cyrilzakka/clinical-trials huggingface dataset:
Premedication With Nebulized Ketamine,Dexmedetomidine Versus Midazolam in Oncologic Preschool Children

Evaluate the efficacy of nebulized dexmedetomidine, nebulized ketamine, and nebulized midazolam a premedication prior to general anesthesia (GA) in oncologic preschool children undergo bone marrow aspirate and biopsy.

The preoperative period can be a traumatic time for young children undergoing surgery. Pediatric anesthesiologists strive to minimize distress for children in the operating room (OR) environment and to provide a smooth induction of anesthesia. Preoperative anxiety stimulates the sympathetic, parasympathetic, and endocrine systems, leading to an increase in heart rate (HR), blood pressure, and cardiac excitability. Various drugs have been advocated as premedication to allay anxiety and facilitate the smooth separation of children from parents. The ideal premedicant in children should be readily acceptable and should have a rapid and reliable onset with minimal side effects. Dexmedetomidine is a tasteless, colorless, and odorless drug that acts as a selective α-2 adrenergic agonist with both sedative and analgesic effects via actions in the central nervous system. Ketamine is an N-methyl-d-aspartate receptor antagonist that produces a state of sedation, anesthesia, immobility, analgesia, amnesia, and dissociation from the environment. Midazolam is a water-soluble benzodiazepine known to have a rapid onset and short duration of action, as well as properties of amnesia and anxiolysis. Administered intranasally, midazolam is an effective option for conscious sedation.

Eligibility Criteria:
Inclusion Criteria:

* physical status I and II, scheduled for bone marrow aspirate and biopsy

Exclusion Criteria:

* known allergy to the studied drugs,
* organ dysfunction,
* cardiac dysrrhythmia and/or congenital heart disease,
* psychotropic medication use and mental retardation
Influence of Coffeeberry Ingestion on Soccer Skill Performance

The study of soccer skill performance has 3 objectives. Objective 1 is to compare effects of coffeeberry (300mg) and placebo ingestion on dribbling speed and precision and passing and shooting speed and accuracy compared to placebo. 30 subjects will be assessed before dosing, after a 1 hr resting absorption period, and after simulated soccer match play. Of these 30, 20 subjects will proceed to Objective 2 (45 minutes of intense simulated soccer match play) and Objective 3 (repeated sprint activity continued until volitional fatigue).


Eligibility Criteria:
Inclusion Criteria:

* Provide valid informed consent prior to any study procedure
* Male soccer players age 16 to 28 years
* 5-year soccer playing experience
* 1-year regularly soccer training
* Free of injuries
* Willing to avoid alcohol in the 48-h period prior to main trials.
* Willing to avoid caffeine, caffeinated and decaffeinated products, apples, and, berries/cherries for 24-h prior to main trials
* Willing to record food intake over the 48-h period prior to the first trial and replicate for second trial
* Willing to abstain from strenuous physical activity for 24-h before all visits

Exclusion Criteria:

* Smoking
* Cardiovascular diseases
* Diabetes or other metabolic disease
* Presence of injuries
* Major illnesses or surgery in prior 90 days
* Participation in another clinical trial in the past month
Trial of Computerized SBI to Reduce Teen Alcohol Use

The goal of this project is to test the effectiveness of a computer-facilitated alcohol screening and brief intervention (c-ASBI) system for 12- to 18-year-old primary care patients in a multi-site, randomized comparative effectiveness trial. The investigators hypothesize that, among 12- to 18-year olds patients coming for annual well-care, those receiving c-ASBI will have lower rates of any alcohol use at 3-, 6-, and 12-month follow-ups compared to Treatment As Usual (TAU).

The Specific Aims are to 1) Test the effects of c-ASBI on any alcohol use; 2) Test the effects of c-ASBI separately as a prevention, therapeutic, and risk-reduction intervention; 3) Test the effects of c-ASBI separately on cannabis and tobacco use; explore its effects on other drug use; and 4) Assess potential moderators (e.g., age, gender, race/ethnicity, substance use history +/-, parent/sibling/peer substance use), mediators (e.g., Youth to Provider Connectedness,20 perceived harmfulness of alcohol and drug use), and explore c-ASBI's mechanism of action.

Eligibility Criteria:
Inclusion Criteria:

* Arriving for well or non-emergent care at one of participating study sites
* Have an email address
* Have internet address

Exclusion Criteria:

* Unable to read or understand English
* Living away at college at the time of the recruitment visit
* Not available for computer/telephone follow-ups
* Judged by the provider to be medically or emotionally unstable at time of visit
Evaluation of the Clinical Performance of the Quantra System With the QStat Cartridge in Trauma

This pilot study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the QStat Cartridge in trauma patients.

The Quantra System is a fully integrated and automated in vitro diagnostic device which uses SEER Sonorheometry, an ultrasound-based technology, to characterize the viscoelastic properties of a whole blood sample during coagulation. The QStat Cartridge was developed to monitor hemostasis in patients that may experience a range of coagulopathies of various etiologies including fibrinolytic defects. This includes the trauma patient population. The cartridge consists of four independent channels each containing different sets of reagents, which provide four measurements performed in parallel yielding five parameters that depict the functional status of a patient's coagulation system.

This single-center, prospective, observational pilot study will evaluate the performance of the Quantra System with the QStat Cartridge as compared to standard coagulation tests and comparable measures using conventional viscoelastic testing methods.

Eligibility Criteria:
Inclusion Criteria:

* Subject is ≥ 18 years of age
* Subject is a trauma patient and is a candidate for a ROTEM test to be performed to access coagulopathy
* Subject must be experiencing major trauma (preferably requiring the highest level of team activation) with active bleeding or deemed at high risk of significant bleeding according to mechanism of injury.
* Subject is willing to participate, and is willing to consent (either prospectively or by deferred consent)

Exclusion Criteria:

* Subject is younger than 18 years of age
* Subject weighs less than 110 pounds
* Subject is known to have received antifibrinolytic therapy immediately prior to presentation to trauma unit
* Subject is unable to provide written informed consent (either prior to performing any study related procedures or by deferred consent)
* Subject is currently enrolled in a distinct study that might confound the results of the proposed study
* Subject is affected by a condition that, in the opinion of the clinical team, may pose additional risks.
Functional MRI Study of Cortical Modifications to Light Stimulation in Patients With Photophobia

Photophobia is a common and disabling symptom in patient with dry eye syndrome. The aim of this study is tried to better understand this complain analyzing brain activation during a luminous stimulation to highlight modification of cortical activation.

Dry eye syndrome is a frequent and underestimated disease whose incidence tends to increase because of the population ageing and behaviors modification (time spent using screens increased, wearing of contact lenses...). Photophobia deteriorates the quality of life in patients with dry eye syndrome decreasing outdoor activities. This symptom is not understood and does not seem to be linked with dry eye syndrome severity. The study will compare cortical activation after luminous stimulation of 16 patients eyes (8 patients with dry eye syndrome and photophobia vs 8 asymptomatic patients) using functional MRI (fMRI).

The primary study endpoint was the extent of magnetic signals in visual cortex after luminous stimulation. Secondary endpoints were the spatial activation extent in the 3 areas of the visual cortex (Brodmann areas 17,18,19).

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic subjects : presence of bilateral photophobia with an impact on daily activities (driving, outdoor activities, screens use, socio-professional activities...) in a context of patent dry eye syndrome
* Asymptomatic subjects : no dry eye syndrome and no photophobia
* Patients able to understand medical information and sign consent.

Exclusion Criteria:

* Ophthalmological pathologies of cornea, iris, optic nerve or retina
* MRI contraindications (metallic prosthesis, pacemaker, claustrophobia)
* Neurological pathology which may affect MRI results
* Subjects under legal protection
Regional Nerve Blocks to Improve Analgesia and Recovery in Older Adults Undergoing Spinal Fusion

This initial study is a feasibility study for implementing thoracolumbar interfascial plane, or TLIP, blocks in older adults undergoing spinal fusion. TLIP blocks are done by using anesthesia. In this case, it will be done to either side of the back where surgery will be performed. This has been shown to decrease pain the patients have post-operatively in previous research. In this study, the investigators will examine recruitment rates, completion of assessments, dropout rate, gather patient feedback, and identify barriers to performing TLIP. Further, this feasibility study will provide data to determine adequate sample size and refine methods and outcomes for a future randomized clinical trial. The ultimate goal is to perform a large, appropriately powered randomized control trial to determine the effect of TLIP blocks on pain, physical function and disability, opioid consumption, and delirium in older adult undergoing spinal fusion.


Eligibility Criteria:
Inclusion Criteria:

* Are 65 or older
* Indicated for lumbar spinal fusion of less than or equal to 3 levels
* Undergoing elective surgery
* no contraindications to local anesthetic or procedures
* no severe cardiac or respiratory disease
* no preexisting cognitive dysfunction/dementia

Exclusion Criteria:

* 64 years old and younger
* emergency treatment
* pathologic fractures
* seeking revision surgery
* major liver or kidney dysfunction
* coexisting hematological disorder or irreversible abnormal coagulation
* patients with previous diagnosis of dementia or SLUMS score \<20
* patient unable to communicate/cooperate/language barrier
* BMI\>40
* allergy to study medications
* opioid tolerant (oral opioid intake morphine equivalent =\< 60 mg/day)
* other sources of chronic pain like fibromyalgia
* patients with associated significant CNS or respiratory disease (home oxygen requirements)
* incarcerated patients
* psychiatric illnesses preoperative neurological deficits greater than one motor group, less than three out of five motor functions
* pregnant or breast feeding
Exenatide Once Weekly for Smoking Cessation

The purpose of this study is to identify a potential new treatment for smoking cessation.


Eligibility Criteria:
Inclusion Criteria:

* Be English-speaking volunteers who desire to quit smoking and are willing to make a quit attempt during the course of the study;
* Have smoked ≥10 cigarettes a day for at least one year and provide a breath carbon monoxide (CO) ≥10 ppm;
* Have a negative pregnancy test, if female of childbearing potential;
* Have HbA1C levels between 5.7 and 6.4% or BMI of or greater than 25 kg/square meters
* Not currently using any therapy for glycemic control (either injectable \[i.e. insulin\] or oral agents);
* Have vital signs as follows: resting pulse between 50 and 95 bpm, BP between 90-150 mmHg systolic and 45-95 mmHg diastolic;
* Have hematology and chemistry laboratory tests that are within reference limits (within 10% above or below), with the following exception: pancreatic tests (lipase and amylase) must be within normal limits;
* Have a medical history and brief physical examination demonstrating no clinically significant contraindications for study participation, in the judgment of the principal investigator.

Exclusion Criteria:

* Meet criteria for the following psychiatric and/or substance use disorders as assessed by the Mini International Neuropsychiatric Interview (MINI): items C (current manic or hypomanic episode only), I (alcohol abuse - Alcohol Addendum-past 3 months only; current alcohol dependence), J (substance abuse -Substance Abuse Addendum - past 3 months only; current substance dependence), K (current psychotic disorder or current mood disorder with psychotic features).
* Individuals who meet criteria for non-exclusionary psychiatric disorders that are considered clinically unstable and/or unsuitable to participate as determined by the Principal Investigator and/or Study Physician.
* Individuals rated as moderate (9-16) to high (17 or greater) on suicidality as assessed by Module B of the MINI.
* Have personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2;
* Have type 1 diabetes mellitus;
* Have severe cardiovascular disease (history of myocardial infarction, life-threatening arrhythmia, or worsening angina pectoris);
* Have active temporomandibular joint disease;
* Have severe gastrointestinal disease (i.e. severe gastroparesis);
* Have previous history of pancreatitis or are at risk for pancreatitis;
* Have creatinine clearance (CrCl) \< 30;
* Have any previous medically adverse reaction to study medications, nicotine, or menthol;
* Be pregnant or lactating or unwilling to provide a negative pregnancy test before study entry;
* Not using a reliable form of contraception (e.g., abstinence, birth control pills, intrauterine device, condoms, or spermicide);
* Have any illness which in the opinion of the primary investigator would preclude safe and/or successful completion of the study.
Cortisol Augmentation of a Psychological Treatment in Warfighters With Post Traumatic Stress Disorder (PTSD)

This study seeks to examine the efficacy of hydrocortisone administration in the augmentation of the therapeutic effects of Prolonged Exposure (PE) therapy, an empirically tested treatment shown to be effective in the the treatment of posttraumatic stress disorder (PTSD). The augmentation builds on both the translation of neuroscience findings demonstrating the effects of glucocorticoids (GCs) on learning, and on empirical clinical findings from other investigators demonstrating beneficial effects of GCs in reducing traumatic memories in trauma-exposed persons.


Eligibility Criteria:
Inclusion Criteria:

* A primary diagnosis of chronic PTSD according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic criteria, resulting from a deployment-related traumatic event, and a minimum PTSD severity of 50 (CAPS).
* The veteran must either be unmedicated or on a stable psychotropic regimen (i.e., 1 or more months on the same regimen).

Exclusion Criteria:

* Lifetime history of psychotic disorder, bipolar disorder, or obsessive compulsive disorder.
* Moderate or severe traumatic brain injury (TBI).
* A medical or mental health problem other than PTSD that requires immediate clinical attention.
* Substance abuse or dependence within the last 3 months.
* Suicidal risk (as determined by response of 5 or 6 on the suicidality items of the Montgomery Asberg Depression Rating Scale (MADRS)) and/or assessed suicide risk on the basis of clinical judgment.
* Persons on a psychotropic medication regimen that has not been consistent for one month.
* Presence of diabetes mellitus or any current unstable medical illness or condition that represents a contraindication to taking glucocorticoids (this will be determined by history and/or abnormal laboratory findings at medical clearance).
* Unwillingness to discontinue other specialized psychotherapy for PTSD during the 10 weeks of study treatment and the 6 week follow-up. (Self-help (non-trauma focused) groups or supportive counseling can be continued but not initiated.)
* Pregnant women or those planning to become pregnant within the study period will not be enrolled. Female participants must agree to use an effective method of birth control (i.e., oral contraceptive, Norplant, diaphragm, condom, or spermicide, abstinence) during the course of the study to ensure they do not become pregnant during the course of the study.
Neuropsychological Evaluation of Psychiatric and Neurological Patients

This study will allow researchers to use various types of tests to evaluate cognitive and sensory functions. These tests, referred to as "batteries" will evaluate attention, executive functions, general intellectual functioning, language, memory, motor functions, orientation, personality, selected sensory and perceptual functions, vigilance (alertness), and visual-spatial functions. Children and adult patient will receive different test batteries.

The goals of this research study are to;

1. Create descriptions based on the performance of each patient on the test batteries. Then use this information to relate patient behavior to their neurophysiological, neuroradiological, and biochemical descriptions.
2. Define subgroups of patients based on their neurobehavior in order to decrease the variability of psychiatric diagnoses, treatments, and prognoses.

Neuropsychological tests are used to provide an assessment of cognitive functions in patients with idiopathic generalized epileptic (IGE) disorders and their first-degree relatives. The battery comprises tests designed to tap attention, memory, selected sensory and perceptual functions, vigilance, and visual-spatial functions. Modified batteries have been developed for the assessment of children ages 5-8, and children ages 8-16. The data provided by these batteries are compared with genetic profiles of the same participants that have been ascertained from blood samples analyzed by colleagues at the Mount Sinai School of Medicine/Columbia University in New York City.

Eligibility Criteria:
* INCLUSION CRITERIA:

Patients.

Normal volunteers.

EXCLUSION CRITERIA:

Subjects over 95 years of age.

Subjects with a history of alcohol or drug abuse, psychopathology, or central nervous system pathology, other than that which defines group membership, may be excluded.
Does the Position of the Esophageal Entrance Determine the Cricoid Force Necessary to Occlude the Esophageal Lumen

This investigation was designed to assess if the the position of esophageal entrance would detrmine the cricoid force necessary to occlude the esophageal lumen? in anesthetized, paralyzed non obese patients using the Glidescope ® video laryngoscope (GVL).

80 adult patients (40 women, 40 men) scheduled to undergo elective surgical procedures requiring general anesthesia and necessitating endotracheal intubation, were included in this study. Patients eligible for participation were aged 18-60 yrs., ASA physical status I or II and BMI \< 30 kg/m2. Before anesthesia induction, CP was verified as follow: the cricoid cartilage was first identified and then held between the thumb and middle finger and the pressure was applied by the index finger with a force that could be tolerated by the patient. After loss of consciousness, four predetermined forces: 0 , 10 , 20 and 30 N were chosen in a randomized method. Therefore, after applying the predetermined force, a GT 20 F insertion trial was performed and two outcomes were considered: 1) Failure of GT insertion: effective CP. The next trials were not attempted. 2) Success of GT insertion: ineffective CP. The patient received a second attempt with increasing force to the next scale of force. If the attempt was effective (failure of GT insertion) , the relevant force is considered as the effective CP force. Same trial was repeated using 0, 10, 20 and 30 N respectively in in a randomized fashion for each patient. The cricoid force was standardized by reproducing 10, 20 and 30 N on a weighing scale prior to each application.

Four anesthesia providers (operators) participated in the study: The first operator performed CP in all patients with his back towards the video monitor; the second operator performed laryngoscopy using GVL and GT insertion trials and he was not aware about the nature of study ; the third operator assessed the effectiveness of the applied CP and determined the position of the esophageal entrance in relation to the glottis. The fourth operator, who was standing behind the second operator, signaled to the second operator to start attempt for each trial with the predetermined CP forces and to the first operator who applying CP to stop or continue accordingly.

In order to "blind" the second operator, a screen separated the laryngoscopist and the first operator applying CP, while the hand position for the CP was maintained, even when CP was not applied. Data collected before staring surgery.

Eligibility Criteria:
Inclusion Criteria:

•No-obese patients (BMI \< 30)

* ASA 1\&2
* G.A needs intubation

Exclusion Criteria:

* ASA 3 and 4
* Contre indication to cricoid pressure
HCV Positive Heart Donors

Study subjects active on the waiting list for a heart transplant at the NYU Langone Transplant Institute who are hepatitis C (HCV) negative will receive a heart transplant from a donor who tests positive for HCV. The study will entail surveillance for the development of HCV viremia post-transplant. Patients who develop HCV viremia post-transplant will be treated with an FDA-approved, pan-genotypic direct acting antiviral drug, Mavyret. Patients who are treated with Mavyret will be monitored for clearance of viremia and for sustained virologic response.


Eligibility Criteria:
Inclusion Criteria:

* Listed for an isolated heart transplant at NYU Langone Health
* Able to travel to the NYU Langone Health for routine post-transplant visits and study visits for a minimum of 6 months after transplantation
* No active illicit substance abuse
* Weight at least 50kg
* Women of childbearing potential must agree to use birth control in accordance with Mycophenolate Risk Evaluation and Mitigation Strategy (REMS) after transplant due to the increased risk of birth defects and/or miscarriage
* Both men and women must agree to use at least one barrier method after transplant to prevent any secretion exchange
* Able and willing to provide informed consent

Exclusion Criteria:

* HIV positive
* HCV RNA positive or history of previously treated HCV
* Hepatitis B surface antigen positive or on active antiviral treatment for HBV
* Pregnant or nursing (lactating) women
* Use of strong CYP3A inducers
Infant-parent Skin-to-skin Contact During Screening for Retinopathy

Retinopathy of prematurity (ROP) is a feared complication of premature birth. If discovered in time, the disease can be treated, and impaired vision or blindness can be reduced. Premature infants are therefore examined regularly after birth. However, the examination is painful and stressful for the infant. Painful experiences might lead to a pathological stress response later in life and should therefore be prevented.

In this study skin-to-skin contact with a parent is tested for relief of pain and stress in preterm infants being examined for retinopathy of prematurity.


Eligibility Criteria:
Inclusion Criteria:

* Infants \< 32 weeks of gestational age (\< 31+6 weeks)

Exclusion Criteria:

* Infants with ongoing analgesic treatment