cyrilzakka/clinical-trials huggingface dataset:
Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders Trial

Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) is a protocolized intervention based on American College of Cardiology/American Heart Association and US Preventive Services Task Force guidelines designed to initiate preventive cardiovascular care for emergency department patients being evaluated for acute coronary syndrome. The overarching goals of this proposal are to (1) determine the efficacy of EMERALD at lowering low-density lipoprotein cholesterol (LDL-C) and non high-density lipoprotein cholesterol (non-HDL-C) among at-risk Emergency Department (ED) patients who are not already receiving guideline-directed outpatient preventive care and (2) inform our understanding of patient adherence and determinants of implementation for ED-based cardiovascular disease prevention strategies.

EMERALD involves (1) ordering an ED lipid panel, (2) calculating 10-year atherosclerotic cardiovascular disease (ASCVD) risk, (3) prescribing a moderate- or high-intensity statin, (4) providing healthy lifestyle counseling, and (5) bridging patients to ongoing outpatient preventive care (primary care or cardiology, depending on risk level).

We hypothesize that EMERALD will be associated with lower LDL-C and non-HDL-C at 30- and 180-days vs. usual care. The primary outcome will be percent change in LDL-C at 30-days. Secondary outcomes include percent change in LDL-C at 180-days and non-HDL-C at 30- and 180-days. We will randomize 130 ED patients with possible acute coronary syndrome 1:1 to EMERALD or usual care, which will provide 90% power with a two-sided alpha of 0.05 to demonstrate a 10% difference in percent change in LDL-C at 30-days between arms.

Eligibility Criteria:
Inclusion Criteria

1. Evaluation for Acute Coronary Syndrome
2. Age 40-75 Years
3. 10-year Atherosclerotic Cardiovascular Disease (ASCVD) Risk ≥7.5% or Known Diabetes or

Known ASCVD:

1. Myocardial Infarction
2. Unstable Angina
3. Percutaneous Coronary Intervention
4. Coronary Artery Bypass Graft
5. Stroke
6. Transient Ischemic Attack
7. Peripheral Artery Disease

Exclusion Criteria

1. ST-Segment Elevation Myocardial Infarction (STEMI) Activation
2. ST Depression \>1 mm in Contiguous Leads
3. On a Lipid Lowering Agent (Statin, PCSK9 Inhibitor, Bempedoic Acid, Ezetimibe, Inclisiran, etc.)
4. Inability to Return for 30-day Follow-up
5. Unstable Vitals (Systolic blood pressure \<90, HR \>120 or \<50, oxygen saturation \<90%)
6. Statin Intolerance
7. Any Resulted High-Sensitivity Troponin I ≥100 ng/L
8. End-stage renal disease (ESRD) and/or glomerular filtration rate (GFR) \<30 mL/min/1.73 m2
9. Liver Cirrhosis
10. Pregnancy
11. Anticipated Hospitalization or Placement into an Observation Protocol
12. Life Expectancy \<1 Year
13. Transfer from Another Hospital
14. Prisoner
15. Non-English Speaking
Quetiapine for Delirium Prophylaxis in High-risk Critically Ill Patients

Scheduled, low-dose quetiapine is effective in preventing delirium in high-risk critically ill, trauma/surgical patients. Prophylaxis also reduced ventilator duration and ICU length of stay.

Objective: To evaluate the efficacy of scheduled quetiapine for delirium prophylaxis in critically ill, trauma/surgical patients identified as high-risk for delirium utilizing a validated prediction model.

Design: Prospective, open-label, single-center study. Setting: Trauma/surgical intensive care unit at an academic medical center. Patients: Eighty two adult trauma/surgical patients who were admitted to the intensive care unit and were at high-risk for the development of delirium (PRE-DELIRIC Score ≥50%, past medical history of dementia, past medical history of alcohol misuse, or past medical history of drug abuse).

Interventions: Patients were randomized by unit location to receive pharmacologic prophylaxis for delirium (quetiapine 12.5 mg every 12 hours) or no pharmacologic prophylaxis for delirium within forty-eight hours of admission to the intensive care unit.

Measurements: The primary end point was the incidence of delirium during admission to the intensive care unit (ICU). Secondary end points included time to onset of delirium, ICU and hospital lengths of stay, ICU and hospital mortality, duration of mechanical ventilation, and adverse events. Delirium was assessed using the confusion assessment method for the intensive care unit.

Eligibility Criteria:
Inclusion Criteria:

* Trauma/surgical patients admitted to the trauma/surgical ICU

Exclusion Criteria:

* sustained RASS of -4/-5 during the complete ICU admission
* presence of a condition preventing delirium assessment
* anticipated or known ICU length of stay of less than 48 hours
* taking antipsychotics prior to admission
* history of schizophrenia, epilepsy, parkinsonism, or levodopa treatment
* primary neurologic event/injury with GCS ≤ 9 during the first 48 hours of ICU
* current treatment with a continuous infusion neuromuscular blocking agent
* pregnancy
* screened positive for delirium upon admission to the ICU.
Reaching Consensus on the Definition of Difficult Cholecystectomy

Being able to predict the difficulty of a preoperatively can increase safety and improve results. However, a consensus must be reached regarding the definition of a cholecystectomy as "difficult". The aim of this study is to achieve a national expert consensus.

Methods A Delphi study was conducted. Based on the literature, a history of biliary pathology, preoperative clinical, analytical, and radiological data, and intraoperative findings were selected and rated on a Likert scale.

Inter-rater agreement was defined as "unanimous" when 100% of the participants gave an item the same the Likert scale rating; as "consensus" when ≥80% agreed; as "majority" when the agreement was ≥70%.

A Delphi study was conducted. Inter-rater agreement was defined as "unanimous" when 100% of the participants gave an item the same the Likert scale rating; as "consensus" when ≥80% agreed; as "majority" when the agreement was ≥70%.

Eligibility Criteria:
Inclusion Criteria:

* Spanish surgeons
* experts in laparoscopic cholecystectomy, with more than 10 years of experience

Exclusion Criteria:

* not Spanish
* not experts in laparoscopic cholecystectomy.
Efficacy and Safety Study of Combination of Ginkgo Extract and Ginseng Extract(YY-162)in Children With ADHD

This study will evaluate clinical efficacy and safety of treatment with YY-162 in children with ADHD

This is Double-Blind, two arms, multi-center, Interventional, 8 weeks study starting with YY-162(Combination of Ginkgo extract and Ginseng extract in children with ADHD. Assessment of efficacy and safety will be performed at the baseline, weeks 2,4, and 8. At the first visit, a full psychiatric history, demographic date and physical examination will be undertaken. Throughout the study, the following procedures, documentations and evaluations will performed; K-ARS, IOWA Conner's rating scale , CGI-S/I, ATA, Children's color trails test and stroop test, Intelligence test(from KEDI-WISC) and adverse event reporting.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects aged from 6 to 12
* Subjects must meet DSM-IV criteria for ADHD based-on the K-Schedule for affective disorder and schizophrenia(K-SADS-PL-K) interview
* Subjects signed a written consent form voluntarily.
* Patient 's assent to participate in the study and written informed consent form signed by one of the parents, parent surrogates, or legal guardian.
* Subjects who can keep visit schedule and whose parent/ parent surrogates or legal guardian can willingly complete assessments defined in the study protocol
* Subjects/parents, parent surrogates or legal guardian who can understand the participation of the study and voluntarily withdraw from the study at any time

Exclusion Criteria:

* Subjects who have difficulty swallowing tablet.
* Subjects who have known allergy to plant extracts.
* Subjects who meet DSM-IV diagnostic criteria for current major depressive disorder or anxiety disorder requiring drug therapy.
* Subjects who have any history of bipolar disorder, psychotic disorder, and substance use disorder, have been diagnosed with a pervasive developmental disorder, organic brain disease and seizure disorder.
* Subjects who have significant suicidal ideation.
* Subjects with mental retardation
* Subjects with Tourette's syndrome requiring drug therapy.
* Subjects who have been administrated Methylphenidate or Atomoxetine within recent 3 months and Ginkgo extract or Ginseng extract within recent 1 month.
* Subjects who currently have a significant medical conditions (e.g. diseases of cardiovascular, hepatic, renal, respiratory, glaucoma).
* Subjects who have abnormalities in the ECG or show clinically significant abnormalities of laboratory results, including serum chemistries and hematology.
* Subjects who are currently taking alpha-2 adrenergic receptor agonist, antidepressant, antipsychotic, benzodiazepines, modafinil,anticonvulsant
* Subjects who receive psychosocial treatment during the drug trial.
* Subjects who are not able to swallow the study drug.
Surpoint Algorithm for Improved Guidance of Ablation for Ventricular Tachycardia

Vistag SurPoint is a proprietary module that generates a numerical tag index which can be used as multiparametric lesion quality marker to guide ablation in the clinical setting for ablation of atrial arrhythmias. SurPoint tag index has studied to guide ablation of ventricular arrhythmias, such as premature ventricular complexes, but its effectiveness and safety for ablation of Ventricular Tachycardia in patient with Ischemic and Non-Ischemic Cardiomyopathies is not well established.

In this single center prospective observation registry, a ventricular ablation strategy utilizing radiofrequency delivery duration cut off determined by a maximum Surpoint index value of 550 will be compared to conventional operator determined duration of radiofrequency delivery based on combination of time (i.e. 30, 60, 90, and 120 seconds), magnitude of impedance drop, attenuation of abnormal electrograms, and achieving non-capture with high-output pacing after ablation.

The Surpoint Tag Index Ablation group will be matched with a control group of patients undergoing VT ablation using the conventional time-based radiofrequency strategy and the patients in this group will be selected using propensity matching based on relevant baseline patient and clinical characteristic variables.

Primary outcomes of interest: Recurrence of sustained ventricular tachycardia or Internal Cardiac Defibrillator Therapy.

Secondary outcomes of interest: Hospitalization for ventricular tachycardia, repeat ablation procedures, all-cause mortality, acute procedural complications, rate of steam pops during ablation procedures

Follow up: Up to 24 months after ablation procedure. Follow up will be obtained by office visits and device interrogation reports.


Eligibility Criteria:
Inclusion Criteria:

* Structural Heart Disease: Ischemic or Non-Ischemic Cardiomyopathy
* Sustained Monomorphic Ventricular Tachycardia documented by ECG or CIED interrogation

Exclusion Criteria:

* If clinical ventricular arrhythmia is predominantly PVCs, polymorphic ventricular tachycardia, or ventricular fibrillation
* Myocardial infarction or Cardiac Surgery within 6 months
* Severe mitral regurgitation
* Stroke or TIA within 6 months
* Prior Ventricular Tachycardia Ablation
Taekwondo Practice in Adolescents With Attention Deficit Hyperactivity Disorder

Attention Deficit Hyperactivity Disorder (ADHD) is one of the most common neuro-developmental/behavioral disorders among adolescents. Sport and physical activity seem to play a major role in the development of cognition, memory, selective attention and motor reaction time, especially among adolescents with ADHD. In this context, the objective of this study was to investigate the effects of a one and a half year long Taekwondo (TKD) intervention on cognitive function in adolescents with ADHD.


Eligibility Criteria:
Inclusion Criteria:

* Adolescents with Attention Deficit Hyperactivity Disorder

Exclusion Criteria:

* Participants with good attentional performance
CD160 Expression in Corneal Vessels

Despite improvements in corneal transplantation, anti-angiogenic and anti-lymphangiogenic factors remain to be be identified. CD160 is an anti-angiogenic target: its expression seems to be restricted to some immune cells and to activated endothelial cells. We hypothesized that CD160 is expressed in blood and lymphatic human corneal neovessels and is involved in corneal graft rejection pathogenesis

After informed consent, patients enrolled for corneal graft surgery at the Robert Debré University Hospital, Reims, France, will be included.

Routine general and eye examination including cornea photographs will be performed.

During surgery, a quarter of patients' cornea and of donors' corneoscleral rim will be spared for immunohistochemistry analyzes.

Eligibility Criteria:
inclusion criteria :

* 18-year-old or more patients
* enrolled for penetrating keratoplasty or deep anterior lamellar keratoplasty surgeries at the Robert Debré University Hospital, Reims, France
* considered able to give an informed written consent exclusion criteria :
* none
Effect of Tegoprazan or RAPA113 on Pharmacodynamics/Pharmacokinetics of Clopidogrel in Healthy Male Volunteers

This study aims to evaluate the influence of tegoprazan or RAPA113 on the pharmacodynamics/Pharmacokinetics of following co-administration of tegoprazan or RAPA113 and clopidogrel in healthy male volunteers.

Evaluation Criteria:

* Primary outcome Pharmacodynamic assessments using P2Y12 assay
* Secondary outcome Pharmacokinetics assessments on Cmax,ss, AUCτ,ss, tmax,ss, Cmin,ss , CLss/F 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 adult males 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 ≥ 18.5 kg/m2 and ≤ 27.0 kg/m2 at the time of screening
* Helicobacter pylori negative
* Voluntarily decided to participate in the study and provided written informed consent before any screening procedure

Exclusion Criteria:

* Has a history of or currently has clinically significant liver, kidney, nervous system, immune system, respiratory system, endocrine system, blood, tumor, cardiovascular system or psychiatric disease
* Has a history of gastrointestinal diseases (such as Crohn's disease, ulcer, etc.) or surgery (except for simple appendectomy or hernia) that can affect the absorption of drugs
* Has a genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
* Has a clinically significant history of hemorrhage (e.g. Gastric ulcers, intracranial bleeding, haemophilia, gastrointestinal bleeding, urinary tract bleeding, vitreous hemorrhage, etc.)
* P2Y12 Reaction Unit (PRU) by P2Y12 assay outside the upper/lower limit of normal range by 10% at screening
* Considered ineligible to participate in the study based on screening test(by asking condition, vital sign, 12-lead ECG, physical exam, laboratory test etc.) results :

  1. Platelet, PT and aPTT levels outside the upper/lower limit of normal range by 10%
  2. AST (GOT), and ALT (GPT) levels greater than 1.25x of the upper limit of normal range
  3. Blood total bilirubin levels greater than 1.5x of the upper limit of normal range
  4. Hemoglobin levels less than 12.0 g/dL
  5. eGFR (estimated Glomerular Filtration Rate) using MDRD (Modification of Diet in Renal Disaster) \< 60 mL/min/1.73 m2

     : eGFR (estimated glomerular filtration rate) (mL/min/1.73m2) = 175 x \[serum creatinine (mg/dL)\]-1.154 x \[age\]-0.203
  6. positive as a result of serum examination (B-type hepatitis test, hepatitis C test, human immunodeficiency virus test, syphilis test)
  7. Systolic blood pressure \< 90 mmHg or \> 150 mmHg, diastolic blood pressure \< 50 mmHg or \> 100 mmHg, or pulse rate \< 45 beats/minute or \> 100 beats/minute when vital signs are measured in sitting position after resting for at least 5 minutes during screening
Evaluation of MolecuLight i:X as an Adjunctive Fluorescence Imaging Tool to Clinical Signs and Symptoms for the Identification of Bacteria-containing Wounds

This is a non-randomized evaluation for which 160 adult patients will be imaged at outpatient wound care clinics who present with a wound of unknown infection diagnostic status and are receiving standard treatment. The MolecuLight i:X Imaging Device will be used as an adjunctive tool in the assessment of the wound and may be used to guide the targeted sampling of a wound (using a conventional punch biopsy method).


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects presenting at an advanced outpatient wound care clinic with wound(s) (e.g. DFU, VLU, PU, SSI)
* 18 years or older

Exclusion Criteria:

* Treatment with an investigational drug within 1 month before study enrolment
* Subjects with recent (\<30 days) biopsy of target wound
* Subjects with wounds that cannot be completely imaged by study device due to anatomic location
* Inability to consent
* Any contra-indication to routine wound care and/or monitoring
Ultrasound Guided Intermediate Cervical Plexus Block and Additional Perivascular Local Anesthetic Infiltration

For ultrasound guided intermediate cervical plexus block this randomized comparison is testing the hypothesis, that an additional perivascular infiltration is associated with increased block quality.

The innervation of the neck is complex and involves the cervical and the brachial plexus as well as cranial nerves. So is the wall of the carotid arteries innervated by vagal and glossopharyngeal nerve as well as the sympathetic trunk. When carotid surgery was performed under regional anesthesia, so additional infiltration of local anesthetic by the surgeon was common, particularly during preparation of the carotid arteries.

Introduction of ultrasound guidance made it possible to guide the needle directly to the vascular wall. But this procedure is considered very demanding, because of guiding the needle in an anatomical region with artifacts (because of calcification), sudden movements (e.g. because of swallowing) and compromised coagulation (antithrombotic medication). On the other side there are no clinical data proving the benefit of an additional perivascular infiltration with local anesthetic. Therefore, this investigation is testing the hypothesis, that an additional perivascular infiltration is associated with increased block quality.

Eligibility Criteria:
Inclusion Criteria:

* carotid surgery (symptomatic and asymptomatic carotid stenosis)
* adult patients (18 years or older)
* ASA-risk-groups I-IV
* informed consent

Exclusion Criteria:

* drug allergy: local anesthetics
* pregnancy, lactation period
* participation in other studies
* addiction to drugs or alcohol
* non-cooperative patients
* no approval to regional anesthesia
Re-Engineered Discharge for Diabetes Care Transitions

The goal of this project is to test a novel bedside SDOH screening intervention coupled with post-discharge navigation for hospitalized patients with a diabetes diagnosis to reduce unmet social needs, compared to usual care.

The investigators are conducting this research to test a computer-based screening tool and a care coordination protocol to help people with type 2 diabetes who report unmet social determinants of health.

Social determinants of health (SDOH) are the conditions in the environments where people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality-of-life outcomes and risks. - Office of Disease Prevention and Health Promotion Examples of SDOH include factors such as housing, transportation, education, job opportunities, income, and access to healthy food, clean air and water, and health care services. Participants who join this research will be asked to complete a screening survey about their health. Then, participants will be randomly assigned (like pulling a name out of a hat) to one of two groups:

* Those in Group 1 will be partnered with a patient navigator whose role will be to review the results of the screening survey and help coordinate care before leaving the hospital and for 90 days after.
* Those in Group 2 will receive treatment as usual. A list of community-based resources will be provided.

Participants in both groups will complete surveys at the beginning of the study and again at 30 and 90 days after leaving the hospital. The investigators will make reminder calls to participants in both groups about data collection and will collect information from the medical record for as long as 90 days after leaving the hospital.

Eligibility Criteria:
Inclusion Criteria:

* adult aged 18 years or older
* diagnosed with type 2 diabetes
* hospitalized at Univ of Massachusetts-affiliated hospital
* endorsed at least 1 unmet social need via screening survey

Exclusion Criteria:

* pregnancy
* discharge to short or long-term nursing facility or hospital
* medical contraindication
* cognitive impairment
* unable to provide informed consent
Effects of Therapeutic Touch in Patients With Female Genital Neoplasia: a Randomized Controlled Clinical Trial

This is a randomized controlled prospective study on the use of therapeutic touch in patients diagnosed with gynecological cancer. The patients will be randomized into three groups: control group (will not receive any interventions with therapeutic touch), placebo group (will receive simulated therapeutic touch intervention by individual not knowing this technique) and treatment group(will receive therapeutic touch intervention by a trained therapeutic touch therapist). Two different quality of life questionnaires will be applied (before and after treatment). Levels of cortisol, salivary IgA, hematological indices and telomerase activity before and after the use of therapeutic touch will be compared between groups.

This project is a randomized controlled prospective study on the use of therapeutic touch in patients diagnosed with gynecological cancer. The patients will be randomized into three groups: control group (will not receive any interventions with therapeutic touch), placebo group (will receive simulated therapeutic touch intervention by individual not knowing the practice) and treatment group (will receive therapeutic touch intervention by a trained therapeutic touch therapist). Two different quality of life questionnaires (World Health Organization quality of life questionnaire - WHOQOL-Bref and the quality of life Core-30 questionnaire - EORTC QLQ-C30) from the European Organization for Research and Treatment of Cancer will be applied before and after treatment. Levels of cortisol, salivary IgA, hematological indices and telomerase activity before and after the use of therapeutic touch will be compared between groups.

Eligibility Criteria:
Inclusion Criteria:

* female patients
* age over 18 years
* diagnosis of neoplasms of the female genitalia
* Signature of the consent form

Exclusion Criteria:

* history of previous contact with the therapeutic touch technique
* use of psychotropic drugs, severe neurological or psychiatric disorders that make it impossible to participate in the study.