cyrilzakka/clinical-trials huggingface dataset:
Intra-patient Study With Polymer Free Drug Eluting Stent Versus Abluminal Biodegradable Polymer Drug Eluting Stent With Early OCT (Optical Coherence Tomography) Follow up

The objective of the study is to evaluate the process of early re-endothelialization of the Coroflex® ISAR Drug-eluting stent compared with the Ultimaster® Drug-eluting stent

The objective of the study is to evaluate the process of early re-endothelialization of the Coroflex® ISAR Drug-eluting stent compared with the Ultimaster® Drug-eluting stent

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years
* Signature of informed consent
* Patients with angina and a clinical indication for coronary revascularisation with a drug-eluting stent
* Presence of at least 2 lesions to be revascularised with similar angiographic characteristics

  * Reference lesion diameter with at most a difference of 0.5 mm
  * Maximum difference in lesion length of 10 mm
  * Lesions able to be treated with only 1 stent

Exclusion Criteria:

* Lesions due to restenosis
* Lesions in saphenous vein grafts
* STE-ACS ( ST elevation- Acute Coronary Syndrome)
* Cardiogenic shock
* Dual antiplatelet therapy contraindication for\> 3 months
* Follow-up catheterisation contraindicated

  * Chronic kidney failure with creatinine \> 2 mg/dL
  * Allergy to iodinated contrast agents
  * Serious complication from vascular access in previous catheterisation
* Ineligible for evaluation via optical coherence tomography

  * Lesion located \<5 mm from aorto-ostial junction
  * Severe proximal angulation \>90º
* Bifurcation lesion requiring a strategy with two stents
* Angiographic characteristics that promote stent malposition

  * Aneurysm or coronary artery ectasia
  * Presence of a thrombus classed as TIMI (Thrombolysis In Myocardial Infarction )2 flow or higher
  * Severe calcification, in particular in cases of calcium spike
  * Severe lesion angulation
* Inability to do reliable follow-up, in the investigator's opinion
Efficacy and Safety of T1225 1.5% Versus Tobramycin 0.3 % in the Treatment of Purulent Bacterial Conjunctivitis

To demonstrate the efficacy of T1225 1.5% eye drops, in comparison to reference product, for the treatment of purulent bacterial conjunctivitis, and to assess the safety

The aim of the present study was to compare the efficacy and safety of T1225 1.5% eye drops administered BID for 3 days in comparison to reference antibiotic eye drops, tobramycin, for the treatment of purulent bacterial conjunctivitis. The study was conducted as a Phase III, multicentre, international, investigator-masked, randomised, parallel-group, non-inferiority study in newborns, children, and adults.

Eligibility Criteria:
Inclusion Criteria:

* Male or female \>= 1 day old (newborn, infant, child, adult);
* written informed consent by patient or legally acceptable representative;
* purulent bacterial conjunctivitis (unilateral or bilateral) defined as bulbar conjunctival injection (mild, moderate, or severe) AND conjunctival purulent discharge (mild, moderate or severe).

Exclusion Criteria:

* Bacterial conjunctivitis diagnosed \>= 7 days ago;
* bacterial infection due to trauma or foreign body;
* dacryocystitis;
* corneal ulceration or keratitis;
* viral ocular infection; closed angle glaucoma;
* acute allergy conjunctivitis;
* clinically significant ocular abnormality;
* organic amblyopia, monophthalmia;
* corrected visual acuity below 20/100;
* contact lens wearer;
* newborn (i.e. 0-2 months old) not born at term (\< 37 weeks of amenorrhea);
* ocular surgery, laser in situ keratomileusis (LASIK), laser epithelial keratomileusis (LASEK), or photo-refractive keratectomy (PRK) in last 12 months;
* ocular laser treatment in last 3 months;
* systemic macrolide antibiotics in last month;
* systemic steroids in last 2 weeks or during the study;
* topical ocular macrolide antibiotics and/or topical ocular steroids and/or non-steroidal anti-inflammatory drugs (NSAIDs) in last week;
* topical (ocular, nasal, bronchial etc.) treatments and/or systemic NSAIDs in last day;
* immunosuppressives and/or any systemic antibiotic on D0.
Compassionate Use of Mifepristone in Brain/Nervous System and Other Cancers

The purpose of this study is to see if mifepristone prevents worsening of your cancer. Mifepristone is an antiprogesterone agent, a drug which blocks female hormones, that is commonly used for the termination of pregnancies. It has not been approved by the Food and Drug Administration for use in the treatment of cancer. It is unlicensed in the United States for your condition. However, previous work has indicated that mifepristone may be useful due to how it works. It is being made available for use in the United States for compassionate use through the Feminist Majority Foundation.

This is a compassionate use of mifepristone treatment for patients with conditions that could respond to an antiprogesterone agent, including:

* Meningioma.
* Breast cancer
* Colon Cancer
* Endometrial Stromal Sarcoma
* Bilateral Chronic Central Serous Retinopathy
* Cushing's Syndrome
* Metastatic Adrenocortical Cancer
* Ovarian Cancer
* Other conditions as determined by the attending physicians

Eligibility Criteria:
Inclusion Criteria:

* All patients 18 years of age or older.
* Patients must sign an informed consent.
* Patients should be in such a health condition in the opinion of the attending physician that with the administration of mifepristone benefits may outweigh risks.

Exclusion Criteria:

* Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.
Comparison of Two Endoscopic Biopsic Needles for Pancreatic Tumors

This observational study compared quality of histological sampling of pancreatic EUS-FNB with the 20-gauge Procore® and 22-gauge Acquire® needles. In total, 68 patients were recruited. Histological diagnosis was achieved and a histological core biopsy was obtained in 82% of patients (28/34) in the 20-gauge Procore® group and 97% of patients (33/34) in the 22-gauge Acquire® group (P=0.1). Core biopsy specimens obtained were significantly longer with the 22-gauge Acquire® needle with a mean cumulative length of tissue core biopsies per needle pass of 4,33±3,46mm vs. 7,9±4,35mm for the 20-gauge Procore® (P\<0,01). Reproducibility of this simple histological criterion was validated in intra and inter-observer.

Between March and December 2017, 68 EUS-FNB were consecutively performed in our unit for a pancreatic or peripancreatic mass. The choice of the needle depended upon the availability at the time of admission: 34 punctures were performed with a 20-gauge Procore®, and 34 with a 22-gauge Acquire®. Histological material was studied in a blinded manner with respect to the needle, and cumulative length of tissue core biopsies per needle pass was determined. Intra and inter-observer variability of this criterion was then evaluated.

Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients ≥18 who were referred for EUS-FNB for solid pancreatic or peripancreatic mass were included

Exclusion Criteria:

* non-accessible pancreatic mass because of history of Billroth II or Roux-en-Y reconstruction
* coagulation disorders (such as partial thromboplastin time \>42 seconds, prothrombin time \[Quick value\] \<50%, platelet count \<50 000/mm³), treatment with clopidogrel, pregnancy.
* patients \<18 years of age
Evaluation of the Irritation Potential of Products in Human Eyes

To evaluate the human eye irritation potential of one test sunscreen formulation.


Eligibility Criteria:
Inclusion Criteria:

* Must be healthy males or females between the ages of 18 to 60 years inclusive with no medical conditions of the eyes.
* Do not wear contact lenses or, if he/she does wear contact lenses, is willing to refrain from wearing these during the test period.
* Willing to report any medications taken during the study.
* Willing to have the test materials instilled into the eyes and follow all protocol requirements.
* Have been informed and have given written consent to participate in the study.

Exclusion Criteria:

* Has ocular disease or peri-orbital dermatitis or trauma, infections or chronic eye conditions that may affect the study outcome.
* Has systemic illness which affects the eyes, including diabetes, thyroid disease, sarcoidosis, hypertension, atherosclerosis, lupus, multiple sclerosis, sickle cell disease, AIDs (Acquired Immune Deficiency Syndrome), severer rheumatoid arthritis. results as determined by the investigator.
* Must not have a history of pre-existing sensitivity or other types of allergy to any eye products.
* Must not have received and used an Investigational New Drug within the thirty days immediately preceding the study.
NET for SGBV Survivors in Eastern DR Congo

Throughout the last 10 years Narrative Exposure Therapy (NET) has evolved as one of the most effective, culturally sensitive trauma interventions. In the present study the effectiveness of NET delivered by trained health personnel in a sample of survivors of sexual and gender based violence (SGBV) who suffer from Posttraumatic Stress Disorder (PTSD) will be assessed. Structured baseline, 3 and 6 month follow up interviews will be administered to assess the main outcome measures PTSD and shame. The trial will take place in Goma, DR Congo, where SGBV and its sequelae has been a major problem.

Participants will be recruited through local NGOs and eligible clients randomized to the treatment (NET; app. N=100) or treatment-as-usual control (app. N=100) group, respectively. At baseline, 3-month and 6-month post-treatment, sociodemographic data, trauma exposure - esp. SGBV, PTSD, dissociation, shame, functionality and depression will be assessed in a structured interview. The interviews will be conducted by blind Congolese psychological interviewers after an intensive 3-weeks training and continuous supervision.

Eligibility Criteria:
Inclusion Criteria:

* SGBV survivors (event happened more than 4 weeks ago)
* PTSD diagnosis (DSM-5)

Exclusion Criteria:

* Acute psychosis
* Signs of cerebro-organic disease
* Acute drug or alcohol intoxication
A Neoadjuvant Study of Tislelizumab and SX-682 for Resectable Pancreas Cancer

The purpose of this study is to evaluate the safety and clinical activity of tislelizumab (an anti-PD-1 antibody) in combination with SX-682 (a CXCR1/2 inhibitor) in subjects with newly diagnosed and surgically resectable pancreatic adenocarcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and willingness to sign a written informed consent document.
* Age ≥18 years.
* Newly diagnosed have histologically or cytologically proven adenocarcinoma of the pancreas.
* Tumor must be resectable.
* Patient's acceptance to have a tumor biopsy.
* ECOG performance status 0 or 1
* Patients must have adequate organ and marrow function defined by study-specified laboratory tests.
* For both Women and Men, must use acceptable form of birth control while on study.

Exclusion Criteria:

* Have received any anti-pancreatic cancer therapy.
* Have been diagnosed with another malignancy whose natural history or treatment has the potential to interfere with safety or efficacy assessment of this study.
* Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures
* Subjects with active, known or suspected autoimmune disease that may relapse.
* Systemic steroid therapy (\> 10mg daily prednisone equivalent) or immunosuppressive therapy within 14 days of first dose of study drug administration.
* Active infection requiring systemic therapy.
* Infection with HIV or hepatitis B or C at screening•
* History of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases, etc.
* Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, pulmonary embolism, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness/social situations that would limit compliance with study requirements.
* Prior allogeneic stem cell transplantation or organ transplantation
* Any major surgical procedure requiring general anesthesia ≤ 28 days before first dose of study drug.
* Have received a live vaccine ≤ 28 days before first dose of study drug.
* Use of QT prolonging drugs within 2 weeks before the start of SX-682 dosing and for the length of the study.
* ECG demonstrating a QTc interval ≥ 470 msec or patients with congenital long QT syndrome.
* Severe hypersensitivity reaction to any monoclonal antibody.
* Concurrent participation in another therapeutic clinical study
* Pregnant or breastfeeding
The Effect of Intravenous Prehydration on the Hemodynamic Status of Healthy Parturients Undergoing Spinal Anesthesia for Cesarean Delivery

Regional anesthesia (spinal, epidural) is considered the method of choice for anesthesia obstetric deliveries because of the ability to use fewer drugs, a more direct experience of childbirth and the capability to provide excellent postoperative analgesia. However, the incidence of hypotension after spinal anesthesia for cesarean delivery is high and can lead to maternal and fetal morbidities. Certain interventions may reduce the incidence and severity of spinal anesthesia induced hypotension, including the use of vasopressors and intravenous pre- or co-hydration using different types of volume expanders; crystalloid or colloid solutions. Such interventions aim to increase maternal cardiac output, which is the key in attenuating the hypotensive response to spinal anesthesia.

The primary purpose of this study is to compare the efficacy of intravenous prehydration (preloading) of healthy parturients scheduled for caesarean section with either a crystalloid (Ringer's lactated) or colloid solution (HES 130/0.42) in the prevention of hypotension after spinal anesthesia.

The FloTrac/VigileoTM device provides continuous monitoring of maternal cardiac output by employment of a minimally invasive technique based on arterial pulse contour analysis. Assessment of maternal hemodynamic status using the FloTrac/VigileoTM constitutes a secondary outcome. Other secondary outcomes are total amount of vasopressors used, neonatal outcome, intraoperative side effects and maternal satisfaction scores.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) I and II parturients
* singleton gestation
* term gestation (gestational period more than 37 weeks)

Exclusion Criteria:

* extremes of weight (\<50 Kgr or \>120 Kgr)
* extremes of height (\<150 cm or \>180 cm)
* baseline heart rate less than 65 bpm
* active labor
* known fetal abnormalities
* placental abruption, placenta previa/accreta
* pregnancy induced hypertension
* anemia (hemoglobin \< 9 gr/dl)
* cardiac, respiratory or renal disease
* diabetes mellitus
* spinal cord abnormalities
* previous spinal surgery
* preexisting neurological dysfunction
* known allergy to any protocol medication
* any absolute contraindication to regional anesthesia
EMRI SureScan™ Clinical Study

The purpose of this clinical study is to confirm safety and efficacy in the clinical magnetic resonance imaging (MRI) environment of the investigational EnRhythm MRI™ SureScan™ Pacing System (used in support of Revo MRI™ SureScan Pacing System launch).

This study is a prospective, multi-center global study.

Eligibility Criteria:
Inclusion Criteria:

* Subject has, or is at risk of having, a heart beat that is too slow and his/her doctor has determined he/she needs a pacemaker.
* Subject available for follow-up at study center for length of study.
* Subject able and willing to undergo elective MRI scanning without sedation.

Exclusion Criteria:

* Subject has, or is at risk of having, a heart beat that is too fast and his/her doctor has determined he/she needs an implantable cardioverter defibrillator (ICD).
* Subject needs or will need another MRI-scan, other than those required by the study, during the required study follow-up period.
* Pregnant women, or women of child bearing potential who are not on a reliable form of birth control.
* Subject with exclusion criteria required by local law.
* Subject who intends to participate in another clinical study during this clinical study.
The Metabolic Characteristics in Sublobar Areas of PRE Based on FDG-PET Study

Epilepsy is a chronic brain disease that is caused by various factors and characterized by recurrent, episodic and temporary central nervous system dysfunction. In the past few decades, despite the continuous development of antiepileptic drugs, there are still 20%-30% patients with epilepsy progressing to pharmacoresistant epilepsy (PRE), which leads to a significant increase in the morbidity and mortality of epilepsy. For those fraction of PRE, surgical treatment may be the only possible way to cure epilepsy. Accurate presurgical evaluation play an important role in making surgery decision and defining surgical extent and achieve better surgical outcome. Imaging, especially interictal fluorine-18-fluorodeoxyglucose-positron emission tomography (FDG-PET) is widely used in preoperative evaluation, which is of great significance in the detection of epileptogenic foci. Previous studies on FDG-PET have found that FDG-PET has a wide range of hypometabolism inpatients of PRE varying from different epileptic origins. Therefore, exploring the characteristics of glucose metabolism originating in different brain areas of resistant epilepsy can help to better interpret the results of FDG-PET and guide the preoperative localization of such patiens and better understand the potential mechanism of seizure propagation in PRE.


Eligibility Criteria:
Inclusion Criteria: (a) Pharmacoresistant Epilepsy may be defined by International League Against Epilepsy (ILAE）as failure of adequate trials of two tolerated and appropriately chosen and used AED schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom (judged by two epileptologists); (b) conventional MRI negative or nonspecific abnormalities; and (c) detailed information of long-term video-EEG, FDG-PET, high resolution MRI (HR-MRI) and neuropsychological assessment were acquired, (d) focal epilepsy defined by combining clinical, electrophysical and neuroimaging.

Exclusion Criteria: (a) generalized or multifocal epilepsy or the patient's electroclinical features were inconsistent with pharmacoresistant epilepsy; (b) idiopathic focal epilepsy; and (c) unsatisfactory imaging quality.

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Oxygenation Methods and Non-invasive Ventilation in Patients With Acute Respiratory Failure and a do Not Intubate Order

ICU care of patients considered "palliative" but without contraindications to admission to intensive care, for whom a do-not intubate order decision was made upon admission represents a particular target for non-invasive oxygenation techniques. The benefits of non invasive ventilation (NIV) in this population are debated especially in cancer patients. The more recently used nasal humidified high flux canula oxygenation (HFNC) therapy may have benefits over NIV in these patients. It is supposed to have better tolerance and could allow better compliance and thus higher efficiency. These potential benefits are major for such a population for which tolerance and symptomatic relief are priority goals

Observational prospective multicenter study Primary outcome: To analyze the efficacy and tolerance of NIV and HFNC in patients admitted to intensive care unit, or intermediate catre unit for acute respiratory insufficiency for whom a a do-not intubate order decision was taken upon admission or after extubation if the patient initially received mechanical ventilation.

Secondary outcomes: To analyze the efficacy and tolerance of NIV and HFNC according to the following reason for ICU admission: chronic obstructive pneumopathy decompensated COPD, severe heart failure, evolutive cancer or hematologic malignancy; to analyze tolerance and acceptability of different techniques; to analyze the duration of the oxygenation methods use; to analyze the modalities of eventual withdrawing life support therapies and the associated sedative and opioid treatments; to analyze the satisfaction for the use of the non invasive technique by the relatives and the caregivers; to analyze mortality at D28 and D90 and quality of life at 3 and 6 months in surviving patients

Eligibility Criteria:
Inclusion Criteria:

* acute respiratory failure defined by respiratory rate\>25/min and or hypoxemia (sPO2 \<92% with O2 \>3l/min)
* admission in ICU or intermediate care unit
* decision to not intubate the patient or to not re-intubate the patient
* indication to NIV or HFNC-O2
* French social security affiliation

Exclusion Criteria:

* refusal to participate
* legal protection
* pregnancy
* prophylactic treatment by VNI or HFNC-O2 after extubation
Danish Randomized Trial on Leadless vs Transvenous Pacing

The purpose of this study is to evaluate the quality of life, patient acceptance and exercise capacity with leadless compared to transvenous pacing in elderly patients with new-onset high-grade atrioventricular block. Consecutive patients with high-grade atrioventricular black and preserved sinus node function with indication for permanent pacemaker implantation according to the latest european guidelines, are included in a prospective, partly patient and accessor blinded and partly open label, 1:1 randomized combined parallel and cross-over trial to implantation with 1) a Micra AV Transcathter Pacing System or 2) an Azure XT DR dual chamber pacemaker.


Eligibility Criteria:
Inclusion Criteria:

* First time pacemaker implantation on class I or II ESC recommendations for AVB with an expected amount of right ventricular pacing \>80% of the time,
* Age 75 years or older
* Intact sinus node function
* Expected survival more than 12 months based on clinical evaluation
* Able to provide informed consent

Exclusion criteria:

* Persistent or previous cardiac implantable electronic device i.e., pacemaker, ICD, or CRT.
* Persistent, or chronic atrial fibrillation
* Reversible AVB
* Transient AVB due to ongoing ischemia
* Heart failure NYHA class III-IV
* Heart failure with branch block and indication for CRT implantation, irrespective of NYHA class
* Indication for primary or secondary prophylactic ICD implantation
* Acute myocardial infarction (AMI) within 3 months
* Severe chronic pulmonary disease with pulmonal hypertension limiting exercise capacity
* Expected survival \< 12 months based on clinical evaluation
* Performing high intensity sport
* Participation in another trial with experimental treatment
* Contraindication against device implantation (e.g., concurrent infection)
* Failure to provide informed consent
QUARTO-II Study to Evaluate the Management of Patients Resynchronized With the QuartetTM LV Quadripolar Lead

Optimization and evolution of the patient will be evaluated over 6 months after the implant.

Patient will be enrolled into the study after Informed Consent signature and CRT-D+quadripolar (QuartetTM) LV lead.

Eligibility Criteria:
Inclusion Criteria:

* Patient with implanted CRT-D device and a QuartetTM quadripolar lead by St. Jude Medical in the left ventricle.
* Patient with an echocardiographic study performed during 1 month prior to the implant and in whom End Systolic Volume of the Left Ventricle (LVESV) has been measured
* Patients who have granted their informed consent.
* Patients above 18 years.

Exclusion Criteria:

* Patients that have been previously resynchronized.
* Patients with aortic stenosis or aortic valve prosthesis
* Patients who are or may potentially be pregnant.
* Patients with a life expectancy \<12 months.
* Patients who cannot attend the monitoring visits established by the protocol.