cyrilzakka/clinical-trials huggingface dataset:
Identification of Non Invasive Biomarkers of Immune Endothelial Injury and Repair Associated With Cardiac Allograft Vasculopathy

Heart transplantation is the best option for patients with end-stage heart failure. Cardiac allograft vasculopathy (CAV) is the leading cause of death following cardiac transplantation and is not managed by current therapies. Its pathogenesis traduces in an accelerated form of coronary artery disease (CAD) with similarities to atherosclerosis but also particular features of endothelial dysfunction associated to the alloimmune conflict and humoral responses toward the graft. Intravascular ultrasound (IVUS) is the validated invasive method for late CAV diagnosis, but occurs lesions are established. Identification of reliable non-invasive early endothelial injury biomarkers that reflect mechanisms of cardiac damage thus remain a major challenge to optimize therapeutic management of post transplant morbidity. Endothelial dysfunction is a central feature of both CAV and CAD and results from a desquilibrium in the balance of endothelial lesion and repair that is partly controlled by recipient immune system. Through their expression of receptors sensing antibodies (FcR CD16) and endothelial stress-induced signals (CX3CR1 fractalkine receptor and NKG2D MICA receptors), Natural Killer (NK) cells represent effector cells with unique potential to generate both humoral and innate immune injury of graft endothelium.


Eligibility Criteria:
Inclusion Criteria:

* Subject \> 18 years at the time of the inclusion,
* Subject having benefited from a heart transplant more than 11 months ago in the service of cardiac surgery concerned whatever is the treatment to immunosuppresseur current
* Subject benefiting from a coronarography within the framework of their surveillance comment-Clerk's Office beyond 12 months
* Subject having given their consent
* Affiliated to the Social Security

  \* HTC with Cardiac allograft vasculopathy:
* Subject with coronaropathies diagnosed by the coronarography

  \* TC without Cardiac allograft vasculopathy:
* Subject without coronaropathies diagnosed by the coronarography

  \* untransplanted
* Untreated Subject by immunosuppresseurs
* Subject without antécédaent of transfusion
* Subject without history of transplantations
* Subject with coronaropathies diagnosed by a coronarography

Exclusion Criteria:

* Presenting a contraindication to the coronarography
* Subject refusing to practise the examination of coronarography
* Subject reaches(affects) of a cancer other one than cutaneous
* Subject achieves of hepatic Incapacity (ALAT and\\or ASAT \> 3N)
Efficacy of Artemether/Lumefantrine for the Treatment of Uncomplicated Malaria.

Artemether-lumefantrine has been used in Tanzania as first-line treatment for uncomplicated malaria since 2007. Nonetheless, a report of increased proportion of patients with parasitaemia on day 1 following treatment with artemisinin based combination therapies has emerged from Kenya. Similarly, resistance against artemisinins has been confirmed in South-East Asia and it can spread to Africa. Therefore, the purpose of this study was to assess the efficacy of Artemether-lumefantrine for the treatment of uncomplicated malaria among children after five years of wide scale use of the drug in Tanzania.

Artemisinin based combination therapies (ACTs) are currently recommended by the World Health Organization (WHO) as first-line treatment for uncomplicated malaria in all malaria endemic countries including Tanzania, that adopted the policy in 2007. ACTs have proven to be highly efficacious in different parts of the world with different malaria endemicity. Artemisinins clear asexual parasites rapidly and they are also potent against P. falciparum gametocytes, hence reducing disease transmission and spread of drug resistance. Nonetheless, a report in Kenya shows an increase in proportion of patients with parasitaemia on day 1. Most recently, resistance against artemisinins has been confirmed in four countries of South-East Asia, and it may spread to Africa.

In order to safeguard ACTs life span, WHO recommends all suspected malaria cases to be confirmed with parasitological diagnosis, followed by prompt treatment with effective antimalarials. It also emphasizes on the need to conduct efficacy studies for the first and second line antimalarial treatments after every two years so as to be able to detect resistance early on its course. Therefore, based on this notion, this study aimed to assess the therapeutic efficacy of Artemether/Lumefantrine among children with uncomplicated falciparum malaria in Bagamoyo district, five years after its wide scale use in Tanzania.

Eligibility Criteria:
Inclusion Criteria:

* Mono-infection with P. falciparum
* Parasitaemia level of 2000 - 200,000/μL
* Absence of danger signs or signs of severe malaria
* Axillary temperature ≥ 37.5°C or history of fever 24 hours prior to coming to the facility
* Absence of other concomitant infections like pneumonia which can cause fever
* No use of antimalarial drug two weeks prior to the study
* Consent to comply to the protocol.

Exclusion Criteria:

* Presence of general danger signs or signs of severe falciparum malaria
* Severe malnutrition
* Febrile condition due to diseases other than malaria, such as measles, acute lower respiratory infection or other known chronic diseases
* Regular medication which might interfere with antimalarial pharmacokinetics
* History of hypersensitivity reactions or contraindications to any medicine being used in the trial.
Randomized Clinical Trial to Evaluate Immunogenicity and Safety in Mexicans Newborns

Polio is a highly infectious disease caused by a virus. It invades the nervous system, and can cause total paralysis in a matter of hours. The virus enters the body through the mouth and multiplies in the intestine. Initial symptoms are fever, fatigue, headache, vomiting, stiffness in the neck and pain in the limbs. One in 200 infections leads to irreversible paralysis (usually in the legs). Among those paralysed, 5% to 10% die when their breathing muscles become immobilized. There is no cure for polio, it can only be prevented. Polio vaccine, given multiple times, can protect a child for life.

Compare in newborns the immunogenicity and safety of the vaccine OPV produced by Birmex compared with the vaccine OPV produced by Sanofi Pasteur, both produced in Vero cells.

This is a randomized clinical trial, which includes 320 newborns of both sexes and residents of the state of México, 160 newborns receive the vaccine OPV Birmex and 160 newborns receive the vaccine OPV Sanofi Pasteur

Eligibility Criteria:
Inclusion Criteria:

* Newborns babies
* Weight ≥ 2.5 kg
* Have not received any doses of Polio Vaccine
* Whose parents or guardians reside in the work area
* Whose parent or guardian accept to sign written informed consent (by the other, father or guardian).

Exclusion Criteria:

* Born of a high-risk pregnancy.
* Weight ≤ 2.5 kg
* Presence of fever, diarrhea, known immunosuppression, respiratory infections.
* Treatment with immunosuppressants.
* Having neurological diseases.
* Require or received surgery in oropharynx.
Chronic Heat Therapy for Improving Vascular Health

The purpose of the study is to investigate whether long-term heat therapy (i.e. 8 weeks of hot tub 4-5x per week) improves biomarkers of cardiovascular health in young, healthy, able-bodied individuals. Although exercise is a potent means of improving cardiovascular health, many patients are unable to exercise effectively, and thus there is high demand for novel therapies to better manage cardiovascular risk in these patients. If successful, this study will set the groundwork for heat therapy to be used as an alternative treatment in patients who have limited exercise capabilities for the prevention of cardiovascular disease.

Exercise training is a potent means of improving cardiovascular (CV) risk; however, exercise is challenging for many patient populations. Passive heat therapy may provide a simple and effective alternative to exercise for improving CV health, and no one has yet studied the physiological benefits of chronic heat exposure in humans. Heat exposure induces the expression of heat shock proteins, which can have a multitude of beneficial effects on the CV system, many of which are common to exercise training. In particular, these benefits include upregulation of many cellular pathways associated with improved vascular function, a predominant contributor to CV health. The goal of the study is to determine the effects of chronic passive heat therapy on vascular function in young, healthy, able-bodied individuals. The investigators will perform a randomized-controlled trial in which subjects participate in 8 weeks of either heat therapy or thermoneutral water immersion (sham). Heat therapy will entail 8 weeks of hot water immersion sufficient to raise core temperature \>38.5°C for 1h, 4-5 times per week. Thermoneutral water immersion will entail 8 weeks of immersion in 36°C water for the same duration as heat therapy. In both subject groups, the investigators will measure various well-established biomarkers of vascular function before and after 8 weeks of heat therapy, including measures of arterial stiffness (arterial compliance, beta-stiffness, and pulse wave velocity), endothelium-dependent dilation (flow-mediated dilation), and intima media thickness. The investigators will investigate the effects of heat therapy on the microvasculature and on the mechanisms behind improvements in vascular function in the cutaneous microcirculation, an ideal site for pharmacodissecting the molecular pathways involved, using microdialysis paired with laser-Doppler flowmetry. If successful, these studies will serve as a basis for developing heat therapy as a novel means of improving CV risk, which has the potential to reshape the treatment of patient populations with limited exercise capabilities.

Eligibility Criteria:
Inclusion Criteria:

* Young, healthy, able-bodied

Exclusion Criteria:

* Diagnosis of any chronic diseases related to the cardiovascular system (e.g. hypertension, cardiovascular disease, diabetes, etc.),
* Currently taking prescription medications (except contraceptives)
* Body mass index over 27 kg/m2
* Current smoking
* Currently pregnant or breast-feeding
Liposomal Bupivacaine in Adductor Canal Blocks (ACB)

The purpose of this study is to evaluate whether liposomal bupivacaine is superior to normal bupivacaine in terms of providing better pain control postoperatively after total knee arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

1. The subject is scheduled for elective unilateral primary TKA
2. The subject is ≥ 18 years
3. The subject's primary anesthesia care team has planned for a neuraxial anesthetic (i.e. spinal, epidural or combined-spinal epidural)
4. The patient consents for an adductor canal block
5. Willing and able to sign an informed consent.

Exclusion Criteria:

1. Patients unwilling or unable to consent to participate in the study.
2. Prisoners.
3. Pregnancy.
4. Reported to have mental illness or belonging to a vulnerable population.
5. Subject is \< 18 years of age.
6. Patients receiving general anesthesia for the total knee arthroplasty.
7. Subject has impaired decision-making capacity per discretion of the Investigator.
8. Any condition for which the primary anesthesia care team deems neuraxial anesthesia inappropriate.
9. Significant pre-existing neuropathy on the operative limb.
10. Significant chronic pain disorders (i.e. fibromyalgia, complex regional pain syndrome I \& II, among others).
11. Subject has sustained a significant trauma to the operative knee.
12. Chronic Opioid Use (daily or almost daily use of opioids for \> 3 months).
13. Known hypersensitivity and/or allergies to local anesthetics.
14. Previous surgery on the affected knee excluding arthroscopic or open meniscectomy.
15. Patients with impaired renal function such that they cannot receive IV Toradol.
Evaluation of Ceftaroline Fosamil Versus a Comparator in Adult Subjects With Community-acquired Bacterial Pneumonia (CABP) With Risk for Methicillin-resistant Staphylococcus Aureus

The purpose of this study is to determine whether ceftaroline is effective and safe for the treatment of patients with Community-acquired Bacterial Pneumonia (CABP) at risk for infection due to Methicillin-resistant Staphylococcus aureus (MRSA).

A Multicenter, Multinational, Randomized, Double-blind Study to Evaluate the Efficacy and safety of Ceftaroline fosamil Versus Ceftriaxone Plus Vancomycin in Adult Subjects with Community-acquired Bacterial Pneumonia at Risk for Infection Due to Methicillin-resistant Staphylococcus aureus.

Eligibility Criteria:
Inclusion Criteria:

* Subjects are required to meet All of the following inclusion criteria:

  1. Male or female, ≥ 18 years old
  2. Presence of CABP requiring hospitalization
  3. Presence of CABP meeting the following criteria:

I. confirmed pneumonia (new or progressive pulmonary) II. Acute illness (≤ 7 days' duration) with at least 3 clinical signs or symptoms consistent with a lower respiratory tract infection

MRSA Risk Factors

• MRSA-positive blood culture or respiratory specimen or a risk factor for MRSA such as a history of colonization with MRSA

Exclusion Criteria:

* Subjects must Not meet any of the following exclusion criteria at baseline:

  1. History of any hypersensitivity or allergic reaction to any β-lactam antimicrobial
  2. Suspected or microbiologically-documented infection with a pathogen known to be resistant to any of the study drugs
  3. Non-infectious causes of pulmonary infiltrates (eg, pulmonary embolism, chemical pneumonitis from aspiration, hypersensitivity pneumonia, congestive heart failure)
  4. More than 24 hours of potentially effective systemic antibacterial therapy for CABP within 96 hours before randomization
  5. End-stage renal disease \[Creatinine Clearance (CrCl) \< 15\], including hemodialysis
  6. Evidence of significant hepatic, hematological, or immunocompromising condition
Mohs Surgery: Patient Satisfaction & Quality of Life (QOL)

The purpose of this study is to examine whether there is significant difference between two groups: extra care (EC) and usual care (UC) in improvement of patients' quality-of-life (QoL) scores between the baseline and 90-day post-surgery in patients undergoing Mohs micrographic surgery (MMS).


Eligibility Criteria:
Inclusion Criteria:

1. Female and/or male subjects undergoing Mohs micrographic surgery for Basal Cell Carcinoma (BCC) and/or Squamous Cell Carcinoma (SCC).
2. Subjects must be at least 18 years of age.

Exclusion Criteria:

1. Subjects who are not able to complete the surveys (pre-surgery, 1 week post-surgery, and 3 months post- surgery)
2. Subjects under the age 18
3. Subjects unable to consent
4. Subjects who are not undergoing Mohs micrographic surgery for Basal Cell Carcinoma (BCC) or Squamous Cell Carcinoma (SCC).
Epidural Versus Continuous Wound Ropivacaine Infusion Analgesia

Study Hypothesis: The analgesic requirements and pain scores postoperatively differ between the epidural and continuous wound infusion techniques.

The analgesic requirements and pain scores postoperatively differ between the epidural and continuous wound infusion techniques, in patients undergoing myomectomy or hysterectomy.

Eligibility Criteria:
Inclusion Criteria:

Patients ASA I-II scheduled for abdominal hysterectomy or myomectomy -

Exclusion Criteria:

Age older than 60 and younger than 25 years, body weight exceeding the 30% of the ideal, consumption of analgesics, sedatives, anxiolytics, antidepressants, calcium channel blockers, CNS disease or insulin dependent diabetes

-
Developing Anesthesia as Post Traumatic Stress Disorder (PTSD) Therapy

This preclinical phase 1 development study in healthy volunteers seeks to identify if low doses of commonly used non-triggering anesthetic agents might have clinical utility for modulating emotional memory processing and to understand the nature of the brain mechanisms of drug action. Optimally, a drug, dose and brain mechanism of action will be identified that will form the foundation for future use in clinical studies of patients with PTSD.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults.
* Between the ages of 18 and 35.

Exclusion Criteria:

* Pregnancy.
* Left-handed.
* Unusual facial anatomy.
* History of esophageal reflux.
* Respiratory problems.
* Central nervous system disorders.
* Cardiovascular problems.
* Kidney disease.
* Diabetes.
* History of Substance abuse.
* History of adverse anesthetic reactions.
* Hepatitis.
* Failure to pass MRI screening questionnaire.
* Fear of small-enclosed spaces.
* Mental illness.
* Non-native English speakers.
Neurophysiological Measures of Auditory Perception and Rehabilitation in Cochlear Implanted Patients

This study aims at investigating new automatic fitting techniques for cochlear implant patients based on objective measures. For this reason, the evolution of these neurophysiological measures, expressing the encoding of pure tones and speech, will be characterized in cochlear implanted patients as a function of post-implantation time and will be compared to those of normal hearing subjects. Moreover, the effect of auditory training with new tools based on serious games will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* native French speaker
* no medical treatment for behavior or neurological disorders
* normal or corrected vision
* right-handed
* normal ORL examination
* valid affiliation to social security
* absence of participation to another study

For the cochlear implanted patients:

* aged from 1 to 70
* bilateral severe to profound deafness
* cochlear implant
* congenital deafness, pre or post lingual

For the normal-hearing subjects:

* Aged from 18 to 70
* Normal tonal audiometry

Exclusion Criteria:

* No signed consent
* Treatment for depression, epilepsy, Parkinson's or Alzheimer's disease
* Physical health deficiency
* Mental retardation
* Neurological or psychiatric disease incompatible with the testing procedure
* Schooling in a foreign language
* Foreign language spoken at home with both parents
* Invalid social security
* For the normal hearing subjects, no known hearing deficits
The Efficacy and Safety of Iguratimod (IGU) in the Treatment of Primary Sjögren's Syndrome

A multi-center, prospective, open-label, randomized controlled study of efficacy and safety of Iguratimod in patients with Primary Sjögren's syndrome


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with pSS by meeting the 2016 ACR/EULAR Classification Criteria.
* The patient complained of dry mouth and eyes.
* Positive anti-SSA/Ro-60 antibody at screening.
* IgG≥16 g/L.
* No hormone, immunosuppressant, biological agents or other treatments were received within 4 weeks before screening;
* Pregnancy test of is negative. Use effective contraceptives during the trial (female)
* Those who did not participate in any drug trial within 12 weeks before enrollment

Exclusion Criteria:

* Pregnant or lactating or planning to get pregnant during the duration of the study.
* Complicated with other CTD
* Complicated with malignancy
* mental illness, a history of alcohol abuse, immunodeficiency, uncontrolled infections, and drug or other substance abuse
* serious systemic damage, glucocorticoids, other immunosuppressants and biological agents should be added to control the condition: Heart, liver (transaminase/bilirubin \>1.5 times the upper normal limit), kidney (Cr≥133mmol/L), lung (FVC % \< 60%), blood (white blood cell \<3×109/L, HGB\<80g/L, PLT\<80×109/L), etc.
* Fundus/visual field lesions;
* Allergic to any component of the study drug (IGU and/or HCQ);
* the investigator considers the patient to be unsuitable for entry into the study
Evaluation of Methods for Diagnosis of Cytomegalovirus Pneumonia in Mechanically Ventilated Patient

Viral infections are only recently been investigated in patients on mechanical ventilation (MV) in ICU. It is especially the progress in the direct detection of these pathogens that allowed intensivists to try to assess objectively the impact of viruses in their patients. This is of course of viral infections "Community" (influenza virus, rhinovirus ...), but some viruses also occur under mechanical ventilation in immunocompetent adults. This is called viral infection "nosocomial" whose Herpesviridae are the most frequent and best studied. This replication Herpesviridae in ICU patients is usually a reactivation as primary infection. This reactivation is explained by the fact that after a few days of mechanical ventilation appears immunoparalysis, which can make the bed of bacterial or viral infection.Several studies have compared the pp65 antigenemia for quantitative PCR in immmunodéprimés patients. For example, in transplant patients (solid organs), the sensitivity of antigenemia was 91%, Quantitative PCR of 95.6% while the specificity was 57% and 81.6% respectively. No work, however, has to date compared these techniques in the intensive care patient. In a subject shortly epidemiological study, the sensitivity of the quantitative PCR performed on the LBA is 80%, when compared to antigenemia. Moreover this same study shows that half of the positive PCR on the BAL are not accompanied by a positive antigenemia, suggesting that PCR may be more sensitive than antigenemia. This exam has never been validated to date in intensive care. Finally, no work has so far evaluated the diagnostic performance of quantitative PCR performed on BAL


Eligibility Criteria:
Inclusion Criteria:

* Patient in ICU with ventilator-associated pneumonia suspicion

Exclusion Criteria:

* ICU pateint undergoing invasive ventilation for less than 48 hour
A Retrospective Study on Extranodal Lymphoma or Lymphoma of Rare Pathological Types

The aim of this study is to retrospectively collect clinical information on patients with extranodal or rare lymphomas, and to explore the best treatment strategy for these lymphomas in the real-world population.

Lymphoma is a highly common malignant tumor in Asia. For specific extra-abdominal sites or rare pathological subtypes of lymphoma, traditional chemotherapy protocols often cannot provide satisfactory results for patients. This study aims to retrospectively collect clinical information on patients with extranodal lymphoma or rare pathological subtype lymphoma, including the distribution of involved sites, clinical and molecular characteristics of different lymphoma subtypes, clinical treatment protocols, and prognosis, to explore the best treatment strategy for these lymphomas in the real-world population.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years (including 18 years old).
2. Patients newly diagnosed with non-Hodgkin lymphoma with extranodal involvement, whether it is primary, secondary, or cannot be determined; Or patients newly diagnosed with non-Hodgkin lymphoma of rare pathological types, including IVLBCL, SMZL, ALCL, AITL, MALTL.
3. Patients who have received systematic clinical treatment.
4. Patients with measurable lesions, at least containing one effective evaluation of efficacy.

Exclusion Criteria:

1. Patients who only receive supportive treatment.
2. Patients who cannot obtain effective evaluation data of efficacy.