cyrilzakka/clinical-trials huggingface dataset:
AQT90 FLEX NTproBNP2 Test Kit - 23004 - Reference Interval Study

The purpose of this study is to establish the overall (age- and sex independent) at least 95th percentile upper reference limit (URL) of the NTproBNP2 Test Kit on the AQT90 FLEX analyzer.

The NTproBNP2 Test is an in vitro diagnostic assay for the quantitative determination of N-terminal pro-B-type natriuretic peptide {NT-proBNP) in EDTA or lithium heparin whole blood or plasma specimens on the AQT90 FLEX analyzer in point of care/ near-patient testing and laboratory settings. It is intended for use as an aid in the diagnosis of heart failure. The test is also intended for use as an aid in the risk stratification of patients with acute coronary syndrome and heart failure.

The NTproBNP2 CAL Cartridge is an in vitro diagnostic reagent intended for the calibration adjustment of the NTproBNP2 Test on the AQT90 FLEX analyzer by establishing points of reference to estimate NT-proBNP values.

The AQT90 FLEX analyzer is an immunoassay instrument based on the quantitative determination of time-resolved fluorescence to estimate the concentrations of clinically relevant markers on whole-blood and plasma specimens to which a relevant anticoagulant has been added. It is intended for use in point of care/ near-patient testing and laboratory settings.

Eligibility Criteria:
Inclusion Criteria:

* Subject must have given their valid consent to donate their sample in the sample bank
* Subjects must have been 18 years of age or older at the time of sample collection
* Subject must have answered yes, to being generally healthy, in the health questionnaire
* Subjects must, as a minimum, have completed questions regarding age, gender, race, and ethnicity

Exclusion Criteria:

Answered yes to any of the conditions below (Information gathered from a self-reported health questionnaire or results from blood sample tests):

* Current medications for treating cardiovascular diseases at the time of sample collection
* Current antibiotics (Indicates ongoing infections)
* Known to suffer from any of the illnesses below at the time of sample collection:

  * Disease(s) of/or affecting the cardiovascular system
  * Congestive heart failure
  * Hypertension
  * Previous history of any heart disease
  * Diabetes (Either self-reported in questionnaire or a glycosylated hemoglobin (HbA1C) in the diabetic range (above 6.4%)
  * Renal dysfunction or failure (An estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73m2.) This is to be calculated using information on age, sex and creatinine using the 2021 chronic kidney disease epidemiology (CKD-EPI) creatinine equation.
  * Cancer or history of cancer
Combined Effect of LIMICOL and Physical Activity on LDL Cholesterol and Muscle Function.

Cardiovascular disease (CVD), foremost among which ischemic heart disease and stroke, are the leading cause of mortality and morbidity in France. These diseases are multifactorial origin and even if it is not possible to act on risk markers such as age, sex, or heredity, risk factors like high cholesterol, smoking , hypertension, obesity, diabetes and physical inactivity, are the main target of prevention strategies. Dydlipidemias have a role in the formation of CVD in participating in the genesis of atherosclerosis. The cholesterol and LDL-cholesterol in particular is subject to oxidation process in plasma. The molecules of oxidized LDL-cholesterol, small and dense, easily penetrate the arterial endothelial wall and are greeted by macrophages. Following a succession of different processes including inflammation, atherosclerotic plaque is formed. The result is either an arteriopathy when the arterial lumen narrowing, or atherothrombosis in the event of plaque rupture. Given this pathophysiology, reduce blood lipids, including LDL-cholesterol and reducing oxidation and inflammation are interesting strategies in the context of cardiovascular prevention. Several scientific study showed that nutritional supplementation with some plant extracts such as artichokes, garlic, red yeast rice, or the sugar cane policosanol helps to reduce several cardiovascular risk factors including regulate concentrations of circulating lipids.

In this study, we hypothesize that the food supplement LIMICOL contributes to reducing LDL cholesterol in the context of care for patients (dietary measures and physical activity)


Eligibility Criteria:
Inclusion Criteria:

* BMI between 25 and 35 kg/m²
* Subject has a stable weight for at least three months before the start of the study.
* LDL ≥ 1.50 g/L
* 0.9 g/L ≤ triglycerides ≤ 4.00 g/L
* Subject able and willing to comply with the protocol and agreeing to give his informed consent in writing;
* Subject affiliated with a social security scheme

Exclusion Criteria:

* Subject having a confirmed or suspected food allergy, notably to one of the components of the study product;
* Subject suffering from a severe chronic condition deemed incompatible with participation in the study by the investigator
* Subject with glaucoma
* Subject with uretroprostatic disorder
* Subjet anxious (score \>9 HAD scale)
* Subject with diabetes
* Subjet with treatment anticoagulant
Vitamin D Supplementation and Clinical Outcomes in Severe COVID-19 Patients

Single center, open label randomized clinical trial.

Study location: tertiary hospital center (University Hospital Split, Croatia). All COVID-19 patients with positive PCR test admitted to ICU and in need for respiratory support will be eligible for inclusion in this study.

Patients admitted to ICU with severe COVID-19 disease and in need for invasive or non-invasive respiratory support with low levels of vitamin D (\<50 nmol/l) measured on admission. All patients are older than 18 years and have confirmed COVID-19 disease with PCR test.

Intervention:

All patients included in this study will receive standard of care. Patients randomized into intervention group will be receiving 10 000 IU of cholecalciferol daily. Supplement will be administered orally or via gastric tube during ICU stay or for at least 14 days in case of ICU discharge before day 14. Supplementation will begin within 48 hours of admission to ICU. Supplement will be prepared and administered by experienced nursing staff. For patients receiving supplementation, vitamin D levels will be checked on days 7 and 14. In case that vitamin D levels are \> 150 nmol/l or if the calcium levels are consistently \> 2.6 mmol/l, further supplementation will be stopped.

Outcomes:

Primary outcome is number of days spent on ventilator.

Secondary outcomes: all-cause mortality on day 28, all-cause mortality on day 60, mortality at hospital discharge, clinical improvement at day 28 (WHO clinical progression scale), days spent in ICU, days spent in hospital after discharge from ICU, need for dialysis at day 28, bacterial superinfections, neutrophile to lymphocyte ratio, disease severity (CRP levels, PaO2/FiO2 ratio, D-dimer levels, fibrinogen, ferritin, PCT), adverse outcomes.

Hypothesis: patients receiving Vitamin D supplementation will have shorter number of days spent on mechanical ventilation.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to ICU with severe COVID-19 disease and in need for invasive or non-invasive respiratory support with low levels of vitamin D (\<50 nmol/l) measured on admission. All patients are older than 18 years and have confirmed COVID-19 disease with PCR test.

Exclusion Criteria:

* Patients will be excluded from study in case of calcium levels that are consistently above normal serum range (\> 2.6 mmol/L, \> 10.5 mg/dL) or if vitamin D levels are \> 150 nmol/L.
Functional MRI Study of Attention in Normal Controls and Traumatic Brain Injured Patients

The purpose of this study will be to assess the attentional ability of patients with mild to moderate traumatic brain injury (TBI) using the functional Magnetic Resonance Imaging (fMRI) technique. Methodology for specific aim 1: sagittal pilot scan, 3-D anatomical MRI, Whole brain echo-planar imaging (EPI), and functional MRI techniques with traumatic brain injured subjects doing a Continuous Performance Test (CPT) attention task and compare the pattern of activation with those of normal controls to see if there is a failure to activate frontal lobes in the traumatic brain injured subjects.


Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate brain injury patients referred to the UCI Brain Imaging Center.

  * Mild brain injury patients will be defined as having a Glascow Coma Scale (GCS) scale of 13-15.
  * Moderate brain injury brain injury patients will be defined as having a Glascow Coma Scale (GCS) scale of 9-12 .
* Normal healthy control subjects (20)

Exclusion Criteria:

* Pre-accident neuropathology, psychopathology, or secondary neuropathological complications, or chemical abuse
* Patients who required intracranial surgical intervention
* Children, pregnant women, or institutionalized individuals unable to freely give consent
* Patients with implanted surgical clips (hemostatic clips) or other ferromagnetic material
* Patients engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials, or who may have imbedded metal fragments from military activities
* Patients with permanent (tattoo) eye-liner or with facial make-up (severe eye irritation has been reported)
* Patients with metallic implants, because they may cause artifacts in diagnostic images due to magnetic field distortion
* Patients with implanted prosthetic heart valves
* Patients with pacemakers, neuro-stimulation devices
* Subjects who have severe claustrophobia.
Physiologic Growth Hormone Effects in HIV Lipodystrophy

This study will investigate long-term, low-dose growth hormone administration in HIV-infected patients with reduced growth hormone (GH) secretion and increased visceral adiposity. We hypothesize that low-dose growth hormone will reduce visceral fat. Secondary endpoints will include measures of insulin-like growth factor-1 (IGF-1), glucose homeostasis, lipids, blood pressure,bone density, cardiovascular risk and safety parameters.

This study will investigate long-term, low-dose growth hormone administration in HIV-infected patients with reduced growth hormone (GH) secretion and increased visceral adiposity. We hypothesize that low-dose growth hormone will reduce visceral fat preferentially over subcutaneous fat, and increase lean body mass. Secondary endpoints will include measures of IGF-1, glucose homeostasis, lipids, blood pressure,bone density, cardiovascular risk and safety parameters. Dosing of growth hormone will be based on patients' IGF-1 levels and will not exceed 6mcg/kg/day.

Eligibility Criteria:
Inclusion Criteria:

* Men and women age 18-60
* Previously diagnosed HIV infection
* Stable antiviral regimen for at least 12 weeks prior to enrollment
* Waist-to-hip ratio \>0.90 for men and \>0.85 for women
* Evidence of at least one of the following recent changes: \*increased abdominal girth,

  \*relative loss of fat in the extremities, \*relative loss of fat in the face
* Simulated peak GH response to arginine/GHRH of less than 7.5 mcg/dL

Exclusion Criteria:

* Use of Megace, anti-diabetic agents, GH, or other anabolic agents, pharmacologic glucocorticoid (prednisone \>5 mg/day or its equivalent) for 3 months prior to enrollment. Patients on a standard dose of testosterone for documented hypogonadism will be allowed to enter the protocol. Women taking standard estrogen replacement therapy for \>3 months will be allowed in the study.
* Diabetes mellitus
* Other severe chronic illness
* HgB \<9.0 g/dL, creatinine \>1.4 mg/dL, or PSA \>4 ng/mL
* Positive BHCG or failure to use appropriate birth control during study. Acceptable methods include oral contraceptives, depo provera or combined progesterone-estrogen injections, transdermal contraceptive patches, IUD's, barrier devices (condoms, diaphragms), and abstinence.
* Carpal tunnel syndrome
* Active malignancy or history of pituitary malignancy, history of colon cancer or prostate malignancy
Exophthalmometry With 3D Face Scanners

This study investigates diagnostic methods to measure eyeball protrusion with a smartphone face scanner compared to the traditional Hertel exophthalmometer. The study aims to validate a new reliable, fast and convenient smartphone app to measure the protrusion of the eyeball in different diseases such as Graves' disease, orbital tumors, orbital fractures or orbital inflammation, as well as other rare diseases.

BACKGROUND: Accurate and reproducible measures of abnormal eyeball protrusion are important for diagnosing different causes of exophthalmos, as well as following patients with Grave's orbitopathy and retroorbital tumors. The current clinical gold standards for measuring abnormal eyeball protrusion is the Hertel exophthalmometer, which is prone to reading errors and inconvenient to use.

OBJECTIVE: The purpose of the EX3D-project is to replace the historic Hertel Exophthalmometer with a state-of-the-art mobile smartphone app that every ophthalmologist can carry in his pocket.

METHODS: The investigators developed an accurate and easy to use method for measuring abnormal eyeball protrusion using the TrueDepth camera of the iPhone 11 in comparison with a high-resolution 3D scanner as a reference to compare with the Hertel Exophthalmometer.

OUTCOMES:

1. Accuracy and precision of 3D face-scanner and iPhone in comparison to Hertel Exophthalmometer.
2. Test re-test reliability in comparison to Hertel Exophthalmometer.
3. Inter-operator reliability against Hertel Exophthalmometer.
4. Patients before and after exophthalmos changing treatment.
5. Applicability in daily clinical practice.

BROADER IMPACT: The invention makes exophthalmometry quick, easy and objective. A mobile smartphone application would replace measurements with the traditional Hertel Exophthalmometer, which are cumbersome, prone to reading errors and have a poor inter-rater reliability as well as test-retest reliability.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Able to cooperate with the study investigations (hearing, comprehension)
* Exophthalmos (Grave's disease, orbital tumors, orbital inflammation, orbital fractures, rare causes (congenital, e.g. microphthalmos)
* health controls

Exclusion Criteria:

* Unable to sign informed consent
* Unable to cooperate with the examinations (hearing loss, neurological deficits)
Peculiarities of Pain in Patients With Mine-explosive Wounds Depending on the Localization of the Wound at the Stages of Treatment

Mine-explosive wounds in the general structure of combat sanitary losses reach 25%. They are characterized by significant damage resulting in high intensity pain. In patients who received mine-explosive injuries in the conditions of hostilities, such pain has its own unique features. It is necessary to pay more attention to the problem of pain treatment in patients of this category, because about 87.2% of cases have negative results of treatment - it becomes chronic.

Over the last ten years, the amount of pathology caused by mine-explosive devices has increased significantly. Mine-explosive wounds in the general structure of combat sanitary losses reach 25%. They often have a combined character. Such an injury must be considered as a multifactorial injury resulting from the combined impact on a person of a shock wave, gas jets, flames, toxic products, fragments of the hull, secondary projectiles, which cause severe injuries in the area of direct damage and the body as a whole. Mine-explosive injuries are characterized by multiple, combined or combined injuries with a high degree of severity - 8-10%. Also, even in peacetime, terrorists often use powerful explosive devices. Here, the mortality rate is 10-20% of the total number of injured, and 80-90% suffer from the consequences - mine-explosive injuries. Compared to the wars of the past, the number of seriously wounded with combined injuries has increased to 25-30%. This is primarily due to the use of high-precision ammunition and mine-explosive ammunition. In general, multiple and combined damage in local conflicts today is 25-62%. Lethality in case of mine-explosive injury reaches 37-41.4%. The mortality rate among the wounded with mine-explosive injuries who were admitted to the stage of qualified medical care was 17.4%, more than half of the wounded died as a result of blood loss. In 63.7%, death occurs in the first 24 hours after injury.The direct and most frequent causes are shock and blood loss (49.1%), destruction of vital organs (28.4%). About 90% of all combat deaths occur before the wounded reaches the first stage of treatment.

The peculiarities of pain in patients with mine-explosive wounds depending on the localization of the wound at the stages of treatment need to be studied, because the subjective feelings and emotional experiences experienced by patients during the wounding in combat conditions through the prism of psychological disorders have their own characteristics. Since in 87.2% of cases it is not possible to achieve a positive result of treatment, the data of our study will play an important role in their treatment.

Eligibility Criteria:
Inclusion Criteria:

* the presence of gunshot wounds

Exclusion Criteria:

* no gunshot wounds
Postprandial Dysmetabolism

Type 2 diabetes (T2D) is a common disease associated with multiple complications and an increased risk of cardiovascular morbidity and mortality. Also, it is a heavy economical burden on society. 1st degree relatives of patients with T2D have an increased risk of developing T2D. This risk can be modified by the ingested diet: a traditional north European diet rich in saturated fat increases the risk, while a Mediterranean diet rich in monounsaturated fat protects from development of T2D and cardiovascular disease.

T2D is a part of the metabolic syndrome consisting of T2D, hypertension, adipositas, dyslipidemia and steatosis. The pathogenesis of the metabolic syndrome is partly explained by fasting dyslipidemia, postprandial dysmetabolism (derangement of lipid and carbohydrate metabolism) and impaired metabolic flexibility. Partly, it can be explained by a chronic low-grade inflammation in peripheral tissue. The dysmetabolism and the inflammation are correlating entities exerting their influence through common biochemical pathways. This is established in patients with T2D, but sparsely studied in healthy relatives of patients with T2D.

In this project, the investigators will study postprandial dysmetabolism, inflammation, oxidative stress, adipocytokines, incretins, appetite regulating hormones and the expression of the genes involved in above mentioned. We will compare healthy 1st degree relatives of patients with T2D with healthy controls with no family history of T2D and look into differences in the response to meal stimulation with respectively saturated and monounsaturated fat. The subjects will be thoroughly examined with a hyperinsulinaemic euglycaemic clamp and a DEXA scan. Before and after the meal stimulation, we will perform calorimetry (in order to determine the metabolic rates), take blood samples and perform muscle and fat tissue biopsies. The biopsies will be used for studies of a vast number of genes.

The project will give us new valuable knowledge about the interaction between the intermediate metabolism and the innate immune system and the early pre-diabetic changes in the 1st degree relatives of patients with T2D. In the long run, the project will contribute to improving our guidance and treatment of persons at risk of developing T2D.


Eligibility Criteria:
Inclusion Criteria:

* Relatives: Minimum 2 1st degree relatives with type 2 diabetes or 1 one 1st degree relative with type 2 diabetes and history of gestational diabetes.
* Controls: No family history of type 2 diabetes and fasting blood glucose \<6.0 mM.

Exclusion Criteria:

* Cardiovascular, renal or endocrine disease.
* Treatment with steroids.
* Psychiatric history.
* Abuse of alcohol or narcotics.
* Smoking.
* Pregnancy or breast-feeding.
The PREVENT AGITATION Trial II - Children ≤1 Year

Emergence agitation is a clinical condition in which the child experiences a variety of behavioural disturbances including crying, thrashing, and disorientation during early awakening from anaesthesia. Emergence agitation is a common challenge in children with a reported incidence of approximately 25% ranging from 10 to 80 %. Clonidine is often used off-label in paediatric anaesthesia e.g. sedation in the intensive care unit, prevention of withdrawal symptoms after long-term sedation, as premedication before induction of anaesthesia or as treatment/prevention of emergence agitation. The study is designed as a randomised, placebo-controlled clinical trial evaluating efficacy and safety of a single dose of intraoperative clonidine in children 3-12 months, including pharmacokinetics.


Eligibility Criteria:
Inclusion Criteria:

* Paediatric patients (male and female), aged 3- ≤ 12 months
* Scheduled general anaesthesia with sevoflurane and opioid. Induction with propofol is optional
* The legally acceptable representative for the study participant provides written informed consent/assent for the trial

Exclusion Criteria:

* ASA \>2
* Cardiac, neuro and trauma surgery
* Ex-premature (\<37 weeks) • Premedication with clonidine
* Intubated prior to scheduled anaesthesia or is expected to require intubation after the procedure
* Critical illness incl. hemodynamic instability (inotropic drugs needed)
* Bleeding requiring transfusion prior to scheduled anaesthesia
* Planned for a postoperative nurse-controlled analgesia pump including a continuous infusion of opioid
* Malignant disease
* Cardiac disease incl. arrhythmia
* Chronic lung disease that may influence study results or study participation in the opinion of the Investigator or may comprise safety and well-being of the patient
* Mental retardation
* Neurological disease including symptoms similar to emergence agitation
* Has or is suspected of having a family or personal history of malignant hyperthermia
* Has or is suspected of having an allergy to study treatment or its excipients
* Any condition that can in opinion of the Investigator, deteriorate safety and well-being of the patients or interfere with pharmacokinetic data
* Positive Covid-19 test or clinical suspicion of Covid-19 (according to current local guidelines)