bioihbjkbjnl/mcl2 huggingface dataset:
Management of Acute Pulmonary Hypertensive Crisis in Children With Known Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: Phenylephrine; Epinephrine; Arginine Vasopressin
Intervention description: 5 subjects will get Phenylephrine during cardiac catheterization in patient with known Pulmonary Arterial Hypertension.Dose will be 1ug/kg body weight. Pressures in the pulmonary artery will be measured before and after the drug administration.; 5 subjects will get Epinephrine during cardiac catheterization in patient with known Pulmonary Arterial Hypertension.Dose will be 0.5-1ug/kg body weight. Pressures in the pulmonary artery will be measured before and after the drug administration.; 5 subjects will get Arginine Vasopressin during cardiac catheterization in patient with known Pulmonary Arterial Hypertension.Dose will be 1ug/kg body weight. Pressures in the pulmonary artery will be measured before and after the drug administration.
Intervention MeSH terms: Phenylephrine; Vasopressins; Arginine Vasopressin; Epinephrine; Racepinephrine; Oxymetazoline; Epinephryl borate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 1 Year
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      Pulmonary arterial hypertension (PAH) is a disease where the blood pressure in the pulmonary
      arteries (PAP) is high. PAH increases the risk of adverse events, including death, during and
      or after procedures. The severity of baseline PAH correlates with the incidence of major
      complications, such that those with PAP higher than their systemic blood pressure (SBP) had a
      8 fold increased risk of complications. These children present for procedures where an acute
      exacerbation of their chronic illness-termed Pulmonary Hypertensive (PH)crisis, can occur,
      often resulting in death if not detected and managed expeditiously. Unfortunately there is
      little data and no consensus in the pediatric literature on how PH crisis should be managed.

      --------------------------------------------------------------------------------
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients presenting for cardiac catheterization procedure with a diagnosis of PAH
             either by previous cardiac catheterization or echocardiography

        Exclusion Criteria:

          -  Children presenting for cardiac catheterization who do not have PAH;

          -  Children with PAH but with intracardiac shunts
Repeated Amiodarone Dosing In Cardiac surgicaL Procedures
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: AMIODARONE
Intervention description: Assess the effectiveness of different dosing strategies of amiodarone.
Intervention MeSH terms: Amiodarone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is a single-center, prospective, randomized, open-label trial of subjects who
      develop atrial fibrillation after non-emergent cardiac surgery at the University of Kentucky
      Chandler Medical Center (UKCMC). Patients will be randomized to receive either a conventional
      amiodarone dosing regimen (CDR) or a repeated amiodarone bolus dosing regimen (RBDR).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must be 18 years old or older

          -  Subject must be willing to give written informed consent

          -  Subject must undergo or scheduled for non-emergent cardiac surgery, including coronary
             artery bypass grafting (CABG), non-infectious valve repair or replacement, atrial or
             septal defect repair, thoracic aortic replacement surgery, or any combination of these
             procedures

        Exclusion Criteria:

          -  Documented allergy to amiodarone or iodine

          -  History of atrial fibrillation or other heart conduction system abnormality

          -  History of cardiac maze, pulmonary vein isolation, or other procedure affecting the
             conduction system

          -  Scheduled cardiac maze, pulmonary vein isolation, or other procedure affecting the
             conduction system

          -  Low cardiac index or cardiogenic shock requiring pharmacologic or mechanical support

          -  History of pre-existing respiratory system disease requiring oxygen therapy prior to
             admission

          -  History of cirrhosis or other chronic liver diseases

          -  Pregnancy or breastfeeding mothers

          -  Prisoner status
The Effect of Intravenous Acetaminophen on Post-Operative Pain After Craniotomy
Condition: Pain
MeSH terms: Pain, Postoperative
Intervention: Acetaminophen; Placebo
Intervention description: Acetaminophen 1 g intravenous given at the beginning and end of surgery.; Placebo to match acetaminophen given at the beginning and end of surgery.
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Patients selected for this study were being treated for Moyamoya disease and required two operations, scheduled 1-2 weeks apart. With random assignment, patients were administered 1 gram of intravenous acetaminophen at the beginning and end of surgery, and placebo during the other operation.
Masking: Double (Participant, Care Provider)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to determine the efficacy of IV acetaminophen when administered
      to neurosurgical patients at the beginning and end of their surgery. If the result is
      improved pain control with less opioid consumption postoperatively, then those patients may
      also experience less opioid related side effects such as nausea/vomiting, pruritus, and
      sedation. While numerous other studies have failed to show a benefit of IV acetaminophen
      after neurosurgical procedures, we are studying the administration of 1 g in two doses over
      the course of the operation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a diagnosis of bilateral moyamoya disease scheduled for bilateral
             external-carotid to internal-carotid bypass surgery to be done in two stages.

        Exclusion Criteria:

          -  Allergy or history of reaction to acetaminophen. Patients with liver disease. Anyone
             not able to provide informed consent.
Effect of Fosaprepitant on Motor Evoked and Somatosensory Evoked Potentials Under General Anesthesia
Condition: Postoperative Nausea
MeSH terms: Postoperative Nausea and Vomiting
Intervention: Fosaprepitant 150 mg
Intervention description: Antiemetic used to prevent nausea and vomiting after general anesthesia.
Intervention MeSH terms: Fosaprepitant; Aprepitant
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: A single group of up to 50 patients will be administered a standard dose of fosaprepitant 150 mg IV after induction of anesthesia. A standard neuromonitoring setup utilizing motor evoked potentials, and somatosensory evoked potentials will be used as indicated for the type of surgery. After baseline neuromonitoring measurements have been made, but prior to surgery starting, we will administer the fosaprepitant to determine if there are any effects on the motor evoked potentials or somatosensory evoked potentials measurements.
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if intravenous fosaprepitant can interfere with
      nervous system monitoring signals in patients having surgery under general anesthesia. This
      medication has numerous effects on the sensory nerve transmission which can theoretically
      have effects on the ability to accurately measure somatosensory evoked potentials.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Having a surgical procedure requiring general anesthesia, having a surgical procedure
             where neuromonitoing with somatosensory evoked potentials and motor evoked potentials
             neuromonitoring is requested by the surgical team

        Exclusion Criteria:

          -  Patient refusal, allergy to the drug or any of its excipients, pre-operative motor or
             sensory deficit
Impact of Acthar on Everyday Life of Participants With Severe Keratitis
Condition: Keratitis
MeSH terms: Keratitis
Intervention: Acthar
Intervention description: Acthar gel for subcutaneous injection
Intervention MeSH terms: Adrenocorticotropic Hormone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Severe or recalcitrant keratitis

Summary:

      We will need about 36 participants for this study.

      Volunteers might be able to participate if:

        -  they have bad noninfectious keratitis

        -  early treatments failed or were not well tolerated

      Participants will be in the study for about 22 weeks:

        -  4 weeks for tests to see if the study might be good for them

        -  12 weeks of treatment with Acthar gel

        -  4 weeks to wean off Acthar gel and follow-up with the doctor
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has severe or recalcitrant keratitis

          -  Did not respond to, or tolerate, treatment with topical cyclosporine, Lifitegrast, or
             any immunosuppressant to treat keratitis

          -  If able to reproduce, agrees to use 2 forms of effective contraception with a partner
             of the opposite sex for the duration of the study (through Visit 6)

          -  Has normal eyelids, and protocol-defined physical and medical eye attributes

          -  Agrees to avoid wearing contact lenses during the trial

        Exclusion Criteria:

          -  Is pregnant or breast-feeding

          -  Is defined as vulnerable, or is employed by, or related to anyone involved in the
             study

          -  Has a medical condition or history that might, per protocol or in the opinion of the
             investigator, compromise the participant's safety or study analysis
Fall Prevention in Older Adults With OAB
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: Fesoterodine
Intervention description: Fesoterodine, the drug used in this study, is an appropriate medication for routine and standard care of overactive bladder.
Intervention MeSH terms: Fesoterodine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: prospective cohort design examining effects in adults aged 65 and older with OAB undergoing treatment with medication in a clinical setting. A follow up period of 8 weeks has been selected because this is the period of maximal drop in adherence.
Masking: None (Open Label)
Enrollment: 74.0
Sex: Female
Minimum age: 65 Years
Healthy volunteers: No

Summary:

      Though OAB treatment may improve physical activity, there is a lack of easily administered
      instruments for measuring physical activity in older adults. Aim is to validate instruments
      to measure physical activity and preference for medication, and to determine the effect of
      preference for anti-cholinergic medication on adherence, physical activity, and falls risk.
      It's plan a prospective cohort study of adults aged 65 or older with OAB undergoing treatment
      with anti-cholinergic medication.
    

Eligibility criteria:

        Inclusion Criteria:

        adults aged 65 or older, urinary urgency of quite a bit severity or more on the Overactive
        Bladder Questionnaire-Short Form (OABq-SF), eligible for pharmacologic therapy for
        overactive bladder

        Exclusion Criteria:

        predominant stress incontinence (on UDI-6), current/recent use (6 m) or contraindication to
        anti-cholinergic medication, severe voiding difficulties, men on 5-alpha reductase
        inhibitors, severe neurologic disease, recent anti-incontinence or prolapse surgery, other
        urinary tract conditions such as calculus or recurrent UTI.
Opioid Analgesia for MAB
Condition: MAB; Pain
Intervention: Oxycodone 10mg oral; Placebo
Intervention description: Oxycodone 10mg oral given for pain control in addition to standard of care medications in women undergoing medical abortion; Placebo given in addition to standard of care medications in women undergoing medical abortion
Intervention MeSH terms: Oxycodone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Double Blind
Enrollment: 172.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Our primary objective will be to determine if a strong opioid, oxycodone, given at a dose
      recommended for severe pain in addition to ibuprofen decreases maximum pain scores compared
      to ibuprofen and placebo in women undergoing medical abortion (MAB). Results of this study
      will help future providers understand whether prescribing opioids are an important adjunct
      for pain control in women undergoing MAB.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 18 years or older

          -  Seeking elective medical abortion

          -  In good health

          -  Pregnancy with intrauterine gestational sac up to 10 0/7 weeks, dated by ultrasound

          -  Able and willing to receive text messages via phone

          -  Literate in English

          -  Able and willing to give informed consent and agree to the study terms

          -  Have assistance at home; no motor vehicle use while taking study medications

        Exclusion Criteria:

          -  Lack of access to cell phone and texting capabilities

          -  Early pregnancy failure

          -  Contraindications to the study medications: Oxycodone, Ibuprofen

          -  Contraindications to medical abortion with Mifepristone or Misoprostol

          -  History of methadone or heroin use

          -  Used alcohol in the past 24 hours

          -  Used marijuana >4 times per week

          -  Any opioid in the past 30 days

          -  Using additional pain medications
(mo)BETTA Trial in Transwomen for Optimization of ART
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: B/FTC/TAF; Current ART
Intervention description: B/FTC/TAF is bictegravir + tenofovir alafenamide + emtricitabine in one pill (single tablet regimen); Current ART is emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Transgender women; Bictegravir

Summary:

      The purpose of this study is to determine the safety and tolerability of a new HIV
      medication, bictegravir plus emtricitabine plus tenofovir alafenamide (B/FTC/TAF, 3 HIV
      medications combined into one pill) in HIV-infected transgender women (TW).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Self-identified transgender woman (TW)

          -  HIV infection

          -  Undetectable HIV viral load (HIV-1 RNA <50 copies/mL) at screening and for >/=24 weeks
             prior to entry.

          -  Current HIV treatment with FTC plus TDF or TAF and a 3rd agent.

          -  No changes in ART in the 12 weeks prior to screening.

          -  Current female hormone therapy use.

          -  Ability and willingness of subject to provide informed consent.

        Exclusion Criteria:

          -  Current or planned use of prohibited medications (Phenobarbital, Phenytoin,
             Carbamazepine, Oxcarbazepine, Rifampin, Rifapentine, St. John's Wort, Echinacea,
             Dofetilide, Cisapride, Atazanavir)

          -  Change or initiation of lipid- and/or glucose-lowering therapy in the 12 weeks prior
             to entry, or planned need for such therapy during the study period.

          -  Current use of androgen therapy.

          -  Intent to significantly modify diet or exercise habits, or to enroll in a weight loss
             intervention during the study period.

          -  Anticipated need to initiate or change doses of medications with anti-inflammatory
             properties within the study period.

          -  Screening laboratory values as follows: (ANC <500 cells/mm^3; Hemoglobin <10 gm/dL; Cr
             Cl <30 mL/min (estimated by CKD-Epi equation); AST or ALT >3x ULN)

          -  Evidence of resistance to any component of the current ART regimen (genotypic or
             phenotypic)

          -  Current use of bictegravir in another investigational setting

          -  Current use of other investigational agents that the participant could not receive
             unchanged, if needed, throughout the study period (unless approved by the study team)

          -  Any condition that the study investigator believes would make the candidate unsuitable
             for participation
Informing Tobacco Treatment Guidelines for African American Non-Daily Smokers
Condition: Smoking Cessation
Intervention: Nicotine Replacement Therapy; Smoking Cessation Counseling
Intervention description: Participant has choice of from over-the-counter nicotine patch, nicotine gum or lozenge.
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 278.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The researchers are testing if counseling alone or counseling plus over-the-counter nicotine
      replacement therapies (NRT), like the patch,gum, or lozenge, helps African American non-daily
      smokers quit smoking.
    

Eligibility criteria:

        Inclusion Criteria:

          -  African American adults who are interested in quitting and whose smoking patterns meet
             criteria for non-daily smoking as determined by eligibility screening

        Exclusion Criteria:

          -  Contraindications to behavioral counseling, nicotine gum, patch, or lozenge and unable
             to complete study procedures as determined by eligibility screening
Study of Ocular Penetration of Topically Administered Fluoroquinolones
Condition: Cataract Extraction
MeSH terms: Eye Injuries, Penetrating; Cataract
Intervention: Moxifloxacin 0.5% ophthalmic solution; Besifloxacin 0.6% ophthalmic suspension
Intervention description: Administer moxifloxacin study drug prior to cataract surgery.; Administer besifloxacin study drug prior to cataract surgery.
Intervention MeSH terms: Moxifloxacin; Besifloxacin; Ophthalmic Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      This study is being conducted to evaluate the intraocular penetration of Moxifloxacin 0.5%
      ophthalmic solution (Vigamox) and Besifloxacin 0.6% ophthalmic suspension (Besivance) after
      pre-operative topical administration in subjects undergoing cataract surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who have a visually significant cataract and are planning to have cataract
             surgery.

          -  Subjects who are willing/able and have signed informed consent approved by the
             Institutional Review Board.

        Exclusion Criteria:

          -  Subjects who have a known hypersensitivity, allergy, or contraindication to any
             fluoroquinolone medication, in any form.

          -  Subjects who signs of ocular infection or active inflammation in the study eye.

          -  Subjects who have corneal pathology, including epithelial defect, corneal scarring, or
             severe dry eye syndrome.

          -  Subjects who have used any disallowed medication (including antibiotics) during the
             time period designated as described in the protocol.

          -  Subjects who have any active or chronic/recurrent ocular or systemic disease that is
             uncontrolled and is likely to increase the risk of infection to the patient or
             confound the results of the study.

          -  Subjects who are pregnant (or suspect to be pregnant) or nursing/lactating.

          -  Subjects who have participated in any study of an investigational drug or device
             within 30 days prior to enrollment.