cyrilzakka/clinical-trials huggingface dataset:
Assessing Microvascular Resistance Via IMR To Predict Cumulative Outcome in STEMI Patients Undergoing Primary PCI

The purpose of this study is to assess whether the Index of Microcirculatory Resistance (IMR) can be considered a prognostic predictor for the occurrence of events at one year of follow up after primary Percutaneous Coronary Intervention (PCI) in ST-Elevation Myocardial Infarction (STEMI) patients.

Any correlation between IMR and the short and medium term outcomes, defined as cardiovascular death, re-Myocardial Infarct (MI), re-hospitalization for Heart Failure (HF), resuscitation or Implantable Cardioverter Defibrillator (ICD) appropriate shock, will be assessed in the study.

Prospective, multicentre study designed to evaluate IMR ability to predict events occurrence, defined as Cardiovascular death, re-MI, re-hospitalization for HF, resuscitation or ICD appropriate shock, during a 1 year follow-up period.

All participants will have the culprit lesion treated following clinical practice and guidelines; Fractional Flow Reserve (FFR) and IMR will be measured after the primary PCI procedure to evaluate treatment success and myocardial viability. Non-culprit lesions will be functionally evaluated through FFR index and will be treated if FFR will show functional stenosis. FFR and IMR will be measured to evaluate treatment success and myocardial viability. Patients will be followed-up at 1m, 6m and 1y periods.

Eligibility Criteria:
Inclusion Criteria:

1. Patient of legal age in hosting country able and willing to provide informed consent form
2. Hospital admission either within 12 h of symptom onset or between 12 and 24 h after onset with evidence of continuing ischemia
3. Electrocardiographic ST-segment elevation ≥1 mm in two or more contiguous ECG leads, or with a left bundle-branch block (LBBB)
4. Multivessel diseased patients with lesions in the proximal 2/3 part of the vessels
5. Culprit Lesion EyeBall (EB) identified during evaluation of basal angiography
6. Presence of at least one non-culprit lesion \>50% EB detected in the basal angiography and eligible for PCI for which the operators decision is to perform a staged pre-discharge angioplasty procedure

Exclusion Criteria:

1. Patients who cannot give informed consent
2. A life expectancy of less than 1 year
3. Patients who are pregnant or nursing
4. Contra-indication to angiography
5. Allergy/intolerance to Adenosine
6. Contra-indication/Allergy/Intolerance to contrast media or to medical therapy foreseen for PCI
7. Documented allergy to Adenosine diphosphate (ADP) inhibitors (aspirin and clopidogrel)
8. New infarct on the same area of a previous infarct
9. Critical non treatable Lesion EB\>70% downstream of the culprit lesion
10. Absence of non-culprit lesion/s
11. Patient with hemodynamic instability not controllable with medical therapy and/or need intra aortic balloon pump implantation (IABP)
12. Prior Coronary Artery Bypass Graft (CABG) or indication for CABG
13. Patients with Left Main (LM) coronary artery disease requiring revascularization
Prospective ED Headache Cohort Study

The purpose of this study is to determine how often headaches recur and to learn how to predict continued suffering from headache after emergency department discharge.

The majority of the 5 million people who arrive at Emergency Departments (ED) with a headache every year are suffering from an acute exacerbation of a chronic, recurrent headache disorder. The role of the ED in treating these patients has been ill-defined. Often emergency physicians will treat the acute exacerbation and will not attend to the natural history of the disease. However, about two thirds of primary headache patients will suffer a recurrent headache in the 24 hours after discharge from the ED. And, many patients will continue to suffer recurrent headaches for months after their ED discharge.

The purpose of this study is to learn how often headaches recur and to try to find a way to predict who will have a recurrent headache after ED discharge.

After standard ED treatment for headache, participants in the study will be asked to answer questions about prior headaches and medical history, and some census-like questions about race/ethnicity, salary, and education via a 20-minute interview with a research associate. The researchers will follow-up with 10-minute telephone calls to each participant's home in 24 hours and in 3 months with additional questions. Total length of time for study participation is approximately 40 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Emergency Department patients who present primarily for headache.
* Need to consent to and be available for follow-up
Topotecan and Melphalan for Retinoblastoma

The purpose of this study is to evaluate topotecan and melphalan for retinoblastoma patients.

To evaluate the effectiveness and complications of topotecan and melphalan for intraocular injection in retinoblastoma patients.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed as retinoblastoma
* receiving eyeball-sparing treatment

Exclusion Criteria:

* disease progression during follow-up
Erector Spinae Plane Block for Uncomplicated Renal Colic

This research study is to determine how well the Erector Spinae Plane Block (ESPB) works for kidney stone pain and any possible side effects.


Eligibility Criteria:
Inclusion Criteria:

* Imaging confirmation of urolithiasis on the index encounter or prior encounter within 7 days
* Patient received one dose of parenteral pain medication in the emergency department (ED)

Exclusion Criteria:

* Pregnancy or breastfeeding
* Prisoner or incarcerated individual
* Therapeutic anticoagulation or coagulopathy.
* Active treatment for urinary tract infection (either acute infection or chronic therapy)
* Prior spinal surgery in the thoracic region
* Allergy to local anesthetic or prior local anesthetic
* Soft tissue infection overlying the injection site
* Positive for coronavirus
* Inability to communicate verbally or read/write in English
* Currently taking strong CYP1A2 inhibitor (fluvoxamine, amiodarone, fluoroquinolones, etc.)
* Glucose-6-phosphate dehydrogenase deficiency (G6PD)
E-Cigarettes: Dynamic Patterns of Use and Health Effects

The proposed research will provide in-depth, longitudinal data, based on real-time reports, which will address key priorities for the FDA including, increased understanding of the relations between electronic cigarette (e-cig) use and 1) nicotine dependence, 2) reductions in combustible cigarette (CC) use, 3) attempts to quit CC use and the success of those attempts, and 4) health-related outcomes such as biomarkers of exposure and carcinogenicity.

Primary Aim: Characterize e-cig use patterns both acutely and over 2 years and relate them to patterns of CC use (including reduced CC use), nicotine dependence and related variables (e.g., withdrawal suppression), and attempts and success in quitting CC use. Investigators will use ecological momentary assessment (EMA) to obtain fine grained, real-time data on e-cig and CC use. These data will be used to test the hypotheses that increasing and higher levels of e-cig use, measured in real-time, will be negatively related to CC use, nicotine dependence, and CC withdrawal severity and positively related to CC quit attempts and CC cessation success.

Secondary Aim 1: Determine how the use of e-cigs is related to biomarkers of tobacco exposure and cancer risk, and to acute and chronic pulmonary health outcomes. Investigators will examine the relation between e-cig use and cancer biomarkers, exposure biomarkers, and pulmonary function.

Secondary Aim 2: Identify person factors, contextual variables, and patterns of behaviors and symp-toms that predict e-cig and CC use patterns and key outcomes (e.g., CC cessation, health-related outcomes), and identify variables that moderate relations between e-cig use and such outcomes. Investigators will attempt to identify contextual variables and person factors that predict increased e-cig use, decreased CC use (including cessation), reduced nicotine dependence, and significant changes in biomarkers and health outcomes. Further, investigators will identify variables that moderate such relations, revealing factors and events that make changes in e-cig and CC use, and associated outcomes, especially likely.

Eligibility Criteria:
Inclusion Criteria:

* Specific eligibility requirements are:

  1. ≥ 18 years old
  2. able to read and write English
  3. no plans to quit smoking and/or e-cig use in the next 30 days
  4. not currently taking smoking cessation medication
  5. not currently in treatment for psychosis or bipolar disorder
  6. participants must report either that they have:
* smoked at least 5 cigarettes per day for the past 6 months and not used e-cigs within the last 3 months ("exclusive smokers")
* used nicotine-containing e-cigs at least once a week for the past month and have smoked at least 5 CCs/day for the last 3 months ("dual users").

Exclusion Criteria:

* Individuals not meeting any one of the inclusion criteria. Those not meeting any one (or more) of criteria 1-5 and either criterion 6a or 6b will be excluded.
Efficacy of Diclofenac Potassium Versus Acetaminophen in Febrile Children With Acute Upper Respiratory Tract Infections

The purpose of this study is to assess if a single dose of Diclofenac potassium (0.5 mg/kg) is more or as effective as a single dose of Acetaminophen (10 mg/kg) in the reduction of fever during 2 hours, in the treatment of febrile children with acute upper respiratory infections.

This is a comparative double blind, double dummy, randomized study on the effectiveness of Diclofenac potassium versus Acetaminophen in febrile children with acute upper respiratory tract infections. The patient will be randomized to either group: Group A (Diclofenac potassium (0.5 mg/kg) or Group B (Acetaminophen (10 mg/kg)). A Health Care Professional trained will measure the temperature during 2 hours. During the study period, parents or legal representatives will be invited to fill a survey about the habits and knowledge regarding fever management at home.


Eligibility Criteria:
Inclusion Criteria:

* Male and female outpatients, aged 2 to 6 years presenting tympanic temperature ≥ 38.5 ° C and no greater than 39.5° C, associated with acute upper respiratory tract infections
* Parents or legal representatives who have provided written informed consent and provided a phone number for the call at end of study

Exclusion Criteria:

* History of hypersensitivity to any drugs or excipients of the study
* Any medication, surgical, or medical condition, which might significantly alter the absorption, distribution, metabolism, or excretion of medications
* Background or suspected hematological disorders, febrile seizures, asthma, peptic ulcer or gastrointestinal bleeding
* Neurological and hemodynamics disorders
* Evidence of liver or kidney impairment or heart failure
* Patients who have received previous treatment with antipyretics; acetaminophen (up to 4 hrs), NSAIDs (up to 6 hrs) or antibiotic therapy (at least 12 hours)
* Any surgical or medical condition, which in the opinion of the investigator, may place the patient at risk

Other protocol-defined inclusion/exclusion criteria may apply
A Study of Repeat Dosing of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection

Primary objective: To assess the pharmacokinetics, Safety and immunogenicity of Repeat Dosing of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection With Severe Hemophilia A(FRSW117) Secondary objectives: To assess Preliminary efficacy of Repeat Dosing of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection With Severe Hemophilia A.


Eligibility Criteria:
Key Inclusion Criteria:

* The activity of the coagulation factor VIII (FVIII:C) \< 1%.
* Patients previously treated with FVIII concentrate (s) for a minimum of 150 exposure days (EDs) prior to study entry
* Normal prothrombin time or INR \< 1.3
* Negative lupus anticoagulant

Key Exclusion Criteria:

* Hypersensitive to any of the excipients of the test materials (e.g. allergic to murine or hamster origin heterologous proteins)
* History of hypersensitivity or anaphylaxis associated with any FVIII or II immunoglobulin administration
* Current FVIII inhibitor-positive or history of FVIII inhibitor-positive
* Other coagulation disorder(s) in addition to hemophilia A.• Significant hepatic or renal impairment (ALT and AST \> 2×ULN; serum bilirubin level \> 2 × upper limit of normal (ULN), Urea /BUN \> 2×ULN, Cr \> 176.8 µmol/L)
* One or more clinically significant tests for Human Immunodeficiency Virus (HIV), Antisyphilitic spirulina (TPHA) and Hepatitis C Virus (HCV) Antibody
* Patients who received any anticoagulant or antiplatelet therapy within one week prior screening or need to receive an anticoagulant or antiplatelet therapy during the period of clinical trials
* Patients having major surgery or receiving blood or bood components transfusion within 4 weeks prior screening or having planned major surgery schedule during the study
* Patients who previously participated in the other clinical trials within one month prior screening
* Any life-threatening disease or condition which, according to the investigator's judgment, could not benefit from the trial participation
* Patient who is considered by the other investigators not suitable for clinical study

Other protocol-defined inclusion/exclusion Criteria May Apply.
Device-detected Paroxysmal Atrial Fibrillation

This study will use an automated blood pressure monitor (Microlife WatchBP03) with an inbuilt algorithm to detect atrial fibrillation (an irregular heart rhythm) in patients with an implanted pacemaker who have previously documented paroxysmal (intermittent) atrial fibrillation. This study will compare the Microlife device detected atrial fibrillation episodes to the pacemaker detected atrial fibrillation episodes.

The modified Microlife blood pressure monitor is able to detect atrial fibrillation (AF) with high sensitivity (95%) and specificity (86%) and has a positive predictive value of 68% and negative predictive value of 98% for single readings. In addition, the modified device was also able to accurately classify the majority of the anomalous non-AF rhythms, although the specificity was highly variable, dependent upon the rhythm. However sinus rhythm was detected with a specificity of 97%. However, we do not currently know if the device would demonstrate a similar sensitivity in detecting AF in patients with paroxysmal AF.

Therefore, the present study will assess the sensitivity and specificity of the automated oscillometric device using a new AF algorithm among pacemaker patients with fast AF and atrial high-rate episodes and evaluate the effect of the specific rhythm abnormalities on the specificity for AF.

Eligibility Criteria:
Inclusion Criteria:

* Patients with an implanted pacemaker for sick sinus syndrome with previously documented AF with atrial high-rate episodes

Exclusion Criteria:

* Any patient who's pacemaker has had previously documented atrial sensing or pacing problem issues
* Patients with permanent AF
Stress Multidetector Computed Tomography (MDCT) an New Diagnostic Tool for Myocardial Disease

The goal of this study is to evaluate the ability of MDCT under stress to assess myocardial ischemia. There is some preliminary data in the literature showing the ability of MDCT under stress to bring relevant information about myocardial ischemia. Stress MDCT will have several advantages over single photon emission computed tomography (SPECT) imaging namely: shorter acquisition time, lower irradiation dose, lower cost. The feasibility of such experiment is still debated and need to be address in a clinical study.

Hypothesis: Cardiac dual source computed tomography (DSCT) performed during dipyridamole infusion allows for 1) myocardial perfusion analysis and detection of myocardial ischemia and 2) good quality evaluation (artefact free) of the coronary artery anatomy. Cardiac DSCT during dipyridamole infusion may assess in a single volume acquisition relevant information about coronary anatomy and myocardial ischemia that required today two different examinations each with a cost and side effects. Recently investigators showed on animal models as well as in humans that MDCT during stress test could detect myocardial ischemia.

Purposes: 1) To evaluate the diagnostic potential sensitivity, specificity of coronary DSCT during dipyridamole infusion for the assessment of myocardial ischemia with myocardial single photon emission computed topography (SPECT) as standard of reference. 2) To evaluate the feasibility (presence of artefact, number of coronary segment assessable) of coronary DSCT during dipyridamole injection.

Methods: This prospective study will include patients referred from the department of cardiology of Nord hospital. Inclusion criteria will be: patients who required functional evaluation of a known coronary artery lesion. Patients will be successively include. Each patient will undergo myocardial SPECT and coronary DSCT during dipyridamole injection. Coronary DSCT image analysis will determine the severity and the extension of the ischemic territory. Statistical analysis will determine the reproductibility of the described technique, compared the DSCT with SPECT as standard of reference and determined sensitivity, specificity and predictive values (positive and negative) of the described technique.

Eligibility Criteria:
Inclusion Criteria:

* Patients who required functional evaluation of a known coronary artery lesion

Exclusion Criteria:

* Disorders of the heart rhythm
* Myocardial infarct dating less than a month
* Unstable anger
* Congestive heart failure stages 3 and 4 of NYHA
* Renal failure
* Pregnancy and feeding
* History of anaphylactic reaction in the injection of iodized product
Efficacy and Safety of a Triple Eradication Scheme for Helicobacter Pylori Based on Tegoprazan vs Esomeprazole

In Mexico, quadruple therapy is used to treat Helicobacter pylori (H.P.) at the expense of greater adverse effects, costs, and lower adherence to treatment. According to evidence, a competitive potassium channel blocker (P-CAB) is non-inferior to a proton pump inhibitor (PPI) and can improve the eradication rate of H.P. while maintaining triple therapy antibiotics (amoxicillin-clarithromycin) without increasing adverse effects, fewer drugs and better adherence to treatment. It is proposed to study the effect of a P-CAB in the eradication of H.P. as part of a triple therapy in Mexican patients, assuming that the efficacy and safety of a triple therapy of amoxicillin-clarithromycin-tegoprazan will be superior to amoxicillin-clarithromycin-esomeprazole.

160 patients with a diagnosis of H.P. infection with indication for treatment in accordance with the IV Mexican Consensus on Helicobacter Pylori, evaluated in the Gastroenterology outpatient clinic, will be recruited. Participants will be randomized into two groups, one group will receive tegoprazan 50 mg BID, clarithromycin 500 mg BID and amoxicillin 1 gr BID for 14 days and the second group will receive esomeprazole 40 mg BID, clarithromycin 500 mg BID and amoxicillin 1 gr BID for 14 days. Through complementary studies, telephone calls and application of questionnaires, adherence to treatment will be evaluated and adverse events will be monitored, and once the treatment period is completed, a breath test will be performed between days 28-42 to verify eradication, thereby evaluating effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* First-degree relatives with a history of gastric cancer.
* Clinical diagnosis of uninvestigated dyspepsia in patients under 50 years of age.
* Diagnosis of Gastric Mucosa - Aassociated Lymphoid Tissue (MALT) Lymphoma.
* Iron deficiency anemia.
* Unexplained thrombocytopenic purpura.

Exclusion Criteria:

* Patients who have social coverage.
* Previous eradication treatment for Helicobacter Pylori.
* Acute upper gastrointestinal bleeding and active gastric and/or duodenal ulcer.
* History of surgery that affects gastric acid secretion (vagotomy, gastrointestinal resection).
* Disorders of gastric acid hypersecretion (Zollinger-Ellison Syndrome).
* Any serious hematological, cardiovascular, neurological, nephro-urological, hepatic and pulmonary disorders.
* Pregnancy or lactation.
* Allergy to any of the study medications.
Liver Biomarkers in Anorexia Nervosa

The main goal of the Liver Biomarkers in Anorexia Nervosa (LIBAN) study is to determine the prevalence of liver fibrosis in patient with Anorexia Nervosa.

Prevalence of hepatic fibrosis will be non-invasively investigated, in the Anorexia Nervosa inpatient population, using the Fibroscan ®. Furthermore, liver blood markers will be assessed.

Eligibility Criteria:
Inclusion Criteria :

* Patient over 15 years old
* Diagnosis of Restricted Eating Disorders including Anorexia Nervosa according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
* Admission to the endocrinology, diabetology and nutrition department of the Nantes University Hospital.

Exclusion Criteria :

* Chronic active viral hepatitis
* Hemochromatosis
* Other genetic, autoimmune, toxic or drug-induced hepatitis
* Treatment with a drug known to induce fatty liver disease (amiodarone, carbamazepine, tamoxifen, valproate, clozapine, anti-retrovirals) unless the dose has been stable for ≥ 3 months
* Excessive alcohol consumption (≥ 30 grams per day in men, ≥ 20 grams per day in women)
The Effect of the Free-toroidal Design Lenses on the Subjective Visual Quality in the Myopic Population

A prospective, self-control, double-blind design was conducted in Tianjin. Two hundred participants were assigned to wear two kinds of spectacle glasses. To examine the effect of free-toroidal design and aspherical lens on the subjective visual quality among the myopic population.

A prospective, self-control, double-blind design was conducted in Tianjin. Two hundred participants were assigned to wear two kinds of spectacle glasses. To examine the effect of free-toroidal design and aspherical lens on the subjective visual quality among the myopic population. The subjective visual quality of clarity and comfort were determined using a questionnaire when first wearing the glasses and after 1week.

Eligibility Criteria:
Inclusion Criteria:

* health volunteers
* their spherical refraction from -0.50 to -8.00 Diopter, with the cylinder diopter less than -3.00 Diopter
* best corrected visual acuity (BCVA)≥ 20/20 in both eyes
* stable refraction (no change greater than 0.5 Diopter within two years)

Exclusion Criteria:

* if they had Aphakic or intraocular lens eyes, had a history of trauma, active eye disease or ocular surgery, serious systemic diseases, or had a wearing history of corneal contact lenses.
Olfactory Stimulation for Very Low Birth Weight Infants

This is a RCT study examining whether odor administration to mothers of very low birth weight infants promotes stabilization of vital signs compared with common nursing care. This study used breast milk olfactory stimuli familiar and liked by premature infants to understand the effects of olfactory stimuli on the physiological indicators of very low birth weight infants, the effect on the time of complete enteral nutrition, and the effects on growth and development of very low birth weight infants.

Fluctuations in vital signs of very low birth weight infants may lead to poor prognosis. Research Objectives:

To evaluate the effect of olfactory stimulation of breast milk on the stability of physiological indexes of very low birth weight infants Subjects: Very low birth weight infants whose gestational age are less than 32 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age at birth \<32 weeks;
* Birth weight \< 1500 g;
* Admission to hospital within 24 hours after birth;
* Mother can provide breast milk

Exclusion Criteria:

* Severe congenital malformations;
* Complicated congenital heart disease;
* Congenital gastrointestinal disease;
* Intraventricular hemorrhage