cyrilzakka/clinical-trials huggingface dataset:
EUS-FNA With 22G Procore Needles vs 22G Conventional Needles

Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is an important investigation tool to obtain tissue for diagnosis. Nowadays, the performance of EUS-FNA varies with accuracy rates ranging from 60% - 100%. Needles with different diameters have been explored to retrieve tissue specimens. The diagnostic yields, successful rates and safety profiles are similar. It has been suggested that although thinner needles provide less cellular material than do larger needles, the specimens from the former are less contaminated by blood, and thus easier to interpret. In addition, thinner needles may be easier to use because of greater flexibility, particularly for locations requiring important scope bending. As a result, a new 22G FNA needle has been designed in order to improve the tissue-sampling rate (ECHO-HD-22-C, Cook Endoscopy, USA). There is a reverse bevel at the tip of the new needle with promotes collection of core sample by shearing material from target lesion during retrograde movement of the needle in the lesion. The feasibility and safety of this newly design EUS-FNA needle have been demonstrated in a recent multicenter, pooled, cohort study using the 19G version. Successful puncture was technically feasible in 98.2% of cases and the overall accuracy of 92.9%. There were no complications related to the technique.

The aim of this study is to compare the tissue-sampling rate and the diagnostic accuracy rate of EUS-FNA between the uses of the convention and newly designed 22-gauge needles.

Endoscopic ultrasound (EUS) - guided fine needle aspiration (FNA) is a well-established technique for tissue sampling of intestinal and extra-intestinal mass lesions. The accuracy of EUS-guided FNA varies from 60% - 100% with a complication rate of 0% - 3%. The diagnostic accuracy of the procedure can be improved by the use immunohistochemical studies and genetic analyses.It may also be improved by obtaining a larger biopsy specimen with a core biopsy needle. However, puncturing with a core-biopsy needle may not be always feasible due to the technical difficulty of inserting the larger needle through the bended endoscope. As a result, the advantage of a core-biopsy needle on providing a larger amount of cellular material is offset by a higher rate of technical failures, especially in the setting of a transduodenal puncture. Recently, a new 22G FNA needle with a reverse bevel at the tip has become available (ECHO-HD-22-C, Cook Endoscopy, USA.). The design of the device promotes the collection of core samples by shearing material from target lesion during retrograde movement of the needle in the lesion. Hence, the aim of this study is to compare the tissue-sampling rate and the diagnostic accuracy rate of EUS-FNA using 22G conventional and Procore needles.

Eligibility Criteria:
Inclusion Criteria:

* Ages of 18-80 undergoing EUS-guided tissue acquisition
* Informed consent available

Exclusion Criteria:

* Coagulopathy
* Previous history of upper gastrointestinal surgery
* Contraindications for conscious sedation
* Pregnancy
The Estimation of Abdominal Pressure by the Bladder and Gastric Pressure

The investigators aim to compare the bladder pressure to the gastric pressure in critically ill patients.

In critically ill patients, we will measure the gastric pressure by a gastric balloon and the bladder pressure by the intra-vesical pressure to find the optimal method to estimate the abdominal pressure.

Eligibility Criteria:
Inclusion Criteria:

* Critically ill patients during invasive mechanical ventilation

Exclusion Criteria:

* Contraindication to measure the bladder pressure
MagneThermoPro : Magnetic Resonance Thermography of Human Prostate

The objective of this project is to offer a very innovative solution for measuring temperature variations in MRI on the prostate. Multiparametric prostate MRI can detect target lesions, on which targeted biopsies are then performed. The use of a temperature mapping on the prostate in MRI would make it possible to evaluate a focal treatment of the prostate by laser under MRI guidance

Prostate MRI has become the benchmark examination to search for tumor targets, thanks to a multi-parameter protocol, including T2 sequences, diffusions, and T1 with gadolinium injection. A PIRADS prognostic score is performed on the different sequences and if the lesions are at high risk of malignancy (PIRADS 4 and 5), a targeted biopsy is performed. Minimally invasive ablations called focal treatments are developing more and more: HIFU, cryotherapy, laser, etc. Ultrasound remains the most widespread examination due to its availability, but with less sensitivity than MRI. Ablations are performed under ultrasound with fusion of MRI images In order to assess the ablation area under MRI, the measurement of temperature variations appears necessary to verify the effectiveness of ablation and the lesion volume. Temperature maps are feasible in cardiac MRI during radiofrequency. The thermal mapping MRI sequence is performed in cardiac MRI at the IHU in Bordeaux.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Patient with indication of injected multi-parameter MRI for the diagnosis of prostate cancer.
* Signed informed consent.
* Person affiliated or beneficiary of health insurance

Exclusion Criteria:

* MRI contraindications (Pace Maker, metallic foreign body, metallic heart valve).
* Contraindication to gadolinium salt,
* Patient under legal protection
Treatment of Diabetic Macular Edema With 0.5mg Intraocular Ranibizumab (Lucentis)

In this prospective, open-label clinical study is to investigate the behavior of the retinal functions during development of diabetic macular disease (DME) under the influence of Lucentis. Measurements with the multifocal electroretinogram (ERG) and microperimetry is used here as an objective criteria to information about the retinal function obtain.


Eligibility Criteria:
Inclusion Criteria:

1. diabetic macular edema with center involvement in at least one eye
2. patients with a central retinal thickness
3. patients with a BCVA of 78-24 EDTRS letters
4. decrease in vision is due to DME and not due to other causes, in the opinion of the investigator
5. Type 1 or type 2 diabetes mellitus diagnosed 2 years prior to screening

Exclusion Criteria:

1. history or evidence of severe cardiac disease
2. clinical or medical history uncontrolled hypertension or diabetes
3. of unstable angina, acute coronary syndrome, myocardial infarction or revascularization with 6 months
4. ventricular tachyarrhythmias requiring ongoing treatment
5. history or evidence clinically significant peripheral vascular disease, such a intermittent claudication or prior amputation
6. clinically significant impaired renal or hepatic function
Bimatoprost Versus Travoprost at Cairo University

Bimatoprost has been shown to provide effective IOP lowering in patients of all races. Conversely, travoprost has been shown to be more effective in black patients than in Caucasians in some studies. However, Noecker et al 2004 compared bimatoprost with travoprost in African-Americans with glaucoma or OHT, and found that bimatoprost was more likely than travoprost to achieve target pressure at 3 months.

These racial differences in efficacy of these medications warrant further investigations. The investigators study aim to compare the IOP-lowering efficacies of bimatoprost and travoprost in an Egyptian population with primary open-angle glaucoma (OAG) or ocular hypertension (OHT).


Eligibility Criteria:
Inclusion Criteria:

* Glaucoma and Ocular Hypertension

Exclusion Criteria:

* Any ocular disease or medication that may raise the intraocular pressure.
Ba253BINEB Compared to Ba253MDI (Metered Dose Inhaler) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

The objective of this study is to investigate the efficacy and safety of Ba253BINEB during the continuous 4 weeks administration to the patients with COPD using Ba253MDI (Tersigan® aerosol) as the comparator drug.


Eligibility Criteria:
Inclusion Criteria:

The patients with COPD (chronic bronchitis, emphysema) and who satisfy the following criteria

1. Patients whose symptoms are stable and have at least 4 symptomatic days a week
2. Patients with FEV1.0/FVC of \<= 70% in the screening test
3. Patients aged \>= 40 years or older
4. Patients must be able to inhale the study drug via BINEB and MDI
5. Patients must be able to understand the patient information form

Exclusion Criteria:

Those who correspond to the following shall be excluded from the subjects of study.

1. Patients complicated with bronchial asthma, making the assessment of drug efficacy against COPD difficult
2. Patients who are constantly administered oral steroid
3. Patients with glaucoma
4. Patients who have prostatic hypertrophy
5. Patients with hypersensitivity to anticholinergic drugs or Beta2 agonists.
6. Patients with serious hepatic disease, kidney disease or heart disorder and who are judged by the investigator as inappropriate as the subjects of study
7. Women who are pregnant or who may become pregnant, or nursing women
8. Patients who are judged by the investigator as inappropriate as the subjects of the study
A Study of the Safety and Immunogenicity of Repeated rhC1INH Administration

Hereditary angioedema ("HAE") is a disease characterized by recurrent tissue swelling affecting various body locations. Recent literature shows that patients with frequent attacks may benefit from long-term prophylaxis. This study aims to evaluate the safety and prophylactic effect of weekly administrations of 50 IU/kg recombinant C1 Inhibitor ("rhC1INH").


Eligibility Criteria:
Inclusion Criteria:

* Aged at least 18 years
* Signed informed consent
* Comfirmed diagnosis of HAE with baseline plasma level of functional C1INH activity of less than 50% of normal, and/or proven HAE ,mutation in C1INH gene.

Exclusion Criteria:

* A history of anaphylaxis or severe allergy (i.e. requiring medication) to food, proteins and/or drugs.
* A history of allergic reactions to C1INH products or rabbit protein.
* Any reported SAE related to study drug administration (withdrawal criterium)
* Elevated IgE against rabbit dander (\>0.35 kU/L; ImmunoCap assay; Phadia)
* A diagnosis of acquired C1INH deficiency.
* Woman of child bearing potential, pregnancy or breast-feeding
* previous treatment within the last 3 months with plasma-derived C1INH
* Any clinically significant abnormality in the routine haematology, biochemistry and urinalysis
* Any condition or treatment that in the opinion of the investigator might interfere with the evaluation of the study objectives.
* Any changes since screening that would exclude subject based on above exclusion criteria.
Three-dimensional Perception of Sounds in Military with Acoustic Trauma

Spatial hearing capacities of soldiers with acoustic trauma are evaluated in ENT consultations with routine tests (i.e. tonal audiometry, voice audiometry). While the results conclude that soldiers with acoustic trauma have sufficient abilities to carry out professional missions, soldiers report recurring complaints of sound localization (spatial hearing), i.e. difficulties in identifying the position of sound sources in their environment. However, there is currently no objective test to identify and objectify these complaints of spatial hearing.

The investigators have developed a new approach (SPHERE) based on virtual reality and 3D motion tracking, allowing us to evaluate and record the spatial hearing performance of subject with hearing deficit. This system allowed us to highlight localization deficits in three-dimensional space.

This project explores and quantifies the spatial hearing impairments of soldiers with acoustic trauma. The quantification of the spatial hearing capacities will allow to define a specific rehabilitation strategy of spatial hearing deficits.


Eligibility Criteria:
Inclusion Criteria:

acoustic traumatized military group :

* Age between 18 and 65 inclusive
* Active or reserve military personnel
* Diagnosis of noise trauma for at least one month
* Regularly followed up in the ENT department of the Desgenettes Army Training Hospital in Lyon or in the medical offices of the Army Medical Centers.
* Able to understand the experimental instructions
* Affiliated to a social security scheme
* Having been informed of the study and having given their agreement to participate normal hearing group :
* Age between 18 and 65 years inclusive
* Able to understand the experimental instructions
* Affiliated to a social security scheme
* Having been informed of the study and given their agreement to participate

Exclusion Criteria:

* Known current or past neurological or psychiatric disorder
* Oculomotor/visual disorder
* Bilateral vestibular areflexia
* Person under court protection, guardianship or curatorship
* Pregnant or breastfeeding woman
* Known hearing loss for normal hearing group
Reforming Pediatric Procedural Training

This study is randomized trial of a procedural skills training curriculum utilizing simulation to teach basic procedural skills to pediatric residents.

This study is designed to evaluate a formal curriculum for teaching basic procedures to pediatric interns at Children's Hospital, Boston. The incoming class of interns for the academic year '05-06 will be randomly assigned to participate in the curriculum or not. Four procedures including intravenous catheter insertion, venipuncture (blood drawing), bag-and-mask ventilation, and lumbar puncture (spinal tap) will be taught. Interns will then be tested on their ability to perform these skills on anatomic models and on live patients. Our hypothesis is that interns receiving the formal curriculum will be more confident and more successful in performing these procedures than those who do not.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric Intern in the Boston Combined Residency Program for AY '05-'06

Exclusion Criteria:

* None
Philippine Child Health and Policy Experiment

The long-term consequences of poverty on child health, including cognitive development, are one of the world's great tragedies. In the Philippines, diarrhea, acute lower respiratory infections, and the attendant problems of malnutrition, are the leading causes of childhood illness. The Philippine government plans to launch a broad national Health Sector Reform Agenda (HSRA) that will address the problems of poverty and illness in children. The introduction of these reforms provides an exceptional opportunity to conduct a social experiment. Four institutions, already involved in the design and implementation of the HSRA, plus leading experts in international health, government, and health measurement will collaborate on this project to collect longitudinal data and measure the impact of HSRA reforms on child health outcomes in a population. We will measure the health impacts of two experimental interventions: (1) expansion of health insurance coverage, and (2) capitation of providers. Our research will measure the impact of health reforms on the physical and cognitive health outcomes of children age 0-4. We will use a block design of 21 sites throughout the Philippines: seven for each of the two interventions, and seven matched controls. We will measure the quality of clinical practice using vignettes and will measure health outcomes using objective clinical tests. We will also use an advanced sampling strategy and panel data to link clinical practice with population health outcomes. This unparalleled research opportunity will yield significant insights about specific, unanswered questions of tremendous importance: Does health care serve as a social intervention that ameliorates the effects of morbidity and malnutrition on cognitive development? How effective are government policies at creating incentives to improve the quality of clinical practice? Do financial and organizational policies actually lead to better health and developmental outcomes? The results from this study will provide insights into the linkages between increased access, high quality care, and health outcomes in children.


Eligibility Criteria:
Inclusion Criteria:

* Children presenting to participating hospitals
PK/PD Study of Intranasal Insulin in Type I Diabetes

This study is designed to compare the safety and tolerability of two different doses of intranasally administered regular human insulin with those of a single dose of the rapid-acting insulin analog lispro Humalog® after subcutaneous injection. In addition to safety and tolerability, various pharmacokinetic (PK) and pharmacodynamic (PD) parameters will be evaluated by means of the euglycemic glucose clamp technique.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects with type 1 diabetes between the ages of 18 and 65 years, inclusive.
2. Type 1 diabetes clinically diagnosed ≥ 12 months.
3. Treated with multiple daily insulin injections ≥ 12 months or an insulin pump.
4. HbA1c ≤ 10 % by local laboratory analysis (one retest within a week is permitted with the result of the last test being conclusive).
5. Fasting serum C-peptide ≤ 0.3 nmol/L.
6. BMI between 18-28 kg/m², inclusive.
7. Signed, written IRB-approved informed consent.

Exclusion Criteria:

1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, oncologic, or neurologic (to include history of seizures) disease; hypoglycemic episodes; intercurrent illness (such as influenza); or allergic disease (including severe drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). Clinical significance to be determined by the PI.
2. History of recent nose bleed, history of nasal polyps, nasal surgery other than cosmetic rhinoplasty or cauterization.
3. As judged by the investigator, clinically significant findings in laboratory data. (Anemia with hematocrit less than 33% at screening is specifically exclusionary.)
4. Clinically significant abnormal ECG at screening, as judged by the Investigator.
5. Clinically significant abnormalities in vital signs at screening, as judged by the Investigator.
6. Known allergy to trial product or any other ingredient in the study drug.
7. Positive HIV 1 (human immunodeficiency virus) antibody test, hepatitis B (anti-HBsAg) or hepatitis C (anti-HCV) antibody test.
8. History or evidence of alcohol or drug abuse within the past 3 years.
9. History of deep leg vein thrombosis or a frequent appearance of deep leg vein thrombosis in 1st degree relatives (parents, siblings or children) as judged by the Investigator.
10. Use of drugs that may interfere with the interpretation of study results or are known to cause clinically relevant interference with insulin action or glucose utilization.
11. Blood donation or high volume phlebotomy, e.g., \>500 mL, within 56 days before dosing.
12. Participation in a study of any investigational drug or device 30 days before enrollment in this study.
13. The subject is unfit for the study in the opinion of the investigator.
14. Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods (adequate contraceptive measures include sterilization, hormonal intrauterine devices, oral contraceptives, sexual abstinence or vasectomized partner).
Aspirin Dose and Atherosclerosis in Patients With Metabolic Syndrome

The purpose of the study is to test higher versus lower doses of aspirin on markers of atherosclerosis in patients at risk of a first heart attack.

Aspirin reduces risks of heart attacks, strokes, and deaths from cardiovascular causes in patients who have survived a prior event as well as during an acute heart attack. Aspirin also prevents a first heart attack.

Low dose aspirin is sufficient to achieve complete inhibition of platelet aggregability, or stickiness, and this is the mechanism whereby aspirin prevents formation of blood clots.

Our research is designed to explore whether higher doses of aspirin provide additional benefits on markers of atherosclerosis.

Eligibility Criteria:
Inclusion Criteria:

* 1. Age 40 to 80 years, inclusive.

  2. No previous heart attack or a stroke, or other forms of these diseases.

  3. Have at least three of the five characteristics listed below, indicating presence of metabolic syndrome, as defined by NCEP-III:
  1. waist measuring more than 40 inches (for men) or more than 35 inches (for women),
  2. high density lipoprotein (HDL) cholesterol levels lower than 40 milligrams per deciliter (mg/dl) in men or 50 mg/dl in women,
  3. triglyceride (TG) levels above 150 mg/dl,
  4. blood pressure greater than 130 millimeters of mercury (mmHg) systolic or 85 mmHg diastolic,
  5. fasting blood sugar greater than 110 mg/dl

Exclusion Criteria:

1. Patients taking greater than 81mg aspirin daily.
2. Patients taking anti-platelet drugs such as clopidogrel or non-steroidal anti-inflammatory drugs (NSAIDs) or anticoagulant drugs such as warfarin, during the last two weeks.
3. Patients taking any of the following medications for less than 3 months, or who plan to take them for the first time during the next 3 months: ACE-inhibitors, angiotensin receptor blockers, calcium channel blockers, or statins.
4. Patients who are currently cigarette smokers.
5. Women patients who are pregnant, planning to become pregnant, nursing a child, or taking hormone replacement therapy.
6. Patients with any coagulation, bleeding or blood disorders.
7. Patients who are sensitive or allergic to aspirin.
8. Patients with documented history of any gastrointestinal disorders, including bleeding ulcers.
9. Patients with any evidence of cancer or history of significant cardiovascular disease (including heart attack, stroke or drop attacks termed transient ischemic attacks (TIAs), or blockages of the arteries in the legs termed peripheral arterial disease (PAD)), kidney, liver, lung, blood, or brain disorders.
10. Patients with asthma, rhinitis, or nasal polyps.
11. Patients with any abnormal laboratory value or physical finding that, in the view of the responsible clinician, may interfere with interpretation of the study results, be indicative of an underlying disease state, or compromise the safety.
12. Patients with Class IV heart failure.
13. Patients with severe aortic insufficiency, or aortic regurgitation.
14. Patients with hearing loss or tinnitus.
15. Patients with tremors which cause them not to be able to remain motionless for approximately 30 seconds.
TENS in Optimizer(R) Patients

Systemic skeletal muscle atrophy (cachexia) is a typical side effect of chronic heart failure.

Patients with cachexia can benefit from transcutaneous electrical neuromuscular stimulation (TENS). It is applied to strengthen the musculature and improve exercise tolerance and quality of life.

It is unclear if application of TENS can cause electromagnetic interference (EMI) in patients with Optimizer® pacemaker systems for improvement of heart failure.

This pilot safety study enrolled 6 patients with chronic heart failure and reduced left ventricular ejection fraction. All patients had an Optimizer® pacemaker system implanted for a minimum of 6 months, no patients had any ventricular arrhythmic episode 3 months prior to the study, and all were in clinically stable condition and willing to participate in this study.

Neuromuscular stimulation was administered via TENS in 4 different modes (HF, LF, Burst, MF) on the right and left musculus trapezius and on both musculi quadriceps femoris. All patients were tested for EMI without or with cardiac contractility modulation (CCM) delivery of the Optimizer®-system respectively.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years, with implantation of the Optimizer ® \>6 months ago, clinically stable condition and without any ventricular arrhythmic episode in the last 3 months.

Exclusion Criteria:

* Local swelling or edema at the site of stimulation, intolerance to electrical stimulation, or presence of other metallic implants at the site of stimulation