cyrilzakka/clinical-trials huggingface dataset:
Color Priming and Patient Decision-Making in the Emergency Department: Priming "Threat" in Patients With Low-Risk Chest Pain

This will be a prospective cross-sectional study evaluating a convenience sample of patients in the ED with low-risk chest pain defined by a HEART score of 3 or less.

This will be a prospective cross-sectional study. We will evaluate a convenience sample of patients in the ED with low-risk chest pain defined by a HEART score of 3 or less. Patients will be consented for participation and will fill out one of two surveys concerning their chest pain and chances of adverse cardiac events based on their HEART score. One survey will be printed in red text and feature red graphics; the other will be printed in black-and-white and feature black and-white graphics. The surveys will otherwise be identical. Enrolled patients will be asked to fill out survey questions related to their perception of their safety and their comfort with their discharge.

Eligibility Criteria:
Inclusion Criteria:

* All patients 18 years or age and older presenting to the ED with a complaint of chest pain who are found to have a HEART score of 3 or less.

Exclusion Criteria:

* Patients who refuse to provide consent.
* Patients unable to fill out the survey due to clinical instability, severe pain, or disorientation as determined by an emergency physician.
* Incarcerated patients.
* Patients who have a HEART score of \>3.
* Pregnant women.
Investigation of Subclinical Markers of Multiple Sclerosis

Transcranial magnetic stimulation (TMS) studies reported consistent and substantial impairments in the central nervous system (CNS) in multiple sclerosis (MS). Studies of peripheral nervous system (PNS) function comprising electromyoneurography (EMNG) reported impairments of the PNS in MS that were less pronounced and inconsistent. Neurophysiological studies are generally small and cross-sectional and with the poor grouping of MS patients according to MS type.

The objective of the study is to investigate clinical, neurophysiological, and immunological markers in relapsing-remitting MS patients, and in patients with relapsing-remitting MS treated with immunomodulation. The results of the study may contribute to a better understanding of the pathophysiology of multiple sclerosis and can provide guidance in the diagnosis and treatment of patients with relapsing-remitting MS.

The following techniques will be applied:

* Neurophysiological testing will be performed with navigated transcranial magnetic stimulation (nTMS) incorporating an individual MRI of each subject's brain performed on a 1,5 MRI scanner using a series of neuropsychological protocols. Mapping of the primary motor cortex for upper and lower extremity muscles with a recording of motor evoked potentials (MEP) will be performed.
* Electromyoneurography (EMNG) assessment of lower and upper extremities for motor and sensory nerves;
* Neuropsychological assessment will include the general questionnaire and battery of cognitive and psychological tests;
* Immunoassays on blood samples include determination of different markers on monocytes and lymphocytes using flow cytometry, as well as determination of CD163 in serum samples using ELISA.
* Clinical examinations include neurological, biochemical, neuroradiological, and neuropsychological testing.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with a documented diagnosis of relapsing-remitting MS according to the Mc Donald criteria (2005) and with EDSS achievement of 0-3.5 according to the modified Kurtzke's EDSS (Expanded disability status scale) for the assessment of neurological function and incapacity of patients with multiple sclerosis

Exclusion Criteria:

* Patients with metals in the body (e.g. pacemaker, dentures)
* Patients with new pregnancies (verbally confirmed)
* Patients with new head trauma
* Subjects unwilling to sign a consent or follow study procedures
Pilot Study to Develop 3 Tesla MRI for Evaluation of Renal Tumors

The goal of this clinical research study is to find out if "3 Tesla" MRI is as good as CT scan in the evaluation of kidney tumor(s).

Objectives:

To provide preliminary data to enable subsequent development of an MRI protocol at 3 Tesla for evaluation of renal tumors and their vascular supply, which can be adopted in patients who are unable to undergo CT evaluation.

"3 Tesla" MRI is a new MRI scanner that in theory, can produce better images than currently available MRI scanners.

Currently, CT scanning is the main way of evaluating tumors in the kidneys. However, there are some patients who cannot have CT scans (usually, because of allergy to CT contrast medium or kidney damage/failure). It is with these patients that researchers are hoping to use a technique (using MRI) that is as good as CT scanning.

As part of your standard of care, your doctor is requesting a CT scan of your kidneys and abdomen. If you take part in this study, you will have a "3 Tesla" MRI scan of your kidneys and abdomen as well, within 15 days following your routine CT.

For the "3 Tesla" MRI scan, you will be lying flat on the MRI scanner, and as with a regular scan, you will have a small needle placed in a vein in your arm to inject the contrast dye. A diuretic, Lasix, will be given to help distend the internal tubes in the kidney to help view your kidney better. The MRI scan will take between 1-2 hours to perform. As with regular scans, you may be asked to hold your breath on occasions.

If there is a concern about your kidney function, blood (about 1 teaspoon) will be drawn to test your kidney function before you have the MRI.

Your participation in the study will be complete at the end of the MRI scan. The routine CT scan will be the main decision making examination. However, if the MRI shows something different and potentially relevant to your care, your referring physician will be informed.

This is an investigational study. A total of 45 patients will take part in this study. All will be enrolled at MD Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who have undergone or are due to undergo a CT Renal Protocol study, in the course of pre-operative evaluation for renal tumor surgery.
2. Written informed consent will be obtained.

Exclusion Criteria:

1. Patients with an allergy to both gadopentetate dimeglumine and gadodiamide MRI contrast agents.
2. Patients with certain metallic implants, e.g., cardiac pacemakers, cardiac defibrillators, aneurysm clips, neurostimulators, and certain metallic foreign bodies. Implanted medical devices must be MRI compatible at 3.0 Tesla field strengths.
3. Patients with claustrophobia, or requiring sedation for the MRI scan.
Closed-loop Vasopressor Infusion Using Continuous Noninvasive Blood Pressure Monitoring

Intraoperative hypotension and blood pressure variability are associated with postoperative complications in surgical patients.

The investigators have developed a closed-loop vasopressor (CLV) controller that titrates norepinephrine to correct hypotension.

After having tested the system in a small cohort series of patients undergoing major surgeries, the investigators aimed to test the feasibility of the CLV controller guided noninvasively and continuously with the ClearSight system (Edwards Lifesciences, USA) in three high risk patients undergoing renal transplant surgery

Intraoperative hypotension is frequent in patients undergoing surgery and can negatively impact organ perfusion.

The investigators have developed a closed-loop vasopressor (CLV) controller to more efficiently correct hypotension.

The investigators tested it extensively in preclinical studies and recently demonstrated its feasibility and excellent performance metrics in a short series of high-risk patients undergoing major surgical procedures.

In these studies, the controller was linked to a minimally-invasive advanced hemodynamic monitoring device utilizing an arterial line which then controlled a vasopressor infusion. However, the vast majority of patients who undergo surgery do not require an arterial line but should still benefit from rapid corrections of hypotensive episodes that are less rapidly detected via an intermittent non-invasive blood pressure cuff. Fortunately, completely noninvasive technology now allows us to continuously monitor blood pressure and therefore extend the use of our closed-loop vasopressor system to patients in whom an arterial catheter would not typically be placed. Patients undergoing renal transplant surgeries are the ideal patient population.

The investigators aimed to test the feasibility of guiding our CLV controller with a continuous noninvasive blood pressure monitoring device (ClearSight system, Edwards Lifesciences, Irvine, CA, USA) in three patients (case series)

Eligibility Criteria:
Inclusion Criteria:

1. Adult high risk patients undergoing renal transplant surgery
2. Patients equipped with a clearsight advanced hemodynamic monitoring system

Exclusion Criteria:

1. Atrial fibrillation
2. No consent obtained from the patient.
3. Ejection fraction \< 30%
A Study of RO5186582 in Down Syndrome Among Children 6 to 11 Years of Age

This study will evaluate the safety, tolerability, efficacy, and pharmacokinetic and pharmacodynamic activity of 3 different dosages of RO5186582 compared with placebo. A total of approximately 46 participants will be enrolled, in order to have at least 32 evaluable, and will be randomly assigned to 1 of 4 treatments in a 1:1:1:1 ratio, with 9 children per treatment arm. The target ratio between 6-8 years and 9-11 years age groups is approximately 1:1 in each treatment arm, with a minimum of 3 children per age group in each treatment arm.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Down syndrome, except for mosaic Down syndrome
* Available parent or caregiver to attend clinic visits and provide information about the participant's behavior and symptoms

Exclusion Criteria:

* Any primary psychiatric comorbid disorder
* History of infantile spasms, West syndrome, Lennox-Gastaut syndrome, early infantile epileptic encephalopathy, treatment-refractory epilepsy with cognitive/developmental regression, severe head trauma, or central nervous system (CNS) infection
* Seizure event of any type within 12 months prior to Screening or relevant changes in anti-epileptic drugs 6 weeks prior to enrollment
* Significant sleep disruption
* Significant gastrointestinal, renal, hepatic, endocrine, or cardiovascular disease
* New-onset or ongoing hematologic/oncologic disorder
* Severe lactose intolerance
* Participation in another clinical study within 1 month or 6 half-lives prior to first dose, or any extent of participation in Study BP29589 (NCT02451657)
Study to Evaluate the AIO-001 in Healthy Participants

This goal of the open-label single dose study is to evaluate and compare the safety, tolerability, pharmacokinetic (PK), and immunogenicity of AIO-001 using two different formulations in 16 healthy volunteers.

This is an open-label single dose, parallel group, 24-week, Phase 1 study in 16 healthy participants.

The study is designed to evaluate and compare the safety, tolerability, PK, and immunogenicity of AIO-001 using two different formulations (Formulation A and Formulation B) in 16 healthy volunteers (8 receiving each formulation).

The study will include a screening visit from Day -28 to Day -2. Eligible participants will be admitted to the clinical site on Day -1 and will be confined until completion of the assessments on Day 3. Participants will return to the clinical site for outpatient visits for study assessments and laboratory tests.

Eligibility Criteria:
Inclusion Criteria:

1. Able to understand the study procedures and provide signed informed consent to participate in the study.
2. Male or female.
3. Non-smokers. Light smokers (no more than 5 cigarettes daily \[approximately 50 to 60 mg of nicotine per day\], or products with equivalent amount of nicotine within 3 months prior to screening) may be permitted.
4. ≥18 and ≤55 years of age.
5. BMI \>18.5 and \<32.0 kg/m2 and body weight ≥45.0 kg.
6. Healthy participants.

Exclusion Criteria:

1. Any clinically significant abnormal finding at physical examination at screening.
2. Clinically significant abnormal laboratory test results or positive serology test results for hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen and antibody, or QuantiFERON®-TB tuberculosis (TB) test at screening.
3. Positive pregnancy test or lactating female participant.
4. Positive urine drug screen or alcohol breath test.
5. History of anaphylaxis, or severe allergy.
6. Previous exposure to thymic stromal lymphopoietin antibody.
Slow Continuous Ultrafiltration Using Central vs Peripheral Line: Feasibility of Implementation, Safety and Efficacy in Acute Heart Failure Syndromes.

Slow continuous ultrafiltration using central vs peripheral line: feasibility of implementation, safety and efficacy in acute heart failure syndromes.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years
* Patients hospitalized with primary diagnosis of acute heart failure defined as ≥ 2 of the following criteria:
* Peripheral or sacral edema
* Jugular venous distension or venous central pressure \> 10 mmHg
* Hepatomegaly or ascites
* Pulmonary edema or pleural effusion on x-ray or pulmonary wedge pressure or end-diastolic pressure \> 20 mmHg.
* High pro-BNP
* Randomization during first 24 hours
* Serum creatinine levels \< 3mg/dL, and K \< 6 mmol/L
* The patient should be able to communicate with research staff and meet with study procedures.
* The patient will signed informed consent.

Exclusion Criteria:

* Diagnosis of severe aortic stenosis or severe obstruction to the LVOT, tamponade, cardiac hypertrophic or restrictive cardiomyopathy.
* Impossibility of venous catheterization
* Acute coronary syndrome
* Creatinine greater than 3.0 or K greater than 6 mmol/L.
* Systolic blood pressure less than or equal to 100 mmHg
* Hematocrit greater than 45%
* Prior administration of IV vasoactive drugs in the emergency room (ER)
* Clinical instability requiring pressors during hospitalization
* Sepsis
* On or requires renal dialysis.
Virtual Reality During Hemodialysis

The main objective of this investigation is to assess if an intradialysis virtual reality exercise-based program results in an improvement in physical function and if it results in high adherence rates to exercise. The secondary aim is to assess the effect of intradialysis VR in physical activity level, health related quality of life and in cognitive function.

Participants will be randomized into one of two groups. The first group will start with 12 weeks of virtual reality exercise during hemodialysis and will carry on with a control period of 12 weeks. The second group will start with a control period of 12 weeks (no exercise) and will carry on with a virtual reality exercise period of 12 weeks.

The virtual reality exercise will undertake up to 30 minutes of exercise. After warming up, participants will play to an adapted 'treasure hunt' game. Their legs movements will be the players projected into an individual tv that will give them feedback regarding their achievements. The aim of the game will be to achieve the higher possible score.They will move their legs to pick up coins and to avoid bombs. An adapted Kinect technology will be used for the game development. The exercise session will end-up with a cool-down period that will include simple lower limb stretching exercises.

Eligibility Criteria:
Inclusion Criteria:

* At least 3 months in hemodialysis treatment
* Clinically stable

Exclusion Criteria:

* Recent cardiac events (less than 3 months)
* Unable to exercise
A Study of the Efficacy and Safety of Two Doses of Topiramate Compared to Placebo and Propranolol in the Prevention of Migraine

The purpose of this study is to evaluate the safety and efficacy of two doses of topiramate (100 and 200 mg daily) versus placebo and propranolol in the prevention of migraine. The study will also assess dose response relationship of topiramate, estimate the relative efficacy of topiramate versus propranolol in prevention of migraine, and evaluate the effect of migraine prevention with topiramate versus placebo on Health Related Quality of Life.

This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of two doses of topiramate versus placebo and propranolol in the prevention of migraine headaches. The study consists of 4 phases: Baseline Phase (evaluation of eligibility criteria and tapering of any migraine prophylaxis medications patients are taking), Core Double-Blind Phase (patients are randomized to receive either 100 milligrams\[mg\]/day topiramate, 200mg/day topiramate, 160mg/day propranolol or placebo for a total of 26 weeks), Blinded Extension Phase (patients continue the same dose of medication until the sponsor terminates the study or a patient withdraws from the study), and Taper/Exit Phase (medication of patients exiting from the study is tapered over 7 weeks). The primary hypothesis is that one or two topiramate doses (100, 200 mg/day) will be superior to placebo in the prophylaxis of migraine based on the change in the monthly (28 days) migraine period rate from the prospective Baseline Phase to the Core Double-Blind Phase. Oral medication (100 milligrams\[mg\]/day topiramate, 200mg/day topiramate, 160mg/day propranolol, or placebo) during the 26-weeks Core Double-Blind Phase. Doses may be continued until the termination of the study or withdrawal by the patients during the Blinded Extension Phase.

Eligibility Criteria:
Inclusion Criteria:

* Medical history consistent with migraine with or without aura according to the International Headache Society (IHS) for at least 1 year prior to the study
* Between 3 to 12 migraine periods and no greater than 15 headache days (migraine and non-migraine) per month during the Baseline Phase
* No clinically significant abnormalities on neurological exams, electrocardiogram (ECG) or clinical laboratory test results at baseline
* Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing abstinence, or practicing an acceptable method of contraception (requires negative pregnancy test)

Exclusion Criteria:

* Patients with headaches other than migraine
* Patients with episodic tension or sinus headaches
* Onset of migraine after age of 50 years
* Patients who have failed more than two adequate regimens for migraine prophylaxis
* Patients who overuse pain medications or certain other medications
Cytokines Profile at the Beginning of Pregnancy

A mechanism by which obesity could influence the increase in obstetric complications as more weight is gained, apart from oxidative stress (3) would be the changes in the expression profile of T helper (Th) cells. Due to the increase rate of obesity among Mexican women, the aim was to determine if there is some association between the weight changes in pregnancy and the cytokines Interleukin (IL)-10, IL-4, Interferon gamma (IFN-γ) and Tumor Necrosis Factor alpha (TNF-α).

Pregnant women older than 18 years old were invited to participate and all were asked to sign the informed consent. Women with congenital heart disease, disabling diseases, infectious diseases and autoimmune diseases were excluded and those whose clinical follow-up was lost were discarded from the final analysis.

Weight and height were measured using a calibrated using an adult scale (Seca, Hamburg, Germany). Blood Pressure (BP; mmHg) was checked by auscultation using a standard sphygmomanometer (Riester Big Ben® Square; Jangingen, Germany). All mothers received written nutritional guidance depending on the characteristics of each patient.

The expression levels of IL-10, IL-4, IFN-γ and TNF-α was performed by the ELISA technique.

Quantitative variables will be represented by measures of central tendency. Once the Kolmogorov test is performed for the normality of the variables, either the Student's T test or the Mann Whitney U test will be used to compare both groups. With the same criteria for normality either Pearson or Spearmen correlation will be used among the cytokines and anthropometric variables, considering a significant difference at p ≤ 0.05. The statistical analysis will be carried out in the Statistical Package for the Social Sciences (SPSS) program, version 19.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women older than 18 years old were invited to participate and all were asked to sign the informed consent.

Exclusion Criteria:

* Women with congenital heart disease, disabling diseases, infectious diseases and autoimmune diseases were excluded and those whose clinical follow-up was lost were discarded from the final analysis.
Vitamin D Deficiency in Subjects With Chronic Hepatitis C Compared to Healthy Volunteers

The objective of this study is to assess the prevalence of vitamin D deficiency in patients with chronic Hepatitis C compared to a matched control group of healthy individuals in the Sioux Falls area. It is the hypothesis of this study that vitamin D deficiency is more common in patients with chronic Hepatitis C compared to the healthy control group.

In this study, we will measure vitamin D levels in patients with chronic Hepatitis C and healthy individuals. This study will be important to assess vitamin D inadequacy in patients with chronic Hepatitis C and healthy individuals in this area.

Eligibility Criteria:
Inclusion Criteria for Study Group:

* Men and women between the ages of 25 and 55
* Diagnosis of chronic hepatitis C

Exclusion Criteria for Study Group:

* Taking a vitamin D supplement (by itself or as part of a multivitamin), a calcium supplement and/or biphosphonates
* Has acute hepatitis C infection
* Has chronic hepatitis B infection
* Had gastric bypass surgery
* Has chronic kidney disease

Inclusion Criteria for Control Group:

* Men and women between the ages of 20 and 60
* Has a body mass index (BMI) between 20 and 35

Exclusion Criteria for Study Group:

* Taking a vitamin D supplement (by itself or as part of a multivitamin), a calcium supplement and/or biphosphonates
* Has any significant illness or medical problem that is not under control or being controlled by medication
* History of hepatitis or abnormal liver chemistry tests
* History of intravenous drug use
Assessing Depression in a Geriatric Cancer Population

The goal of this study is to learn more about how we measure depression in elderly cancer patients (patients aged 70 and older). Depression is one of the most common causes of emotional distress in the elderly and continues to be under-recognized. This is a problem because depression can have a negative impact on quality of life. The symptoms of depression are linked to poor health outcomes and higher costs of health care. In fact, depression is one of the top five concerns facing the elderly today.

We have a few questionnaires that have been used to measure depression, but we do not know how these measures work with people with cancer. This study will help us answer this question. To complete this study, we need people who may or may not be feeling down or depressed.

If you choose to take part, you will be asked to do the following:

1. Fill out questionnaires that ask about:

   * Your age, eduction, race, and income
   * Your mood

   In all, these questionnaires will take about 10 minutes to complete.
2. Answer questions about your mood. This will also take about 10 minutes to complete.

Eligibility Criteria:
Inclusion Criteria:

1. Age 70 and older
2. Diagnosis of early or late stage prostate cancer, or diagnosis of early or late stage breast cancer
3. Actively engaged in one of the following cancer treatments: chemotherapy, radiation therapy, hormone therapy
4. Able to provide informed consent
5. Ability to converse, write and read English

Exclusion Criteria:

1.Major psychopathology or cognitive impairment likely in the judgment of the research staff to interfere with the participation or completion of the protocol.