntary written consent (patient or parent/guardian for minors with assent) prior to any research related procedures or treatment.

Skin Graft Donor (either hematopoietic cell transplantation donor for the EB patient \[Arm A\] or EB patient herself/himself \[Arm B\])

* Age \> 2 years (based on prior safety testing of the device)
* Healthy on physical examination in the opinion of the evaluating provider
* Negativity for Hepatitis B and C, HIV, and HTLV1/2 within 30 days of donation
* Voluntary written consent (donor or parent/guardian for minors with assent) prior to any research related procedures
A Phase 1 Single and Multiple Ascending Dose Study of LTG-001 Administered Orally in Healthy Participants

This is a sequential, randomized, double-blind, placebo-controlled Phase 1 single (SAD) and multiple (MAD) ascending dose study to evaluate the safety, tolerability, and pharmacokinetics (PK) of orally administered LTG-001 in healthy male and female participants


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants aged 18 to 55 years, inclusive, at the time of signing the informed consent.
* Overtly healthy with no clinically relevant abnormalities based on the medical history, physical examinations, clinical laboratory evaluations, and 12-lead ECG that, in the opinion of the investigator, would affect participant safety.
* Body mass index (BMI) within the range of 18-32 kg/m2 (inclusive).

Exclusion Criteria:

* Inability to take oral medications or gastrointestinal abnormalities potentially impacting absorption
* Clinically significant cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, gastrointestinal, immunological, dermatological, neurological, or psychiatric disease which could interfere with, or the treatment for which might interfere with, the conduct of the study or which would, in the opinion of the investigator, unacceptably increase the participant's risk by participating in the study
* Past or current history or evidence of alcohol abuse and/or dependence on recreational drug use
* Donation of over 500 mL blood ≤ 3 months prior to start of participation
* Has known psychiatric disorders that would interfere with the cooperation with the requirements of the study
* Participant is under legal custodianship.
A Pilot Study - Safety and Efficacy of Nailprotex® for Onychomycosis Treatment

This study was designed to demonstrate the efficacy of this product in non-dermatophyte (Scytalidium dimidiatum) onychomycosis and chronic paronychia treatment in Thai patients.

Onychomycosis is the common superficial fungal skin infection in general population. According to the previous study, the prevalence of tinea pedis and onychomycosis in general Thai population were 3.8% and 1.7% respectively. However, this problem has been neglected for treatment due to asymptomatic clinical manifestations and low effects in quality of life.

In Thailand, the previous studies reported that the aetiological pathogens of this disorder were non-dermatophyte mold (51.6%), dermatophyte (36.3%) and yeast (6%). Additionally, Scytalidium dimidiatum was the majority causative agents in non-dermatophyte mold.

Systemic therapy such as azoles group and terbinafine is recommended for the standard management of tinea capitis. In contrast, a prolonged course may be induce serious side effects. So that topical therapy is the alternative treatment in older patients who are limited in drug usage. Especially, non-dermatophyte onychomycosis is the recalcitrant condition. Moreover, none of the standard regimen is recommended.

Nailprotex® is the novel topical treatment in onychomycosis and chronic paronychia. The active ingredient is phenol which is extracted from Olea European leaf. It is able to inhibit the fungal growth. Additionally, this product has been applied for nail care in many European countries over 10 years. The serious side effects have never been reported. Therefore, this study was designed to demonstrate the efficacy of this product in non-dermatophyte (Scytalidium dimidiatum) onychomycosis and chronic paronychia treatment in Thai patients.

Eligibility Criteria:
Inclusion Criteria:

* Male or female participants was 18 years old or above.
* Participants were diagnosed Scytalidium dimidiatum onychomycosis or chronic paronychia by dermatologists based on clinical presentation and mycological identification.
* Participants accept the aim of this project and sign the consent form by themselves.

Exclusion Criteria:

* Participants have other nail disorders before participate the research.
* Participants have the history of immunocompromised host.
* Participants were diagnosed onychomycosis more than 3 nails or matrix involvement.
Effect of Air Cleaner on the Indoor Allergen Sensitized Allergic Rhinitis Patients

This study aimed to assess the impact of air cleanser on allergic rhinitis patients and indoor air quality. Air cleaners will be installed in the bedrooms and living rooms of the mite allergic rhinitis patients who aged 18-60 years.

Main parameters:

- Symptom medication score of allergic rhinitis

Supportive parameters:

* Visual analog scale of allergic rhinitis
* Quality of life score of allergic rhinitis
* Indoor air quality measurement
* Indoor allergen level measurement

The most important principle in the treatment of allergic diseases is to avoid or reduce exposure to the causative antigen. Causative agents that induce allergic diseases or exacerbate symptoms are classified into indoor and outdoor allergens. House dust mites and pet's hair are typical indoor antigens. Air pollution as well as allergens are important deterioration factors, and environmental management is essential for alleviating symptoms of allergic diseases. Therefore, we are about to evaluate the impact of the air cleaner to the allergic rhinitis patients.

A total of 45 patients will be enrolled in the study and a real air cleaner and a mock-up air cleaner will be randomly installed at ratio of 1: 1 to measure rhinitis symptoms and the changes in indoor air quality after 6 weeks of operation.

Eligibility Criteria:
Inclusion Criteria:

* Adults between 19 and 65 years of age
* Allergy specialist diagnosis of Moderate to severe persistent allergic rhinitis
* Retrospective Rhinoconjunctivitis total symptom score higher than 7
* Allergy against house dust mite: Skin prick test, with a more than 3 mm wheal, Serum specific IgE higher than 0.35 kUA/L measured by ImmunoCAP
* Who can read and write Korean
* Participants those who voluntarily agreed to this study

Exclusion Criteria:

* Allergy against seasonal allergens (tree, grass, weed pollens)
* Patients with rhinitis due to other causes (drug induced rhinitis or infectious rhinitis etc.)
* Patients with severe anatomical abnormality that may cause nasal blockage such as nasal septum deviation or nasal polyps
* Chronic systemic corticosteroids (≥ 3 months continuous use in past 12 months)
* Participants planning to move or change residence within the study period.
* Staying away from the home continuously for more than 5 days in the study period.
* Having air cleaner previously
* Having indoor smoker
* If pregnancy test is positive or pregnancy is possible during study period.
* Any other reason the participants is deemed unsuitable for participation in clinical trials
Surgical Vs Transcatheter Aortic Valve Replacement in Young Patients

The study objective is to demonstrate that the clinical outcomes of the Myval balloon-expandable THV series are non-inferior to those of SAVR in patients with symptomatic severe aortic stenosis aged 65 to 75 years.

Prospective, randomized, multinational, multicenter, open label, trial of 1180 patients treated with surgical bioprosthetic aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR).

Eligibility Criteria:
Inclusion Criteria:

Participant will be included if all the following criteria are met:

1. Patients aged ≥65 and ≤75
2. Symptomatic severe aortic stenosis (mean gradient≥40mmHg, and or peak velocity\>4m/sec).
3. Patients with symptomatic heart disease due to severe native calcific aortic stenosis, as judged by a multidisciplinary heart team (including a cardiac surgeon), for whom SAVR or transfemoral TAVR is deemed feasible and approved by the local heart team.Signed informed consent for participation in the clinical investigation

Exclusion Criteria:

Participant will not be included if any one of the following conditions exists:

1. Unable to understand and follow clinical investigation-related instructions or unable to comply with the clinical investigation protocol
2. Life expectancy less than 1 year
3. Known hypersensitivity or allergy to aspirin, clopidogrel or any Device frame components.
4. Under judicial protection, tutorship, or curatorship
5. Participation in another trial before the primary endpoint
Oxygen Uptake in Weaning of Patients From Prolonged Mechanical Ventilation

1.Research hypothesis: during weaning patient from prolonged mechanical ventilation, if the work load caused by weaning was below the patient's AT, oxygen uptake will be constant. Otherwise, if the work load was above the patient's AT, the oxygen uptake will increase.

1. Patient: who have tracheostomy tubes and with prolonged mechanical ventilation
2. Measurement: oxygen uptake(V̇O2) and respiratory mechanics during the spontaneous breathing trials
3. Outcome: Correlation between the oxygen uptake(V̇O2) and the weaning outcome

2.Specific aims:

1. to investigate the prognostic value of oxygen uptake in weaning patients from prolonged mechanical ventilation
2. Subgroup analysis may suggest which weaning protocol potentially benefit the most for each population group (cardiovascular disease, chronic pulmonary disease, neuromuscular disease, cerebrovascular disease)


Eligibility Criteria:
1. Inclusion criteria:

   Adult \>20 y/o Total duration of mechanical ventilation ≥ 10 days Received tracheostomy Defervescence Meeting the criteria of weaning phase (see supplementary protocols)
2. Exclusion criteria FiO2 \>50 % Unstable hemodynamics Fever with active infection No spontaneous respiratory drive Dynamic airway collapse
The BRIDGE Registry: Safety and Efficacy Registry of Bx Cypher Stent

The objective of this study is to establish the safety and efficacy of the treatment with Cypher DES in diabetic patients with documented ischemia due to stenosis (small coronary artery 2.5 -3 mm in lumen diameter, with lesion between 15 mm 30 mm in length, ) in native coronary arteries.

The objective of this study is to document that the use of Cypher DES in these diabetic patients undergoing percutaneous revascularization for stenosis is safe.

Safety will be assessed over a period of 12 months.

This is a prospective, multicenter, comparative, non randomised, open registry of 1000 patients who will be followed up to 12 months at 100 sites in France.

Patients will be screened according to normal practice and in relation to the inclusion and exclusion criteria. Patients should have a documented ischemia related to the target vessel.

Procedure of stent placement should be done under existing in hospital procedural protocol and care should be taken to follow Cordis instructions as set forth in the Instructions For Use.

Follow up will be done according to normal procedure and the minimum should be a telephone contact at 1, 6 and 12 months.

All data gathered during the enrollment, procedure, follow up and when specific events to the patient may occur, will be entered into the Internet CRF form, by the treating physician or a person from his staff specifically appointed to this task.

Patient enrollment is anticipated to last 8 months.

Eligibility Criteria:
Inclusion Criteria:

1. NIDDM treated with oral antidiabetics for at least 3 months, or IDDM treated for at least 3 months with documented HbA1C;
2. Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B I-II) OR patients with documented silent ischemia;
3. Target lesion stenosis is \>50% (visual estimate);
4. Target vessel diameter, between 2.5 and 3.0 mm
5. Target lesion length minimum 15 mm and maximum 30mm

Exclusion Criteria:

1. CK and CK-MB enzymes above normal or elevated troponin level (as determined by site criteria) at the time of treatment;
2. Has unstable angina classified as Braunwald III B and A or C I-II-III, or is having a peri-infarction;
3. Unprotected left main coronary disease with \>=50% stenosis;
4. Significant (\>50%) stenosis proximal or distal to the target lesion that might impede inflow or runoff and can not be revascularized before or during the index procedure;
5. Have an ostial target lesion;
6. Documented left ventricular ejection fraction \<=30%;
7. In-Stent restenosis;
8. Chronic total occlusion.
Exploring Interactions Between Growth Hormone and the Microbiome

The goal of this study is to characterize the microbiome and metabolomics of children with Growth Hormone (GH) deficiency, prior GH treatment initiation and compare it to healthy children


Eligibility Criteria:
Inclusion Criteria:

* Children with GH deficiency

Exclusion Criteria:

* Turner syndrome
* End state renal disease (ESRD)
* Prader-Willi syndrome
* Systemic illness
* Antibiotics/Antifungal in the last 3m
GFR Measurement With Contrast-enhanced Dynamic MRI

The aim of the study is to optimize and validate this MR-based GFR measurement in patients with a renal transplant, compared with the reference method, the Cr51- EDTA method: to select the most accurate combination of post-treatment of renal MR images and then evaluate its intra- and inter-rater reliability.

Cr51- EDTA method is considered the reference method for measurement of glomerular filtration rate (GFR). However, this method requires several hours and several blood and urinary samplings. Therefore, the ability to get access to this parameter with a simple, valid and reliable method would be a significant progress in clinical follow-up of patients with renal disease. Contrast-enhanced dynamic MRI is now able to give this access to functional parameters as GFR, rapidly and non invasively, becoming an alternative to Cr51-EDTA method. If the acquisition method has been optimized, some problems remain unsolved: is the movement correction worthwhile for the accuracy of the measurement ? Which model provides the most accurate results ? What is the best way to calculate the total GFR (addition of all the voxels or the product of a mean value by the cortical volume)? These questions can be answered only by a comparison with a reference method.

The reference method will be performed after standard hydration, with intravenous injection of 100 µCi of Cr51- EDTA and urinary and blood samplings every 30 minutes during 3h. Dynamic MRI will be performed with fast 3D T1-weighted gradient-echo sequences during 5 minutes after injection of a third of a clinical dose of gadolinium. Post-treatment of images will be done on an off-line program allowing movement correction, conversion of signal intensity into concentration and application of different models. 8 combinations of post-treatment will be tested and compared to the reference method.

Eligibility Criteria:
Inclusion Criteria:

* Patient with a renal transplant presenting with a graft dysfunction or a suspicion of vascular complication (renal artery stenosis...) or of urinary complication (dilatation of excretory system, collection) justifying to perform a non urgent MR examination
* Calculated glomerular clearance (MDRD method) \> 20 ml/min
* Age ≥ 18 yo at the time of inclusion
* Negative pregnancy test
* Affiliation to the Social Security
* Written informed consent signed

Exclusion Criteria:

* Contra-indication to MRI: neurovascular clips, pacemaker, cochlear implant, orbital metallic object, claustrophobic patients...
* Contra-indication to gadolinium: previous hypersensitivity to Gd-Chelates
* Pregnancy or breastfeeding women
* Adult under legal supervision
Biological and Electrocardiographic Biomarkers for Risk Stratification in Hypertension.

Risk stratification of hypertensive patients includes assessment of traditional cardiovascular risk factors and subclinical target organ damages particularly left ventricular hypertrophy (LVH).

LVH may routinely screened by transthoracic echocardiography by measuring the left ventricular mass (LVM).

However, transthoracic echocardiography suffers from several pitfalls: poor reproducibility, technical limitations and unavailability at a first evaluation by general practitioners.

Other biomarkers may be particularly helpful in hypertension risk stratification. The amplitude of the R wave in aVL lead is a simple validated ECG parameters of LVH and a strong predictor of cardiovascular events and mortality.

Plasma N-terminal pro Brain Natriuretic Peptide (NT-proBNP) is also strongly related to LVM and is an independent predictor of all-cause mortality in hypertension.

The main objective of our study is to determine the additive prognostic value of R wave in aVL and NT proBNP on all-cause and cardiovascular mortality.

Secondary objectives are to determine the addition prognostic value of NT-proBNP and R wave in aVL combined in comparison to each marker taken into account

This study will include 1600 patients who had a work-up of their hypertension in the Cardiology Department of Croix-Rousse Hospital (Hospices Civils de Lyon, Lyon, France) from January 1997 to January 2014.

Their data will be collected in an Access database; their vital status will be obtained by the INSEE unit CépiDC.


Eligibility Criteria:
* Inclusion Criteria:

  * \>18 years old
  * men or women
  * questionnaire completion and physical exam during their first stay in the Cardiology Department of from January 1997 to January 2014.
* Exclusion Criteria:

  * Patients refusal