bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Race/Ethnicity and Genes on Acetaminophen Pharmacokinetics
Condition: Pain; Fever; Hepatotoxicity
Intervention: Acetaminophen
Intervention description: 2 x 500 mg by mouth once
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 95.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Although acetaminophen is the most commonly used nonprescription drug in the USA, little is
      known regarding the influence of genes and race/ethnicity on acetaminophen disposition. The
      investigators long-term goal is to understand the causes of differences in acetaminophen
      disposition between people that are the result of genetic variation and ethnicity and may
      predispose individuals to a higher risk of acetaminophen hepatotoxicity. The aim of this
      particular study is to measure the rate of elimination of acetaminophen via the 3 main
      pathways (glucuronidation, sulfation and oxidation) in self-identified White-Americans
      (n=100) and African-Americans (n=100). These rates will then be correlated with selected
      genetic polymorphisms in genes encoding enzymes involved in acetaminophen metabolism. Two
      main hypotheses will be tested: 1. African-Americans eliminate acetaminophen more rapidly by
      glucuronidation than do White-Americans. 2. Elimination via glucuronidation, sulfation, and
      oxidation in subjects will be significantly correlated with the presence of polymorphisms in
      the UGT1A6, SULT1A1, and CYP2E1 genes, respectively.
    

Eligibility criteria:

        Inclusion Criteria:

          -  self-declared white/Caucasian

          -  self-declared African-American

          -  active

          -  ambulatory

          -  no evidence of medical disease

        Exclusion Criteria:

          -  alcohol use of 3 or more drinks per day

          -  HIV or hepatitis (B or C) infection

          -  isoniazid

          -  disulfiram

          -  phenobarbital

          -  phenytoin

          -  carbamazepine

          -  rifampicin

          -  valproic acid

          -  probenecid

          -  St. John's Wort
Multicenter, Nonrandomized, Prospective Study of Pulmonary Embolism Removal With the AngioJet 6F Ultra System
Condition: Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Embolism
Intervention: AngioJet Ultra PE Thrombectomy System
Intervention description: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pulmonary Embolism; Acute Pulmonary Embolism; Sub-massive Pulmonary Embolism; Massive Pulmonary Embolism; Pulmonary Thromboembolism

Summary:

      The purpose of this European Post Market Follow-up Plan is designed to evaluate the safety,
      efficacy, adverse events and any new information that may surface regarding the use of the
      AngioJet Ultra PE Thrombectomy Catheter System in patients with thrombus in the main
      pulmonary and lobar arteries ≥ 6mm in diameter.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Symptomatic pulmonary embolism patients >18 years

          2. Availability of a baseline contrast-enhanced chest computed tomogram or conventional
             pulmonary angiogram with evidence of pulmonary embolus in at least one main or lobar
             pulmonary artery ≥ 6mm in diameter

          3. Availability of a baseline transthoracic echocardiogram with sufficient image quality
             permitting the measurement of right ventricular (RV) and left ventricular (LV)
             dimensions in the apical or subcostal four-chamber view

          4. Echocardiographic evidence of right ventricular dilatation with a subannular RV/LV
             ratio ≥ 0.9 from the apical or subcostal four-chamber view

          5. Appropriate informed consent was obtained from the patient or legal representative

        Exclusion Criteria:

          1. Patient has underwent Cardiopulmonary Resuscitation (CPR) in the last 48 hours

          2. Patient is participating in any other clinical study

          3. Pregnancy, lactation or parturition within the previous 30 days (positive pregnancy
             test, women of childbearing age must be tested or use a medically accepted method of
             birth control)

          4. Inability to comply with study Follow-up assessments (e.g. due to geographic)

          5. Previous enrollment in this study
Corticosteroids for Immune Reconstitution Inflammatory Syndrome (IRIS)
Condition: Immune Reconstitution Inflammatory Syndrome; Leukoencephalopathy, Progressive Multifocal
MeSH terms: Leukoencephalopathy, Progressive Multifocal; Leukoencephalopathies; Immune Reconstitution Inflammatory Syndrome; Syndrome
Intervention: Methylprednisolone; Prednisolone
Intervention description: In intravenous form (for a daily dose of 1 g/day on treatment days).; Oral prednisolone used as a taper, with suggested dosages starting at 80 mg and tapering to 5 mg.
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: IVMP; corticosteroids; IRIS; Progressive Multifocal Leukoencephalopathy; Immune reconstitution inflammatory syndrome; PML

Summary:

      The objectives of this study are to explore the effects of administering high-dose
      corticosteroids to participants who developed progressive multifocal leukoencephalopathy
      (PML) while on natalizumab as measured by time-course change in functional status based on
      Karnofsky Performance Status Index through 6 months following the completion of plasma
      exchange (PLEX; or equivalent), survival at 6 months following the completion of PLEX (or
      equivalent), and incidence and severity of adverse events (AEs) and serious adverse events
      (SAEs); to characterize the evolution of immune reconstitution inflammatory syndrome (IRIS)
      as measured by time course changes in Global Clinical Impression of Improvement (GCI-I),
      Symbol Digit Modalities Test (SDMT), brain magnetic resonance imaging (MRI),
      magnetoencephalography (MEG), chemokines, cytokines, C-reactive protein (CRP), John
      Cunningham virus (JCV) load and cell count in cerebrospinal fluid (CSF); and to characterize
      the time course elimination of serum natalizumab concentrations in the study population
      following the last PLEX (or equivalent) procedure.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Must have been receiving natalizumab for multiple sclerosis (MS) prior to the
             diagnosis or suspicion of Progressive multifocal leukoencephalopathy (PML).

          -  Subject must be willing to undergo or have completed plasma exchange (PLEX) prior to
             initiating study treatment.

        Key Exclusion Criteria:

          -  History of severe allergic or anaphylactic reactions or known hypersensitivity to any
             drug including hypersensitivity to corticosteroids.

        NOTE: Other protocol defined inclusion/exclusion criteria may apply.
Multi-dose Acetaminophen for Patients Undergoing General Anesthesia
Condition: Recovery Following Cholecystectomy
Intervention: Acetaminophen; normal saline
Intervention description: patients 50kg or more receive1000mg in 100milliliters of normal saline every 4 hours to a maximum dose 4000mg/24 hours. <50kg receive 12.5mg/kg to a maximum of 75mg/kg/24 hours.; 100mL of normal saline every 4 hours to a maximum administration of 400mL
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 88.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Study Objective The aim of the proposed study is to examine the effect of Q4 hour multidose
      IV acetaminophen on patients' readiness for discharge. In doing so the investigators will
      also investigate the various factors that could potentially contribute to a patient's
      readiness for discharge such as overall opioid consumption, time to rescue medication,
      incidence of postoperative nausea and vomiting, pain scores, and perioperative stress markers
      and their overall correlation with IV acetaminophen intake.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Undergoing ambulatory laparoscopic cholecystectomy.

          -  American Society of Anesthesiologists physical status 1, 2 or 3.-

        Exclusion Criteria -

          -  Cognitively impaired (by history) and unable or unwilling to consent

          -  Chronic steroid or opioid user (as prescribed for a chronic systemic illness)

          -  Parturient or nursing mother. Patients who have been informed by a physician that they
             have liver or kidney disease
A Study to Evaluate the Duration of LASTACAFT® in Acute Allergic Conjunctivitis
Condition: Conjunctivitis, Allergic
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: alcaftadine 0.25% ophthalmic solution; olopatadine 0.2% ophthalmic solution; dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%
Intervention description: One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.; One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.; One drop of placebo instilled in each eye at Day 0 and Day 14.
Intervention MeSH terms: Olopatadine Hydrochloride; Dextrans; Pharmaceutical Solutions; Ophthalmic Solutions; Lubricant Eye Drops; Alcaftadine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 127.0
Sex: All
Minimum age: 10 Years
Healthy volunteers: No

Summary:

      This study will evaluate the duration of action of LASTACAFT® and Pataday™ as compared to
      artificial tears (placebo) in the prevention of ocular itching associated with allergic
      conjunctivitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of eye allergies within the past 24 months

          -  Willing to not wear contact lenses at least 72 hours prior to the study start and
             during the study period

        Exclusion Criteria:

          -  Current eye infection

          -  Eye surgery within 3 months or vision correction surgery within 6 months

          -  Any planned surgery during the study or 30 days after the study
Tranexamic Acid in Surgery of Advanced Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: Tranexamic acid; 0.9% NaCl solution
Intervention description: Tranexamic acid, 100 mg/ml; 15 mg/kg body weight added to 100 ml 0.9% NaCl solution given as a single dose intravenously immediately prior to skin incision at surgery; 0.9% NaCl solution; 0.15 ml/kg body weight added to 100 ml 0.9% NaCl solution. The volume is given intravenously immediate before skin incision at surgery.
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 100.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Tumor of ovary; Surgical blood loss; Postoperative blood loss; Preventive therapy; Thromboembolism

Summary:

      The purpose of the study is to determine if a standardized single dose tranexamic acid given
      intravenously immediately preoperatively reduces the perioperative bleeding volume and
      reduces the need of blood transfusion in women undergoing surgery for advanced ovarian
      cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females ages 18 or older with a pelvic or abdominal tumor suspected or
             histopathologically proven ovarian cancer FIGO stage II-IV who are undergoing primary
             surgery with the intention of performing optimal cytoreductive radical surgery.

          -  Understand and speak Swedish

          -  Accept participation in the study after written and verbal information and sign
             informed consent.

        Exclusion Criteria:

          -  Allergy to tranexamic acid

          -  Having had tranexamic acid within the recent 30 days

          -  Previous or present episode of thromboembolic events .

          -  Previous or present treatment within the recent 3 months with anticoagulant.

          -  Previous or present known coagulopathy

          -  Myocardial infarction within the previous 12 months or instable angina pectoris which,
             according to the investigator, may increase the risk for complications significantly
             in case of a lowering of the hemoglobin.

          -  Significant renal failure with serum-creatinine > 250 µmol/l.

          -  Severe psychiatric dysfunction or mentally substantially disabled.
Use of Electrical Impedence to Measure Lean Body Weight as a Determinant of the Dose of Contrast Media for Abdominal CT
Condition: IV Contrast Dosing
MeSH terms: Body Weight
Intervention: Isovue 370; Weight calculation
Intervention description: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 139.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: IV contrast; contrast dosing

Summary:

      There are several different methods that can be used to determine the dose of iodinated
      contrast material for a CT scan. These include a standard fixed dose, a dose based on total
      body weight, a dose based on body mass index, a dose based on lean body weight, and a dose
      based on estimated lean body weight. The fixed dose method uses a predetermined amount of
      contrast material for all patients having a CT scan of the abdomen regardless of size. This
      is the standard procedure currently used at Duke. The other methods use the patient's weight,
      either the total body weight or lean body weight, to determine the amount of contrast
      necessary for the CT exam. For this study, the investigators will use the fixed dose, total
      body weight, the lean body weight, and estimated lean body weight methods. The purpose of
      this study is to evaluate these five methods of determining the IV contrast volume and which
      may be best for abdominal CT scanning.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male or non-lactating, non-pregnant females

          -  18 years or older who are able to give written informed consent

        Exclusion Criteria:

          -  a chronic underlying liver disease such as cirrhosis, fatty infiltration of the liver
             or glycogen storage diseases

          -  patients with a prolonged cardiac transit time such as those with a congested heart
             failure, a history of prior cardiac valve replacement, or restrictive/constrictive
             pericarditis

          -  patients having undergone any other radiological procedure utilizing iodinated
             contrast with the 24 hours prior to the CT exam

          -  patients above a certain total body weight (440 lbs.) due to limitation of the scales
             themselves (determined by manufacturer)

          -  any subjects with a history of hypersensitivity to iodine-containing compounds or
             renal insufficiency (serum creatinine >1.8)

          -  subjects with implanted electronic devices (pacemakers, defibrillators, insulin pumps,
             etc.)
Effect of Allopurinol and Febuxostat on Urinary 2,8-Dihydroxyadenine Excretion
Condition: Adenine Phosphoribosyltransferase Deficiency
Intervention: Allopurinol; Febuxostat
Intervention description: This is a clinical trial comparing the effect of 80 mg/day of febuxostat to 400 mg/day of allopurinol on the urinary excretion of 2,8-dihydroxyadenine in patients with APRT deficiency.; This is a clinical trial comparing the effect of 80 mg/day of febuxostat to 400 mg/day of allopurinol on the urinary excretion of 2,8-dihydroxyadenine in patients with APRT deficiency.
Intervention MeSH terms: Allopurinol; Febuxostat
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Xanthine dehydrogenase inhibitor treatment, pharmacotherapy

Summary:

      This exploratory pilot study was an open-label, crossover, single-center and non-randomized
      clinical trial designed to compare the effect of the standardly employed doses of allopurinol
      (400 mg/day) and febuxostat (80 mg/day) on the urinary 2,8-dihydroxyadenine (DHA) excretion
      in patients with adenine phosphoribosyltransferase (APRT) deficiency.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients 18 year and older who are enrolled in the APRT Deficiency Registry of The
             Rare Kidney Stone Consortium.

        Exclusion Criteria:

          -  Patients do not want to interrupt drug (allopurinol) treatment for a total of two
             weeks as requested in protocol. No other exclusion criteria if inclusion criteria are
             met.
Platelet Inhibition in Patients With Systolic Heart Failure
Condition: Systolic Heart Failure
MeSH terms: Heart Failure; Heart Failure, Systolic; Systolic Murmurs
Intervention: Prasugrel 10 mg daily x 2 weeks; Clopidogrel 75 mg daily x 2 weeks
Intervention MeSH terms: Clopidogrel; Prasugrel Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 19 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Heart failure; Antiplatelet therapy; Platelet aggregation; Clopidogrel; Prasugrel

Summary:

      The investigators aim to determine if patients with systolic heart failure treated with
      prasugrel achieve greater platelet inhibition compared to those treated with clopidogrel.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients 19 to 74 years of age.

          -  Patients with a left ventricular ejection fraction <35% by echocardiogram, SPECT
             myocardial perfusion study, cardiac MRI, cardiac computerized tomographic angiogram or
             invasive left ventricular angiogram within the last 6 months.

          -  Patients with NYHA Class III-IV heart failure at the time of enrollment.

        Exclusion Criteria:

          -  Recent hospitalization within 30 days

          -  Patients expected to undergo major surgery or PCI in the next 30 days

          -  Patients taking clopidogrel, prasugrel, ticagrelor, ticlopidine, or cilostazol

          -  Patients listed for heart transplantation or having left ventricular assist device
             placement

          -  Patients with known allergy to either medication

          -  Patients with prior history of stroke or transient ischemic attack

          -  Patients with known intracranial neoplasm, aneurysm, or arteriovenous malformation

          -  Patients with a history of bleeding requiring hospitalization for treatment

          -  Patients taking oral anticoagulants

          -  Patients with body weight <60 kg

          -  Women who are pregnant or breastfeeding

          -  Patients with hemoglobin <10 mg/dl or platelet count <100,000/ul at baseline

          -  Patients with known clotting or platelet disorders

          -  Patients with a baseline INR > 1.4

          -  Patients with liver function tests (AST or ALT) > 2 times normal

          -  Patients with a suspected change in their use of aspirin during the study (starting,
             stopping, or changing dose of aspirin)

          -  Patients unwilling to consent to CYP2C19 genetic testing.
Intravenous Lidocaine Versus Morphine for Severe Pain in the ED
Condition: Pain
Intervention: Intravenous lidocaine; Intravenous morphine
Intervention description: Intravenous lidocaine drip over 10 minutes followed by intravenous lidocaine drip over 50 minutes; Emergency department provider chooses appropriate dose of intravenous morphine
Intervention MeSH terms: Lidocaine; Morphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Objective: Evaluate the analgesic efficacy of intravenous (IV) lidocaine versus provider
      chosen dose of IV morphine for the treatment of severe pain in the emergency department.

      Study design: Open-label, randomized controlled pilot study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has severe pain (NRS ≥7)

          -  Subject has anticipated ED stay of ≥1 hour

        Exclusion Criteria:

          -  High acuity trauma patients

          -  Patients deemed to critically ill by ED provider

          -  Active psychosis

          -  Pregnancy

          -  History of heart block or bradycardia

          -  Allergy to lidocaine or amide type local anesthetic

          -  History of seizures