cyrilzakka/clinical-trials huggingface dataset:
Comparative Analysis of the Th17 Cellular Response in Active and Inactive Pemphigus Vulgaris Patients

This study will compare the pattern of Th17 immune response in active and inactive pemphigus subjects. Skin and serum samples will be taken at the moment of enrollment.

Pemphigus is an autoimmune disease characterized by production of autoantibodies against desmogleins 1 and 3, which are part of the epidermis desmosomes. The first line of treatment are corticosteroids with or without the use of adjuvants (e.g. azathioprine, mycophenolate or rituximab). T lymphocytes are responsible for the initiation and maturation of the humoral response and the B cell activation required for the production of autoantibodies. In the last decade, the Th17 immune response has been implicated in the pathogenesis of pemphigus. Recently, the existence of tertiary lymphoid organ-like structures within the skin lesions was suggested. This structures contain T lymphocytes, B lymphocytes and plasma cells; these cells interact and create a local microenvironment for the production of autoantibodies. Most of the T cells in this structures are T helper CD4+ and express IL-21, and half of them produce IL-17.

In this study the investigators aim to evaluate comparatively the Th17 and T regulatory immune response in the lesional skin and serum of active and inactive pemphigus subjects that are treated with corticosteroids with or without adjuvants and a third group of healthy subjects. The investigators will study skin and serum due to the difference of lymphocytes and cytokines in both tissues. The primary hypothesis is: active pemphigus vulgaris subjects will have different levels of TH17 response in comparison to inactive patients.

The investigators will use descriptive statistics, association and correlation test of hypothesis.

Eligibility Criteria:
Inclusion Criteria:

1. Current cutaneous activity of pemphigus
2. Subjects will be treated with corticosteroids with or without adjuvants
3. Accept and sign the informed consent

Exclusion Criteria:

1. Pregnancy
2. Concurrent autoimmune diseases with skin lesions
3. Concurrent diagnosis of cancer
4. Concurrent active infectious disease
Association Between Depression and Iron Metabolism in Hemodialysis Patients

This study assesses the association of depression symptoms and iron metabolism in patients undergoing hemodialysis.

The Beck Depression Inventory (BDI), second version, was used to quantify the levels of depression. Mean age, duration of HD, hemoglobin levels, serum ferritin levels, serum iron levels, TSAT, TIBC, serum albumin levels, CRP and energy consumption (kcal/week) were included in the model as multivariate variables. Backward stepwise logistic regression (ROC) analysis was performed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with stable undergoing hemodialysis

Exclusion Criteria:

* Patients those who refused to join present study, and those who could not complete the questionnaires by themselves, and the patients with chronic hepatitis B or C were excluded.
Performance of EEG During Emergence Agitation in Nasal Surgery.

The purpose of the study is to evaluate the relationship between perioperative electroencephalogram and emergence agitation in the nasal surgery. Previous studies showed that low frequency band wave activity increased during emergence delirium in pediatric patients. It is still not enough to explain the relationship between emergence agitation and electroencephalogram in adults. Researchers will demonstrate the relationship between parameters related electroencephalogram and emergence agitation in adults undergoing nasal surgery.

Researchers use Sedline to perform perioperative EEG measurements of young adult patients undergoing nasal surgery under general anesthesia with sevoflurane. Emergence agitation occurrence and EEG patterns are observed.

The researchers record the patient's sex, type of surgery, pre-education on emergence agitation, preoperative hospital anxiety and depression scale (HADS), postoperative pain, amount of analgesics administered in the surgery/recovery room, and PACU time. Investigators check the correlation between EEG and perioperative variables. Investigators also compare EEG and perioperative variables for those who were given an explanation of emergence agitation and those who were not.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 19-55 years who are undergoing nasal surgery under general anesthesia using inhalational agent

Exclusion Criteria:

* CNS disease (ex.dementia, stroke, brain tumor, psychological disorder..)
* unable to communicate
* general anesthesia history within 6 months
* disagree to participate in study
Decontamination of Incubators in a NICU (Neonatal Intensive Care Unit)

Nosocomial infections are responsible for morbidity and mortality in hospitalized neonates. The environment of the neonates and especially the incubators can constitute the reservoir of pathogenic bacteria. That is why decontamination of incubators is a major step in the fight against nosocomial infections in NICUs.

The hypothesize is that the usual procedure of decontamination, based on antiseptic molecules, is not sufficient to eradicate all pathogenic bacteria from the incubators.

In this study the investigator's aim to assess the efficacy of the usual procedure of decontamination and to compare it with another procedure based on steam pulverization. Another objective will be to explore a possible contamination of the hands of the healthcare workers, that can be involved in the cycle of transmission of bacteria to neonates. Finally, clinical data about the neonates housed in the incubator will be retrieved from clinical reports, to identify the occurrence of sepsis and if so, to compare the bacteria involved in the sepsis and the bacteria present in the incubator.


Eligibility Criteria:
Inclusion Criteria:

* Healthcare workers involved in the decontamination process of incubators during the study period (period of sampling of incubators before and after decontamination)
* The two people involved in the sampling of incubators
* The patients (neonates) that will be housed in one incubator decontaminated and sampled during the study period

Exclusion Criteria:

* Refusal to participate for healthcare workers and people involved in the sampling
* Refusal to give access to the clinical data of his child for the parent of the patients included in the study-
The Protection Effect of Speeda® Rabies Vaccine for Human Use

The objective of this study was to achieve the post-marketing protective effect research of Speeda® rabies vaccine for human use from Chengda Bio.

When found the injury who is bitten by the animal to three-level, the investigators would enroll the participant after explaining the protection and making him signed the informed consent. The patient would inject rabies vaccine as follow the national regulation, meanwhile the investigators would get the blood samples to detect whether the man-killer carries the rabies virus.

Eligibility Criteria:
Inclusion Criteria:

* Parent/legal acceptable representatives of children or the adult participants are willing and able to understand the protocol requirements and provide informed consent signed
* Participant is considered to be in good health including the body and mental status on the basis of reported medical history and limited physical examination and live in local ≥ 12 months before injured
* The man-killer could found and detect whether it carries the virus

Exclusion Criteria:

* Known bleeding disorder or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth
* Apply passive immunity preparation
Safety, Tolerability, and Pharmacokinetics of AMG 827 in Adolescents With Asthma

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics in adolescent and adult subjects with intermittent or mild to moderate persistent asthma.


Eligibility Criteria:
Inclusion Criteria:

* Male and/or female subjects 12 to \< 18 years of age at the time of randomization
* Male and/or female subjects between 18 and 50 years of age (inclusive) at the time of randomization
* Body weight ≥ 36 kg at screening
* Intermittent or mild to moderate persistent asthma for at least the past 3 months prior to study enrollment (as defined by the 2004 Global Initiative for Asthma \[GINA\] guidelines.

Exclusion Criteria:

* Experienced an asthma exacerbation (defined as a disease episode resulting in treatment in an emergency room or urgent care facility, or an episode treated with oral corticosteroids) during the 3 months prior to study enrollment.
* Hospitalized for asthma during the 6 months prior to study enrollment; or ever intubated for the treatment of asthma.
* Use of oral corticosteroids within 3 months prior to study enrollment.
Impact of Atrial Fibrosis Surface Area on the Occurrence of Atrial Fibrillation in Patients With Ischemic Stroke of Undetermined Origin: a Prospective Cardiac MRI Pilot Study.

Atrial fibrillation is a cardiac arrhythmia most often originating in the left atrium, causing anarchic electrical activity and thus a loss of atrial contraction. This increases the risk of stroke through clot formation in the atrium, but also of heart failure. Atrial fibrillation is a major cause of stroke, accounting for more than 25% of all strokes. In addition, a quarter of ischemic strokes remain without an obvious cause at the end of hospitalization, and it is recommended that atrial fibrillation be detected intensively with long-term heart rhythm recording. Implantable loop recorders can detect 30% of atrial fibrillation cases over the 3-year battery life of these devices, after a stroke of undetermined origin. However, these devices require a small operation to implant them under the skin, and they are expensive.

The hypothesis of this study is that MRI imaging of the left atrium would enable better selection of patients to receive an implantable loop recorder. MRI can quantify the proportion of the left atrium with scar tissue, which is likely to favour the onset of atrial fibrillation. If the results confirm this hypothesis, the number of patients requiring an implantable loop recorder could be reduced, and perhaps an anticoagulation strategy based on MRI data could be introduced.

In addition to the usual follow-up by cardiologists and neurologists, participation in this study involves a cardiac MRI (with contrast agent) within 3 months of the stroke.


Eligibility Criteria:
Inclusion Criteria:

* Patient who has provided free, written and informed consent
* Patient of legal age
* Patient with cryptogenic ischemic stroke within 30 days of inclusion, documented by brain imaging (cerebral angioscan or cerebral MRI)
* Patients scheduled for implantable loop recorder implantation within 3 months of ischemic stroke in search of silent AF:

  * cryptogenic ischemic stroke or stroke with probable cardioembolic cause
  * no history of atrial fibrillation
  * no long-term anticoagulant therapy
  * with life expectancy \>12 months

Exclusion Criteria:

* Person not affiliated to national health insurance
* Person under legal protection (curatorship, guardianship)
* Person under court order
* Pregnant, parturient or breast-feeding
* Adult unable to give consent
* Patient diagnosed with AF during stroke assessment
* Patient with a contraindication to MRI or gadolinium injection:

  * Severe renal impairment (\<30ml/min Cockroft clearance due to gadolinium injection)
  * Claustrophobia / contraindication to MRI (metal implant not MRI compatible)
  * History of hypersensitivity to gadoteric acid or gadolinium-based contrast agents, and to meglumine
  * Uncontrolled asthma
Detection of Subclinical Enthesitis by Ultrasonography

Detection of subclinical enthesitis by ultrasonography

A total of 30 patients with psoriasis and 30 age-matched healthy controls, all without musculoskeletal diseases, will be recruited. They will undergo dermatological assessment and a blinded ultrasound (US) evaluation. Clinical assessment included demographics, severity of psoriasis and musculoskeletal clinical examination. Evaluation consisted of the detection of grey scale (GS) enthesitis and Power Doppler signal in enthesis areas. The Madrid Sonography Enthesitis Index (MASEI) scoring system was used to quantify the extent of sonographic entheseal abnormalities.

Eligibility Criteria:
Inclusion Criteria:

* Age≥18years
* Patients with psoriasis without musculoskeletal symptoms
* Healthy controls
* No joint involvement and no clinical symptoms and signs of enthesitis and synovitis

Exclusion Criteria:

* Have history of gout or arthritis or peripheral neurological disease of lower extremity.
* Have history of trauma and intensive sport activity in last 2 weeks.
* Have received any systemic therapy (i.e. DMARD, NSAIDs, corticosteroids, immunosuppressants, retinoids or biological agents) in 3 months
* Pregnant or breast-feeding
Normal Human Plasma Level of iNOS Study

The discovery that inducible nitric oxide synthase (iNOS) circulates in people who are developing the sepsis pathology has provided an opportunity to develop a first-in-class diagnostic test for the onset of sepsis. This study is designed to determine the normal human plasma level of circulating iNOS as the initial reference level against which hospitalized patients at risk for the development of sepsis can be compared to ascertain if the patient is at risk for becoming septic based upon an elevated level of plasma iNOS.

Infections in intensive care units (ICUs) and other hospital settings can be caused by different types of organisms, such as bacteria and fungi. Yearly, these infections cause at least 2 million patients in the USA to enter the early stages of the sepsis pathology (pre-sepsis) which will lead to more than 750,000 cases of sepsis that can deteriorate into life-threatening severe sepsis with organ dysfunction and septic shock with multiple organ failure and result in more than 250,000 deaths per year. At present, an accurate clinical lab test to predict the onset of the sepsis pathology does not exist. Thus, there is a large unmet clinical lab need for a test that can aid physicians in assessing the risk their hospitalized patients have for developing the sepsis pathology. A reliable test for predicting very early the onset of sepsis would be a major medical breakthrough. However, a reference level for normal healthy individuals is needed against which plasma levels can be compared for increased (or decreased) levels of iNOS.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Aged 18-79 years of age
* In generally good health

Exclusion Criteria:

* Cannot be a prisoner
Investigation of the Gut Microbiota in Patients With Acute Myeloid Leukemia

This cohort study aims to investigate the composition and activity of the gut microbiota of patients newly diagnosed for acute myeloid leukemia (AML), in relationship with their food habits and cachectic hallmarks. The recruitment for this study is currently ongoing with the help of clinicians, nurses and data managers at the Saint-Luc clinics, University Hospital Leuven (Campus Gasthuisberg) and University Hospital Gent.

Primary Objective

•To assess the composition and activity of the gut microbiota in patients with acute myeloid leukemia (AML) compared to matched control subjects.

Secondary Objectives

* To investigate correlations between the gut microbiota, cachectic hallmarks and gut microbiota-related markers in the blood (gut permeability markers, microbial compounds, microbial metabolites).
* To characterize the changes in the gut microbial ecosystem that are induced by chemotherapy and associated with colitis.
* To assess whether the composition of the gut microbiota can predict the severity of chemotherapy-related colitis.

Study Design

This is an academic multi-centric prospective study. The study is composed of two cohorts (Fig. 1). In Cohort A, patients are included before any chemotherapy. Biological samples (urine, feces, blood) are collected, alongside information on nutritional habits, appetite and medical records. Muscle strength and body composition are also measured. Only patients receiving a standard chemotherapy are included in Cohort B. In Cohort B, biological samples are collected and body composition, muscle strength and appetite are evaluated at 2 different time points, at the end of the chemotherapy (T1) and at discharge (T4).


Eligibility Criteria:
Inclusion Criteria:

* Patients with

  * A diagnosis of AML and related precursor neoplasms according to WHO 2008 classification (excluding acute promyelocytic leukemia) including secondary AML (after an antecedent hematological disease (e.g. MDS) and therapy-related AML)
  * Acute leukemia's of ambiguous lineage according to WHO 2008
  * A diagnosis of refractory anemia with excess of blasts (MDS REAB) 2 and IPSS (International Prognostic Scoring System)-R score \> 2.
* World Health Organization performance status 0, 1 or 2
* Sampled bone marrow and/ blood cells at diagnosis with molecular analysis.
* Written informed consent
* Good command of the French or Dutch language

Exclusion Criteria:

* Age \< 18 years
* Age \> 75 years
* Pregnancy
* Antibiotics consumption during the last 30 days before inclusion
* Recent chemotherapy (\< 3 months), with exclusion of hydroxyurea
* BMI \>30
* Any history of chronic intestinal affections (Crohn disease, inflammatory bowel disease, gluten intolerance)
* Gastric bypass
* Current treatment with antidiabetic or hypoglycemic drugs
Study of ADHD Children's Sensitivity to Memory Error Production

The purpose of the study is to test whether children with Attention Deficit/Hyperactivity Disorder (ADHD) are more susceptible to false memory production using a DRM paradigm. The number of "critical decoy production" errors will be analyzed and compared to the calibration of the test.

During a neuropsychological assessment, as part of the clinical routine, children with a diagnosis of ADHD, without neurological etiology, aged 8 to 10 years will be offered an additional task. This task, a DRM adapted to the child, consists of learning several lists of words. Each list exposes words belonging to the same lexical field, to a concept not explicitly mentioned in the list, called critical lure. Immediately after the presentation of a list, the child is asked to recall as many words as possible. Recall of the critical lure gives an indication of the production of false memories. The number of critical lures produced by these children will be compared to the calibration of the test, currently being published. The investigator will also verify if the production of critical lures can be correlated with other variables such as performance on intellectual, executive and attentional tasks, proposed during the clinical routine assessment.

The investigator hypothesize that ADHD children will recall more critical lures than the norm, and fewer correct responses than the norm.

The data collected is taken from the child's psychological file. The only personal information used, beyond test performance, is the child's gender and age. The procedure is anonymous.

Eligibility Criteria:
Inclusion Criteria:

* Age between 96 and 131 months
* Child referred by a doctor for a neuropsychological assessment
* Child with ADHD diagnosis
* Sufficient command of the French language
* Non-opposition of the child and his/her parents

Exclusion Criteria:

* Severe psychiatric comorbidity: major depressive episode, bipolar disorder, generalized anxiety disorder, autism spectrum disorder
* Major neurological history: severe head trauma, stroke, severe epilepsy, brain tumor
* Repeating a class during school
* Presence of an intellectual disability
* Use of methylphenidate treatment less than 48 hours before the experiment
* Completion of an intellectual assessment using the Wechsler Intelligence Scale for Children (WISC-V) dated less than one year before the meeting
Oral Water Ingestion in Heart Transplant Patients

In this study the investigators propose to assess the hemodynamic response to the ingestion of 16 fl oz of water. The investigators will test the hypothesis that water ingestion will increase the systemic vascular resistance.

In this study we propose to assess the hemodynamic response to the ingestion of 16 fl oz of water. We will test the hypothesis that water ingestion will increase the systemic vascular resistance. This study will occur in patients status post cardiac transplantation during their clinical right heart catheterizations. Invasive hemodynamics including cardiac outputs and plasma norepinephrine levels will be measured before and 30 min after the water ingestion.

Eligibility Criteria:
Inclusion Criteria:

* s/p cardiac transplantation scheduled for clinical right heart catheterization
* age \> 18 years

Exclusion Criteria:

* significant tricuspid regurgitation
* inability to safely swallow 500 ml of water
* other major medical comorbidities such as advanced renal disease where water ingestion may be harmful to patient
Study of Motexafin Gadolinium for the Treatment of Renal Cell (Kidney) Cancer

The purpose of this study is to find out if renal cell (kidney) cancer that has spread to other parts of the body will respond to treatment with motexafin gadolinium (MGd).


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* Histologically confirmed renal cell carcinoma with clinically or pathologically confirmed progression
* Ineligible for interleukin-2 (IL-2) treatment and/or have had 2 or fewer prior treatments
* Measurable disease
* Hemoglobin ≥ 9 mg/dL
* ECOG performance status of 0, 1, or 2
* Willing and able to provide written informed consent

Exclusion Criteria:

* Inadequate bone marrow, renal and liver function by laboratory criteria

  * Absolute neutrophil count \< 1500/µL;
  * Platelet count \< 100,000/µL;
  * AST or ALT \> 2 x upper limit of normal (ULN);
  * Alkaline phosphatase \> 5 x ULN;
  * Total bilirubin \> 2 x ULN;
  * Creatinine \> 2.0 mg/dL.
* Evidence of central nervous system metastases within past year
* Uncontrolled hypertension
* Known history of porphyria, G6PD deficiency or HIV
Effect of Smoking on Saliva Composition and the Development of Dental Erosion

The aim of this study is to investigate whether smoking is associated with changes in salivary composition and/or predisposition to erosion.

Healthy volunteers are observationally wearing an intraoral device with both bovine tooth specimens (enamel and dentin) and resin specimens twice for two hours each. Afterwards, specimens are eroded extraorally and calcium release into the acid is measured.

Total protein concentration and protein composition of the salivary pellicles on the resin samples are measured. Additionally, salivary parameters (unstimulated and stimulated saliva flow rate, pH, buffer capacity, total protein content and protein composition as well as concentration of inorganic calcium, phosphate, and fluoride) are measured.


Eligibility Criteria:
Inclusion Criteria:

* Volunteers aged between 20 and 50 years who are able to give written consent

Exclusion Criteria:

* Non-fulfillment of the inclusion criteria
* Intake of medications or diseases altering salivary secretion
* Refusal to use fluoridated toothpastes
* Known allergies to substances used in the study
* Orthodontic treatment or malfunction which does not allow wearing an intraoral device