cyrilzakka/clinical-trials huggingface dataset:
Cardiovascular Effects of Incremental Diesel Exhaust Inhalation in Middle-Aged Healthy GSTM1 Null Human Volunteers

Purpose: A growing body of epidemiological data suggests an increased risk of cardiovascular events associated with air pollutants. Reactive oxygen species (ROS) have been implicated as a potential mechanism for the adverse effects of air pollutants and genetic polymorphisms of the glutathione-s-transferases (GSTs) have been shown to participate in the antioxidant defenses to air pollutants. This study examined the dose effects of diesel exhaust exposure on the cardiovascular system in healthy middle-aged subjects.

Participants: Six healthy 50-75 year-old male and female subjects with GSTM1 null genotype had 3 sequential exposures to the diesel exhausts at concentrations approximately 100 µg/m3, 200 µg/m3, and 300 µg/m3 for 2 hours with a about 2 weeks of interval between exposures.


Eligibility Criteria:
Inclusion Criteria:

* Age 50-75 years old generally healthy male and female.
* Normal resting ECG.
* Oxygen saturation greater than 94% at the time of physical exam.

Exclusion Criteria:

* A history of angina, cardiac arrhythmias, and ischemic myocardial infarction or coronary bypass surgery.
* Cardiac pacemaker.
* Uncontrolled hypertension (\> 150 systolic, \> 90 diastolic).
* Neurodegenerative diseases such as Parkinson's and Alzheimer disease.
* A history of chronic illnesses such as diabetes, cancer, rheumatologic diseases, immunodeficiency state, known cardiovascular disease, chronic respiratory diseases such as chronic obstructive pulmonary disease or severe asthma.
* History of bleeding diathesis.
* Currently taking HMG-CoA reductase inhibitors for hyperlipidemia including lovastatin, pravastatin, simvastatin, and atorvastatin.
* Currently taking beta-blockers to control hypertension and/or arrhythmias.
* Use of oral anticoagulants.
* Participants must refrain from all over-the-counter NSAIDs for a period of two weeks prior to exposure. Low-dose aspirin will be acceptable. Medications not specifically mentioned here may be reviewed by the investigators prior to a participant's inclusion in the study.
* Subjects who are currently smoking or have smoking history within 1 year of study (defined as more than one pack of cigarettes in the past year).
* Subject is pregnant, attempting to become pregnant or breastfeeding.
* No exposure will be conducted within 4 weeks of a respiratory tract infection.
Impact of Aspiration Thrombectomy During Carotid Stenting

The purpose of this study is to determine whether aspiration thrombectomy following carotid stent deployment will reduce the number of procedure related signals as identified by diffusion weighted MRI of the brain.

Studies have demonstrated that carotid artery stenting is a safe and effective alternative to carotid endarterectomy for high or standard risk patients with symptomatic stenosis. Despite the routine use of embolic protection devices, numerous studies have shown that carotid stenting is associated with a higher degree of intracranial emboli by diffusion-weighted MRI of the brain. A potential solution to minimize this effect is the use of aspiration prior to distal embolic protection removal.

Eligibility Criteria:
Inclusion Criteria:

* ICA stenosis greater than 50 percent by carotid angiography
* Documented hemispheric ischemic stroke, TIA, amaurosis fugax, or retinal stroke in the last six months ipsilateral to the stented lesion

Exclusion Criteria:

* Subject less than 40 years of age
* Pregnant subjects
* Asymptomatic carotid stenosis
* Total occlusion of target carotid artery
* Inability to deploy distal protection device or stent in target vessel
* Allergy to both aspirin and approved thienopyridine anti-platelet drugs (clopidogrel/ticlopidine)
* Multiple carotid stenoses in same vessel that cannot be covered by single stent
* Ipsilateral intracranial stenosis requiring treatment
* Isolated common carotid stenosis
* Stenosis less than 50 percent by angiography
* Chronic or paroxysmal atrial fibrillation not treated with warfarin or dabigatran.
* Life expectancy less than 30 days
* Active bleeding diathesis
* Suspected Myocardial Infarction within 72 hours prior to carotid stenting
* Presence of intracranial tumor arteriovenous malformations or aneurysm requiring treatment
* Inability to undergo DWMRI
* Unwillingness to participate or provide consent
* Subjects using a legally authorized representative for consent for participation
* Concurrently enrolled in another study
* Stroke, TIA, amaurosis fugax ipsilateral to the treated lesion more than 6 months from randomization
* Occlusive or critical ilio-femoral disease that precludes safe femoral access to the aortic arch
* Severe atherosclerosis of the aortic arch or origin of the innominate or common carotid arteries
* Prior large stroke, multiple lacunar infarcts, or dementia
* Stenosis that contain visible thrombus
Study to Verify the Feasibility of Collecting a Broad Variety of Individual Health Data

The purpose of the OBSERVE PILOT is to verify the feasibility of collecting individual health data which is obtained through blood samples, continuous monitoring devices, medical imaging, a questionnaire, and a blood pressure monitor.

Feasibility of collecting individual health data within the OBSERVE PILOT is described as the ease of gathering a broad variety of data by assessing: (1) the willingness of the subjects to participate in the study, (2) the logistics corresponding with the variety, and (3) the regulatory aspects of gathering a broad variety of data.


Eligibility Criteria:
Inclusion Criteria:

* The subject is able and willing to provide written informed consent prior to research specific data collection.
* The subject must be older than 18 years old.

Exclusion Criteria:

* The subject should not suffer from glaucoma.
* The subject should not be allergic to eye drops.
A Phase 1 Study of Osilodrostat (LCI699) in Healthy Volunteers and Subjects With Impaired Hepatic Function

To assess the pharmacokinetics of a single oral dose of osilodrostat (LCI699) 30 mg in subjects with mild, moderate and severe hepatic impairment compared with subjects with normal hepatic function.


Eligibility Criteria:
Inclusion Criteria:

* Weight ≥50 kg and BMI between 18-38kg/m2.
* Stable liver cirrhosis and evidence of hepatic impairment.
* Free of significant medical disorders unrelated to underlying hepatic impairment

Exclusion Criteria:

* History of any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs
* Subjects with ongoing alcohol or drug abuse
* Symptoms or history of encephalopathy (Grade 2 or above)
* History or presence of liver disease or liver injury (healthy volunteers only)
* History or presence of impaired renal function
* Clinical evidence of severe ascites.
* Total Bilirubin \> 6 mg/dL,
* Subjects with a serum free cortisol test results that is below the lower limit of normal (based on central laboratory) during the screening period
* Concomitant use of a drug that is a strong inducer of the CYP3A4/5 pathway

Other protocol-defined inclusion/exclusion criteria may apply -
The Application of the Flipped Model in the Nursing Process and Evaluation of Its Reflection in the Clinic

Teaching the nursing process that nursing students will use throughout their professional career is very important. In this direction, considering the Z generation, innovative and technology-based teaching methods should be used. Since the subject of the nursing process is the building block of nursing, its teaching should also be effective. The use of innovative and technology-based education methods that will increase the active participation of the students in the teaching of the nursing process, reinforce the learning, and encourage them to use problem-solving and critical thinking skills has been very important in recent years. For this reason, this research was planned to examine the effect of flipped learning(FL) on students' problem solving and critical thinking skills and their views on this model in nursing process teaching. In this study, it will be carried out with mixed method. In the quantitative part of the research, pre-test-post-test, experimental design with randomized control group will be used, and in the qualitative part, case study and phenomenological design will be used.

Ethics committee approval was obtained from the Sakarya University Faculty of Medicine.In this study, it will be carried out with mixed method.

In the quantitative part of this research, pre-test-post-test, experimental design with randomized control group will be used, and in the qualitative part, case study and phenomenological design will be applied. Considering the losses as a result of the G-power analysis, the sample of the research was planned to consist of 23 students in the intervention group and 23 students in the control group. A stratified randomization process will be carried out by applying the pre-test data to the students who meet the inclusion criteria of the study.

In this study, FL will be applied to the intervention group for 5 weeks, while the traditional method will be applied to the control group for 5 weeks.

In the quantitative dimension of the research, critical thinking disposition scale and problem solving inventory will be used. A semi-structured interview form will be used in the qualitative aspect of the research.

Eligibility Criteria:
Inclusion Criteria:

Not having seen the subject of the nursing process before

* Adequate internet access
* Being willing to participate in the study.

Exclusion Criteria:

* Not willing to participate in the study
Effects of Early Nutrition on Growth

The primary objective of the study is to compare the growth of infants fed standard infant formula with infants fed a reduced calorie and protein formula.


Eligibility Criteria:
Inclusion Criteria:

* good health
* singleton birth with gestational age 37-42 weeks
* infant's birth weight \>or = to 2500 grams
* exclusive breastfeeding or exclusively formula feeding
* within a defined geographical boundary
* mother has no problems communicating in English

Exclusion Criteria:

* adverse maternal, fetal or infant medical history
* congenital disease or malformation affecting growth or development
* illness or social problems in mother or infant
* temporary residents
Safety, Tolerability, and Efficacy of Deferasirox in MDS

Open label, single arm study on Deferasirox treatment in MDS patients with chronic transfusional hemosiderosis.

Patients receive daily oral dosis of Deferasirox in order to eliminate the quantity of iron administered during transfusions and, if needed, to reduce the overload of already present iron.

After an screening phase in which patients are evaluated according to eligibility criteria, a one year treatment phase foresees monthly visits to evaluate safety and efficacy signs.

It has been widely shown that an appropriate chelating therapy in chronic anemias transfusion dependent can prevent the overstock of iron and can reduce the already existing overstock reducing, then, the co-morbidity and improving survival.

In particular, some authors have shown in MDS affected patients undergoing intensive chelating therapy with deferoxamine haematological recovery with a reduction of the need of transfusions.

With the present study, we plan to evaluate the safety and efficacy of a therapy with the new oral chelating Deferasirox in MDS patients with transfusional hemosiderosis.

This is an open label, single arm study on Deferasirox treatment in MDS patients with chronic transfusional hemosiderosis.

Patients will receive daily oral dosis of Deferasirox in order to eliminate the quantity of iron administered during transfusions and, if needed, to reduce the overload of already present iron.

After an screening phase in which patients are evaluated according to eligibility criteria, a one year treatment phase foresees monthly visits to evaluate safety and efficacy signs.

Eligibility Criteria:
Inclusion Criteria:

* Patients, both males and females, with low and intermediate I risk (IPSS score) Myelodysplastic syndrome and transfusion-induced hemosiderosis.
* Age \>=18 years
* Patients who never received chelation therapy or who received a therapy with Desferal after a day of wash out
* Medical history of at least 20 blood transfusions (equivalent to 100 ml/kg of red cells concentrate).
* Availability of data concerning blood transfusions during the 12 weeks before screening
* Serum ferritin \>= 1000 µg/L at least twice (at least 2 week interval between the 2 analysis) during the year before the screening
* Life expectancy \> 12 months
* Availability of at least 3 complete blood counts (before transfusions) during the 12 weeks before the screening

Exclusion Criteria:

* Diagnosis different from MDS (i.e. myelofibrosis)
* Severe renal impairment (creatinine clearance \< 60 ml/min)
* ALT/AST \> 500 U/L
* Active B and/or C hepatitis
* Patients treated during the past 4 weeks with experimental drugs for MDS (including thalidomide, azacitidine, arsenic trioxide). These patients become eligible after a "wash out" of at least 4 weeks
* Concomitant treatment with another iron-chelating agent
Time-dependent Change in the Retention Force of the Implant Overdenture

This descriptive longitudinal study aimed to investigate the retention force of implant-supported overdentures applied to edentulous individuals at Marmara University Faculty of Dentistry, examine the retention force and its time-dependent change, and evaluate patient satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* 50-65 years old,
* Volunteer to participate in the study,
* Upper edentulous jaw with full denture, lower edentulous jaw with two-implant overdenture

Exclusion Criteria:

* Pregnant or lactating women
* Those who do not want to sign the consent form,
* Patients with a history of malignancy, radiotherapy, or chemotherapy
* Patients whose maxilla was rehabilitated with implant overdenture
* More than 2 implants for lower jaw implant overdenture
How Astigmatism Influences Corneal Biomechanics and Intraocular Pressure

The aim of the study was to identify whether preoperative corneal astigmatism can influence corneal biomechanics and the assessment of intraocular pressure (IOP) following micro-incision phacoemulsification.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis and qualification for cataract surgery, corneal astigmatism of equal to or less than 2.25 Dcyl

Exclusion Criteria:

* corneal astigmatism higher than 2.25 Dcyl, history of any other corneal disease (infection, trauma, ulceration, autoimmune inflammation, Fuchs Dystrophy, keratoconus, corneal scars, preoperative insufficiency of corneal endothelium), glaucoma and chronic use of non-glaucoma eye drops, blepharitis, dry eye, use of contact lenses diabetes or a history of corneal refractive surgery
Ultrasound Parameters to Predict Difficult Airway

Ultrasound has become an essential tool for the daily work of any doctor, but in certain specialties such as Anaesthesiology, its use has greatly increased the safety offered to patients throughout the perioperative period, either to perform nerve blocks, for vascular access, intraoperative hemodynamic management or any other use that allows increasing quality of care.

The management of the upper airway and the diagnosis of pathological conditions are essential skills for any doctor especially for Anaesthesiologist, ER physician, or Intensive Care physician. Because an inadequate airway management continues to be an important contributor to patient mortality and morbidity, any tool that can improve it should be considered as an addition to conventional clinical evaluation.

Unfortunately, most of the clinical parameters that should allow us to assess a potential difficult airway, do not always lead us to an adequate prediction, that is why US(Ultrasound) is use as an emerging tool in many fields, is also gathering strength in this search for a definitive predictor parameter.

Ultrasound has many obvious advantages (safe,fast, repeatable, portable, widely available and gives dynamic images in real time).

Sonographic studies are operator-dependent and although the identification of basic structures could be acquired with only a few hours of training, but more complex studies require a learning curve of months or even years. The high frequency linear probe (5-14 MHz) is probably the most suitable for the airway because images are of superficial structures (within 0-5 cm below the skin surface).

The growing academic interest in the use of US to look for predictors of difficult airway is centred mainly on measurements at the level of pretracheal tissues.

But the greatest limitation of these studies is the disparity of the fat distribution that exists between different ethnic groups and and sexes, and the lack of standardization method in patient´s intubation conditions.

So, the investigator propose to assess different ultrasound windows at the level of pretracheal tissues such as independent predictors of Difficult Airway.


Eligibility Criteria:
Inclusion Criteria:

* Patients (male or female) ASA I-III, aged between 18 and 90 years, undergoing scheduled surgery requiring orotracheal intubation. The signature of the informed consent is required authorizing its inclusion in the study.

Exclusion Criteria:

* Obesity class II defined as a BMI greater than 35.
* Pregnant.
* Cervical tumors, goiter or patients who have required radiotherapy at the cervical level
* Abnormalities that condition anatomy alterations such as facial / cervical fractures.
* Maxillofacial abnormalities
* People who cannot give their consent.
Treatment for Subjects With Active Rheumatoid Arthritis (RA)

The purpose of this study is to assess the safety of etanercept liquid administered once weekly to subjects with RA.


Eligibility Criteria:
Inclusion Criteria: - Fulfill the 1987 American Rheumatism Association (ARA) criteria for RA - Active RA at the time of enrollment, receipt of concomitant methotrexate at a dose of up to 25 mg a week is permitted - Screening lab results must demonstrate:

* AST and ALT less than or equal to 2 times the upper limit of normal hemoglobin greater than or equal to 8.5 g/dL;
* Platelet count greater than or equal to 125,000/cm3;
* White blood cell count (WBC) greater than or equal to 3500 cells/cm3;
* Serum creatinine less than or equal to 2 mg/dL - Before any study specific procedure is performed, the subject must provide informed consent for participation in the study Exclusion Criteria: - Previous receipt of etanercept - Receipt of antibody to (tumor necrosis factor) TNF alpha or other TNF inhibitors within 90 days of Day 1 - Currently enrolled in other investigational device or drug trials, or participation in investigational trial within the past 30 days - Receipt of intra-articular corticosteroids within 14 days prior to Day 1 - Receipt of any disease-modifying anti-rheumatic drugs (DMARDs) within 28 days of Day 1 - Receipt of cyclophosphamide within 6 months of Day 1 - Concomitant corticosteroids greater than 10 mg/day of prednisone (or equivalent) during 14 days prior to Day 1 - Dose of nonsteroidal anti-inflammatory drug (NSAID) must be stable for 14 days prior to Day 1 and must not exceed the recommended dose in the product information sheet - Subject is not using adequate contraception - Subject is pregnant or breast-feeding - Subject has significant concurrent medical disease
Feasibility and Acceptability of Powdered Multinutrient Formula

The study aims to test the feasibility and acceptability of 1) consumption of EMPowerplus Lightning Sticks, 2) at-home collection of blood and urine samples, and 3) remote visits and completion of online behavioral questionnaires.

The study aims to test the feasibility and acceptability of 1) consumption of EMPowerplus Lightning Sticks, 2) at-home collection of blood and urine samples, and 3) remote visits and completion of online behavioral questionnaires. A limited number of blood samples will be used to generate cytokine data to test the ability to detect these molecules from the Tasso device-collected plasma. Parent and child questionnaire responses will examined for signals of change, but no formal statistical comparisons will be performed. This study will inform us whether a larger efficacy study is possible in this population.

Eligibility Criteria:
Inclusion Criteria:

1. Age inclusive of and between 7 and 16 years at the time of enrollment
2. Verbally willing to ingest one EmpowerPlus Lightning Stick daily
3. Attend all virtual study appointments and complete questionnaires
4. Have been previously enrolled in a multinutrient study OR complete a screening to match with participants from that study in terms of age and symptoms of ADHD and emotional dysregulation
5. Be medication and supplementation free (if supplement ingredient is contained in the Lightning Stick) prior to study initiation
6. Willing to collect blood and urine samples, once, at home.

Exclusion Criteria\*:

1. Neurological disorder involving brain or other central function (e.g., history of, or suspected, intellectual disability, autism spectrum disorder, epilepsy, multiple sclerosis, narcolepsy) or other major psychiatric condition requiring hospitalization (e.g. significant mood disorder, active suicidal ideation, or psychosis), based on parent/guardian self-report of child's condition
2. Any serious medical condition, including inflammatory bowel disease, history of cancer, kidney or liver disease, hyperthyroidism, diabetes Type I or II
3. Known allergy to any ingredients of the intervention
4. Any known abnormality of mineral metabolism (e.g., Wilson's disease, hemochromatosis)
5. Taking any medication with primarily central nervous system activity, including stimulants used to treat symptoms of ADHD
6. Any disability that would interfere with participant answering questions verbally
7. Non-English speaking
8. Pregnancy or sexually active at baseline. \*Exclusion criteria will be based on parent/guardian report on child. If the parent/guardian reports medical exclusion criteria, or concerns about eligibility, data provided by parent/guardian will be confirmed by review of medical records with release of information signed by parent/guardian. Potential participants may be reviewed virtually by study physician in the case of any concerns about participation.
The Influence of Inspiratory Muscular Training (IMT) on Diaphragmatic Mobility in Morbidly Obese

The purpose of this study is whether an inspiratory muscle training protocol would be associated with an improvement in of the diaphragm mobility, an increase in pulmonary function values , gain strength and endurance of respiratory muscles and improving quality of life.

Few studies have investigated the effects of an inspiratory muscle training in obese patients on the diaphragmatic mobility and thickness. Obesity, especially morbid, triggers changes in the respiratory system, which can affect the work activities and daily life of individuals with this multifactorial syndrome. These functional changes in mechanical ventilation may be linked to weakness and poor respiratory muscle strength, so by promoting rehabilitation of these muscles can minimize the losses that come with obesity

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 40 kg/m²
* Absence of acute or chronic lung disease

Exclusion Criteria:

* Acute or chronic inflammatory process
* Thyroid disorders