cyrilzakka/clinical-trials huggingface dataset:
Getting SMART for Pediatric Epilepsy

The purpose of this study is to evaluate the effect of melatonin for improving sleep in pediatric epilepsy.

Sleep disturbances are more prevalent in children with epilepsy whose sleep can be disrupted by seizures occurring during the night and/or during the day. Melatonin is a naturally occurring hormone produced in the pineal which regulates sleep-wake cycles and facilitates quality sleep. Therefore, the purpose of this study is to evaluate the effect of melatonin for improving sleep in pediatric epilepsy.

Eligibility Criteria:
Inclusion Criteria:

- Children aged between 1 and 18 years with a confirmed diagnosis of epilepsy and with sleep problems

Exclusion Criteria:

* Children who are bedridden with limited mobility
* Children with liver or kidney dysfunction
* Children on medication for sleep or mood problems within 4 weeks before the baseline clinic visit
* Adolescent girls who are pregnant or breastfeeding
* Adolescent girls who have sexual activities but cannot take effective contraceptive measures during the trial
Cardio-respiratory Responses During Hypoxic Exercise in Individuals Born Prematurely

This project will consist of two studies, each investigating resting and exercise cardio-respiratory responses during exposure to hypoxia in individuals born prematurely and individuals born at full term of two different age groups: Kids (10-14 yrs) and Adults (18-22 yrs).Additional study will be performed on a preterm adult cohort (15 participants) that will investigate potential differences between hypobaric and normobaric hypoxia as outlined in the following section.

The study protocol in each age group will comprise two visits to the laboratory testing sessions in a randomized order. On one occasion the participants will perform a resting hypoxia test and a graded exercise test to voluntary exhaustion in normoxic condition ((NORM; fraction of inspired oxygen (FiO2)=0.209, placebo). On a second visit the participants will perform a hypoxia sensitivity test and a graded exercise test to voluntary exhaustion in hypoxic condition (HYPO; FiO2=0.120 corresponding to terrestrial altitude of approx. 4000 m). Indirect calorimetry, near infrared spectroscopy and ECG measurements will be performed throughout all tests. During both testing sessions the participants will also undergo anthropometry measurements and pulmonary function testing. The outline of the research visits is presented in the bellow figure:

Eligibility Criteria:
Inclusion Criteria:

Healthy male individuals

PRETERM group; gestational age: ≤ 32 weeks; gestational weight ≤ 1500 g

CONTROL group: full term born individuals ≤ 38 weeks

Exclusion Criteria:

Medication required that may interfere with the interpretation of the results

Chronically illnesses

Hormonal therapy

Recent sub-standard nutritional status

Family history of respiratiory, cardio-vascular, renal or hematological disease History of: thyroid dysfunction, renal stones, diabetes, allergies, hypertension, hypocalcaemia, uric acidaemia, lipidaemia or hyperhomocystinaemia

History of mental illness

Smoker within six months prior to the start of the study

Abuse of drugs, medicine or alcohol

Participation in another study up to two months before study onset

No signed consent form before the onset of the experiment

Blood donors in the past three months before the onset of the experiment

Vegetarian and Vegans

Migraines

History of vestibular disorders

Claustrophobia
Oral Contraceptive (OC) Progestin Dose and Breast Proliferation

The purpose of this research study is to gain a better understanding of the changes that may occur in the breast when a woman uses an oral contraceptive (birth control pill). Some research indicates that women who use birth control pills with lower amounts of progestin (a hormone in the birth control pill) may have lower breast cell growth than women who use birth control pills with a higher amount of progestin; this research will examine that in detail.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-34.
2. Premenopausal.
3. Currently taking or want to start oral contraceptives for contraception
4. Non-smoker.
5. Competent to give informed consent (as judged by the investigator).
6. Provided written informed consent.
7. Willingness to refrain from smoking and consumption of grapefruit or grapefruit juice during the study (grapefruit interferes with metabolism of exogenously administered OCs).

Exclusion Criteria:1.

1. Abnormal breast examination.
2. History or current therapeutic or prophylactic use of anticoagulants.
3. Known bleeding disorder or history of unexplained bleeding or bruising.
4. History of breast cancer or previous diagnostic breast biopsy.
5. Known allergy to local anesthetic.
6. Currently pregnant or pregnant within the previous 6 months.
7. Having any standard contra-indication to being prescribed OCs.
A Clinical Research of Qi Deficiency and Blood Stasis Syndrome (Different Disease With Syndrome)

The main purpose of this research is to reveal the curative effect mechanism of Yiqihuoxue prescription which treat the disease of qi deficiency and blood stasis. And at the same time this study also try to confirm yiqi huoxue fang qi deficiency blood stasis treatment of coronary heart disease (CHD) heart failure the curative effect and security.

Modern research has shown that the main mechanism of the qi deficiency and blood stasis of coronary disease combined with cardiac failure is the disorder Nerve-endocrine-immune network mechanism, disorder of energy metabolism, blood coagulation/anticoagulation imbalances, vascular endothelial injury and the expression of inflammatory factors and cytokines disorder, etc. Some studies have identified that the Chinese traditional medicine of supplementing qi and activating blood circulation drugs could adjust the nerve - endocrine - immune network, improve endothelial function, improve ventricular remodeling, ameliorate heart function, alleviate the clinical symptoms, enhance the quality of life, and so on. This study by comparing the curative effect of Yi-Qi Formula, Huoxue prescription and two prescription of yiqi huoxue (buyang huanwu decoction and Qishen Yiqi Drop Pill) on improving energy metabolism, ameliorating heart function, adjusting the blood coagulation and the expression of cell adhesion factor, improving endothelial function, to reveal the curative effect mechanism of Yiqihuoxue prescription which treat the disease of qi deficiency and blood stasis, and confirm the TCM theory that "Qi and blood are correlated.

Eligibility Criteria:
Inclusion Criteria:

1. Age 40 to 75;
2. Patients with ischemic heart failure： LVEF less than or equal to 45% measured by echocardiography in modified Simpson method
3. Qi deficiency and blood stasis syndrome;
4. New York Heart Association (NYHA) Class II to Ⅲ ;
5. Submitted informed consent

Exclusion Criteria:

1. Combin the pulmonary embolism, or acute coronary syndrome (acs) ,or acute cerebrovascular disease;
2. Combin other heart diseases: valvular heart disease, dilated cardiomyopathy, hypertension heart disease, pulmonary heart disease,congenital heart disease;
3. Hypertension and diabetes patients treated with drugs but not controlled within standard limit;
4. Severe hepatic and renal dysfunction, malnutrition, malignant tumour;
5. Active tuberculosis or rheumatoid diseases;
6. Nosohemia, organ transplantation,uremia;
7. Psychosis and drug abuse;
8. Allergic to the drugs or one component medicine of the drugs of this study ;
9. Participated in other trials within 1 month ;
10. Being pregnant, planning for pregnancy or breastfeeding;
A Comparative Clinical Study to Assess Pain Score and Wound Healing Following Fractional Ablation With a DFG Laser and CO2 Laser

This research study aims assess whether the Difference Frequency Generation (DFG) laser could be a better alternative to the CO2 laser in terms of reduced side effects and patient downtime.

The primary goal of this study is to compare the pain score and wound healing time in healthy subjects undergoing low fluence fractional ablation using the DFG and CO2 lasers. The secondary objective involves assessing the impact of each laser on dermal vasculature using an Optical Coherence Tomography (OCT) imaging system.

Participants will be treated with the DFG and CO2 laser to the upper thighs. Photography, pain scores, and OCT imaging will be recorded over the course of the study visits.

The investigators plan to enroll 23 healthy subjects to complete the study. Subjects must be equal to greater than 18 years old and may be any gender or Fitzpatrick skin type.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be able and willing to provide written informed consent and comply with the requirements of the study protocol;
* Subjects must be in good general health, based on answers provided during the screening visit;
* Subjects must be able to read and understand English.
* Subjects must be above the age of 18.
* Subjects must have no history of skin conditions that affect the integrity of the skin barrier.

Exclusion Criteria:

* Are pregnant or lactating;
* Have a history of drug or alcohol abuse or have reported habitual alcohol intake greater than 2 standard drinks per day \[e.g., 2 beers, 2 glasses of wine, or 2 mixed drinks\];
* Are smoking or have a history of smoking;
* Presence of eczema, psoriasis, skin wounds or ulcers, or any other skin disease on the thighs;
* Have birth marks, tattoos, scars, or any other disfiguration of the skin in the skin area of interest;
* Presence of sunburn or tan in the treatment area;
* Use of any topical application of retinoids in the area of interest or systemic retinoids in the past 6 months;
* Use of any prescription topical medication, such as corticosteroids or hydroquinone on the skin area of interest in the past 6 months;
* History of blood-clotting abnormality;
* History of keloid formation or hypertrophic scarring;
* History of allergic reaction to local anesthesia, aluminum chloride, and/or glycerol;
* Investigator, interfere with study evaluations or pose a risk to subject safety during the study;
* Exhibits any clinical conditions or takes any medication which in the opinion of the investigator may interfere with the study or pose a risk to subject safety during the study;
* Is not able to follow study protocol.
Study of Safety and Efficacy of ANG-3070 in Chronic Kidney Disease

The major objective is to demonstrate the safety and efficacy of ANG-3070 in patients with primary glomerular disease and persistent proteinuria.

To evaluate the safety and efficacy of ANG-3070 in patients with primary glomerular disease and persistent proteinuria while on the SOC, as measured by a reduction in the 24-hour urinary protein excretion.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female participants aged 18 and older.
2. Diagnosis of a primary glomerular disease confirmed from a past renal biopsy. Participants with genetic forms of FSGS may be enrolled without a renal biopsy if the clinical picture is consistent with the genetic testing results.
3. Estimated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) ≥ 40 mL/min/1.73m2.
4. Urinary protein excretion ≥ 1 g/day on a 24-hour urine collection.
5. All participants must be on the SOC therapy, including the maximally tolerated/recommended doses of an ACEi or ARB, but not both.

Exclusion Criteria:

1. Positive Hepatitis B (HBV), Hepatitis C (HCV), or human immunodeficiency virus (HIV) viral screening; historical or during screening.
2. Aspartate Aminotransferase (AST) or alanine Aminotransferase (ALT) or total bilirubin \> 2 x ULN.
3. Hemoglobin A1C \> 8.5%.
4. Known predisposition to bleeding and/or thrombosis
5. Type I diabetes mellitus.
6. Renal disease secondary to systemic disease including but not limited to: systemic lupus erythematosus, anti-neutrophil cytoplasmic antibodies -associated diseases, anti-glomerular basement disease, secondary forms of focal segmental glomerulosclerosis, renal diseases associated with para-proteinemias, C3 glomerulopathy, and diabetic kidney disease.
Clinical Evaluation of an IGRA Test for the Diagnosis of Active and Latent Tuberculosis

Methodology This is a single-center study carried out as part of routine patient care.

The aim of the study is to determine the performance of the 2nd generation TB-IGRA test in the diagnosis of tuberculosis.

It is planned to include 500 patients. An enrolment of 455 subjects will enable us to demonstrate sensitivity-specificity levels of 92% for a 95% confidence interval and a 0.05 degree of precision. To take account of non-analyzable samples or tests, the investigator will include 500 subjects

Eligibility Criteria:
Inclusion Criteria:

* Individual at least 18 years of age
* Patient presenting for treatment of tuberculosis disease
* Having undergone or benefiting from screening for tuberculosis using a medically prescribed reference IGRA test.
* Informed patient who has not expressed opposition to participating in the study.

French-speaking patient with unambiguous understanding of oral and written instructions.

Exclusion Criteria:

Persons in a period of exclusion from another study

* Pregnant, parturient or breast-feeding women;
* Person deprived of liberty by judicial or administrative decision
Povidone Iodine Irrıgation at Hip-Knee Arthroplasty

Povidone iodine (PI) solution is an antimicrobial solution that can be used at hip and knee arthroplasty cases. It contains iodine that may be absorbed by the body. This study aims to investigate any absorption caused by PI solution.


Eligibility Criteria:
Inclusion Criteria:

* All patients with hip/knee osteoarthritis who undergo primary arthroplasty

Exclusion Criteria:

* Patients with abnormal thyroid function tests in the preoperative period, a history of the previous thyroid-related disease.
Esomeprazole, Moxifloxacin and Amoxicilin for Rescue Therapy of Helicobacter Pylori Infection

Successful H. pylori eradication therapy remains a challenge in medical practice. Despite promising data for first-line, second-line and rescue treatment options based on clinical trials as well as guidelines and expert recommendations, success rates can often not be reproduced in general practice. Rescue options for patients with failed initial or second-line therapy are definitely needed. The new fluoroquinolone moxifloxacin may represent an effective and save treatment option (in combination with a PPI and amoxicillin) for rescue therapy of H- pylori positive patients.However, optimal duration of therapy (7-day course vs 14-day course) has to be determined

Successful H. pylori eradication therapy remains a challenge in medical practice. Currently, a PPI - based triple therapy containing clarithromycin, amoxicillin or nitroimidazole given for 7 days is the recommended first line treatment approach with an expected eradication success rate of approximately 80%. As second-line treatment option in case of failure, a RBC-based quadruple therapy is currently recommended curing another 80% of patients, leaving a subset of patients with persistent H. pylori infection. Resistance to fluoroquinolones is low in most countries,hence these compounds are potential candidates for second-line and rescue treatment. The new fluoroquinolone moxifloxacin launched by Bayer in 1999 for the treatment of respiratory tract infections, has a broad antibacterial spectrum comparable to levofloxacin but fewer phototoxic and central nervous system excitatory effects. The possible role of moxifloxacin in H. pylori eradication is since under clinical investigation

Eligibility Criteria:
Inclusion Criteria:

* male/female, age \>/=18 years
* Helicobacter pylori infection proven by histology and culture
* indication for eradication therapy according to the Maastricht-III
* at least one failed prior eradication attempt
* pretherapeutic resistance testing (culture)
* written informed consent

Exclusion Criteria:

* in vitro resistance to moxifloxacin or amoxicillin
* current complicated peptic ulcer disease
* daily intake of NSAIDs
* co-medication with drugs known to interact with the study medication
* history of gastric surgery/vagotomy
* medical treatment for depression, known suicide attempt
* severe cardiological diseases such as bradyarrythmia, QT changes
* malignant disease
* gravidity, nursing
* women with child bearing potential must perform contraceptive measures
Breathing Intervention for Cardiac Anxiety

This study examines the impact of a breathing training intervention on cardiorespiratory sensations and anxiety in adults with cardiac arrhythmias.

Patients with cardiac arrhythmias develop increased rates of anxiety and depression. Atrial arrhythmias, such as paroxysmal atrial fibrillation (AF), and ventricular arrhythmias, such as those with implantable cardioverter defibrillators (ICD) are particularly at risk. While ICDs can be life saving, many patients (including those without prior psychiatric illness) develop elevated rates of anxiety and depression, particularly after receiving discharges (shocks) from the device. Treatments involving modulation of the breath have been shown to improve both psychological and cardiac outcomes in patients with AF. Since breathing modulation alters sympathetic balance, this may be a mechanism of the therapeutic effect. This study examines the impact of a breathing training intervention on cardiorespiratory sensations and anxiety in adults with atrial and ventricular cardiac arrhythmias.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 80
* BMI 17 to 35
* Proficient in English language
* Paroxysmal atrial fibrillation or ventricular fibrillation or frequent premature atrial/ventricular contractions

Exclusion Criteria:

* No telephone access
* Active suicidal ideation with intent or plan
* Active drug or alcohol dependence, or active binge drinking within the last month
* Cardiovascular instability, as evidenced any of the following:

  1. New York Heart Association (NHYA) heart failure class IV (i.e., unable to carry on any physical activity without discomfort, symptoms of heart failure at rest, increased discomfort with any physical activity is undertaken)
  2. American College of Cardiology/American Heart Association congestive heart failure stage D (i.e., heart failure symptoms at rest, receiving end of life care).
  3. Unstable angina or exercise induced angina
  4. Persistent atrial fibrillation
* Pacemakers or combined pacemaker/ICDs will be excluded
* Presence of unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic disease; or any other condition that, in the opinion of the investigator, would make participation not be in the best interest (e.g., compromise the well-being) of the subject or that could prevent, limit, or confound the protocol-specified assessments.
Impact of tDCS on Emotional Processing in Healthy Subjects.

The dorsolateral prefrontal cortex (DLPFC) plays a key part in emotional processing and regulation.

Emotions continually influence other cognitive functions such as attentional resources .Emotions also influence a subject's automatic physiological responses .

Transcranial direct current stimulation (tDCS) is an innovative neuro-modulation treatment, often used in major depression.

Various studies have shown that it is possible to modulate emotional processing in healthy subjects, however the impact of this modulation on attentional resources and physiological responses has not been studied. Also, the mechanisms of action of the tDCS on emotional processing are still unclear.

It is necessary to explore the modulation of the DLPFC in healthy subjects in order to better understand the network and mechanisms at stake in the processes.

Thus, investigators plan to study the modulation of the DLPFC (left and right) by tDCS (anode, cathode and placebo) on the processing of emotions and the impact on attentional resources, and physiological responses.

To study the modulation of the DLPFC (left and right) by tDCS (anode, cathode and placebo) on the processing of emotions and the impact on attentional resources, and physiological responses, subjects will undertake 3 tasks before and after a unique tDCS session of 30 minutes.

The first task is a facial expression recognition task, the second measures the attentional processing of emotional information ("Free-viewing task") and the last task focuses on working memory (digit sorting task).

Each task has its cognitive variables but physiological responses will also be measured during each task before and after the tDCS session (Eye movement, i.e. Pupil dilatation and time spent on region of interest; heart rate, skin conductance and respiratory frequency).

3 arms will take part in the study: Anode tDCS Cathode tDCS Placebo tDCS These 3 types of tDCS stimulation will enable us to study the different modulations possible for the DLPFC and the impact on all the variables previously mentioned.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 18 and 65 years
* Written given consent

Exclusion Criteria:

* Psychiatric disorder
* Refusal from the subject
* Addiction except for tobacco addiction
* Ocular disease (except from refraction disorders), neurologic or cardiac disease.
* Neuroleptic or anticonvulsivant treatment
* presence of a specific contraindication for tDCS (e.g., personal history of epilepsy, metallic head implant, cardiac pacemaker)
* pregnant or breastfeeding women
Pseudohyponatremia of Multiple Myeloma is True Hyponatremia

Hypothesis: the hyponatremia of multiple myeloma (m.m.)is true and not pseudohyponatremia by using the stewart approach to acid - base interpretation, would like to show that the positive charged m- proteins produced in m.m.result in true hyponatremia.


Eligibility Criteria:
Inclusion Criteria:

* patients with multiple myeloma