cyrilzakka/clinical-trials huggingface dataset:
Determination of Liquid Flavor and Nicotine Form Outcomes

The purpose of this research study is to find out how different types of electronic cigarette/vape e-liquids with differing sweetness and forms of nicotine affect blood nicotine levels, use behavior (how people puff), and how people feel.

In this study, participants will be asked to do the following:

1. After an initial screening visit, visit the Center for the Study of Tobacco Products 4 more times for approximately 3-hour study visits.
2. Before each visit, abstain from all tobacco products (cigarettes, e-cigarettes/vapes, cigars, and hookah/waterpipe) for at least 12 hours.
3. Allow researcher to take blood pressure readings (with blood pressure cuff on their arm) monitor their heart rate (with a device that attaches to their finger), and allow a nurse to insert an IV catheter into their arm that will stay there for the entire session. This catheter will be used to draw blood periodically (less than 1 tablespoon per sample, 5 samples per visit).
4. During each session, participants will respond to several questionnaires to measure how they feel before and after they use an e-cigarette.
5. In each session, use an electronic cigarette provided by the study team at two separate times. After using the e-cigarette two times, participants will be offered the opportunity to use their own e-cigarette or cigarette.

Eligibility Criteria:
Inclusion Criteria:

* healthy (determined by self-report)
* between the ages of 18-65
* willing to provide informed consent
* use cigarettes, e-cigarettes, or both
* able to attend the lab and abstain from tobacco/nicotine as required and must agree to use designated products according to study protocol

Exclusion Criteria:

* women if they are breast-feeding or test positive for pregnancy (by urinalysis) at screening
* existence of any condition contraindicated for this study protocol as determined by study leadership

Some study details about the eligibility criteria are purposely omitted at this time to preserve scientific integrity. Full details will be posted at the conclusion of the study.
Radiation Dose in Humans From Orally Administered Tc99m-Heparin

This is a research study of a new agent used for evaluation of inflammation in the GI tract. This agent is investigational and thus is being studied to determine appropriate dosing and administration in both normal controls (i.e. people without gastrointestinal complaints) and patients with eosinophilic disease (i.e. those with an immune reaction and inflammation in their bodies with a certain cell called an eosinophil).

The study will test whether the radiolabeled agent will bind to the inflammation of eosinophilic esophagitis patients because an animal model of eosinophilic esophagitis which shows the striking deposition of eosinophil granule proteins is not available.


Eligibility Criteria:
Inclusion Criteria:

* 10 patients with diagnosed EoE (greater than 20 eosinophils per HPF) on esophageal biopsy will be included as the diseased population
* 7 controls (subjects without GI symptoms and known GI disease)

Exclusion Criteria:

* bleeding diathesis or contraindication to esophageal biopsies
* severe sleep apnea
* incarceration
* pregnancy
* inability to lie flat for 2 hours
* history of bleeding disorder
* Use of steroids
* Breast feeding
* Allergy to heparin or history of severe reaction to heparin
* allergy to mucomyst or severe asthma
An Open-Label Study Of Lamictal In Neurotic Excoriation

The goal of the proposed study is to evaluate the efficacy and safety of Lamictal in neurotic excoriation. Twenty subjects with neurotic excoriation will receive 12 weeks of open-label treatment with Lamictal. The hypothesis to be tested is that Lamictal will be effective and well tolerated in patients with neurotic excoriation. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.


Eligibility Criteria:
Inclusion Criteria:

* men and women age 18-65
* current diagnosis of neurotic excoriation

Exclusion Criteria:

* unstable medical illness or clinically significant abnormalities on prestudy laboratory tests or physical examination
* history of seizures
* myocardial infarction within 6 months
* current pregnancy or lactation, or inadequate contraception in women of childbearing potential
* a need for medication other than Lamictal with possible psychotropic effects or unfavorable interactions with Lamictal
* clinically significant suicidality
* lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder
* current or recent (past 3 months) DSM-IV substance abuse or dependence
* illegal substance use within 2 weeks of study initiation
* initiation of psychotherapy or behavior therapy from a mental health professional within 3 months prior to study baseline
* previous treatment with Lamictal
* treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study baseline
* current treatment with an anti-epileptic medication and
* patients who have previously been diagnosed with a medical condition that cause skin itchiness (e.g. liver, kidney, and blood diseases, etopic allergies)
Modality Augmentation for Navigation: Intuitive Fusion With Optical Lightweight Device (US/MR)

The objective of this research is to evaluate functional validation of the MR-US fusion for the Clear Guide SCENERGY system, as well as to evaluate benefits derived from system performance.

Human subjects are proposed to validate the MR-US fusion aspects of the Clear Guide SCENERGY product. For these modalities, Clear Guide Medical will work with the subcontract PI to determine the appropriate clinical procedure to evaluate (1) functional validation of the fusion system and (2) benefits derived from system performance. The selected procedure must be a single-patient interaction (i.e., no follow-up visits). Clinical studies will require approval through the subcontract's IRB. The Clear Guide SCENERGY will be compared to standard clinical practice (either no fusion or an electromagnetic-based fusion system). Clear Guide Medical plans to determine sample size based upon statistical powering for a predetermined clinically-meaningful difference (delta). This delta has not been selected, because this depends on the procedure selected. The anticipated sample size is expected to be around 100 subjects (i.e., 50 per arm), per modality. Blinding will be used, where possible. Clinician-related endpoints cannot be blinded due to obvious equipment differences. Subjects will be placed into treatment group by random. Retention strategies are unnecessary, as there will not be any planned follow-up visits or activities.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing radiological, oncological, or urological intervention procedures
* Able to give written informed consent

Exclusion Criteria:

* Unable to give informed consent
* Vulnerable populations and children
Comparative Acceptability of Tobacco and Menthol Flavored E-cigarettes

The study is a randomized crossover trial. Current menthol smokers will complete a session with each flavor of an electronic cigarette: menthol and tobacco. The objective of this survey is to assess for flavor preference.

Participants who report typically smoking menthol cigarettes will be invited to complete a session. Participants will undergo overnight tobacco/nicotine abstinence before the visit (eCO\<12ppm). Participants will then be randomized 1:1 to e-cigarette flavor order (tobacco e-cigarette, menthol e-cigarette). They will complete a 30-minute ad libitum session with the first product, based on randomization, followed by a 1.5 hour standard washout period, followed by a 30-minute ad libitum vaping session with the second product. Throughout each session, puff topography will be measured via a pressure sensor attached to the e-cigarette device. Participants will complete self-report measures of smoking urges and withdrawal symptoms pre- and post-vaping session. In addition, they will complete measures of subjective vaping experience, perceptions of flavor, product demand, and intentions for future use.

Eligibility Criteria:
Inclusion Criteria:

* typically smoking menthol cigarettes
* Non-Hispanic African American or white/Caucasian,
* ≥21 years old, smoke 5-30 cigarettes per day,
* daily cigarette smoker
* smoked at current rate for at least 6 months
* interested in trying e-cigarettes
* not interested in or unable/unwilling to quit cigarette smoking
* willing to complete one in-person study visits

Exclusion Criteria:

* Interested in quitting cigarettes in the next 30 days
* use of smoking cessation pharmacotherapy in the past 30 days
* use of non-cigarette tobacco products in the past 30 days
* use of e-cigarettes \>5x in lifetime
* use of e-cigarettes ≥4 of the past 30 days
* weight \< 110 lbs
* uncontrolled hypertension (systolic BP ≥ 180 or diastolic BP ≥ 105)
* pregnant, plans to become pregnant, or breastfeeding
* live \>10 miles from study site (Fairway CRU)
* current enrollment is a research study or program that aims to alter tobacco use
First-In-Human Intracoronary OCT-FLIm In Patients Undergoing PCI

Patients will undergo intracoronary imaging using combined optical coherence tomography-fluorescence lifetime imaging (OCT-FLIm) during percutaneous coronary intervention, and the obtained imaging data will be used to assess the efficacy of this dual-modal catheter imaging strategy in characterizing high-risk plaque.

Fluorescence lifetime imaging (FLIm) is a novel imaging approach allowing label-free biochemical characterization of atherosclerotic plaque. A combined optical coherence tomography (OCT) and FLIm that can provide a simultaneous structural and biochemical assessment of atheroma has been constructed successfully. This study sought to investigate whether the dual-modal intravascular OCT-FLIm is able to characterize high-risk plaques in patients undergoing percutaneous coronary intervention.

Forty patients with multivessel coronary artery disease, who had at least one obstructive lesion (\>70% diameter stenosis) that is considered suitable for PCI, will be included in the study. Culprit and mildly stenotic non-culprit plaques will be imaged using OCT-FLIm catheter.

Six-month follow-up assessment is systematically scheduled in all patients to assess temporal changes in FLIm signatures according to treatment strategies (medical therapy, interventional therapy etc).

Eligibility Criteria:
Inclusion Criteria:

* Age: greater than 20, less than 80
* Patients with significant coronary artery disease (diameter stenosis \>70%) requiring coronary revascularization
* Reference vessel diameter: between 2.5 and 4.0 mm
* Obtained informed consent from voluntary participants before study enrollment

Exclusion Criteria:

* Complex coronary lesion (ostial lesion, unprotected left main lesion, chronic total occlusion, grafted vessels, etc)
* Reference vessel diameter: less than 2.5 mm, greater than 4.0 mm
* Coronary lesion with heavy calcification
* Hemodynamic instability during coronary intervention
* Contraindication to antithrombotic therapy
* Chronic renal insufficiency (Serum creatinine \>2.0mg/dL)
* Severe liver dysfunction (AST/ALT \> 5 times of upper normal limit)
* Pregnancy or potential pregnancy
* Life expectancy less than 1 year
* Patient refused to sign the informed consent at enrollment
Comparison of a Novel Leuprolide With Market Leuprolide

This is a single dose, randomized, single blind, parallel group study to evaluate the testosterone suppressive effect in healthy male volunteers of a novel leuprolide acetate 3.75mg depot vs market reference leuprolide acetate 3.75mg depot. The safety, tolerability and the pharmacokinetic properties of the investigational drug and the control drug will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

1. Males of 18-40 years old (inclusive). The age difference of subjects within and between groups should be less than 10 years, at the time of screening.
2. Body weight of at least 50kg. BMI to be 19-24 kg/m2 (inclusive).
3. Able to comprehend the full nature and purpose of the study, including potential risks and side effects; able to cooperate with investigators and to comply with the requirements of the study
4. Signed informed consent form prior to any screening procedures

Exclusion Criteria:

1. Clinically significant and relevant history of cardiovascular, hepatic, renal, hematologic, endocrine, respiratory, neurological diseases or acute/chronic diseases of the digestive tract.
2. History of hypersensitivity towards leuprolide, synthetic LHRH or LHRH derivatives or any excipients of the study formulation.
3. Abnormal and clinically significant 12-lead ECG
4. Abnormal and clinically significant laboratory assessments
5. Blood donation or blood loss greater than or equal to 400mL within 3 months prior to screening
6. Participation of clinical trials within 3 months prior to screening
7. Use of any drugs within 2 weeks prior to screening
8. History of drug abuse within 1 year prior to screening
9. History of alcohol abuse within 1 years prior to screening
10. History of tobacco smoking (more than 5 cigarette per day) within 1 year prior to screening
11. Abnormal testosterone level at screening (not in the range of 168-781ng/dL)
12. Dermatitis or skin anomalies that might affect the administration area and the surroundings
13. Subject or his partner not willing to adopt appropriate contraceptive measures
14. Subjects have a history of depressive illness or sexual dysfunction;
15. Subjects that the investigator deems unsuitable to be enrolled
16. Subject not willing to cooperate with the investigators.
Study to Evaluate the Optimal Dose of Remifentanil During MRI of the Heart Under General Anaesthesia

What is the optimal maintenance dose of remifentanil to ensure apnoea, during breath hold episodes in children having cardiac MR imaging with general anaesthesia?

The management of congenital heart disease depends upon accurate imaging of the heart to define anatomical abnormalities. The use of magnetic resonance imaging has grown in response to this need. Young children, however, are unable to cooperate sufficiently to allow the scan to occur; this necessitates the use of general anaesthesia.

The optimal anaesthetic management of children in this situation is complex. Imaging of an acceptable quality depends on a low (normal) heart rate which is relatively constant during the scan and frequent breath holds to avoid respiratory artefacts. Children undergoing such scans commonly have significant cardiac and non-cardiac disease. A technique, currently used at Alder Hey Hospital, is to use intravenous agents to provide anaesthesia: commonly a mixture of the intravenous anaesthetic propofol and the potent opiate remifentanil. The patient's own ventilation is suppressed by the use of remifentanil which also reduces heart rate and heart rate variability. Controlled ventilation is provided via a ventilator and endotracheal tube. Adequate doses of remifentanil are required to ensure suppression of the patient's ventilation whilst excess doses are avoided to reduce the risk of adverse effects (primarily arterial hypotension) and ensure rapid recovery.

Remifentanil dose has been studied during surgery(3-6), however this is a unique indication and optimal dosage has not been formally studied. In particular the absence of any stimulation from surgery is likely to mean that substantially lower doses of remifentanil will be required.

Eligibility Criteria:
Inclusion Criteria:

* Children of one year (of age) or older and younger than 7 years of age.
* Scheduled for cardiac MR imaging under general anaesthesia at Alder Hey Children's Hospital.
* Parental Consent

Exclusion Criteria:

* Hypersensitivity to any study drug
* Known abnormal response to opiate analgesics or co-morbidity associated with abnormal central control of breathing
* Families unable to understand or complete consent
* Any other contraindication to proposed anaesthetic technique: at the discretion of the responsible anaesthetist.
* Documented significant renal or hepatic dysfunction
Efficacy/ Safety of DNN.22.17.036 in Male Patients With Pattern Hair Loss

Evaluation of the efficacy and safety of DNN.22.17.036 versus 10573048700 in the treatment of male pattern hair loss.


Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and consent to participate in this clinical research, expressed by signing the Informed Consent Form (ICF)
* Male participants age 25 or older and 60 age or younger
* Participants who have an intact scalp in the area of product analysis
* Participants with androgenetic alopecia (AGA) with AGA Norwood-Hamilton Scale \> II
* Participants with at least 20% telogen effluvium of evaluated by Tricholab

Exclusion Criteria:

* Participants who have used immunosuppressants in the 3 months prior to signing the ICF
* Participants with other causes of hair loss or scalp dermatoses
* Participants who have received hair loss treatment in the last 6 months
* Participants with uncontrolled medical conditions, kidney and liver disease
* Participants with a history of hair transplantation, malignancy, hematologic disorders, thyroid dysfunction, malnutrition, and other dermatologic disorders that contribute to hair loss
Preventive and Therapeutic Proximal Sealants

It is of clinical importance to arrest the development of approximal caries at an early stage. The potential for initial caries to develop into manifest lesions has motivated studies on the use of sealants to arrest the progression of caries on both occlusal and approximal tooth surfaces.

Therefore, the aim of the present study was to follow-up and examine after 3.5 years, the efficacy of sealing caries-free or non-cavitated mesial surfaces of first permanent molars abutting lesions on the distal surfaces of second primary molars. The null hypothesis tested here was that preventive and therapeutic sealants do not prevent the development or slow the progression of dental caries over a period of 3.5 years in comparison to non-sealed control surfaces.

The study population comprised 121 schoolchildren aged 8 to 10 years in a high-caries community in Valparaiso, Chile. They were examined clinically and radiographically, divided into 3 groups, and treated accordingly: children in Group A had no carious lesions on the approximal surfaces of 05d-6m and received no sealants; those in group B had active caries on 05d and received a preventive sealant on the caries-free 6m; and those in group C had active caries on 05d with an initial active lesion on 6m and received a therapeutic sealant on 6m. After 3.5 years, standardized follow-up radiographs were obtained for the children that remained.

Eligibility Criteria:
Inclusion Criteria:

* children with high rate of caries in the primary dentition
* active caries on the distal surfaces of the second primary molars at least on both sides of the mouth
* children with no lesions on the adjacent tooth surfaces on the second primary and first permanent molars were included as a general control group

Exclusion Criteria:

* children using medication containing sucrose or with a negative effect on salivary flow
* children using orthodontic devices
* children who refuses to participate
Influence of Eggs on Cognitive Performance

This clinical trial aims to evaluate the nutrients in eggs in healthy adult's cognitive performance. The main questions it aims to answer are:

* How do the nutrients in eggs impact visual cognitive performance (VCP) in generally healthy older individuals?
* Will omega-3 fatty acids in eggs improve VCP in generally healthy older individuals?

Participants will be randomly placed in one of five dietary treatment groups, including four egg whites, two whole regular eggs, two whole omega-3 fortified eggs, four egg yolks, and a no-egg control. Blood will be drawn at baseline. During the first two weeks, participants will eat assigned eggs, consume their usual diet other than the eggs, and keep five food logs. Cognitive performance testing will start on day 15 and be measured over a 10-day period using the Neurotracker (NT) 3-D program. Data on ancillary factors influencing outcomes will be collected, and food will be logged on each NT training day. Blood will be drawn at the end of the study and compared with baseline levels.

Generally, healthy males or 2 years post-menopausal females between 50 and 75 years old will be recruited for this study. Potential subjects will communicate interest to researchers, and a standardized email with a consent form will be sent to persons of interest. Prospective participants will complete a preliminary questionnaire evaluating visual health and Mini Mental State Exam (MMSE) to confirm inclusion criteria met, a study ID will be assigned. subjects will be randomly placed in a control group or one of four intervention groups: four egg whites, two whole regular eggs, two whole omega-3 eggs, and four egg yolks. Eggs will be provided to subjects based on their treatment groups; egg distribution will occur on days 1 and 15. Fifteen days of food logs, five days during the first 14 days of the study, and ten days of food logs each day the subjects train on the Neurotracker software. Food logs will be analyzed using Nutribase software.

Two weeks after the commencement of the study (Day 15), cognitive performance testing will begin. This testing will be conducted over a 10-day period, consisting of 15 training sessions. The Neurotracker (NT) 3-D program will be used for these sessions. On each NT training day, a daily data questionnaire will be used to collect data on ancillary factors that may influence the outcomes of the study.

Blood will be drawn at baseline, on day 15, and at the end of the study. Average nutrient intake and dietary patterns, baseline plasma draws, rate of change, and maximal performance on the NT software will be examined.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and post-menopausal women who are age 50 to 75 years

Exclusion Criteria:

* Taking supplements with \>6 mg L and/or \>2 mg Z two months before the study
* Self-reported diagnosis of age-related macular degeneration, diabetic retinopathy, glaucoma, or other eye conditions that may negatively impact visual cognitive performance