cyrilzakka/clinical-trials huggingface dataset:
Application of Indicator Based-electrical Impedance Tomography Method Assess Lung Regional Perfusion in ICU Patients

This study is an observational study. Investigate the relationship of oxgenation and lung regional ventilation and perfusion assessed by the indicator based-EIT method in the critically ill patients in ICU

1. Written informed consent was obtained from all patients or next of kin before data were included in the study.
2. When the research team was available, adult patients within 1w, who were sequentially admitted to the Department of Critical Care Medicine and required central venous catheters for resuscitation were eligible for the study.
3. Information collected at enrollment included demographic characteristics such as age, sex, Acute Physiology and Chronic Health Evaluation II score (APCHEII); . The global hemodynamic, respiration condition and PaO2 were measured. At the same time, the lung regional ventilation and perfusion assessed by the indicator based-EIT method(injection 10%NaCL).
4. The 10%NaCL was injected by the central venous catheter.

Eligibility Criteria:
Inclusion Criteria:

* Time of admission ICU \< 7days
* Age (\> 18 years old)
* Have been placed central venous catheter based on clinical requirement

Exclusion Criteria:

.Chest skin injured and cannot be monitored by EIT.

* Severe Hypernatremia
* Pregnancy
Efficacy and Safety of Varenicline Among HIV-infected Patients

Cigarette smoking is a major cause of illness among HIV-infected patients (non-AIDS defining malignancies (especially lung cancer), non-AIDS bacterial infections and cardio-vascular diseases). Approximately 50% of HIV-infected patients are regular tobacco smokers. Tobacco smoking cessation has well known benefits on mortality and morbidity in the general population where tobacco cessation assistance programs are increasingly implemented. However, smoking cessation interventions have never been evaluated among HIV-infected patients. This trial aims at evaluating the efficacy and safety of varenicline for smoking cessation compared with placebo.

Cigarette smoking is a major cause of illness among HIV-infected patients (non-AIDS defining malignancies (especially lung cancer), non-AIDS bacterial infections and cardio-vascular diseases). Approximately 50% of HIV-infected patients are regular tobacco smokers. Tobacco smoking cessation has well known benefits on mortality and morbidity in the general population where tobacco cessation assistance programs are increasingly implemented. However, smoking cessation interventions have never been evaluated among HIV-infected patients. This trial aims at evaluating the efficacy and safety of varenicline for smoking cessation compared with placebo. A pharmacokinetic study will be conducted to evaluate the effect of smoking cessation on the plasma concentration of antiretroviral treatment.

Eligibility Criteria:
Inclusion Criteria:

* HIV-infected patients
* adults
* regular smokers (at least 10 cigarettes a day during the last year)
* motivated to stop smoking
* followed in one of the participating clinical ward,
* signed written inform consent

Exclusion Criteria:

* current co-dependency to another psychoactive substance
* ongoing depressive episode
* history of suicidal attempt
* ongoing treatment by interferon
* treatment by efavirenz for less than three months or not tolerated
* previous use of varenicline
* ongoing treatment by bupropion-SR or nicotinic substitute
* ongoing pregnancy
* ongoing breastfeeding
* hypersensitivity to varenicline or to one of its excipients
* drivers, air traffic controller
Comparison of Cardiovascular Risk Stratification in Young People With Type 1 Diabetes by Coronary Calcium Score to ESC/ESA2019 Recommendations

The aim of the study is to compare ESC recommendations on cardiovascular (CV) risk stratification with the achievement of a CAC (Coronary Artery Calcification).

The development of a CAC, currently not systematically offered to these patients to refine CV risk, could make it possible to offer more intensive management of CV risk facors for patients who objectively have a high CV risk as evidenced by a high coronary calcium score.

LDL target recommandations have become more aggressive with a very high level of evidence in type 2 diabetic patients but low in type 1 diabetic patients because there is no specific CV intervention study for T1D patients.

These recommendations have far-reaching consequences because they would justify introducing in young type 1 diabetic patients, considered from the outset to be at moderate cardiovascular risk (young T1DM \<35 years old) or even at high cardiovascular risk (duration of diabetes \> 10 years) or very high cardiovascular risk (duration of diabetes \> 20 years), treatment with statins or even aspirin, based only on the length of time they have had diabetes.

The realization of a CAC, currently not systematically offered to these patients to refine CV risk, could make it possible to propose a more intensive management of CV risk factors for patients with objectively high CV risk attested by a high coronary calcium score.

In this case the introduction of treatment with statins would be indicated.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years and ≤ 35 years; Type 1 diabetic patient (defined by T1DM antibody positivity or onset in pediatric age); In primary cardiovascular prevention (with no CV events); Patient not treated by statins; Duration of diabetes \> 5 years; Equipped with a continuous interstitial glucose measurement system for at least 14 days; No previous CAC performed Patient with social security or with third party coverage. Free subject, without guardianship or curatorship or subordination; Informed consent signed by the patient after clear and fair information about the study.

Exclusion Criteria:

* Cardiovascular secondary prevention patients (with a previous CV event); ECG abnormality suggestive of coronary ischemia; Intolerance or contraindication to statins Person benefiting from reinforced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment, adults under legal protection and finally patients in emergency situations; Pregnant and/or breastfeeding woman.
Signal Intensity Gradient in Cerebral Arteries

Arterial wall shear stress (WSS) contributes to atherosclerosis from its inception, progression, and disruption of plaque. However, there is no previous study for an association between cerebral artery WSS and clinical outcome in patients with ischemic stroke in lenticulostriate artery.

The researchers aimed to investigate whether the signal intensity gradient (SIG) from Time-of-Flight Magnetic Resonance Angiography (TOF MRA) in cerebral arteries, as a surrogate measure of arterial WSS, is associated with clinical outcome, which was determined with modified Rankin Scale (mRS).

The patients (n=294) with the lenticulostriate artery infarction were collected in 3 hospitals with variable locations and sizes (Gunsan, Jeonju, and Seoul). For a clinical outcome, National Institute of Health Stroke Scale (NIHSS) and modified Rankin Scale (mRS) were checked serially from the date of admission. The mRS 2 or less at the 7th day or discharge was defined as a favorable outcome. The arterial SIGs were measured concurrently in both internal carotid, anterior/middle/posterior cerebral, vertebral arteries, and basilar artery from TOF MRA on initial diagnosis. The independent association between the clinical outcome and cerebral arterial SIG was analyzed adjusting for all the possible potential confounders.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 years or older who had brain magnetic resonance imaging (MRI) for acute ischemic stroke within 3 days
2. Patients who underwent diffusion-weighted imaging (DWI) and apparent diffusion coefficient of the cerebral parenchyma, and cerebral angiographic measurements, in which, intracranial arteries should be examined by time-of-flight (TOF) techniques
3. A patient with high signal intensity lesions in the unilateral LSA territory on DWI.

Exclusion Criteria:

1. Patients younger than 18 years of age
2. Patients with moderate to severe (\>50%) stenosis or occlusion of the major intracranial and extracranial arteries, including internal carotid artery (ICA), middle cerebral artery (MCA), anterior cerebral artery (ACA), posterior cerebral artery (PCA), basilar artery (BA), and vertebral artery (VA)
3. Patients whose ischemic stroke was due to or related with cardiac or rare etiology (e.g., arterial dissection, moyamoya disease).
Online Cognitive Behavioural Therapy for Addiction: Efficacy and Cost-Effectiveness in a Pragmatic Clinical Trial

The purpose of this study is to compare the efficacy and cost-effectiveness of a Computer-based Training for Cognitive Behavioural Therapy (CBT4CBT) to treatment as usual in outpatients seeking treatment for substance use disorder.

Fifty-two adult outpatients seeking treatment for substance use disorder from the Centre for Addiction and Mental Health Addictions Program will be randomized to receive either a computer-based training for cognitive behavioural therapy or treatment as usual for eight weeks. Participants will complete interviews, questionnaires, and other assessments (urine toxicology and physiological assessments) at week 0, at week 8, and at 6 month follow-up). Measures will assess alcohol and drug consumption, substance use disorder symptoms and associated features, quality of life, and healthcare costs.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Fluency in English
3. Understanding and willingness to comply with study requirements
4. Meet diagnostic criteria for current substance use disorder
5. Have used substance in the past 30 days
6. Treatment-seeking for substance misuse

Exclusion Criteria:

1. Unable to read at sixth grade level
2. Untreated or unstable severe psychiatric or medical disorder
3. Acute suicidal or homicidal ideation
Influenza Vaccination for Parents and Other Caregivers in the Pediatric Medical Home

We hypothesize that when offered influenza vaccine at little or no cost, in a setting where the value of the vaccine is connected to one's high risk child, vaccination rates for parents will approach 90-95%, similar to rates obtained in the Neonatal Intensive Care Unit environment.


Eligibility Criteria:
Inclusion Criteria:

* Parents or caregiver adults who accompany at-risk children to a Pediatric Care outpatient clinic appointment. High risk children are defined as those 0 to 5 years of age, or who have any of the following diagnoses:

  * Sickle cell disease
  * Asthma
  * Cystic fibrosis
  * Chronic renal disease
  * Congenital heart disease
  * Cancer
  * Any immunodeficiency

Exclusion Criteria:

* Caregivers of children residing in group homes
* Persons whose children do not meet the Center for Disease Control (CDC) definition of high-risk
* Persons who have had allergic reactions to influenza vaccination or any other vaccination in the past
* Persons who are allergic to eggs or egg products
* Persons who are allergic to thimerosol
* Previous diagnosis of Guillain-Barré syndrome (GBS)
* Persons who are moderately to severely ill at the time the vaccination is to be given
A Four Week, Open-Label Study of Azithromycin Ophthalmic Solution, 1% (P08641)

One objective of this study is to determine the levels of markers of inflammation on the eyelid margin of subjects with blepharoconjunctivitis and compare them with those of healthy volunteers. Another objective is to determine in subjects with blepharoconjunctivitis the effect of azithromycin ophthalmic solution, 1 % on markers of inflammation of lid margins and conjunctivae and on signs and symptoms of blepharoconjunctivitis.


Eligibility Criteria:
Inclusion Criteria:

* Have a current diagnosis of posterior blepharoconjunctivitis in both eyes

(except for healthy volunteers)

* Have a Best Corrected Visual Acuity (BCVA), using corrective lenses if necessary, in both eyes of at least +0.7 LogMAR
* If female, are non-pregnant or non-lactating

Exclusion Criteria:

* Have anterior blepharitis
* Have lid structural abnormalities
* Have had penetrating intraocular surgery in the past 90 days or require

penetrating intraocular surgery during the study

* Unable to withhold the use of contact lenses within 3 days prior to Visit 1

during the study

* Have been diagnosed with ongoing glaucoma
* Have a serious medical condition which could confound study assessments
Intermittent Preventive Treatment With Azithromycin-containing Regimens in Pregnant Women in Papua New Guinea

The purpose of this study is to determine whether repeated courses of sulphadoxine-pyrimethamine (SP) in combination with azithromycin given at Antenatal Clinic, leads to lower rates of low birth weight deliveries (\<2.5 kg) among Papua New Guinean women, than the current standard treatment of SP and chloroquine.


Eligibility Criteria:
Inclusion Criteria:

* pregnant
* 14-26 weeks'gestation
* permanent resident of study area
* exclusive use of study health facilities for primary health care
* Age is between 16 and 49 years

Exclusion Criteria:

* Known chronic illness, e.g. TB, diabetes, renal failure
* Severe anaemia requiring hospitalisation (Hb \< 6 g/dl accompanied by symptoms requiring urgent treatment)
* permanent disability, that prevents or impedes study participation and/or comprehension
* Known multiple pregnancy
Strategy Training and Pets to Promote Stroke Survivor's Cognitive Performance and Community Participation

The study will administer an intervention called strategy training to adult stroke survivors living in the community who do and do not have pets, and will examine the role of a pet in promoting cognitive performance and community participation outcomes.


Eligibility Criteria:
Stroke survivors with pets

Inclusion Criteria:

1. Primary diagnosis of acute stroke
2. At least 3 months after the stroke onset
3. Living in a community residence with a pet
4. Cognitive impairment as indicated by an Executive Interview score of 3 or higher
5. Participation restrictions as indicated by an Activity Card Sort (\<80% of pre-stroke activities)
6. Willing to participate in a 6-week program with 2 intervention sessions per week at home

Exclusion Criteria:

1. Dementia as indicated by Montreal Cognitive Assessment score of 18 or lower
2. Severe aphasia as indicated by the Boston Diagnostic Aphasia Examination Severity Score of 0 or 1
3. Self-report of a central nervous system disorder other than stroke
4. Recent drug or alcohol addiction/abuse within 3 months prior to the Mini-Neuropsychiatric Interview
5. Severe mental illness as indicated by the PRIME-MD
6. Prior exposure to strategy training
7. Currently participate in rehabilitation therapy programs

Stroke survivors without pets

Inclusion Criteria:

1. Primary diagnosis of acute stroke
2. At least 3 months after the stroke onset
3. Living in a community residence
4. Cognitive impairment as indicated by an Executive Interview score of 3 or higher
5. Participation restrictions as indicated by an Activity Card Sort (\<80% of pre-stroke activities)
6. Willing to participate in a 6-week program with 2 intervention sessions per week at home

Exclusion Criteria:

1. Dementia as indicated by Montreal Cognitive Assessment score of 18 or lower
2. Severe aphasia as indicated by the Boston Diagnostic Aphasia Examination Severity Score of 0 or 1
3. Self-report of a central nervous system disorder other than stroke
4. Recent drug or alcohol addiction/abuse within 3 months prior to the Mini-Neuropsychiatric Interview
5. Severe mental illness as indicated by the PRIME-MD
6. Prior exposure to strategy training
7. Currently participate in rehabilitation therapy programs
Improving Dental Care and Oral Health in Children With Autism Spectrum Disorder

A randomized controlled trial (at sites) comparing the efficacy of the established AIR-P Dental Toolkit (control condition) to a combined regimen involving the Dental Toolkit and parent-mediated behavioral intervention (intervention condition) to improve home dental care, oral health outcomes, and dental office visit experiences.

Participation in routine dental care is a significant challenge for children with autism spectrum disorder (ASD) due to a variety of factors, including considerations related to ASD symptoms and associated anxiety and behavioral difficulties. Lack of routine, effective dental care has contributed to a substantial unmet healthcare need for children with ASD, who are at increased risk for excessive plaque, caries, and oral infections.

The purpose of this study is to test a parent-training intervention designed to improve home dental hygiene, compliance with dental office visits, and oral health outcomes in children with autism spectrum disorder. Families of children with an existing diagnosis of ASD will be recruited for participation. All families will receive the Autism Intervention Research Network on Physical Health (AIR-P) Dental Toolkit, which is designed to provide parents with guidance and information about dental care and support strategies for children with ASD. Some families will also participate in a 10-week behavioral parent-training intervention focused on improving home dental care and dental office visit experiences.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking families of children ages 3 to 13 years and 11 months.
* Current diagnosis of ASD confirmed by baseline assessment.
* Parent-reported difficulty participating in dental care.
* Confirmed absence of dental screenings or exams/visits within the previous 6 months.
* Underserved status as defined by Medicaid eligibility.

Exclusion Criteria:

* Children who present with an acute dental condition requiring emergency treatment.
* Children who are currently taking, or have recently discontinued, medications that affect oral and gingival health.
* Anything that, in the opinion of the Site Principal Investigator, would place the subject at unwarranted risk or materially reduce their contribution to the trial's aims due to inability or refusal to adhere to trial procedures and follow-up.

Families will be asked to refrain from participating in any non-study adaptive behavior interventions or therapies focused on dental hygiene. Families will also be asked not to participate in any non-study dental screenings or exams for the duration of the investigation.
Clinical Evaluation of the Cochlear Nucleus CI532 Cochlear Implant in Adults

The purpose of this study is to gather long-term data on the FDA approved CI532 cochlear implant, and CP1000 (Nucleus 7) sound processor

Appropriate candidates will receive a CI532 cochlear implant and be fit with the CP1000 sound processor. Imaging will be completed pre-op, intra-op, and post-op to assess implant location. Speech perception testing as well as subjective questionnaires will be administered over 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. Adults 18 years or older who have a bilateral postlinguistic sensorineural hearing loss.
2. Limited benefit from amplification as defined by test scores of 40% correct or less in the ear to be implanted and 50% or less in the contralateral ear on a recorded monosyllabic word test I. Consistent with the Minimum Speech Test Battery (2011), it is required that all subjects be evaluated at 60 dBA presentation level.
3. Bilateral moderate sloping to profound hearing loss
4. Minimum of 30 days experience with appropriately fit bilateral amplification, fit using the standardized National Acoustics Laboratory (NAL) fitting method
5. Proficient in English
6. Ability to complete testing -

Exclusion Criteria:

1. Previous cochlear implantation
2. Pre-linguistically deafened (onset of hearing loss at less than two years of age)
3. Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
4. Duration of severe to profound hearing loss greater than 20 years
5. Diagnosis of retro-cochlear pathology
6. Diagnosis of auditory neuropathy
7. Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and use of the prosthetic device
8. Unwillingness or inability to comply with all investigational requirements
9. Additional cognitive, medical or social handicaps that would prevent completion of all study requirements-
Aflibercept in Polypoidal Choroidal Vasculopathy

To collect data reflecting the efficacy and safety of aflibercept with and without photodynamic therapy in subjects diagnosed with the polypoidal choroidal vasculopathy subtype of wet age-related macular degeneration


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Men and women ≥50 years of age
* Diagnosis of symptomatic macular Polypoidal Choroidal Vasculopathy (PCV) in the study eye established by Indocyanine Green Angiography(ICGA) at the study center
* Greatest linear dimension of the lesion of \< 5400 mm (approximately, 9 Macular Photocoagulation Study disk areas), assessed by ICGA.
* An Early treatment diabetic retinopathy study (ETDRS) BCVA of 73 to 24 letters in the study eye.

Exclusion Criteria:

* Prior use of intravitreal or sub-tenon corticosteroids in the study eye within 3 months prior to study entry
* Any prior use of intraocular anti Vascular Endothelial Growth Factor (anti-VEGF)agents in the study eye, or systemic use of anti VEGF products within 3 months prior to study entry
* Prior macular laser treatment in the study eye including Photodynamic Therapy (PDT)
* History of allergy to fluorescein used in fluorescein angiography, iodine and/or indocyanine green.
* History of allergy to aflibercept, verteporfin, or their excipients.
Automated Segmentation and Volumetry for Meningioma Using Deep Learning

U-Net-based architectures will be applied to 500 contrast-enhanced axial MR images of different patients from a single institution after manual segmentation of meningioma, of which 50 were used for testing. Tumor volumetry after autosegmentation by trained U-Net-based architecture is final goal.

U-Net-based architectures will be applied to 500 contrast-enhanced axial MR images of different patients from a single institution after manual segmentation of meningioma, of which 50 were used for testing. After preprocessing with Z-isotropification and intensity normalization of images, 3 U-Net-based networks (2D U-Net, Attention U-Net, 3D U-Net) and 3 nnU-Net-based networks (2D nnU-Net, Attention nnU-Net, 3D nnU-Net) will be trained with meningioma-segmented images. For applying to 3D networks, sagittal and coronal images will be reconstructed using axial images. After prediction, the cut-off of the probability function, which is a trade-off, will be obtained with the Gaussian Mixture Modeling algorithm using the probability density function. The voxels having a probability function higher than that will be finally predicted as meningioma. Tumor volume is calculated as the sum of the product of segmented area and thickness of axial images. For performance evaluation, dice similarity coefficient (DSC), precision, and recall will be evaluated compared with manually segmented voxels for validation datasets. The results of volumetry of each model will be compared with manual segmentation-based volume through Pearson's correlation analysis.

Eligibility Criteria:
Inclusion Criteria:

* Radiologically diagnosed meningioma by MRI

Exclusion Criteria:

* under 18 years old
* Multiple meningiomas
* Orbital meningioma
* Any prior treatment for intracranial meningioma before registration