cyrilzakka/clinical-trials huggingface dataset:
Can we Predict Chronic Homelessness?

Homeless men and women suffer more illness and sooner death compared to housed people. Among the homeless, there is a group that suffers more illness than others. This group is usually homeless for several months, makes up a smaller proportion of homeless people and uses more resources from emergency shelters than other homeless people. Some have asked if a difference in thinking skills explains how people who are homeless for a long time need more help in getting and keeping housing compared to other homeless persons.

In this study, thinking skills that help a person plan and make decisions will be screened among those who have been homeless for a long time and those who were homeless for a short time. If there is a difference, then screening may change how future homeless people get the help they need.


Eligibility Criteria:
Inclusion Criteria:

* Men and women, greater than or equal to 18 years old, English speaking
* Group A: currently homeless and/or housed in an emergency shelter or housing facility for chronically homeless individuals ≥ 6 months
* Group B: not homeless ≥4 times in the last 3 years and currently living in stable housing ≥ 6 months and in the last 3 years, has been homeless ≤ 1 month

Exclusion Criteria:

At the time of testing, individuals with the following characteristics will be excluded:

1. Altered mental status (determined by Nurse Coordinator through participant response to questions regarding orientation to person, place and season - score of at least 2/3 is considered intact mental status).
2. Present intoxication (determined by Nurse Coordinator through participant evaluation of odour, either alcohol or non-beverage alcohol).
3. Currently violent or aggressive towards testers (determined by Nurse Coordinator)
Comparison Between the Clinical Assessment of the Undescended Testis and Its' Ultrasonographic Size

In addition to the manual preoperative examination, the undescended testicle will be measured ultrasonographically. The compared data will help us to evaluate the routine need for preoperative ultrasonographic evaluation of the undescended testicle.


Eligibility Criteria:
Inclusion Criteria:

* Boys operated for unilateral cryptorchism

Exclusion Criteria:

* bilateral cryptorchism recurrent operation s/p inguinal operation
Real World Effectiveness of the Cordella Pulmonary Artery Sensor System in Patients With Chronic Heart Heart Failure

This retrospective, non-randomized cohort study will evaluate how well the Cordella PA Sensor System works compared to standard medication treatment in people with chronic heart failure. The study will track patients for two years to see if those using the Cordella system have fewer deaths and hospitalizations related to heart failure.

The study will compare two groups of patients with chronic heart failure:

* One group will use the Cordella PA Sensor System, which monitors heart pressure from home
* The other group will receive standard heart failure medications without a pressure monitoring system

The main goal is to see if patients using the Cordella system have fewer heart failure-related hospital stays and a lower death rate over a two-year period. The study will look especially closely at results for:

* Men and women separately
* Patients with different types of heart failure (preserved or reduced heart function)
* Patients aged 75 and older
* Different racial and ethnic groups
* Patients with kidney disease
* Patients with existing heart devices

The study will use real-world data from:

* Patients using the Cordella system in routine medical care
* Similar patients receiving standard care, identified through medical records and insurance claims Both groups of patients will be carefully matched to ensure they are similar in age, gender, and other important factors that could affect the results.

Eligibility Criteria:
Inclusion Criteria for Cordella PA Sensor System Cohort:

* Received Cordella PA Sensor System implant between 10/1/2024-12/31/2029
* Documented chronic heart failure with NYHA Class III symptoms
* On guideline-directed medical therapy based on ejection fraction status:

  * For reduced EF (≤40%): At least one fill of ACE/ARB/ARNI, MRA, BB, or SGLT2i, and one fill of a loop diuretic
  * For preserved EF (\>40%): At least one fill of a loop diuretic
* Has continuous health insurance enrollment for 12 months prior to implant

Inclusion Criteria for Standard of Care Control Cohort:

* Two or more encounters with diagnosis codes for chronic systolic and/or diastolic heart failure
* Documented ejection fraction reading within 6 months (+ or -) of second heart failure encounter
* On guideline-directed medical therapy based on ejection fraction status:

  * For reduced EF (≤40%): At least one fill of ACE/ARB/ARNI, MRA, BB, or SGLT2i, and one fill of a loop diuretic
  * For preserved EF (\>40%): At least one fill of a loop diuretic
* Has continuous health insurance enrollment for 12 months prior to study entry

Exclusion Criteria:

* No implanted pulmonary artery sensor or monitoring at any time (Standard of Care Control Cohort only)
* Record of temporary mechanical circulatory support during baseline period
* Diagnosis of cardiogenic shock during baseline period
* Receiving palliative care/hospice during baseline period
* Record of end-stage renal disease during baseline period
* Unable to take dual antiplatelet therapy or anticoagulants for one month post implant (Cordella Cohort only)
Light Therapy Device for Neonatal Intraventricular Hemorrhage Grade 3 and 4

The primary purpose of this study is to serve as a pilot study of the EFIL device treatment feasibility of IVH grades 3,4 to guide development of a larger trial. Primary outcomes will assess the following: safety of intervention, recruitment and consent process, acceptability of intervention by parents, retention rates, selection of most appropriate outcome measures, provide sample size estimates for a larger trial, increase the researchers\&#39; experience with the study intervention. A complete list of objectives and aims are listed under "Objectives". This study hopes to treat 12-24 neonates using 650nm light of irradiance 10mW/cm2 for 5 minutes twice a day each day for 12 days. We will also call the parents at 6 months and 12 months to track developmental milestones.


Eligibility Criteria:
Inclusion Criteria:

* neonates with intraventricular hemorrhage grade 3 or 4 less than 1 month old.

Exclusion Criteria:

* neonates without IVH grade 3/4 or older than 1 month.
Effects of an Educational Intervention on Emotional Intelligence in School Students

Objectives: Evaluate the effect on emotional intelligence levels of an educational intervention.

Design: Randomized Clinical Trial

Methods: An intervention on emotional intelligence was conducted in a Primary School. Students were recruited and randomized into intervention or control group (no intervention) by class (cluster). Total sample was 179. Results were measured with EQi-YV and ERQ-CA questionnaires. Statistical analysis was made with Student's t and Mann-Whitney's U tests.


Eligibility Criteria:
Inclusion Criteria:

* Be on 5th or 6th year of Spanish Primary Education.
* Accept informed consent of the study.
* Be able to read, understand and answer both questionnaires

Exclusion Criteria:

* Revoque informed consent.
* Be in two different classes from the school.
* Absence to 25% or more of the lessons.
* Answer less than 80% of any questionnaire.
* Not completing both questionnaires.
Blood Sample Collection Study for Pharmacogenomic Characterization of Participants That Previously Received Namilumab in M1-1188-002-EM (PRIORA, [NCT01317797]) Study

The purpose of this study is to obtain blood samples from up to 14 participants who previously received namilumab in the previous study M1-1188-002-EM (PRIORA, \[NCT01317797\]) to correlate genetic markers with clinical outcomes.

Participants who received treatment with namilumab in the previous study M1-1188-002-EM (PRIORA \[NCT01317797\]) will have two whole blood samples (3 mL each) collected to correlate genetic markers with namilumab treatment responses as determined in the previous study.

The study will enroll approximately 14 participants who received namilumab in the previous study.

• No intervention is administered in this study.

This trial will be conducted in Bulgaria, Spain and The Netherlands. The overall time to participate in this study is 1 day.

Eligibility Criteria:
Inclusion Criteria:

1. The participant (or, when applicable, the participant's legally acceptable representative) voluntarily signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.

Exclusion Criteria:

1. Did not receive namilumab during the PRIORA study (A phase Ib double-blind, placebo controlled, randomized, dose-escalating study).
2. Participants without any response time point recorded 4-week after the last dose of namilumab and beyond this time point
3. Participants who were excluded from post-hoc analysis due to protocol violations during the previous PRIORA study.
IL 6 Measurement Using a New Densitometric Bedside (POC) Test

In a equivalence analysis, we determined whether IL-6 can be assessed using a new densitometric point-of-care (POC) assay (turn-around -time: 20 minutes).IL-6 measurements were compared to test results obtained with conventional ELISA analysis

In an equivalence analysis, we determined whether IL-6 can be assessed using a new densitometric point-of-care (POC) assay (turn-around -time: 20 minutes) that allows IL-6 measurements at the bedside. We then compared the respective test results to those obtained with conventional ELISA analysis

Eligibility Criteria:
Inclusion Criteria:

* Age 18-90
* Written informed consent
Extracorporeal Shockwave Myocardial Revascularization (ESMR) Therapy For The Treatment of Chronic Heart Failure

Evaluation of non-invasive treatment modality, using low-intensity extracorporeal shockwaves for treatment of subjects diagnosed with Congestive Heart Failure, with ischemic etiology.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is male or female 18 years or older.
2. Patient is diagnosed with a Heart Failure with ischemic etiology. Diagnosis is based on medical history, complete physical evaluation, and echocardiography.
3. Patient has documented myocardial segments with impaired contractility. Diagnosis is based on Rest Echo.
4. Patient is diagnosed with no more than 50% of segments akinetic or dyskinetic Diagnosis is based on echocardiography.
5. Patient is classified as NYHA II to IV.
6. Patient should be on a stable dosage of medication for at least 6 weeks prior to enrollment.
7. Patients Ejection Fraction \< 50%.
8. Patient is stable and without clinical events for \> 3 months.
9. Patient has signed an informed consent form.
10. Patient's condition should be stable and should have a life expectancy of \>12 months.
11. Patient's current and past medical condition and status will be assessed using previous medical history, physical evaluation, and the physicians (principle investigator's)medical opinion.

Exclusion Criteria:

1. Patient with intraventricular thrombus.
2. Severe COPD (patients with an FEV1 less than .8 liters).
3. Patient has chronic lung disease including emphysema and pulmonary fibrosis.
4. Patient has active endocarditis, myocarditis or pericarditis.
5. Patient is simultaneously participating in another device or drug study, or has participated in any clinical trial involving an experimental device or drug, including other drugs or devices enhancing cardiac neovascularization or any ESWT machine for neovascularization of a competitor company within 3 months of entry into the study.
6. Patients who are unwilling or unable to cooperate with study procedure.
7. Patients who are unwilling to quit smoking during the study procedure (including screening phase).
8. Patients who are diagnosed with severe valvular disease (regurgitation or stenosis).
9. Patient is pregnant.
10. Patient with a malignancy in the area of treatment without complete remission within 5 years(lungs, thorax, ribs).
Effects of Instrument-Applied Spinal Manipulative Therapy on Postureal Control and Autonomic Balance

The purpose of this study is to determine the effects of spinal manipulative therapy on autonomic balance and to determine if there exists a relationship between autonomic state and postural control.

Previous studies have demonstrated that sensory and cognitive systems share some common neural substrate. The afferent neural impuleses of mechanoreception (also known as somatosensation) as produced by joint mechanoreceptors and adjacent muscle spindle cells may impact supraspinal centers. Few studies have been done to determine if the afferent impulses generated by spinal manipulative therapy (SMT) can impact the porcessing that occurs at supra-spinal centers. The relationship between postural control and cognition is studies using a dual-tak methodology, a primary (postural) task will often demonstrate degradation with the addition of a secondary, concurrent (cognitive) task. The current study seeks to determine the effects of SMT on postrual control using a dual-task paradigm, while monitoring autonomic state (using Heart Rate Variability analysis) during the course of therapy. It is thought that SMT can improve HRV status, and postural control within a dual-task situation, and that there will be differences in postural control related to a participant's HRV status. Activities of daily living often invole the coupling of a cognitive task with a complex postural task.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults currently enrolled at Logan College

Exclusion Criteria:

* Lower extremity injury, vestibular disorders
Effect of Tegoprazan on Pharmacodynamics of Clopidogrel in Healthy Subjects

This study aims to evaluate the effects of tegoprazan or esomeprazole administered in combination with clopidogrel on the pharmacodynamics/Pharmacokinetics of clopidogrel in healthy adults

Evaluation Criteria:

* Primary outcome Pharmacodynamic assessments using P2Y12 assay
* Secondary outcome Pharmacokinetics assessments on Cmax,ss, Cmin,ss, Cavg,ss, AUCτ,ss, Tmax,ss, t1/2,ss, CLss/F, Vd,ss/F, and PTF of clopidogrel
* Safety assessments with adverse event monitoring including subjective/ objective symptoms, physical examination, vital signs, electrocardiogram, and laboratory test

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged ≥ 19 years and ≤ 50 years on the date of the written informed consent
* Body weight of ≥ 55.0 kg and ≤ 90.0 kg, with body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 27.0 kg/m2 at the time of screening
* Is given a detailed explanation and fully understood the study, then voluntarily decided to participate and provided written informed consent before any screening procedure
* Negative for serum Helicobacter pylori antibodies
* Judged by the investigator to be eligible for this study based on physical examination, laboratory test, inquiry, etc.

Exclusion Criteria:

* Presence or history of clinically significant liver, kidney, nervous system, respiratory system, endocrine system, blood and tumor, cardiovascular system, urinary system or psychiatric disease
* Presence or history of gastrointestinal disorder (gastrointestinal ulcer, gastritis, gastrospasm, gastroesophageal reflux disease, Crohn's disease, etc.) that may influence the safety and pharmacodynamic assessments of the investigational product and history of gastrointestinal surgery (except simple appendectomy and hernia surgery), hemostatic disorder or hemorrhage-related disease
* Hypersensitivity to drugs including the ingredients of the investigational product and other drugs (aspirin, antibiotics, etc.) or history of clinically significant hypersensitivity
* Positive result in serology tests (Hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test, syphilis test)
* Blood total bilirubin, AST (GOT), and ALT (GPT) \> 1.5 x upper limit of normal range at the screening test
* Platelet, PT and aPTT levels outside the upper/lower limit of normal range by 10% at the screening test
* Systolic blood pressure is \< 90 mmHg or \> 139 mmHg, diastolic blood pressure \< 50 mmHg or \> 89 mmHg, or pulse rate is \< 45 beats/minute or \> 100 beats/minute when vital signs are measured in sitting position after resting for at least 3 minutes at the screening test
* Showing the following findings on ECG at the screening test: QTc \> 450 msec, PR interval \> 210 msec, QRS interval \> 120 msec, Other clinically significant findings
* P2Y12 Reaction Unit (PRU) outside the upper/lower limit of normal range by 10% as a result of P2Y12 assay at the screening test
* History of drug abuse or positive urine screening for drug abuse
* Considered ineligible to participate in the study by the investigator based on laboratory test results or other reasons
A Study to Assess the Safety, Tolerability and Efficacy of OP0201 as an Adjunct Treatment for Acute Otitis Media in Infants and Children Aged 6 to 24 Months

The purpose of this study is to develop a better understanding of the safety, tolerability and efficacy of intranasal OP0201 as an adjunct treatment to oral antibiotics for the treatment of Acute Otitis Media (AOM) in infants and children.


Eligibility Criteria:
Inclusion Criteria includes but is not limited to:

1. Male and female infants and children aged ≥6 months to ≤24 months
2. Diagnosis of Acute Otitis Media (AOM) - moderate to severe bulging of the TM or mild bulging of TM and recent \[less than 48 hours\] onset of ear pain or intense erythema of the TM
3. Score of 5 or more on the 5 question version of AOM-SOS scale1
4. Written informed consent by the child's legal guardian and their willingness to ensure that study instructions are followed, all study-related visits are attended, that treatment administration is given, and Parent/Caregiver assessments are recorded according to the study protocol.
5. Intact tympanic membrane (TM) in both ears (e.g., no perforation)

Exclusion Criteria includes but is not limited to:

1. Allergy to penicillin or cephalosporin
2. History or presence of immunodeficiency disorders
3. Antimicrobial therapy within the 3 days (i.e., 72 hours) prior to Day 1
4. Craniofacial abnormalities (e.g., cleft palate or Down's Syndrome) that may interfere with Eustachian tube function
5. Disorders with decreased mucociliary clearance or higher viscosity of the mucous (e.g., cystic fibrosis, primary ciliary dyskinesia, Kartagener's syndrome)
6. Clinically relevant blockage of 1 or both nasal passages, as determined by the investigator's medical judgment
Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1

The goal of this clinical study is to learn more about the safety and efficacy of switching to a once weekly tablet of islatravir/lenacapavir (ISL/LEN) regimen versus continuing standard of care treatment in people with human immunodeficiency virus (PWH) who are virologically suppressed (HIV-1 RNA levels \< 50 copies/mL) on a stable standard of care regimen for ≥ 6 months prior to screening. The standard of care includes 2 or 3 medicines, antiretroviral agents (ARVs).

The primary objective of the study is to evaluate the efficacy of switching to oral weekly ISL/LEN tablet regimen versus continuing standard of care in virologically suppressed PWH at Week 48.


Eligibility Criteria:
Key Inclusion Criteria:

* HIV-1 RNA \< 50 copies/mL for ≥ 6 months before screening, as documented by:

  1. One HIV-1 RNA \< 50 copies/mL immediately preceding the 24 weeks period prior to screening.
  2. Within 24 weeks prior to screening, if HIV-1 RNA results are available, all levels must be \< 50 copies/mL.
  3. During the 6 to 12 months period prior to screening, transient detectable viremia ≥ 50 copies/mL is acceptable ("blip") as long as it is not confirmed on 2 consecutive visits.
* Plasma HIV-1 RNA levels \< 50 copies/mL at screening.
* Are receiving guideline-recommended standard of care treatment such as International Antiviral Society (IAS), Department of Health and Human Services (DHHS), European AIDS Clinical Society (EACS) consisting of 2 or 3 ARVs for ≥ 6 months prior to screening and willing to continue until Day 1. Individuals in Treatment Group 2 must also be willing to continue their standard of care through at least Week 96.
* Individuals assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified methods of contraception.

Key Exclusion Criteria:

* Prior virologic failure.
* Prior use of, or exposure to, ISL or LEN.
* Active, serious infections requiring parenteral therapy within 30 days before randomization.
* Active tuberculosis infection.
* Acute hepatitis within 30 days before randomization.
* Hepatitis B virus (HBV) infection, as determined below at the screening visit:

  1. positive HBV surface antigen OR
  2. positive HBV core antibody and negative HBV surface antibody. Note: individuals found to be susceptible to HBV infection (eg negative hepatitis B surface antibody at the screening visit, regardless of prior HBV vaccination history) should be recommended to receive HBV vaccination.
* Active hepatitis C virus (HCV) coinfection, defined as detectable HCV RNA. Note: individuals with prior/inactive HCV infection (defined as undetectable HCV RNA) may be enrolled.
* Any of the following laboratory values at screening:

  1. Creatinine clearance (CLcr) ≤ 30 mL/min according to the Cockcroft-Gault formula
  2. Alanine aminotransferase (ALT) \> 5 x upper limit of normal (ULN)
  3. Direct bilirubin \> 1.5 x ULN
  4. Platelets \< 50,000/μL
  5. Hemoglobin \< 8.0 g/dL

Note: Other protocol defined Inclusion/Exclusion criteria may apply.