cyrilzakka/clinical-trials huggingface dataset:
Selective Complex Fractionated Atrial Electrograms (CFAE) Targeting for Atrial Fibrillation

This study will be a multicenter, open, prospective, randomized trial. Patients with either paroxysmal or persistent atrial fibrillation will be considered for the study. (For US, only paroxysmal atrial fibrillation will be considered.) Eligible subjects will be randomized into one of two arms in the study: (1) targeted CFAE ablation or (2) generalized CFAE ablation. Both techniques will then be followed by PVAI (pulmonary vein antral isolation) as part of a hybrid ablation strategy. The nature of the ablation procedures does not allow physicians to be blinded to the randomization.

The purpose of this study is to compare a strategy of targeted CFAE ablation, focusing on regions of continuous electrical activity versus a strategy of generalized CFAE ablation in terms of (1) acute effects on AFCL (atrial fibrillation cycle length), AF regularization, and AF termination; (2) number and distribution of lesion sets delivered; and (3) long term effects on procedural outcome when combined with PVAI as a hybrid strategy.

Eligibility Criteria:
Inclusion Criteria:

Candidates for this study must meet ALL of the following criteria:

* Age ≥ 18 years old
* First-time ablation procedure for AF
* Symptomatic AF which has been refractory to at least one antiarrhythmic medication (AAD). "Symptomatic" patients are those who have been aware of their AF anytime within the last 5 years. Symptoms may include, but are not restricted to, palpitations, shortness of breath, chest pain, fatigue, or other symptoms, or any combination of the above
* One of the following must apply:

  * AF must either be PERSISTENT AF (non-US sites only) or HIGH BURDEN PAROXYSMAL AF - High burden paroxysmal AF is defined as episodes that terminate within 30 days and meet any ONE of the following criteria:
  * More than 1 episode of AF per month in the preceding 6 months with at least 1 episode lasting \>24 hours by symptoms,
  * LA size of \>/= 48 mm in the PLAX (parasternal long axis) view on echocardiography
  * LA volume \>/= 100 cc
  * Total AF history \>/= 10 years
* At least one episode of AF must have been documented by ECG, Holter, TTM, or telemetry strip within 24 months of inclusion in the study.
* Patients must be able and willing to provide written informed consent to participate in the study.
* Able and willing to comply with all pre-, post- and follow-up testing and requirements.

Exclusion Criteria:

Candidates will be excluded from the study if any of the following conditions apply:

* Patients with long-standing persistent AF \>1 year for which cardioversion (pharmacologic or electrical) has failed or will never be attempted.
* Patients with AF felt to be secondary to an obvious reversible cause.
* Patients with contraindications to systemic anticoagulation with heparin or Coumadin.
* Patients who have previously undergone atrial fibrillation ablation.
* Patients who are pregnant (by history of menses or pregnancy test if history is considered unreliable.
* Left atrial size ≥55 mm (PLAX view on echocardiography).
A Study of Bevacizumab in Combination With First- or Second-Line Therapy in Subjects With Treated Brain Metastases Due to Non-Squamous NSCLC (PASSPORT)

This was an open-label, multicenter, single-arm, Phase II trial of bevacizumab combined with first- or second-line therapy in patients with metastatic non-squamous non-small cell lung cancer (NSCLC) with previously treated central nervous system (CNS) metastases. A total of 115 patients enrolled in the study.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Histologically or cytologically confirmed NSCLC except for squamous cell carcinoma
* Treated brain metastases without evidence of progression or hemorrhage after treatment, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period
* Appropriateness for first- or second-line systemic therapy for advanced NSCLC
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Age ≥ 18 years
* For women of childbearing potential and sexually active males, use of an accepted and effective method of contraception (e.g., hormonal or barrier methods, abstinence) prior to study entry and for the duration of the study

Exclusion Criteria:

* Brain biopsy/neurosurgical procedure performed within 3 months prior to Day 1
* Progressive neurologic symptoms
* Active malignancy other than lung cancer
* Current, recent, or planned participation in an experimental drug study
* Prior treatment with an investigational or marketed agent that acts by anti-angiogenesis mechanisms
* Gross hemoptysis within 3 months prior to Day 1
* Inadequately controlled hypertension
* Unstable angina or New York Heart Association Grade II or greater congestive heart failure (CHF)
* Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1
* Myocardial infarction within 6 months prior to Day 1
* Stroke within 6 months prior to Day 1
* Active symptomatic peripheral vascular disease within 6 months prior to Day 1
* History of significant vascular disease
* Evidence of bleeding diathesis or coagulopathy
* Known hypersensitivity to any components of bevacizumab
* Inadequate organ function
* Serious non-healing wound, ulcer, or bone fracture
* Urine protein/creatinine (UPC) ratio of ≥ 1.0
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1, or anticipation of need for major surgical procedure during the course of the study
* Pregnancy or lactation
* Known evidence of disseminated intravascular coagulation (DIC)
* Active infection or fever \> 38.5°C within 3 days prior to Day 1
* Any other medical condition (including mental illness or substance abuse) deemed by the clinician to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results
Nasotracheal Tube Stenting by Nelaton Catheter in Pediatric Dental Surgery

The value of this study is to compare between stented endotracheal tube with nelaton catheter and non stented tube as regard nasotracheal related complications as epistaxis and nasal cavity injury.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients scheduled for dental surgery under general anesthesia age 3-9 years
* physical status American society of Anesthesiologist(ASA) I orII

Exclusion Criteria:

* History of recurrent epistaxis
* Coagulopathy
* Previous nasal surgery
* History of nasal trauma
* Severe renal , hepatic or cardiovascular disease
* History of drug allergy to the drugs used in the study
Assessment of Treatment Patterns of Severe Asthmatic Patients Across the Gulf Region - SevEos Study

SevEos is a cross-sectional, multi-center, non-interventional study aimed to describe the treatment patterns in 250 severe asthma patients across the Gulf region. In addition, the study will determine the current level of asthma control and quality of life in these patients; describe the exacerbation patterns; and determine the current levels of blood eosinophils for the enrolled patients.

The primary objective of this study is to describe the treatments patterns of severe asthmatic patients across four Gulf countries during the past year.

Secondary Objectives

1. To determine the current level of asthma control in these patients. In addition, a comparison of uncontrolled asthma between those with a eosinophilic count ≥ 300 cell/μl and those with an elevated eosinophilic count less than that.
2. To determine the current and past year levels of blood eosinophils, and the percentage of patients with elevated eosinophilic level ≥ 150 cells/μL and ≥ 300 cells/μL
3. To describe the frequency of exacerbations during the past year.
4. To assess the current quality of life (QoL) of these patients.
5. To determine the past year levels of serum IgE.
6. Exploratory objective: To determine the past year levels of other inflammatory biomarkers like periostin and fraction of exhaled nitric oxide (FeNO).

Eligibility Criteria:
Inclusion Criteria:

To be included in this study, patients (both male and female) must fulfill all of the following criteria:

1. Age above 12 years.
2. Body weight of ≥40 kg.
3. Diagnosed by a physician with severe asthma, who requires regular treatment with medium or high dosage Inhaled Corticosteroids (ICS) (patients aged 12-17 years) OR high-dosage ICS ( plus Long-Acting Beta Agonist (LABA) for at least 1 year before enrolment.

\[Note that the value of the medium/high dosage is dependent on the type of ICS

Exclusion Criteria:

Patients who meet any of the following criteria are ineligible to participate in the study:

1. Patient refuses to consent.
2. Another clinically important pulmonary disease is considered to be the primary diagnosis, other than severe asthma (i.e.: COPD, major bronchiectasis, active tuberculosis, and other conditions considered by the principal investigator).
3. Mentally disabled patient or inability to understand the study questions.
4. Unable to read/write.
Effect of Cannabidiol (CBD) on Vision and Driving

The use of cannabis with ∆9-tetrahydrocannabinol (THC) content has been shown to have negative effects on vision and driving. The use of other cannabinoids, such as cannabidiol (CBD), which is not attributed with a psychoactive effect, is increasing significantly. This project aims to investigate whether consuming CBD can negatively affect visual function by assessing a wide range of visual parameters and whether these changes may pose a risk for everyday activities such as driving.


Eligibility Criteria:
Inclusion Criteria:

* Being an occasional cannabis and/or cannabidiol user
* Have a current driving licence
* Have at least one year's driving experience
* Drive at least once a week
* Monocular visual acuity of at least 6/6 (Snellen) with habitual correction for driving
* Absence of binocular disorders

Exclusion criteria:

* Certain past or present medical conditions
* Current cannabis or alcohol use disorder
* Use of other drugs
* Pregnancy or lactation
* Simulator sickness.
Cholinergic Deep Brain Stimulation for Alzheimer's Disease

This project will investigate the potential of Deep Brain Stimulation to improve cognitive abilities and counteract the effects of Alzheimer's disease. Deep Brain Stimulation electrodes targeting the Nucleus Basalis of Meynert (NB) will be implanted bilaterally in a cohort of patients. NB is the sole source of acetylcholine to the neocortex. Such stimulation may not only treat the cognitive symptoms but may have disease-modifying effects. Drawing from animal experiments in non-human primates that showed success of this approach, intermittent stimulation will be delivered at 60 pulses per second for 20 seconds of each minute for one hour per day. The study team will recruit patients, shortly after first being diagnosed with Alzheimer's disease. The study design will test the safety and efficacy of stimulation, potential benefits in cognitive function assessed with a battery of neurocognitive tests, cholinergic neurotransmission evaluated with Positron Emission Tomography, and ability to reverse Alzheimer's biomarkers, including beta amyloid and tau in the cerebrospinal fluid. Successful completion of this project will lead to a potential new intervention for the cognitive impairments of Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria:

* Probable, early-stage AD, as defined by NIA-AA 2018 criteria, including amnestic Mild Cognitive Impairment (MCI)

  * Clinical Dementia Rating (CDR) global score of 0.5-1.0 with a memory box score of at least 0.5
  * MMSE ³ 23
  * Stable cognitive enhancer medication equivalent to 10 mg/day donepezil or less for at least 60 days
  * Stable other medications (e.g., psychotropics)
  * Valid informed consent if female, subjects who are post-menopausal or surgically sterile or willing to use birth control methods for the duration of the study
  * an available caregiver willing to participate
  * subject is living at home and likely to remain at home for the study duration.

Exclusion Criteria:

* Active or unstable psychiatric illness
* Inability to tolerate general anesthesia.
* Another concurrent CNS condition or clinical co-morbidity interfering with the study (ie, stroke, Parkinson's disease, Lewy-Body dementia or other form of dementia, other evidence of significant structural brain pathology).
* Current major psychiatric disorder such as schizophrenia, bipolar disorder or major depressive disorder based on psychiatric consult at screening visit
* Verbal IQ\<85
* Contraindication regarding anesthesia, stereotactic operation, MRI (e.g. claustrophobia, or implants), or PET (e.g. insulin dependent diabetes) procedures
* Inability to undergo PET or MRI imaging
* Active alcohol or substance abuse as defined by DSM5
* Is unable or unwilling to comply with protocol follow-up requirements
* Is actively enrolled in another concurrent clinical trial.
* Terminal illness associated with expected survival of \<12 months
Ultrasound Guided Quadratus Lumborum Block Versus Caudal Block in Pediatric Patient

The purpose of this research study is to find the best way to decrease pain in children whom have had low abdominal surgery. Investigators will perform two technique;Caudal block or Quadratus lumborum block .The method used is often chosen by which one the doctor has more experience using. The Investigator plans to find out if one of the methods is more effective and/or safer than the other method.

The results of this study will help learn how to best control pain in children having surgery low abdominal surgery.

Children aged 1-9 years undergoing lower abdominal surgeries would be recruited in this randomized study.

Children would be monitored by electrocardiogram, pulse oximeter and non-invasive blood pressure.

After preoxygenation for three minutes, anesthesia would be induced with 8% sevoflurane inhalation in 50% oxygen and % 50 air ; 1ug/kg fentanyl and 3 mg/kg propofol is administered intravenously. Then laryngeal mask is inserted when conditions are satisfactory (jaw relaxed, lash reflex disappeared, no coughing, gagging, swallowing).After ethical committee approval, informed written consent will be obtained from all patients.

Consenting patients scheduled to have unilaterally low abdominal surgery(inguinal hernia,hydrocele,undescended testicles surgery will be randomised to unilateral Quadratus lumborum block or caudal block at the begin of surgery.

All patients heart rate,MAP and Oxygen saturation record intraoperatively. All patients will receive paracetamol if requirement for postoperative analgesia.All patient will transfer from PACU to day-surgery unit (DSU) if they achieved Modified Aldrete Score of ten.

All patients will be assessed postoperatively by a blinded investigator: in the postanesthesia care unit and at 30 min 1,2, 4, 6, 12, 24, hour postoperatively.FLACC and Modified Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) score will be used.

Eligibility Criteria:
Inclusion Criteria:

1. Age 1-9
2. ASA physical status I-II
3. Undergoing unilateral low abdominal surgery

Exclusion Criteria:

1. History of developmental delay or mental retardation, which will make observational pain intensity assessment difficult
2. Parent refusal
3. History of allergic reactions to local anesthetics
4. Rash or infection at the injection site
5. Anatomical abnormality
6. Bleeding diatheses
7. Coagulopathy,
8. History of diseases

   1. renal
   2. hepatic
   3. cardiac
   4. upper or lower airway
   5. neurological
Auriculotherapy for Prevention of Postoperative Urinary Retention

Urinary retention is a common complication of epidural analgesia. Auriculotherapy could prevent this complication. This study will be performed among men receiving thoracic epidural analgesia after thoracic surgery.


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled to a lung surgical procedure and thoracic epidural analgesia

Exclusion Criteria:

* Abnormalities of the external ear
* Dialysis or end stage renal failure
* Abnormal urinary tract
* Incapacity to self assessment of comfort and anxiety,
* Contra-indication to total intravenous anesthesia
Liver Transplantation and Uveal Malignant Melanoma

Patients with uveal malignant melanoma with liver metastases have median survival of less than 12 months. There is no established treatment showing increased overall survival. The study will determine if liver transplantation will result in long term survival in patients with liver metastases from uveal malignant melanoma.


Eligibility Criteria:
Inclusion Criteria:

* Uveal malignant melanoma
* Liver metastases
* ECOG 0-1

Exclusion Criteria:

* Extra hepatic disease
* Previous other malignancy
* Previous organ transplantation
Electronic Archive of Patients With Diagnosis and Suspected Prenatal Diagnosis of Aortic Coarctation

The purpose of this prosective and retrospective observational study is to analyze the clinical and echocardiographic characteristics of infants with prenatal diagnosis of suspected aortic coarctation (CoAo) in order to identify clinical and instrumental elements that can predict the risk of developing aortic coarctation in the neonatal period so that we can identify patients who are at high risk and would therefore require intensive care and observation; compared with low-risk patients, for whom early discharge would be evaluable.

Our study has the intention of analysing the clinical and echocardiographic characteristics of infants with prenatal and neonatal diagnosis of suspected CoAo, transferred at birth to the O.U. of Cardiology and Paediatric Cardiac Surgery at the Policlinico di Sant' Orsola in order to identify reliable predictors of CoAo, in particular reliable in presence of the ductus arteriosus of Botallo.

It is an observational study: patients participating in the study will not undergo to any procedures outside the normal clinical practice; likewise, the clinical variables that will be collected for study are those that are commonly collected by the physician in daily clinical practice. This study therefore involves the observation of current clinical practice without the application of any kind of 'intervention'.The primary objective of the study is:

to identify the clinical and/or echocardiographic features predictive of the development of Aortic Coarctation through the creation of a data collection with which to census all patients with a diagnosis of suspected or overt Aortic Coarctation, admitted from 01/01/2007 to 31/12/2026 at the Paediatric Cardiology and Cardiac Surgery Centre of the Policlinico di Sant'Orsola, Bologna.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pre-natal or post-natal diagnosis of aortic coarctation from 01 January 2000 until approval (retrospective phase) and from approval until 31 December 2026 (prospective phase)

Exclusion Criteria:

* Patients whose diagnosis of aortic coarctation is postnatal, considered to be \>1 month after birth
* prenatal diagnosis of genetic disease (e.g., Turner's Sdr)
* coarctation in the setting of complex congenital heart disease
Effects of Episodic Specificity Induction in Normal and Pathological Ageing.

Episodic Specificity Induction (ESI) is a short training that improves the production of episodic details during autobiographical recall in young and elderly people without cognitive impairment. But it remains to be determined 1) whether the mechanisms targeted by the ESI affect memory or executive functioning and 2) whether amnestic type (aMCI) or dysexecutive type (dMCI) mild cognitive impairment patients would benefit differently from this training, which has never been tested. By comparing the effect of the ESI on these patients, this would open up new perspectives for their symptomatic care.


Eligibility Criteria:
Inclusion Criteria:

The participant:

* has provided informed consent obtained in accordance with Good Clinical Practices.
* is affiliated to a social security system.
* speaks fluent French.
* is between 55 and 85 years of age.

For the participants of the control group:

* has a Montreal Cognitive Assessment (MoCA) score equal to or greater than 26;
* has neuropsychological assessment performance (RL/RI 16, D080, TMT, VOSP, Rey's figure) in the norm according to his socio-professional category and age, i.e. less than two deviating scores of -1 standard deviation or less than the 10th percentile per function.

For patients in the TCLa group:

* has at least two scores below the 10th percentile or below -1 standard deviation from the norm on neuropsychological assessment tests that assess memory, based on its socio-professional category and age;
* has less than two scores below the 10th percentile or less than -1 standard deviation from the norm in neuropsychological assessment tests that assess other functions. This is in accordance with the diagnostic criteria of Petersen (2004) and Jak and Bondi (2009).

For patients in the TCLd group:

* has focal executive dysfunction expressed by at least two scores less than the 10th percentile or less than -1 standard deviation from the norm in neuropsychological assessment tests that assess executive functions (TMT, Stroop, verbal fluences, free recall in memory), according to his socio-professional category and age;
* has less than two scores below the 10th percentile or less than -1 standard deviation from the norm on neuropsychological assessment tests that assess other functions (except for free memory reminders and language fluences). This is in accordance with the diagnostic criteria of Petersen (2004) and Jak and Bondi (2009).

Exclusion Criteria:

The participant:

* meets the criteria for a major neurocognitive disorder of the DSM-5.
* has a neurological disorder of infectious origin.
* has a psychiatric illness.
* has a severe uncompensated sensory deficit.
* is a substance abuser.
* has had chronic depression or anxiety that has not stabilized for 3 months.
* refuses to participate.
* is participating in another intervention research project.
* is placed under the protection of justice.
* refuses to sign the consent form.
* is unable to express its consent.
* consumed toxic substances or alcohol at the time of the study.
25OH Vitamin D Overdoses and Risk of Bronchopulmonary Dysplasia or Death

Several studies have demonstrated that vitamin D deficiency at birth is a risk factor of bronchopulmonary dysplasia. However, in an animal model of bronchopulmonary dysplasia vitamin D overdose has also been associated with an increased mortality and an increased lung injury. Such vitamin D overdose has been frequently reported in hospitalized neonates receiving the current supplementation.

The hypothesis is that vitamin D overdose is an independent risk factor of bronchopulmonary dysplasia or death among infants born below 31 weeks gestational age excluding infants with vitamin D deficiency.

This retrospective cohort study will include all infants born before 31 weeks of gestation (WG), who were hospitalized in a tertiary neonatal intensive care unit (NICU) during at least 10 days, for who at least one 25OH vitamin D determination was performed before 36 WG corrected age and whose parents are not opposed to the study. A descriptive analysis of the cohort depending on the occurrence of vitamin D overdose will be performed. A multivariate analysis will determine if vitamin D overdose is an independent risk factor of bronchopulmonary dysplasia or death among preterm infants, adjusting on the covariates known to be associated with bronchopulmonary dysplasia.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria \* :
* Infant born before 31 weeks of gestation.
* hospitalized in the NICU during at least 10 days
* with at least a 25OH-D determination available before 36 weeks corrected age

Exclusion Criteria:

-Infant with at least a 25OH-D below 50 nmol/L