cyrilzakka/clinical-trials huggingface dataset:
Compassionate Use of an Intravenous Fish Oil Emulsion in Infants With Cholestasis

The study will evaluate the safety and efficacy of an intravenous fish oil emulsion (omegaven) in infants with parenteral nutrition associated cholestasis.


Eligibility Criteria:
Inclusion Criteria:

Cholestasis defined as either

* serum bilirubin \> 2mg/dL (two measurements at least 8d apart) that has not responded to 4 weeks of intralipid being reduced to 1 g/kg/d and trace minerals being limited to twice weekly, OR
* serum bilirubin \> 6 mg/dL (single measurement) and rising, in the absence of proven or suspected sepsis

Exclusion Criteria:

* Age \> 1y at time that omegaven is started
* Not expected to survive at least 30 days
* Fish allergy in a first degree relative
* Hemodynamic instability
* Coagulopathy
* Not likely to require PN for \> 30d
* Not expected to survive \> 30d
Bone MicroArchitecture Abatacept (BMA2)

Rheumatoid Arthritis patients management reposes primarily on the use of disease-modifying antirheumatic drugs (DMARDs).

Among DMARDs available in 2015, researchers demonstrated the ability to reduce synovitis, biomarkers of inflammation, and bone destruction.

Given the demonstration of correlation between joint inflammation and structural progression at each joint level as well as the opportunity for bone remodeling with resolution of joint inflammation, researchers expect to observe an improvement in bone micro-architecture parameters specifically in rheumatoid arthritis patients without remaining joint inflammation 3 months following abatacept treatment initiation.

Rheumatoid Arthritis patients management reposes primarily on the use of disease-modifying anti-rheumatic drugs. In patients responding insufficiently to Methotrexate, and/or other disease-modifying anti-rheumatic drugs (DMARD) strategies, with or without glucocorticoids, biological DMARD (TNF inhibitors, abatacept or tocilizumab, and, under certain circumstances, rituximab) should be commenced with Methotrexate. Among DMARD available in 2015, abatacept has demonstrated the ability to reduce synovitis, biomarkers of inflammation, and bone destruction. Monitoring rheumatoid arthritis patients after starting abatacept by US exams observed a strong reduction of power Doppler ultra-sonography at 3 months in two third of patients.

Given the demonstration of correlation between joint inflammation and structural progression at each joint level as well as the opportunity for bone remodeling with resolution of joint inflammation, researchers expect to observe an improvement in bone micro-architecture parameters specifically in rheumatoid arthritis patients without remaining joint inflammation 3 months following abatacept initiation.

Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent form,
* Age ≥ 18 years,
* Rheumatoid arthritis diagnosis according to ACR/EULAR 2010 criteria
* Abatacept therapy sub-cutaneous required according EULAR recommendations
* Patients affiliated to health insurance

Exclusion Criteria:

* Other arthritis than rheumatoid arthritis,
* Contraindication to abatacept,
* Concomitant treatment with zoledronic acid (Aclasta®) or denosumab (Prolia®),
* Injection intravenously or intra-articular at the 2nd and 3rd metacarpophalangeal joint of the dominant hand during the 3 months prior to inclusion,
* Prior or planned joint surgery at the 2nd or 3rd metacarpophalangeal joint of the dominant hand over the one year study,
* No recent used of high density contrast material,
* Pregnancy or breastfeeding.
Sensing Contact Lens-based Device for 24-hour Monitoring of Intraocular Pressure

Glaucoma is characterized by irreversible vision loss through the progressive death of optic nerve fibers unless timely diagnosis and adequate treatment are provided. Medical therapy is aimed at lowering intraocular pressure (IOP) below a clinically determined target level in order to prevent or slow glaucoma progression. IOP is known to vary with the time of day as well as with daily activities.

The current way of assessing nycthemeral IOP fluctuation is to perform repeated discrete tonometry measurements, allowing only snapshot and non-continuous measurements once per hour in the best cases. The procedure is cumbersome, expensive, inconvenient (disturbed sleep cycle as patient is awoken for nocturnal/sleep period measurements) and may not detect crucial IOP values in time.

Sensimed AG has developed a new contact lens (CL)-based device intended to continuously measure IOP over 24 hours. The objective of this study is to investigate the use of device for 24-hour IOP monitoring in healthy subjects and glaucoma patients.


Eligibility Criteria:
Inclusion Criteria:

* For Open Angle Glaucoma (OAG) subjects, a clinical diagnosis of primary OAG, including normal tension glaucoma (NTG) all known untreated IOP measurements \< 22 mmHg using Goldmann Applanation Tonometry (GAT) for NTG no IOP-lowering treatment; otherwise, a 4-week wash-out period prior to the recording
* For healthy subjects, no structural defects, normal visual fields, IOP ≤ 21 mmHg and open angles on gonioscopy
* Aged ≥ 18 years, either gender
* Body Mass Index ≤ 30 kg/m2
* Central Corneal Radius (flat meridian) between 7.5 mm (45 D) and 7.9 mm (42.75 D)
* Central Corneal Thickness between 500 microns and 600 microns
* Difference in IOP absolute value between eyes within 2.5 mmHg at screening in sitting position
* Same direction of IOP variation (positive or negative) for the 2 eyes when moving from sitting to supine positions at screening
* Spherical refraction within ±6.00 diopters and cylinder refraction within ±3.00 diopters
* Having given written informed consent, prior to any investigational procedures

Exclusion Criteria:

* Ocular pathology (other than glaucoma for glaucoma subjects)
* Previous glaucoma, cataract or refractive surgery
* Corneal or conjunctival abnormality, precluding contact lens adaptation
* Severe dry eye syndrome
* Subjects with allergy to corneal anesthetic
* Subjects with contraindications for silicone CL wear
* Subjects with contraindications for Water Drinking Test (WDT) (eg., heart, renal problems)
* Subjects unable or unwilling to comply with the study procedures
* Participation in other interventional clinical research within the last 4 weeks
LAAO With DAPT Versus Antithrombotic Therapy

This study will retrospectively review and compare clinical outcomes between left atrial appendage occlusion with dual antiplatelet therapy versus conventional antithrombotic therapy in patients with atrial fibrillation undergoing drug-eluting stent implantation.

Composite of stroke and major bleeding will be compared after adjusting those groups using inverse probability weighted model.

Eligibility Criteria:
Inclusion Criteria:

* patients with AF who underwent PCI and treated with LAAO and DAPT or conventional antithrombotic therapy

Exclusion Criteria:

-
The Effect of Intraoperative Intravenous Lidocaine Infusion on Postoperative Pain and Recovery in Children (< 7 Years Old) Undergoing Thoracoscopic Surgery

This study aims to investigate the efficacy of intraoperative intravenous lidocaine infusion on postoperative pain management and recovery in pediatric patients undergoing thoracoscopic pulmonary resection.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients aged under 7 years undergoing thoracoscopic pulmonary resection

Exclusion Criteria:

* cardiac dysfunction requiring vasopressors or inotropic agents
* atrioventricular block or bradycardia
* Liver or kidney dysfunction
* Hypersensitivity to local anesthetics
A Trial to Learn How Well REGN7508 Works for Preventing Blood Clots After a Knee Replacement in Adult Participants

This study is researching an experimental drug called REGN7508 (called "study drug"). The study is focused on adults undergoing elective, unilateral (one side) total knee replacement (TKR) surgery.

The aim of the study is to see how effective the study drug is at preventing venous thromboembolism (VTE) and other related diseases after unilateral total knee replacement surgery.

The study is looking at several other research questions, including:

* What side effects may happen from taking the study drug
* How much study drug is in the blood at different times
* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)


Eligibility Criteria:
Key Inclusion Criteria:

1. Undergoing a primary elective unilateral TKA
2. Has a body weight ≤130 kg at screening visit
3. Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and electrocardiograms (ECG's) performed at screening and/or prior to administration of initial dose of study drug as described in the protocol
4. Is in good health based on laboratory safety testing obtained during the screening period as described in the protocol

Key Exclusion Criteria:

1. History of bleeding in the past 6 months prior to dosing requiring hospitalization or transfusion; history of intracranial or intraocular bleeding, excessive operative or post-operative bleeding, and traumatic spinal or epidural anesthesia; history of bleeding diathesis
2. History of thromboembolic disease or thrombophilia
3. History of major surgery, including brain, spinal, or ocular, within approximately the past 6 months
4. History of major trauma within approximately the past 6 months prior to dosing
5. Hospitalized (\>24 hours) for any reason within 30 days of the screening visit
6. Has an estimated glomerular filtration rate (GFR) of \<45 mL/min/1.73m\^2 at the screening visit using one of the following formulas: the Modification of Diet in Renal Disease (MDRD) equation, the Chronic Kidney Disease Epidemiology Collaboration equation, or equivalent equation

Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
Effects of the Ultra-low Frequencies TENS on the Arousal Circuits

Pupil size is associated with the activity of the noradrenergic system, with an increase reflecting a higher state of arousal. Transmucosal electrical stimulation of the tongue could treat disorders related to dysfunctions of this system, and trigeminal stimulation through ULFTENS (TUD) has shown some positive effects. However, no studies have examined the effect of stimulation of the anterior mucosa of the tongue on pupil size as an indicator of arousal. The aim of this study will be to evaluate the effect of ULFTENS stimulation on pupil size in the dark.

Changes in pupil size are indicative of the activity of the noradrenergic system, with pupil dilation associated with a higher state of arousal. According to various studies, odontological ULFTENS, through trigeminal stimulation, can help rebalance this altered system with positive effects. Our goal is to harness the capabilities of ULFTENS by stimulating the dorsal lingual mucosa and evaluating its effects on pupil size in the dark. Healthy women aged between 20 and 30 will be recruited and divided into two groups: a control group and an experimental group. Participants in the control group will lie down on a bed with their eyes closed, and will then be asked to open their eyes without moving their eyelids. Pupil diameter will be measured using a pupillometer for 15 seconds. This procedure will be repeated twice. The experimental group will receive a tongue stimulator connected to the ULFTENS, which will be activated after the first measurement. The stimulation will last approximately 15 minutes, with a second measurement taken after 15 seconds. At the end of the stimulation, the final measurement will be taken. The goal is to measure the pupil diameter of both eyes at the three time points and compare the results between the two groups to assess the effect of the stimulator on arousal circuits.

Eligibility Criteria:
Inclusion Criteria:

* good health status and physical fitness
* female sex
* age between 20 and 30 years
* non-smoker
* no more than 3 espresso coffees per day
* no intake of stimulant or psychotropic drugs in general
* body mass index between 18.5 and 24.9

Exclusion Criteria:

* presence of acute and/or chronic cardiocirculatory and respiratory disorders
* metabolic and autonomic system disorders
* intake of peripheral and central nervous system excitatory or inhibiting substances
* presence of generalized anxiety and/or panic attacks, or mood disorders.
Validation of a Prognostic Score for Good Visual Recovery at One Year Following Combined Surgery for Cataract and Idiopathic Epiretinal Membrane

The prevalence of idiopathic epiretinal membranes (ERM) in people over 50 is estimated at 6 to 19%. Even though most cases show very few symptomats, they may induce alterations of the underlying retina and lead to visual impairment likely to greatly diminish quality of life in patients. Thanks to the ever-improving quality of vitreo-retinal surgery, ablation of these membranes is a frequent and safe procedure allowing a functional gain in the majority of cases. Given the increasing prevalence in the population concerned and the accelerated ageing of the lens after vitrectomy, cataract surgery is often associated with removal of the membrane. On the basis of a study in 142 patients, it was possible to identify clinical and morphological prognostic factors and to inclure them in a score to assess the chances of complete functional recovery at one year following the procedure . Age of the patient, the duration of symptoms, initial visual acuity and the quality of the junction between external and internal segments of photoreceptors in optic coherence tomography (OCT) appeared as significantly related to visual results. Using this score in a new prospective cohort would allow the investigators to make it a reliable and easy-to-use tool at the service of ophthalmologist surgeons and their patients and would provide scientific confirmation of the interest of earlier surgery in this disease. It would also allow the investigators to define in a validated and reproducible manner, a threshold for an ndication for ERM surgery, which is currently based on relatively subjective criteria mostly related to visual acuity.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting idiopathic ERM visible on SD-OCT;
* Indication for combined cataract and ERM surgery in a context of a fall in visual acuity or disabling metamorphopsia;
* Patients who have provided verbal consent;
* Age ≥ 40 years.

Exclusion Criteria:

* Patients with secondary ERM (Diabetes WITH a history of diabetic retinopathy or maculopathy, occlusion of the retinal veins, uveitis intermediate/posterior uveitis or retinal tear/detachment in the studied eye;
* Patient présentant toute autre maculopathie ou neuropathie optique ;
* Patient presenting severe myopia (spherical equivalent ≥ 6 diopters or axial length ≥ 26 mm) ;
* Patients presenting any other ophthalmological disease independent of the ERM and likely to limit visual acuity
* Patients who have already undergone vitrectomy in the studied eye;
* Non-visible or poorly visible fundus due to a cloudy vitreous (Signal on OCT Cirrus \<5, Quality score on OCT Spectralis \< 20, signal trend index on OCT Optovue \< 30)
* Patients without national health insurance cover
* Pregnant or breast-feeding women.
Remote Continues Glucose Monitoring During the COVID-19 Pandemic in Quarantined Hospitalized Patients

This is a randomized controlled trial of isolated patients with diabetes admitted to Nordsjællands Hospital with or without COVID-19-pneumonia. A continuous glucose monitoring (CGM) based system with transmission of glucose data to a central system is used for remote monitoring of glucose levels and compared to standard finger-prick glucose. Blinded (to patients) CGM is mounted in the finger-prick group.

Epidemics and pandemics are a constant threat to health care systems globally. This stresses the importance of preparedness for a large amount of hospitalized quarantined patients in isolation, with the extra challenges it brings. The COVID-19 pandemic challenges the Danish health care system in many aspects: An increased number of citizens are expected to be admitted to hospital due to COVID-19 infected pneumonia and this will demand extra workforce resources, extra use of protective equipment (gowns, masks, gloves, etc) and extra time used for taking protective equipment on and off. In concert these extra demands will drain the health care system and any initiative to reduce these challenges is needed.

In this randomized controlled trial, isolated patients with diabetes will be randomized to either standard care fingerprick glucose + blinded CGM or Dexcom G6 only.

Eligibility Criteria:
Inclusion Criteria:

1. Hospitalized with confirmed COVID-19 infection by real-time PCR or another validated method OR hospitalized with a non-COVID-19 diagnosis AND in isolation at time of inclusion.
2. A documented clinically relevant history of diabetes or newly discovered during hospitalization.
3. Written informed consent obtained before any trial related procedures are performed.
4. Male or female aged over 18 years of age.
5. Must be able to communicate with the study personnel.
6. The subject must be willing and able to comply with trial protocol.

Exclusion Criteria:

1. Known hypersensitivity to the band-aid of the Dexcom G6 sensors
High Flow Oxygen and Non Invasive Ventilation for Hypercapnic Respiratory Failure

this study evaluates high flow oxygen therapy in addition to non invasive ventilation (NIV) to treat hypercapnic respiratory failure. Between sessions of NIV, half of participants will have high flow nasal cannula while the others will have standard low flow oxygen therapy.

High Flow Nasal Cannula (HFNC) is a new way of oxygen therapy that has gained interest in the management of patients with acute respiratory failure. It allows reaching a high flow air up to 60 liters / min via a nasal cannula with a humidification and warming of the air administered. It has a number of physiological effects such as wash out of anatomical dead space, generation of a small PEEP and high inspired fraction of oxygen which enhances compliance and reduces inspiratory efforts.

NIV is the corner stone in the treatment of severe COPD exacerbation. Nevertheless, prolonged application of the facial mask expose to local complications and intolerance which can be a cause of failure, so reducing the duration of exposure to this procedure is important.

The role of HFNC in supplementing NIV effect during hypercapnic respiratory failure has not been assessed. Much of the data available on HFNC are about hypoxemic respiratory failure.

Because of its physiological effects, it can be hypothesized that HFNC in addition to NIV can shorten its duration by facilitating carbon dioxide clearance.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged more than 18 years with a diagnosis of acute-on-chronic respiratory failure and respiratory acidosis requiring NIV.

Exclusion Criteria:

* Patient included in another study
* Patients intubated at ICU admission or within 12 hours
* Contraindication to NIV including: pneumothorax, Hemodynamic instability, GCS less than 12, facial malformation
* Asthma
* A do not intubate order
* Neuromuscular disease
Delivery Vehicles for Prenatal Calcium Supplementation

The SickKids-led research team is currently developing a prenatal micronutrient powder that will contain calcium, iron, and folic acid with different absorption characteristics. Once the powder is developed, it can be incorporated into various oral delivery vehicles. The overall effectiveness of a micronutrient program is highly dependent on the acceptance and regular consumption of supplements (i.e., adherence) by the targeted users. This is a study of the preference, acceptability, and palatability of 4 alternative delivery vehicles for the innovative prenatal multiple micronutrient supplement: traditional tablets, oral disintegrating tablets, unflavoured powder with a suspension agent, and flavoured powder with a suspension agent. This study will be conducted in Dhaka, Bangladesh. This study hypothesizes that that the formulation of the delivery vehicle will impact preference, acceptability, and palatability.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women ages 18 to \< 40 years
* Gestational age of 13-30 completed weeks, estimated based on the recalled first day of the last menstrual period (LMP)
* Current residence in Dhaka at a fixed address
* Plan to remain in Dhaka for the duration of the study

Exclusion Criteria:

* Reported complications of current pregnancy
* Complicated medical or obstetric history that may increase the risk of preterm birth or prenatal complications, based on self-report
* Moderate or severe anaemia (hemoglobin \< 90 g/L, accessed with Hemocue)
Platelet Inhibition by Aspirin, Acetaminophen and NSAID

Nonsteroidal antiinflammatory drugs such as diclofenac or naproxen may interfere with the inhibition of platelet aggregation by aspirin, because they all interact with the platelet cyclooxygenase.This may be of great clinical importance because of an increased cardiovascular event rate (myocardial infarction, stroke). The present randomized, controlled study analyses in vitro platelet aggregation under a combined treatment of healthy volunteers with aspirin and either acetaminophen, diclofenac, naproxen, or placebo.

An in vivo study on healthy volunteers with combinations of well established drugs

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Administration of drugs affecting platelets
* History of bleeding
* Gastrointestinal disorders
* Hypersensitivity to aspirin and/or NSAID
* Pregnancy and breast feeding
An Observational Study to Describe EVUSHELD™ (Tixagevimab/Cilgavimab) Pre-exposure Prophylaxis in Real-world Setting in Japan

This is an observational, cohort study that will use secondary data to describe the baseline demographics and clinical characteristics in patients who received EVUSHELD as PrEP against SARS-CoV-2 infection/COVID-19 in Japan.

All patients who have a record of administration of EVUSHELD in the database will be included in the study. The index date will be defined as the date of first EVUSHELD administration in the database (Day 0) and the patients will be followed up to 6 months after the index date (Day 1 to 180). The look back period is defined as the 12-month period prior to index date (Day -360 to -1). The exposure of interest will be defined as the administration of EVUSHELD for use as PrEP against COVID-19. As the result of feasibility assessment, sample size of the study expected to be approximately 280.

This is an observational, cohort study that will use secondary data to describe the baseline demographics and clinical characteristics in patients who received EVUSHELD as PrEP against SARS-CoV-2 infection/COVID-19 in Japan.

All patients who have a record of administration of EVUSHELD in the database will be included in the study. The index date will be defined as the date of first EVUSHELD administration in the database (Day 0) and the patients will be followed up to 6 months after the index date (Day 1 to 180). The look back period is defined as the 12-month period prior to index date (Day -360 to -1). The exposure of interest will be defined as the administration of EVUSHELD for use as PrEP against COVID-19. As the result of feasibility assessment, sample size of the study expected to be approximately 280.

Eligibility Criteria:
Inclusion Criteria:

* Immunocompromised patients who were administrated EVUSHELD as PrEP and have administration date of EVUSHELD
* patients aged ≥ 12 years at the index date

Exclusion Criteria:

* Patients who have no medical visit records at any time in the 12 months preceding the index date