cyrilzakka/clinical-trials huggingface dataset:
A First-in-Human Study of RPT193 in Healthy Volunteers and Patients With Atopic Dermatitis

This study is a first-in-human, 3-part, multi-center, Phase 1, randomized, double-blind, placebo-controlled study with RPT193 in up to 64 healthy male and female subjects and 30 male and female patients with atopic dermatitis. RPT193 is an orally-available, potent, and selective antagonist of CCR4.


Eligibility Criteria:
Selected Inclusion Criteria:

Parts A \& B (COMPLETED ENROLLMENT):

* Healthy male or female
* 18-55 years of age, inclusive
* At least 50 kg in weight
* BMI: 18.0-30.0 kg/m2, inclusive

Part C (COMPLETED ENROLLMENT):

* Male or female with atopic dermatitis
* 18-65 years of age, inclusive
* BMI between 18.0 (inclusive) and \<40.0 kg/m2
* Body surface area (BSA) with AD involvement ≥10%
* Eczema Area and Severity Index (EASI) score ≥12
* Validated Investigator's Global Assessment (vIGA) ≥3
* History of inadequate response to treatment with topical medications, such as corticosteroids or calcineurin inhibitors, or patients for whom topical treatments are otherwise medically inadvisable

Selected Exclusion Criteria:

Parts A \& B (COMPLETED ENROLLMENT):

* Use of tobacco products within 60 days prior to drug administration
* History of alcohol abuse or drug addiction
* Positive drug and alcohol screen
* Participation in a drug study within 60 days prior to drug administration
* Donation or loss of more than 100 mL of blood within 60 days prior to drug administration.
* Donation or loss of more than 1.5 liters of blood (for male subjects) / more than 1.0 liters of blood (for female subjects) in the 10 months prior to drug administration.

Part C (COMPLETED ENROLLMENT):

* Any serious and/or uncontrolled medical condition
* History of alcohol abuse or drug addiction
* Positive drug and alcohol screen
Targeting the Nine Hallmarks of Aging on DNA Methylation

SRW Laboratories has formulated the Cel System protocol, a group of three formulas designed to interact with each of the 9 Hallmarks of Aging and combined this with an App that supports positive lifestyle changes, with a view that, if we can positively impact each Hallmark, we can support healthy aging.

This study will measure the impact of the Cel System protocol on the biological clocks of the participants, as well as measure established biomarkers associated with the 9 Hallmarks and note any aesthetic changes you may experience to establish evidence of the effect of the Cel System Protocol over time.

Eligibility Criteria:
Inclusion Criteria:

* Men and women of any ethnicity
* 55 years and older
* Female subjects must be post-menopausal
* Participant must be able to comply with treatment plan and laboratory tests
* Participant must be able to read, write, and speak English fluently
* Participant must have a smartphone and be able to download and use the App
* Participant must have an established primary care provider
* Participant must be willing and able to consume study supplements throughout the duration of study period

Exclusion Criteria:

* History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
* Known immune system issues or immunodeficiency disease
* History of viral illness which could be reactivated by immune downregulation
* Presence of clinically significant acute or unstable cardiovascular and cerebrovascular (stroke) disease
* Diagnosis of a transient ischemic attack in the 6 months prior to screening
* Participants infected with hepatitis C or HIV
* Presence of active infection in previous 4 weeks
* Any other illness, psychiatric disorder, alcohol or chemical dependence that in the opinion of the Clinical Investigator would render a participant unsuitable to participate in the study
* Unable or unwilling to provide required blood sample for testing
* Current or previous use of known prescription immunomodulating products (e.g. glucocorticoids, TNF-alpha inhibitors) in the month prior to the start of the trial.
* A known history of blood dyscrasias including coagulopathy
* Any person deemed by the Investigator as having a low likelihood of complying with study protocol (e.g. evidence of history of non-compliance, history of poor follow-up, multiple or complex scheduling conflicts).
* Planned surgical procedure during study period
* Participants who are actively engaged in a weight loss program or have started any new medications during the duration of the trial that can potentially interfere with the study, as deemed appropriate by Principal Investigator.
Dosing of Amicar and Measure of Fibrinolysis by TEG During Cardiac Surgery

This study hopes to determine the optimal antifibrinolytic dosing to decrease bleeding and blood transfusion after cardiac surgery without increasing adverse events


Eligibility Criteria:
Inclusion Criteria:

* Ability to sign informed consent
* Elective cardiac surgery patients undergoing primary surgery involving circulatory arrest

Exclusion Criteria:

* Inability to sign informed consent
* Baseline hypercoagulable condition as defined in medical record
* Coronary disease with untreated lesions or recent coronary stent placement
* Severe renal dysfunction (ESRD) as documented in medical record
Presentation, Patterns of Myocardial Damage, and Clinical Course of Viral Myocarditis

Viral myocarditis has been recognized as a cause of congestive heart failure, however diagnosis and treatment represents a challenging process. Recently, there is an increasing frequency of different cardiotropic viruses in the clinical setting of myocarditis. The introduction of the new molecular techniques in analysing the etiologic agent of acute myocarditis has enhanced significantly the knowledge on the molecular epidemiology of these viruses. The etiology of patients admitted to our university hospital remains unclear. It is therefore important to identify the aetiology associated with myocardial infections.

The purpose of the present study is to analyze the prevalence of a broad spectrum of cardiotropic viruses, including enteroviruses, adenoviruses and parvo B19 virus, in adults with suspected myocarditis with special reference to B19 virus due to its increasing prevalence nowadays.

The results of this study will provide a very important information for the prevalent infectious viral agents in our university hospital which will guide treatment protocol.

Objectives

1. There are almost no data regarding the relative prevalence of viral pathogens associated with myocarditis and the demographic and clinical features related to these infections in Egypt. Therefore, our main interest is to determine the prevalence of the most common viruses in clinically relevant (i.e., hospitalization- requiring) patients with acute or chronic myocarditis, using highly sensitive molecular techniques as the diagnostic tool.
2. Our second aim is to determine the distribution of mono- and coinfections between these viral agents.
3. Finally, to correlate between the microbiological findings in this study and patient characteristics including age, sex, clinical features, regional distribution, and degree of urbanization (determined on the basis of the size of the city and the density of the population) of the patients.

Eligibility Criteria:
Inclusion Criteria:

* all patients with recent unexplained heart failure in last 3 months and diagnosed as myocarditis by cardiac magnetic resonance (CMR) after exclusion of ischemic (by coronary angio) or valvular (by detailed ECHO) causes.

Exclusion Criteria:

* ischemic cardiomyopathy.
* peripartum cardiomyopathy
* valvular etiology of heart failure
Extended Ambulatory Monitoring Improves Risk Stratification in Hypertrophic Cardiomyopathy

Eligible subjects will wear 4 consecutive external monitoring devices for a total of 28 days of monitoring.

Eligible subjects will be monitored with a SEEQ device. The SEEQ device is a patch-like device that is worn externally on the chest and continuously monitors heart rhythm. Each device is worn for seven days and replaced with additional devices for a total of 28 days of monitoring. Subjects will return the SEEQ equipment at the end of the monitoring period. Subjects will be contacted by telephone or seen at the clinic approximately 60 days from the first day of monitoring. Information will be gathered about medications and any cardiac interventions the subject may have had.

Subjects will again be contacted by telephone or seen in the clinic approximately 1 year from study start. Information will be gathered about general health, changes in medications, and cardiac interventions or events. Cardiac testing results will be reviewed.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of HCM Scheduled for routine ambulatory monitoring for risk stratification Followed at the Chanin T. Mast HCM Center at Morristown Medical Center

Exclusion Criteria:

Prior implantation of an ICD History of persistent/permanent atrial fibrillation (AF)
Dynamic Postural Control After Exercise

The aim was to analyze the influence of fatigue on the dynamic postural control in one-leg standing and in jump landing, followed by stabilization or side jumps, and to compare athletes of different levels with control subjects.


Eligibility Criteria:
Inclusion Criteria:

* competitive level (participation in any league) for the high performance athletes group
* participation in sport for 0.5-4 hours per week for the recreationally active subjects

Exclusion Criteria:

* current history of a lower extremity injury requiring training cessation on the day of testing
* neurological diseases
* vestibular or visual disturbances
* cardiovascular diseases medication affecting balance
The Effect of Vitamin D Repletion on Small Low Density Lipoprotein (LDL) Particle Number in Subjects at Elevated Cardiovascular Risk

Vitamin D is a fat-soluble vitamin that is naturally present in very few foods, added to others, and available as a dietary supplement. It is also produced in the body when ultraviolet rays from sunlight strike the skin and trigger vitamin D synthesis. Vitamin D is essential for promoting calcium absorption and maintaining adequate serum calcium and phosphate concentrations to enable normal mineralization of bone and bone growth. Without sufficient vitamin D, bones can become thin, brittle, or misshapen. Vitamin D sufficiency prevents rickets in children and osteomalacia in adults. Together with calcium, vitamin D also helps protect older adults from osteoporosis. Many people have low levels of Vitamin D. Replacing Vitamin D is thought to help lower the risk of heart disease. Vitamin D may be helpful, but it could also be harmful. The investigators are studying the effect of Vitamin D on the level of a harmful kind of cholesterol. Participants will have their cholesterol levels measured and then receive either Vitamin D or a placebo. After 2 months of treatment, the investigators will measure their cholesterol levels again.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years and \< 85 years
2. Vitamin D 25-OH level \<20 ng/ml
3. One of the following risk factors:

   * Known coronary artery disease (CAD) or a CAD equivalent (e.g. diabetes, chronic kidney disease, etc)
   * BMI \> 30 kg/m2
   * Random Glucose Level \> 200mg/dl
   * Increased Waist Circumference (male: \> 40in; Females: \> 35in.)
   * Decreased HDL (Male: \< 40mg/dl; Female: \< 50mf/dl)
   * Framingham Risk Score \> 10%
   * hsCRP \> 2 mg/L

Exclusion Criteria:

1. Serum phosphorus level \> 5.5 mg/dl
2. Estimated GFR \<30 ml/min/1.73m2
3. Use of Vitamin D \>400 IU/day within 1 month of most recent Vitamin D 25-OH determination
4. Use of calcitriol or other "activated" vitamin D
5. Change in statin, ezetimibe, niacin, fibrate dose within 1 month
6. Concurrent participation in an investigational drug study
7. Have any other condition, which in the opinion of the investigator, should prohibit the participation in the study
8. Serum calcium level \>10.5 mg/dl
9. anti-epileptic medication
10. triglycerides \> 400 mg/dL
11. BMI \> 40 kg/m2
12. Evidence of cirrhosis as evidenced by AST \> 3 x upper limit, ALT \> 3 x upper limit, bilirubin \> 1.5 mg/dL , albumin \< 3.0 g/dL, PT \> 14.5 sec
13. Pregnant or Lactating Females
Traveler's Diarrhea (TD) Automated Process

To evaluate and compare the immune responses and safety following a two vaccination regimen by transcutaneous immunization with heat-labile enterotoxin of E. coli (LT) patches or placebo patches.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult males or females, 18-64 years of age (inclusive) at the planned start of the study (first vaccination on Day 0)
* Signed Informed Consent
* Women who are not post-menopausal or surgically sterile must have a negative serum/urine pregnancy test at screening and within 24 hours of each vaccination with understanding (through Informed Consent process) to not become pregnant and to employ an effective form of birth control for the duration of the study. Acceptable forms of birth control are: abstinence, hormonal contraceptives (oral, injectable, implant, patch, ring), double-barrier contraceptives (condom or diaphragm, with spermicide), and IUD.

Exclusion Criteria:

* Laboratory abnormalities \[as determined by the Toxicity Grading Scale (grade 1 4)\] at laboratory screening
* Abnormalities at physical examination \[as determined by the Toxicity Grading Scale (grade 1-4)\]
* Known allergies to any component of the vaccine
* Known allergies to adhesives
* Participated in research involving investigational product within 30 days before planned date of first vaccination or within 90 days after first vaccination
* Donated blood or blood products such as plasma within 30 days prior to planned date of first vaccination or within 90 days after first vaccination
* Ever received investigational enterotoxigenic E. coli, LT, or LT (R192G) or NasalFlu, Berna Biotech, Ltd
* Ever received cholera toxin or vaccine (e.g. Orochol™, Dukoral™)
* History of diarrhea while traveling in a developing country within the last year
* History of abdominal surgery (excluding C-section, hysterectomy, cosmetic surgery, liposuction, appendectomy, cholecystectomy, ventral hernia repair, and other surgeries not pertaining to gastrointestinal problems) or history of, or recent acute gastrointestinal illness
* Positive serology for HIV-1, HIV-2, HBsAg, or HCV
* Medical history of acute or chronic skin disease at vaccination area(s)
* Active skin allergy
* Signs of acute skin infection, sunburn or skin abnormalities at the vaccination area(s) including fungal infections, severe acne, or active contact dermatitis, or a history of keloid formation
* Excessively hirsute and unwilling to clip hair at the vaccination area(s)
* Visible tattoos or marks (tattoos/scars) at the vaccination area(s) that would prevent appropriate dermatologic monitoring of the vaccination site(s)
* Fever greater than or equal to 38.0°C (100.4°F) at the time of planned vaccination
* Women who are pregnant or breastfeeding
* Acute illness at screening and unresolved at time of planned vaccination
* Employee of the investigational site
A Study to Evaluate the Safety and Efficacy of Domperidone in Pediatric Participants With Nausea and Vomiting Due to Acute Gastroenteritis

The purpose of this study is to demonstrate that domperidone suspension plus oral rehydration therapy (ORT) is more effective than placebo plus ORT at reducing the symptoms of vomiting associated with acute gastroenteritis (AG) within the first 48 hours of treatment administration in pediatric participants with AG and mild-to-moderate dehydration.

This is a randomized (study medication assigned to participants by chance), double-blind (neither the researchers nor the participants know what treatment the participant is receiving), parallel-group, placebo-controlled, multicenter (when more than one hospital or medical school team work on a medical research study) study. The study consists of 3 Phases: Screening Phase (-2 to 0 hours prior to baseline on Day 1), Double-blind treatment Phase (up to 7 Days) and follow-up Phase (7 Days). The duration of participation in the study for each participant is at most 15 Days. Efficacy and safety of domperidone will be evaluated. Participants' safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* The participant presents with at least 3 episodes of non-bilious, non-bloody vomiting within the 24 hours prior to visiting the physician's office. The participant has at least 2 signs and symptoms other than vomiting consistent with acute gastroenteritis (AG) (example, fever, nausea, diarrhea, abdominal pain, bloating, or discomfort) within 3 hours prior to visiting the physician's office
* The participant has mild-to-moderate dehydration
* The participant had at least 1 episode of non-bloody diarrhea within the 24 hours prior to the visiting the physician's office

Exclusion Criteria:

* The participant has severe dehydration or severe malnutrition
* The participant who has vomiting and clinical symptoms for longer than 72 hours prior to the baseline physician's office visit
* The participant needs intravenous (IV) fluid replacement
* The participant has chronic severe diarrhea, a previous history of Helicobacter pylori infection or received treatment for H. pylori-induced gastritis, active peptic ulcer, celiac disease, Crohn's disease, ulcerative colitis, eosinophilic esophagitis, malabsorption, short bowel syndrome, post-viral gastroparesis, cyclic vomiting syndrome, or previous gastrointestinal surgery
* The participant has upper respiratory symptoms such as cough, congestion, otitis media or pharyngitis
VCOM Pain Free Research

Studies estimate that 30% of people worldwide experience chronic pain. The mechanisms causing this pain can vary: a neuropathic offender, such as nerve compression; a structural offender, such as long-term effects of soft tissue damage and repair; or nociplastic, dysfunctional offenders, such as fibromyalgia. The type of pain experienced influences diagnostic and treatment choice. In theory, there's a significant blending of these pain types within individuals and across patients, leading many specialists to view pain classification as a spectrum. Multidisciplinary pain management (MPM) is a standard model for addressing and treating different mechanisms of chronic pain using multiple interventions from different disciplines. Although many clinics employing these strategies have resulted in positive and clinically effective outcomes, the creation and implementation of such facilities have not been widespread. With increasing focus on psychosocial factors that impact pain in conjunction with structural and biomechanical offenders, a need for a whole-person, integrated approach to chronic pain management is needed. We propose an observational study to gather data that will inform the design, implementation, and operation of such a chronic pain research clinic.


Eligibility Criteria:
Inclusion Criteria:

* Those experiencing chronic pain, i.e., ongoing pain not relevant to an acute perturbation (e.g., recent injury).

Exclusion Criteria:

* Those subjects seeking pharmaceutical intervention
* Those whose myofascial pain is deemed functional (normal response to acute injury or ongoing pathology
Study to Gather Information About the Proper Dosing of the Oral FXIa Inhibitor BAY 2433334 and to Compare the Safety of the Study Drug to Apixaban, a Non-vitamin K Oral Anticoagulant (NOAC) in Patients With Irregular Heartbeat (Atrial Fibrillation) That Can Lead to Heart-related Complications.

The purpose of this study is to try to find the best dose of the new drug BAY 2433334 to give to participants and to look at how well BAY 2433334 works in patients with irregular heartbeat (atrial fibrillation) that can lead to blood clots, stroke and other heart-related complications. In addition researchers want to compare the safety of the study drug to apixaban, a non-vitamin K oral anticoagulant (NOAC) in patients with atrial fibrillation. This study is also done to learn how the drug in this study moves into, through and out of the body. BAY 2433334, works by blocking a step of the blood clotting process in our body and thins the blood and is a so called oral FXIa inhibitor.

Apixaban, works by reducing the production of blood clotting factors in our body and thins the blood and is a so called non-vitamin K oral anticoagulant (NOAC). Thinning the blood can prevent you from blood clots which can cause a stroke.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be 45 years of age or older at the time of signing the informed consent.
* Participant with AF documented by ECG evidence with

  * CHA2DS2-VASc score ≥ 2 if male or CHA2DS2-VASc score ≥ 3 if female
  * Indication for treatment with an oral anticoagulant in

    * any participant currently not treated with an oral anticoagulant (e.g. treatment naïve) or alternatively,
    * participant on a NOAC in case of at least one bleeding risk feature (history of a prior bleed within the last 12 months requiring medical attention and / or moderate renal dysfunction with eGFR 30-50 ml/min and / or current clinically indicated antiplatelet therapy with Acetylsalicylic acid(ASA) ≤ 100 mg)
* Written informed consent

Exclusion Criteria:

* Mechanical heart valve prosthesis
* Any degree of rheumatic mitral stenosis or moderate-to-severe, non-rheumatic mitral stenosis
* Atrial fibrillation due to a reversible cause, participants in sinus rhythm after successful ablation, or plan for cardioversion or ablation during study conduct
* Requirement for chronic anticoagulation (for a different indication than AF) or antiplatelet therapy (up to 100 mg ASA is allowed). Anticipated need for chronic therapy with Nonsteroidal anti-inflammatory drugs (NSAIDs)
* Treated with a Vitamin K antagonist in the 30 days prior to screening
A Smart Home-based Exoskeleton Robot System for Stroke Patients

In the proposed study, the investigators assumed that high dose of repetitive motor task training using an exoskeleton robot-assisted system may provide benefits in motor shaping and greater brain priming for hand paresis of the stroke patients. Nevertheless, the amount of therapeutic activity with clinicians' guidance is often short of number in therapy sessions.Therefore, using Internet of Things (IoT), connected rehabilitation products and the data they generate that are a new trend of rehabilitation strategy for providing remote home-programs support. The specific aim of this study is to to explore the feasibility of introducing the rental services of a Smart Home-based Exoskeleton Robot System through the IoT business model. And the second purpose is to investigate the effects of applying the exoskeleton robotic device for tenodesisgrip training as a home-based treatment for chronic stroke patients.The expected outcomes of this research are to clarify the feasibility of using IoT business model for launching smart rehabilitation device rental service and the effects of application a high dosage of hand movement training as home program on motor and hand function for patients with chronic stroke.


Eligibility Criteria:
Inclusion Criteria:

* (1) chronic stroke patients with unilateral cerebral infarction or hemorrhage, (2) computed tomography scan that excluded pathologies other than unilateral cerebral hemisphere injury, (3) capacity to perform a pinch task with the thumb and index finger, (4) no major cognitive or perceptual deficit (i.e., visual, auditory, perceptual, praxis, and memory, as determined using Lowenstein occupational therapy cognitive assessment), (5) premorbid right-handedness and (6) first-ever stroke.

Exclusion Criteria:

* not meeting inclusion criteria, and with Wernicke's aphasia or global aphasia leading to difficulty of following instruction.