cyrilzakka/clinical-trials huggingface dataset:
Efficacy of YKP3089 in Patients With Photosensitive Epilepsy

The aim of this study is to evaluate the ability of a single oral dose of YKP3089 to abolish or clearly reduce the IPS-induced photo-paroxysmal EEG response in photosensitive epilepsy patients, and to measure the onset and duration of the effect. Several cohorts will be used, to sequentially investigate different doses.


Eligibility Criteria:
Inclusion Criteria:

* Male or female age 18-60 years.
* A diagnosis and history of epilepsy for which patients are on 0-2 concomitant antiepileptic drugs.
* If the patient is taking two concomitant medications, the second drug must be levetiracetam, gabapentin or pregabalin.
* A reproducible IPS-induced photo-paroxysmal response (PPR) on EEG of at least 3 points on a frequency assessment scale (See Section 6.16) in at least one eye condition and no change of more than 3 frequencies in 2 repeated measurements recorded over the 2 months prior to study entry in at least one eye condition.
* Patients in otherwise good health (with the exception of epilepsy), as determined by the PI via the medical history, a physical examination and screening laboratory investigations.
* A body mass index (BMI) between 18 and 35.
* Able and willing to provide written informed consent to participate in the study in accordance with the ICH, GCP guidelines.

Exclusion Criteria:

* A history of non epileptic seizures (e.g. metabolic, structural or pseudo-seizures).
* Women who are pregnant or lactating.
* Women of reproductive potential who do not agree to use effective birth-control methods.
* Patients taking medications that are known substrates of CYP2B6 and CYP2C19 including but not limited to phenytoin, Phenobarbital, omeprazole, fluvoxamine and efavirenz.
* Any clinically significant laboratory abnormality which, in the opinion of the investigator, will exclude the patient from the study.
* An active CNS infection, demyelinating disease, degenerative neurological disease or any CNS disease deemed to be progressive during the course of the study that may confound the interpretation of the study results.
* Any clinically significant psychiatric illness, psychological or behavioral problems which, in the opinion of the investigator, would interfere with the patient's ability to participate in the study.
* Patients who are suffering from clinically significant active liver disease, porphyria or with a family history of severe hepatic dysfunction indicated by abnormal liver function tests greater than 3 times the upper limit of normal (AST and ALT).
* A history of alcoholism, drug abuse, or drug addiction (within the past 12 months).
* Patients who would normally be contraindicated for YKP3089 administration.
* Patients who have participated in any other trials involving an investigational product or device within 30 days of screening or longer as required by local regulations.
Role of Balloon-Assisted Enteroscopy (BAE) in Small Intestinal Disorders

Overall Aim:

This study is designed to assess the role of ballon-assisted enteroscopy in the management of obscure small intestinal disorders in a tertiary-care center in Upper Eygpt.

Specific objectives:

1. Evaluate the technical success rate and causes of the procedure in our locality
2. Explore the value and safety of BAE in the diagnose and treatment of suspected small bowel diseases.
3. Assess patients' and endoscopists' satisfaction related to the procedure.
4. Define the indications, diagnostic yield and appropriatness of BAE in our center.
5. Determine the value of enteroscopy-obtained biopsy samples in the diagnosis.
6. Perform a cost analysis of BAE in relation to its diagnostic value/yield.
7. Report the therapeutic role of BAE in different small intestinal disorders.

The small intestine is very essential for digestion and absorption and is presented between the stomach and large intestine. Because of its anatomical position, the small intestine was named as a "blind area" leading to difficulty in diagnosis of small bowel disease. The advant of ballon-assisted enteroscopy facilitates the management of the small bowel diseases. There are several causes of obscure small intestinal disorders, which are Angioectasia (20-55%), small bowel tumours (10-20%), Cameron erosions (5-15%), NSAID enteropathy (5%), Dieulafoy lesion (2-3%), Crohn's disease (2-10%), Coeliac disease( 2-5 %), Meckel's diverticulum (2-5%), duodenal varices (1-5%), gastric antral vascular ectasia (GAVE) (1-2%), Ectopic varices (1-2%), Portal hypertensive enteropathy 1-2% (but 60-70% in those with portal hypertension), Radiation enteritis (\<1% ). Obscure gastrointestinal bleeding (OGIB) was the most common indication for enteroscopry and is defined as a bleeding from an unknown site after a negative evaluation of the GI tract with esophagogastroduodenoscopy (EGD) and ileocolonoscopy. OGIB represents about 5% of patients presenting with GI bleeding. OGIB isthe most common indication for enteroscopry, whatever the age groups, but the proportion of patients performing enteroscopy for OGIB was higher in elderly patients. Young patients were indicated for enteroscopy for other complains, such as abdominal pain, or suspicious small-bowel tumor. Egyptian study was done and identified that the source of OGIB in the small intestine represents 69.2%, with negative DBE ﬁndings in 30.8% and the most common lesions were angioectasias followed by GI tumours (30.8%, 19.2%, respectively).

Eligibility Criteria:
Inclusion Criteria:All male and female patients aged ≥18 - ≤80 year-old with suspected small intestinal disorders referred to the above Unit for BAE in the period between March 2020 till March 2022 inclusive irrespective of indication will be included in this study.

Exclusion Criteria:Those who are \<18 years-old and \>80 years-old, those with gastrointestinal obstruction, preganat ladies, and those who fail to provide consent will be excluded.
Management of Early-onset Fetal Growth Restriction: Angiogenic Factors Versus Feto-placental Doppler

This is a multicentre, open-label, randomized controlled trial. A total of 340 singleton pregnancies with an EFW ≤10th percentile between 26+0 and 31+6 weeks will be recruited and randomly allocated to either the control or the intervention group. In the control group, standard Doppler-based management will be used. In the intervention group, different soluble fms-like tyrosine kinase to placental growth factor ratio (sFlt-1/PlGF) cutoffs will be incorporated to the current protocol to adjust the frequency of ultrasounds and to plan elective delivery.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women of at least 18 years old
* Singleton pregnancy
* Ultrasonographic EFW ≤10th percentile between 26+0 and 31+6 weeks of gestation
* Gestational age confirmed by fetal crown-rump length measurement during the first trimester scan (from 11+0 to 13+6 weeks of gestation) or by in vitro fertilization dates.

Exclusion Criteria:

* Major fetal malformations or genetic disorders
* Fetal death
* Refusal to give informed consent
* Stage IV FGR
A Clinical Study of iEPC Intervent Subjects With Cerebral Hemorrhagic Stroke

This is a single centre、single arm、open-label，to investigate the safety and efficacy of EPC transplantation in the brain

The purpose of this study is to evaluate the efficacy and safety of transplantation EPCs intervent subjests with cerebral hemorrhagic stroke.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects ≥ 18 and ≤ 80 years of age
2. Subjects was confirmed cerebral hemorrhagic stroke, included at least one of risk factors(Hypertension, diabetes, coronary heart disease, high blood lipid), and Satisfied with one of the following conditions:

   A. Significant stenosis (\> 50%) of the intracranial and extracranial arteries or their branches due to atherosclerosis, or clinical or imaging manifestations of vascular blockage B. Head imaging (CT or MRI) : cerebral hemispheric infarct lesion diameter of \> 1.5cm; Or there were more than 2 discontinuous lesions in the blood supply area of the same intracranial external artery.

   C. Auxiliary examination: color ultrasonography, CTA, MRA or DSA of the blood vessels in the neck confirmed that the intracranial or extracranial stenosis was greater than or equal to 50%；
3. Serum creatinine ≤ 1.5 mg/dl ； Serum ALT/AST）≤2.5×ULN；ALB≥25g/L；
4. Serum creatinine≤ 176.8umol/L（2.0 mg/dl）；
5. Prothrombin time（PT）≤15s，International standardization rates（INR）\<1.7；
6. The glucose should be control between 2.8\~22.2mmol/L（50\~400mg/dl）；
7. Adult patients were willing to use reliable contraceptives (such as condoms) and not to donate sperm throughout the study period and within three months of discharge
8. Subjects and the guardians able to undergo post-physical therapy/rehabilitation

Exclusion Criteria:

1. Non-atherogenic cerebral infarction: cardiogenic embolization, small artery occlusion type IS, other exact etiology IS, and unknown etiology IS
2. Combined with cerebral hemorrhage or previous intracranial external blood history, arteriovenous malformation and aneurysm history, or prone to hemorrhage (platelet count below 100 x 109/L)
3. The vital signs of subjects are not stable
4. Subjects with Class III/IV cardiovascular disability according to the New York Heart Association Classification
5. At rest systolic pressure of 170mmHg or diastolic pressure of 105mmHg, or other indications of uncontrolled hypertension
6. Subjects have one kinds of tumors within 5 years
7. The subject was suffering from neurological or mental illness
8. Subjects had congenital or acquired immune deficiencies, active tuberculosis and other active infections (e.g., pulmonary infection, urinary tract infection, skin infection)
9. alcoholics
10. Receipt of any investigational drug or device within 3 month
11. Active hepatitis B (HBV DNA\>1000copy/mL), hepatitis C or HIV infection
12. Subjects who have other conditions that were not appropriate for the group determined by the researchers.
Study Comparing Esomeprazole and ASA Combined Together as One Capsule Versus These Medications Taken Separately

The purpose of this study is to investigate whether a fixed dose combination (FDC) capsule of esomeprazole 20 mg and acetylsalicylic acid (ASA) 81 mg has equivalent therapeutic efficacy compared to each of 2 free combinations of ASA tablet 81 mg plus esomeprazole 20 mg in patients at risk of gastrointestinal events using low dose ASA for cardiovascular protection.


Eligibility Criteria:
Inclusion Criteria:

* Non-smoking male and female subjects, aged 18 years or older with a documented history of uncomplicated peptic ulcer(s), or aged 65 years or older
* Body Mass Index (BMI = weight/height2) greater than or equal to 18.5 kg/m2 and less than or equal to 35.0 kg/m2

Exclusion Criteria:

* Known history of hypersensitivity to esomeprazole (e.g. Nexium®) or related drugs such as omeprazole (e.g. Losec®, Prilosec®), lansoprazole (e.g. Prevacid®, Hp-PAC®), pantoprazole (e.g. Pantoloc®, PANTO® IV), or rabeprazole (e.g. Pariet™), a known hypersensitivity to ASA (e.g. Aspirin®) and/or related drugs such as ibuprofen (e.g. Motrin®, Advil®), indomethacin (e.g. Indocin®), diclofenac (e.g. Voltaren®), naproxen (e.g. Aleve®, Naprosyn®), or ketoprofen (e.g. Rhovail®).
* Significant history of pulmonary, endocrine, musculoskeletal, neurological, hematological, liver or kidney disease, or gastrointestinal disease (with the exception of uncomplicated peptic ulcer), unless deemed NCS by the Principal Investigator or Sub-investigator
Effects of Everolimus in Left Ventricular Hypertrophy After Conversion From Azathioprine: A Pilot Study

This is a prospective, open label, single-center study, in kidney transplant recipients with stable renal function for 12 and 120 months after transplantation, that are in use use of calcineurin inhibitors, azathioprine, and prednisone. The prevalence of left ventricular hypertrophy will be investigated before and after conversion of azathioprine to everolimus.

This study will evaluate as primary objectives: the prevalence of left ventricular mass hypertrophy in renal transplant recipients with azathioprine therapy. And assess the ability of everolimus to reduce left ventricular mass after conversion from Azathioprine, using sensitive methods such as MRI. And as secondaries objectives: Renal function (measured GFR) at 3 and 6 and 12 months after conversion, number and severity of episodes of acute rejection proven by biopsy, and the proteinuria at 3, 6 and 12 months after conversion.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years (black and white subjects);
* Kidney transplant recipients of living donor or deceased with creatinine clearance (measured / estimated) \> 50 ml /L for at least 12 months, receiving azathioprine with or without calcineurin inhibitor with or without prednisone.

Exclusion Criteria:

* The subject, in the opinion of the investigator, is not able to complete the study protocol;
* Multiple organ transplant recipient;
* Pregnant women
* Breastfeeding and childbearing age without contraceptive method
* Test for Positive immunodeficiency virus (HIV)
* Treatment of acute rejection in the last 3 months
* Glomerulonephritis new relapse
* New or polyomavirus nephropathy
* protein / creatinine ≤ 150 mg / mmol or 24h proteinuria\> 500mg
Effect of Visceral and Parietal Peritoneum Suturation on Postoperative Vital Signs

In this study the investigators want to asses the effect of peritonisation at c-section on postoperative vital signs which was thought to be an indirect finding secondary to increased sympathetic activity originated from pain caused by stretched peritoneum.

At c-section subject will be randomised into four groups:

Group1: Only visceral peritoneum will be closed

Group 2: Only parietal peritoneum will be closed

Group 3: Both of them will be closed

Group 4: None of them will be closed

During the postoperative period all patients will undergo vital sign screening including urine output, blood pressure measurement, pulse rate and VAS score will be determined at post operative 6th hour and 24th hour.

Eligibility Criteria:
Inclusion Criteria:

* Women underwent uncomplicated c-section

Exclusion Criteria:

* Patient with systemic Diseases
* Pregnant with Obstetric complications
* Pregnant with two or more previous c-sections
Amyloid Imaging And Safety Study Of Subcutaneous Bapineuzumab In Subjects With Mild to Moderate Alzheimer's Disease

This study in individuals with mild to moderate Alzheimer's Disease is designed to assess:(1) safety and tolerability (2) the capacity of subcutaneous bapineuzumab to reduce brain amyloid load as measured by positron emission tomography (PET) scans.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of probable AD
* Age from 50 to less than 89
* Mini-Mental Status Exam score of 18-26 inclusive
* Brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of AD
* Stable doses of medications (cholinesterase inhibitors and memantine allowed)
* Caregiver able to attend all clinic visits with patient
* Amyloid burden on screening PET scan consistent with diagnosis of AD

Exclusion Criteria:

* Significant neurological disease other than AD
* Major psychiatric disorder
* Significant systemic illness
* History of stroke or seizure, autoimmune disease, myocardial infarction within the last 2 years
* Smoking greater than 20 cigarettes per day
* Anticonvulsants, anti-Parkinson's, anticoagulant, or narcotic medications
* Prior treatment experimental immunotherapeutics or vaccines for AD
* Women of childbearing potential
* Presence of pacemakers, CSF shunts, or foreign metal objects in the eyes, skin or body
Epidural Low Dose Morphine in Postoperative Pain After Posterior Lumbar Spinal Surgery

The effect of epidural low-dose morphine-soaked microfibrillar collagen sponge in postoperative pain control after posterior lumbar spinal surgery: a randomized, double-blind, placebo-controlled study


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 Yrs
* Good orientation and communication

Exclusion Criteria:

* opioids or sulfonamides allergy
* Contraindication for use
* Epidural morphine
* Selective COX 2 inhibitor
* Patient-controlled analgesia (PCA)
* ASA class \> 3
* BMI ≥ 35 kg/sq.m.
* Preoperative use of opioids within 6 Wks
* Intraoperative bleeding \> 1000ml
Effectiveness of the uPatient Platform in Prophylactic Treatment in Hemophilia

Research project whose main objective is to evaluate the use of a technology platform (uPatient) to register the prophylactic treatment of patients with hemophilia treated in different Hematology and Hemotherapy services of several hospitals in Spain.

The data obtained in this project will identify the level of compliance to the pharmacological treatment of patients with hemophilia prophylaxis. They will use different psychosocial questionnaires based on scientific evidence and the reliability of these, as well as its specific design for patients with hemophilia. Clinical data were also obtained regarding the joint of patients participating in the study state.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with hemophilia A or B
* Patients over 13 years old
* Patients on prophylactic treatment.

Exclusion Criteria:

* Patients who do not sign the informed consent document
* Patients who do not make domiciliary self-treatment
* Patients who do not have good adhesion to prophylactic treatment
Modified Dynamic Needle Tip Positioning vs Conventional Long-axis In-plane in Radial Artery Cannulation

Conventionally, long-axis in-plane (LA-IP), short-axis out-of-plane (SA-OOP) and dynamic needle tip positioning based on SA-OOP views are commonly used method to image the target vessel during cannulation under US guidance. A modified SA-OOP that add developing line on the ultrasonic probe improve the success rate of cannula insertion into the radial artery on the first attempt.


Eligibility Criteria:
Inclusion Criteria:

1. The diagnostic criteria of coronary atherosclerotic heart disease according to the tenth version of international Classification of diseases(ICD-10);
2. Requires invasive arterial blood pressure monitoring;
3. New York Heart Association(NYHA) classification I, II or III;
4. The American Society of Anesthesiologists (ASA) classification I, II or III;
5. Patients older than 18 years and younger than 85 years (Adult);
6. Patients signed the informed consent before the study.

Exclusion Criteria:

1. Patients with hemodynamically unstable (systolic blood pressure 60 or less);
2. Patients with abnormal results of the modified Allen test;
3. Patients with ulnar artery occlusion;
4. Patients with coagulation disorders;
5. Patients with skin abnormalities such as inflammation or hematoma at the cannulation site;
6. Patients with raynaud disease and prevalent atherosclerosis;
7. Patients with history of hand or wrist trauma or surgery;
8. Patients who have undergone radial artery interventional therapy or radial artery cannulation within 3 months on the puncture side;
9. Patients with BMI more than 40 kg/m2;
10. Patients who have participated in other relevant clinical studies within 3 months.
Evaluation of New Items in Cardiac Echography

Paris Saint Joseph hospital has just acquired a new echocardiography EPIC . This new system has image processing and left ventricular function quantification software which are different from the precedent model Philips IE33.Left ventricular function quantification and myocardial distortion are the main medical examination influencing doctor's decisions.

EPIC can evaluate and quantify the cardiac ejection fraction via new software. Myocardial distortion quantification software also has been modified with new cut off and different calculation method.

The aim of this study is to compare the quality of images and the quantification of cardiac ejection fraction with these new software in order to choose the more reliable and reproducible for patient.


Eligibility Criteria:
Inclusion Criteria:

* patient accepting to stay 15 min more
* Age \> 18 years old

Exclusion Criteria:

* patient not accepting this procedure
Vitamin K Supplementation to Reduce Deficiencies in Adults With Cystic Fibrosis

Cystic fibrosis (CF) patients are at risk for vitamin K deficiencies. Supplementation for fat-soluble vitamins A, D, and E is well established, but in CF, there is little data for vitamin K concerning the optimal dose and frequency of supplementation. Beyond its known role in coagulation, research has highlighted the role of vitamin K for bone health and the control of blood sugar levels. However, after pulmonary complications, the risk of diabetes and bone diseases are two important and frequent complications of CF. Patients with CF being at risk of vitamin K deficiencies, this vitamin could play a role in these complications.

The investigators propose a pilot study (carried out to assess its feasibility on a larger scale) to evaluate if a supplement of vitamin K improves vitamin K serum levels in CF patients by comparing:

* Group A: a vitamin K supplement of 2mg, every day for 6 months
* Group B: a vitamin K supplement of 7mg, twice a week for 6 months

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with CF
* Aged above 18 years
* Pancreatic insufficient
* Subjects with an OGTT test in the last 12 months or subjects who are diabetic

Exclusion Criteria:

* Receive or have received, in the last 6 months, a supplement of vitamin K (dose greater than 500 mcg per day)
* Subjects with a pulmonary function under 30%
* Subjects with severe gastrointestinal disease (Crohn disease, coeliac disease and recent (\<1 year) history of intestinal occlusion).
* Subjects with a history of liver disease (severe or transplant)
* Known allergy or intolerance to phylloquinone (oral form of vitamin K)
* Pregnancy (current or planned in the next 6 months)
* Subjects with signs of active secondary infections should wait at least 1 month after the end of antibiotic treatment in order to be included in the study.
Evaluation of the IND One Step Strep A Rapid Test vs. Culture

The purpose of this study is to demonstrate the ability of the IND One Step Strep A test to accurately test a throat swab specimen from a symptomatic patient for the presence or absence of Group A Streptococcus (Strep A) when compared to culture.

Group A Streptococcus is a principal cause of respiratory infections such as tonsillitis, pharyngitis, and scarlet fever. Since pharyngitis can lead to rheumatic fever or acute glomerulonephritis, it is important to differentiate streptococcal pharyngitis from viral disease during early stages of infection. The Strep A Rapid Test is a simple and rapid test which can detect Group A Streptococcal antigen directly from throat swabs allowing physicians to make a rapid diagnosis and to administer therapy immediately. The IND Diagnostic Inc. Strep A Rapid Test is a lateral flow immunoassay utilizing colloidal gold reagents labeled with Strep A antibody. The test detects either viable or nonviable organisms directly from throat swabs within 10 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Male and Female subjects three (3) years of age or older
* Patients exhibiting at least 3 of the following symptoms:

  * fever
  * sore throat
  * swollen lymph nodes in the neck
  * redness of the throat and tonsils
  * white or yellow patches on the tonsils
* Must be able to collect 2 throat swab samples from patient

Exclusion Criteria:

* Patients currently undergoing antibiotic treatment will be excluded from study