cyrilzakka/clinical-trials huggingface dataset:
Association Between Ferroptosis and Epilepsy

Epilepsy is one of the most common neurologic disorders seen in children, often characterized by recurring seizures. Nearly 10.5 million children worldwide are estimated to have active epilepsy. Children with epilepsy are more likely to have developmental health and developmental comorbidities such as depression, anxiety, attention deficit hyperactivity disorder, learning disabilities, and developmental delay compared to children without epilepsy. Status epilepticus (SE) is the most common life-threatening emergency neurological emergency in children and leads to hippocampal neuronal cell death. The animal model proved SE-induced neuronal cell death in hippocampal CA1 and CA3 regions. Classical drugs like carbamazepine or phenytoin often cause behavioral problems and side effects such as unsteady gait, depression, and irritability. In addition, classical medicine did not protect cognitive function and preferred to drive drug-resistant. Therefore, it is necessary to develop a novel therapy to treat epilepsy. Ferroptosis is a new type of cell death, usually accompanied by a large amount of iron accumulation and lipid peroxidation. It is widely accepted that glutamate-mediated neuronal hyperexcitation plays a causative role in eliciting seizures, and cystine/glutamate antiporter inhibition induces ferroptosis. Hence, investigators hypothesize GPX4 dependent ferroptosis pathway may play a key role in eliciting seizures.

To investigate the possible association between GPX4 dependent ferroptosis pathway and epilepsy. Investigators first obtained gene expression of GSE25453 from GEO (https://www.ncbi.nlm.nih.gov/geo), which contained ten medial temporal lobe epilepsy and ten adjacent non-seizure region tissues. Then, investigators further the possible association between GPX4 dependent ferroptosis pathway and epilepsy in school-aged children. Investigators obtained peripheral blood from 20 newly diagnosed untreated school-aged children (6 -12 years) and 20 age-matched healthy controls. Three glutathione peroxidase 4 (GPX4）dependent ferroptosis pathway biomarkers were investigated: Solute Carrier Family 7 Member 11（SLC7A11), GPX4, tumor protein 53 (P53). Western blot and Rt-qPCR were used to investigate the possible changes in these three biomarkers.

Eligibility Criteria:
Seizure group

Inclusion Criteria:

1. Aged between 6 and 12 years old
2. Newly diagnosed untreated epilepsy

Exclusion Criteria:

1. Treated with medicine or another therapy
2. Had history of cancer diseases
3. Had history of endocrine diseases

Healthy control group

Inclusion Criteria:

1. Aged between 6 and 12 years old

Exclusion Criteria:

1. Had history of epilepsy
2. Had history of cancer diseases
3. Had history of endocrine diseases
A Randomized Study With Oral Melphalan + Prednisone (MP) Versus Melphalan, + Prednisone + Thalidomide (MPT) for Newly Diagnosesd Elderly Patients With Multiple Myeloma

The aim of the study is to compare efficacy and toxicity of melphalan and prednisone versus meplhalan, prednisone and Thalidomide in elderly patients with multiple myeloma or patients with multiple myeloma but not eligible for high dose treatment with stem cells support.


Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed of multiple myeloma.
* Age \> 65 years
* ECOG \<= 3
* Written informed consent given at the time of randomization
* Patients with age \<= 65 but not eligible for high dose treatment with stem cells support

Exclusion Criteria:

* ECOG \> 3
* current neoplasm..
* contraindications to use thalidomide
* peripheral neurophaty
Memantine Treatment in Alzheimer's Disease Patients

The aim of this study is to investigate whether there will be any efficacy difference of Memantine treatment in different cognitive severity AD patients stratified with BPSD

Planed to enroll a total of 222 patients with mild, moderate or severe AD treated with Memantine in 2017-2018 from 15 centers.

Eligibility Criteria:
Inclusion Criteria:

1. Probable AD based on the diagnosis criteria of NIA-AA guideline (the U.S. National Institute on Aging and Alzheimer's Association guideline, McKhann et al, 2011\[8\];
2. Male or female, 50 years and older ;
3. All inpatients or outpatients recruited into this study must meet MMSE score ≤24 points, patients with MMSE score as 21-24 points will be enrolled into mild group, patients with MMSE score as 10-20 points will be enrolled into moderate group, patients with MMSE score less than 10 points will be enrolled into severe group.
4. Have a reliable caregiver who can accompany the patient to the site to complete the required study procedures;
5. Provide the informed consent.

Exclusion Criteria:

1. Patients with disturbance of consciousness of any causes;
2. Patients with severe aphasia or physical disability who were unable to complete neuropsychological examination;
3. Patients with mental illness;
4. Patients with a history of alcoholism and drug addiction, or traumatic brain injury, epilepsy, encephalitis, normal-pressure hydrocephalus and other neurological disorders causing cognitive impairment;
5. Patients with systemic diseases causing dementia (e.g. liver and kidney insufficiency, endocrine disorders, vitamin deficiency);
6. Patients with a history of ischemic or hemorrhagic cerebrovascular diseases, and vascular diseases (stroke foci) as confirmed by imaging examination;
7. Subjects who are unwilling or unable to abide by the study requirement.
National Registry of Cardioneuroablation in Recurrent Reflex Syncope

This registry aims to collect patient data on cardioneuroablation for vasovagal syncope from multiple centers in France. The aim is to evaluate success rates, compare techniques and help institutions set up their own cardioneuroablation program

Cardioneuroablation is an emerging technique used to treat patients with vagally-mediated extrinsic bradycardia. It seems particularly efficient in patients with recurrent vasovagal syncope due to a strong cardioinhibitory effect. The procedure consists in using radiofrequency ablation to destroy cardiac ganglionated plexi located in epicardial fat pads around the atrias. Key questions concerning this procedure still remain unanswered: 1) What is the success rate of the procedure 2) Which patients will benefit from this technique? 3) Which fat pads should be targeted during the procedure? 4) What is the best way of identifying the location of these fat pads? 5) What are the long-term effects of this procedure? A multicenter registry seems ideal to try to answer these questions at minimal cost

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 or more
* Recurrent vasovagal syncope (≥2 episodes during the last year) with an asystolic component (≥3 second pause) recorded during a spontaneous episode. The asystole can be related to sinus arrest or paroxysmal AV block.
* Scheduled cardioneuroablation procedure
* Estimated residual battery life ≥ 1 year.
* Patient affiliated to or beneficiary of national health security scheme.
* Patient who have received an information notice and has not objected to the use of their data in the registry.

Exclusion Criteria:

* Contraindication to anticoagulation therapy: major bleeding, risk of major bleeding, severe hepatic disease
* Contraindication to cardiac CT: contrast medium allergies
* Intracardiac thrombus
* Patient detained by judicial or administrative decision.
A Study to Evaluate the Pharmacokinetic Profiles of Single 14 mg Teriflunomide Tablet in Healthy Chinese Volunteers

Primary Objective:

To assess the pharmacokinetic (PK) parameters of teriflunomide after a single oral dose of 14 mg administration in Chinese healthy subjects

Secondary Objective:

To assess the safety and tolerability after a single oral dose of 14 mg teriflunomide in Chinese healthy subjects

* Screening: 2 to 21 days before inclusion (Day -21 to Day -2)
* Institutionalization period: 6 days including 1 treatment day (Day -1 to Day 6, treatment on Day 1)
* Follow-up: 7-10 days (may be extended)
* End of study: Day 38 to Day 41 (may be extended)
* Total study duration: maximum 9 weeks

Eligibility Criteria:
Inclusion criteria :

Male or female subjects, between 18 and 45 years of age, inclusive. Body weight between 50.0 and 95.0 kg, inclusive, if male, and between 45.0 and 85.0 kg, inclusive, if female, body mass index between 19.0 and 24.0 kg/m2, inclusive.

Certified as healthy by a comprehensive clinical assessment and lab test. Subject must use an appropriate contraception method. Having given written informed consent prior to any procedure related to the study.

Exclusion criteria:

Blood donation, any volume, within 3 months before inclusion. Symptomatic postural hypotension, whatever the decrease in blood pressure, or asymptomatic postural hypotension defined by a decrease in systolic blood pressure ≥20 mmHg within 3 minutes when changing from the supine to the standing position.

Excessive consumption of beverages with xanthine bases (\>4 cups or glasses per day).

If female, pregnancy (defined as positive β-hCG blood test), breast-feeding. Any medication (including St John's Wort and traditional Chinese herb medicine) within 14 days before the inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of that drug, with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days.

Any consumption of citrus (grapefruit, orange, etc) or their juices within 5 days before inclusion.

Subject (both male and female) who disagrees to use an appropriate contraception method .

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Mechanisms of LV Remodeling in Hypertensive Patients Working on a Rotational Expeditionary Basis in the Arctic

The main goal of our investigation is to study the mechanisms of formation of left ventricular remodeling in patients with hypertension, working on a rotational expedition basis in the Arctic.

Hypothesis: In patients with hypertension working in the conditions of the Arctic shift, the combination of climatic and geographical factors and rotational expeditionary method of labor contributes to the increase in the left ventricular remodeling processes and leads to the formation of heart failure with preserved ejection fraction.

Eligibility Criteria:
Inclusion Criteria:

* The patient signed the informed consent

Exclusion Criteria:

* Valvular pathology of the heart
* Past cardiac or cerebral complications
* Identified heart rhythm disturbances
* Coronary heart disease
* Patients with severe somatic pathology, whose prognostic survival rate does not exceed 1 year
* The presence of a mental disorder of organic origin
Cardio-fistular Recirculation in Patients With Chronic Heart Failure and Preserved Left Ventricle Ejection Fraction

This is a single-arm cohort study aimed to evaluate change of arteriovenous fistula volume blood flow / cardiac output ratio in patients with chronic heart failure (NYHA I-II classes) and with preserved ejection fraction as a result of a hemodialysis session after a "long" interdialysis interval.


Eligibility Criteria:
Inclusion Criteria:

* signed informed consent,
* \> 18 years
* maintenance ("chronic") hemodialysis,
* native arteriovenous fistula,
* arteriovenous fistula volume blood flow ≥1 l/min,
* arteriovenous fistula volume blood flow / cardiac output ratio \< 0.3,
* interdialysis weight gain \<5% of "dry" body weight,
* sufficient hemodialysis dose (eKt/V \> 1.2),
* chronic heart failure (NYHA I-II classes only),
* preserved left ventricular ejection fraction (≥50%),
* absence of arrhythmias (except first-degree atrioventricular block block),
* absence of heart valve disease (except mitral regurgitation grade I-II),
* absence of intradialysis hypo/hypertension
* "long" interdialysis interval (3 days).

Exclusion Criteria:

* hypo/hypertension during or after hemodialysis,
* arrhythmias (except first-degree atrioventricular block) after hemodialysis.
Elaboration of a Multi-dimensional Indicator of Quality in Palliative Care

The purpose of this study is to elaborate a multi-dimensional indicator of the quality in palliative care for patients of end-of-life.

The study will, as secondary objectives:

* elaborate in a standard manner one set of indicators of organization and inner working of a palliative care setting.
* compare according to these indicators, the qualities of 3 types of palliative care: palliative care unit in hospitals, specified identified bed for palliative care patients and non-specified bed.
* explore the relationship between organizational aspects and results in term of burden.

A multicentric study aims on quality of palliative care and will be conducted in three types of 7 palliative care settings: two hospices, two hospital-based palliative care units and three medical units where a mobile palliative care team intervenes.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years.
* Patient with serious progressive illness and in terminal phase (life expectancy \< 3 months): OMS stage is 3 or 4, regardless of etiology.
* Patient informed their diagnosis or not.
* Hospitalized at the moment of inclusion in one of the following care settings: palliative care unit, identified bed or non-identified bed in a care department of short stay.
* No-oppose to participate to the study, by patients, their families or trusted person.

Exclusion Criteria:

* Patient has difficulties in reading, writing or understanding french language, also their family.
* Hospitalization in the palliative care setting \< 48 hours.
A Study in Erectile Dysfunction

The purpose of this trial is to evaluate if treatment with tadalafil once daily will allow men to return to normal erectile function in those who did not have normal erectile function following as-needed (PRN) Phosphodiesterase Type 5 (PDE5) Inhibitor treatment.


Eligibility Criteria:
Inclusion Criteria:

* At least a 3-month history of erectile dysfunction (ED).
* Are able to read, understand and provide signed informed consent.
* Have an International Index of Erectile Function-Erectile Function (IIEF-EF) domain score that is greater than or equal to 17 and less than 26 at screening.
* Have been taking a maximum dose of sildenafil citrate (100 milligram \[mg\]), vardenafil (20 mg), or tadalafil (20 mg) on as needed basis for at least one month prior to screening.
* Anticipate having the same female sexual partner during the study who is willing to participate in the required number of sexual intercourse attempts and complete study measures during the study.
* Agree to make at least four sexual intercourse attempts during both the 4-week as needed run-in period and the 4-week non-drug run-in period.
* Agree not to use any other erectile dysfunction (ED) treatment, including herbal therapy during the 4-week non-drug, run-in, the double-blind treatment period, the open label period and for 96 hours after the end of the study.

Partner Inclusion Criteria:

* Are female and at least 18 years of age at screening.
* Anticipate having the same male study subject as her sexual partner during the study.
* Able to read, understand and provide signed informed consent.
* Agree to make the required number of sexual intercourse attempts with the male sexual study partner during the study.
* Willing to participate in recording responses to the treatment satisfaction scale.

Exclusion Criteria:

* Have an IIEF-EF domain score of greater than or equal to 26 at screening.
* Prior ineffective treatment with (or nonresponder to) any PDE5 Inhibitor
* Have previously used or are currently using any PDE5 inhibitor once daily.
* Present with ED caused by other primary disorders or ED caused by untreated/inadequately treated endocrine disease.
* Partner unwilling to complete all study requirements.
* History of radical prostatectomy or other pelvic surgery or penile implant, or a clinically significant penile deformity, in the opinion of the investigator
* Exhibit evidence of clinically significant renal insufficiency or hepatobiliary disease, or significant cardiac history as determined by the investigator
* Currently receive treatment with nitrates, cancer chemotherapy, or antiandrogens
* Have previously completed or withdrawn from this study or any other study investigating tadalafil for once-daily use.
Bivalirudin in Stable Ischemic Heart Disease Patients Undergoing PCI

Prolonging infusions may decrease myocardial damage associated with bivalirudin use during primary PCI. The investigators hypothesized that continuing the bivalirudin infusion commenced during the procedure at the PCI recommended dose for 4 hours would prevent myocardial damage.

Bivalirudin is widely used as an anticoagulant during percutaneous coronary intervention (PCI) for coronary heart disease. Prolonging infusions may decrease myocardial damage associated with bivalirudin use during primary PCI . However, whether prolonging infusions of bivalirudin could prevent ischemic complications is unknown. The investigators examined the effects of prolonged drug infusion after elective PCI. The investigators hypothesized that continuing the bivalirudin infusion commenced during the procedure at the PCI recommended dose for 4 hours would prevent myocardial damage.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 to 80 years with stable ischemic heart disease in whom PCI was required.

Exclusion Criteria:

* cardiogenic shock;
* thrombolytic therapy administered before randomization or any anticoagulant administered within 48 hours of randomization;
* active or recent major bleeding or bleeding predisposition;
* major surgery within 1 month;
* clinical syndrome suspicious for aortic dissection, pericarditis, or endocarditis;
* blood pressure higher than 180/110 mm Hg;
* known hemoglobin less than 10 g/dL, platelet count less than 100 × 109/L, aminotransferase level greater than 3 × the upper limit of normal, or creatinine clearance less than 30 mL/min;
* history of heparin-induced thrombocytopenia;
* allergy to any of the study drugs or devices;
* pregnancy or lactation;
* any condition making PCI unsuitable or that might interfere with study adherence; and
* patient unwilling or unable to provide written informed consent.
PICO- Single-use Negative Pressure Wound Therapy System

To compare the rate of wound complications with the PICO dressing versus a standard nonstick gauze dressing in patients undergoing anterior total ankle arthroplasty.

Participating subjects will be randomized to one of the study groups: Group 1 (Control group) or Group 2 (Treatment group). If randomized to Group 1- after surgery, the doctor will apply the standard non-stick gauze dressing to the wound. If randomized to Group 2- after surgery, the doctor will apply the PICO dressing to the wound.

The goal of the study is to measure the rate of wound complications based on wound assessment, patient-reported outcomes surveys, as well as peri- and post-operative data.

Eligibility Criteria:
Inclusion Criteria:

* Patient ≥18 years old
* Subjects undergoing total ankle arthroplasty or uncomplicated revision total ankle arthroplasty
* Subjects able to provide informed consent
* Subjects who are able to understand and comply with study visit schedule and procedures

Exclusion Criteria:

* History of previous deep infection or history of wound complication necessitating plastic surgery intervention
* Allergy to products used in the study
* Pregnant and breastfeeding women due to anesthesia risks
* Subjects with a known history of poor compliance with medical treatment
* Subjects who decline participation in this research study
* Prisoners
The Clinical Efficacy of Belting Stabilization for Shoulder Pain

Application of a belt for stabilization while exercising accelerate and optimize recovery in patients diagnosed with shoulder impingement syndrome.

Stabilization through belts is commonly used as an adjunct for treatment of musculoskeletal problems. Although this treatment is popular among clinicians, there is a paucity of evidence on its use for shoulder pathology. The objective of this double-blinded longitudinal randomized controlled trial (RCT) is to determine the clinical efficacy of stabilization belting applied to patients receiving rehabilitation treatment for shoulder impingement syndrome. The study population will include patients who have been referred to the physiotherapy department of the Holland Orthopaedic \& Arthritic Centre for conservative treatment. Patients will be randomized into the treatment and control groups. The primary outcome measure is the Quick Disabilities of Arm, Shoulder and Hand (QuickDASH) questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of impingement syndrome or post-surgical stiffness with an abnormal scapulothoracic rhythm

Exclusion Criteria:

* Inability to speak or read English
* Evidence of major joint trauma causing fracture
* Infection
* Underlying metabolic or inflammatory disease
* Avascular necrosis
* Frozen shoulder
* Major medical illness
* Psychiatric illness that precluded informed consent
Epi-On Corneal Crosslinking for Keratoconus

Epithelium-On Corneal Crosslinking for Keratoconus.

Subjects with a diagnosis of progressive keratoconus will be evaluated for suitability as a candidate for Corneal Crosslinking (CXL). Subjects that as candidates for CXL will be asked to participate in this study and will undergo the required screening procedures to determine study eligibility. Informed consent will be obtained from each subject before performance of any required any required study procedures that are not part of the investigator's routine examination. All Subjects will be evaluated at screening/baseline, Day 0 (treatment day), then 1 day, 1 week, and 1, 3, 6, 12 months after treatment. Pentacam measurements and measurements of best spectacle-corrected visual acuity will be obtained and baseline and at appropriate times after the epithelium-on CXL procedure. Safety monitoring throughout the study will include observations at appropriate times for adverse events, clinically significant findings on ophthalmic examination, and slit-lamp examination.

The primary efficacy parameter is the change from baseline over time in maximum keratometry (K-Max). Addition analyses for efficacy will include uncorrected visual acuity (UCVA) and best corrected visual acuity (BCVA).

Eligibility Criteria:
Inclusion Criteria:

* 12 to 40 years of age, having a diagnosis of keratoconus, signed written informed consent, willingness and ability to comply with schedule for follow-up visits

Exclusion Criteria:

* Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications (herpes simplex/zoster, recurrent corneal erosion syndrome, corneal melt, corneal dystrophy, etc.) Pregnancy, intent to become pregnant, or lactation during study. Corneal pachymetry \<350 microns at the thinnest point measured by Pentacam in the eye(s) to be treated.

Nystagmus or any other condition that would prevent steady gaze. Other systemic condition that in the investigator's opinion would not allow the patient to be a good candidate for the study.