bioihbjkbjnl/mcl2 huggingface dataset:
Intranasal Midazolam in Children as a Pre-Operative Sedative - Part 2
Condition: Sedation
Intervention: Midazolam; xylocaine; saline placebo
Intervention description: midazolam 0.2 mg/kg given intranasally; intransal xylocaine given in conjunction with intranasal midazolam; intranasal saline given as placebo
Intervention MeSH terms: Lidocaine; Midazolam
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 42.0
Sex: All
Minimum age: 18 Months
Maximum age: 7 Years
Healthy volunteers: No

Summary:

      Midazolam is often given before surgery to sedate a patient before anesthesia is given.
      Children are often given a small dose either by mouth or squirted into the nose. Children
      will often spit out the oral midazolam, making it difficult to know how much medicine, if
      any, they have received. Giving midazolam into the nose is more reliable, but children may
      complain of pain, stinging, and may become upset due to the discomfort. Nosebleeds may also
      occur when midazolam is squirted alone into the nose. The purpose of this study is to see if
      adding a numbing medicine, xylocaine, to the nasal midazolam makes giving the midazolam
      easier and more comfortable without affecting how the midazolam works as a sedative. This is
      follow up to the pilot study, Project # 994. This will expand the previous study, with
      additional participants and revised xylocaine concentration
    

Eligibility criteria:

        Inclusion Criteria:

          1. Children aged 18 months-7 years, scheduled for a minor Ear/Nose/Throat surgical
             procedure requiring mask anesthesia

          2. American Society of Anesthesiologists (ASA) Class 1 or 2

          3. Parent willing and able to provide written informed consent

          4. Parent willing and able to complete the Observed Behavioral Distress (OBD) Visual
             Assessment Scale (VAS)

        Exclusion Criteria:

          1. ASA Class 3 or greater

          2. History of allergy to midazolam or xylocaine

          3. Presence of acute respiratory infection at time of surgery

          4. Parent unwilling or unable to provide informed consent

          5. Parent unwilling or unable to complete the OBD VAS
Pharmacokinetics of Tedizolid Phosphate in Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Tedizolid PO; Tedizolid IV
Intervention description: Participants will be randomized to receive tedizolid oral 200mg once daily for 3 days and crossed over to IV after a 1 week washout.; Participants will be randomized to receive tedizolid IV 200mg once daily for 3 days and crossed over to PO after a 1 week washout.
Intervention MeSH terms: Tedizolid; Oxazolidinones
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The proposed study is designed to characterize the pharmacokinetics of intravenous and oral
      tedizolid in patients with Cystic Fibrosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of CF based on positive sweat chloride or known CF mutation

          -  Age > 17 years

          -  Able to spontaneously expectorate sputum

        Exclusion Criteria:

          -  Any clinically significant laboratory abnormalities

          -  Presence of an ongoing acute pulmonary exacerbation

          -  Pregnancy

          -  Serious past allergy to linezolid or tedizolid

          -  No alcohol, nicotine, or caffeine-containing products during the study period
Suvorexant in Insomnia Co-morbid With Fibromyalgia
Condition: Insomnia; Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Sleep Initiation and Maintenance Disorders
Intervention: suvorexant; placebo
Intervention description: suvorexant 20 mg taken before sleep; placebo taken before sleep
Intervention MeSH terms: Suvorexant
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 10.0
Sex: Female
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: insomnia; fibromyalgia; polysomnography; pain management

Summary:

      This study will compare sleep, pain and daytime sleepiness/fatigue in people with insomnia
      co-morbid with fibromyalgia while treated short-term with suvorexant 20 mg versus placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  meet Diagnostic and Statistical Manual 5th ed criteria for insomnia

          -  meet American College of Rheumatology criteria for fibromyalgia

          -  otherwise good psychiatric and stable physical health

        Exclusion Criteria:

          -  other primary sleep disorders

          -  pain symptoms unrelated to fibromyalgia

          -  current pregnancy or breast-feeding
Oxytocin And Uterotonic Agent Use For Cesarean Delivery
Condition: Uterine Atony; Hypotension
MeSH terms: Uterine Inertia; Hypotension
Intervention: Oxytocin Infusion; Oxytocin Bolus
Intervention description: 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request.; 3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale).
Intervention MeSH terms: Misoprostol; Oxytocin; Methylergonovine; Carboprost; Carboprost tromethamine; Maleic 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: 60.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Uterine Atony; Hypotension; Cesarean Delivery; Hemorrhage; Phenylephrine; Ephedrine

Summary:

      The central objective of this study will be to evaluate a standardized, evidence-based
      regimen versus a conventional regimen for uterotonic drug dosing for elective cesarean
      delivery

      The investigators primary hypothesis is that the proposed uterotonic drug regimen, when
      compared to conventional dosing regimen, during elective cesarean delivery will:

      1. Reduce the overall amount of oxytocin and other uterotonic agents used to obtain
      satisfactory uterine tone.

      Secondary outcomes to be evaluated will be:

        1. Reduce the side effects associated with uterotonic drug use

        2. Reduce the time to establishment and maintenance of adequate uterine tone
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologists (ASA) I or II health status

          -  Age between 18 and 50 yrs

          -  Singleton pregnancies in vertex position

          -  Elective (without prior labor) cesarean delivery with a planned lower uterine
             (pfannenstiel) incision

        Exclusion Criteria:

          -  Conditions that predispose to uterine atony and postpartum hemorrhage
Effect of Dapagliflozin on Hepatic and Renal Glucose Metabolism Subjects
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Dapagliflozin; Placebo
Intervention description: dapagliflozin, 10mg tablet; Placebo for dapagliflozin
Intervention MeSH terms: Dapagliflozin
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
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Researchers hope to determine the organ (liver and/or kidney) responsible for the increase in
      endogenous glucose production (EGP) following the induction of glucosuria (when glucose is
      excreted in detectable amounts in the urine) with an SGLT2 inhibitor, dapagliflozin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  25-35 kg/m^2

          -  Normal Glucose Tolerance subjects (24)

          -  Type 2 Diabetic Subjects (24)

          -  Diabetic subjects must be on a stable dose (more than 3 months) of monotherapy or
             combination therapy with metformin and/or a sulfonylurea

          -  Diabetic subjects must have HbA1c <8.0%

          -  Other than diabetes, subjects must be in good general health as determined by physical
             exam, medical history, blood chemistries, CBC (complete blood count), TSH
             (thyroid-stimulating hormone), T4 (thyroxine), EKG (electrocardiogram) and
             urinanalysis.

          -  Only subjects whose body weight has been stable (± 3 lbs) over the preceding three
             months and who do not participate in an excessively heavy exercise program will be
             included.

        Exclusion Criteria:

          -  Subjects taking drugs known to affect glucose metabolism (other than metformin and
             sulfonylurea) will be excluded.

          -  Individuals with evidence of proliferative diabetic retinopathy, plasma creatinine
             >1.4 females or >1.5 males, or 24-hour urine albumin excretion > 300 mg will be
             excluded.
A Pharmacokinetic Study Comparing VI-0521 With Placebo in Obese Adolescents
Condition: Pediatric Obesity; Childhood Obesity
MeSH terms: Obesity; Pediatric Obesity
Intervention: Placebo; VI-0521 Mid Dose; VI-0521 Top Dose
Intervention description: po once daily; po once daily; po once daily
Intervention MeSH terms: Topiramate; Phentermine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 42.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Adolescent Obesity; Childhood Obesity; Qsymia; Pharmacokinetics; VI-0521; Phentermine; Topiramate

Summary:

      The primary objective of this study is to describe the pharmacokinetic profiles of VI-0521 in
      obese adolescents.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provide written informed consent;

          -  Provide written assent (of study subject);

          -  Adolescent ≥12 and <18 years of age;

          -  Have a BMI ≥ the 95th percentile of BMI for age and gender;

          -  Female subjects must be using adequate contraception;

          -  Willing and able to comply with all study requirements

        Exclusion Criteria:

          -  Condition or disease interfering with metabolism;

          -  Any medical treatment with insulin;

          -  Hyperthyroidism, or clinically significant hypothyroidism;

          -  Any history of bipolar disorder or psychosis, major depressive disorder, or history of
             suicidal behavior or ideation, or any use of antidepressant medications;

          -  Use of chronic systemic glucocorticoid or steroid therapy;

          -  History of any eating disorders;

          -  Any history of laxative abuse;

          -  Prior bariatric surgery;

          -  Any history of nephrolithiasis;

          -  Any history of epilepsy, or treatment with anti-seizure medications;

          -  Positive urine drug screen;

          -  Current smoker or smoking cessation within the previous 3 months of screening;

          -  Obesity of a known genetic or endocrine origin;

          -  Treatment with any over-the-counter or prescription weight loss drug, or
             attention-deficit/hyperactivity disorder (ADHD);

          -  Allergy or hypersensitivity to phentermine or topiramate or history of anaphylaxis to
             any drug;

          -  Use of any investigational medication or device for any indication or participation in
             a clinical study within 30 days prior to screening; or

          -  Any medical or surgical condition which would impair the ability of the subject to
             complete the study, compromise the quality of study data, or pose an unacceptable risk
             to the safety of the subject.
A Study of the Efficacy of Botox in the Treatment of Social Anxiety Disorder
Condition: Anxiety Disorder Social; Anxiety
MeSH terms: Anxiety Disorders; Phobia, Social
Intervention: botulinum toxin A; Placebo
Intervention description: Single treatment visit for 5 injections of botulinum toxin A, 40 units (for females) and 50 units (for males)/; single treatment visit for 5 injections of normal saline
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: social anxiety; botulinum toxin; botox

Summary:

      The goal of this study is to see whether Botox is an effective treatment for social anxiety
      disorder (SAD). Participants will complete two short surveys on depression and anxiety
      symptoms, receive a one-time injection of Botox, and complete the depression and anxiety
      survey 4 weeks after injection and again at 8 weeks after injection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  primary diagnosis of social anxiety disorder

          -  women of childbearing potential on an acceptable form of birth control and are not
             pregnant or lactating

        Exclusion Criteria:

          -  has ever been treated with botulinum toxin A

          -  has another Axis I diagnosis within in the 6-months prior to screening

          -  history of substance abuse within 2-months of screening

          -  current or recent suicidality

          -  scoring greater than 2 on Beck Depression Inventory (BDI) suicidality question

          -  psychotic or bipolar disorder

          -  unstable medical condition

          -  changes in medication or psychotherapy treatment in the month prior to screening

          -  significant risk of committing homicide
PPIs and Gastroesophageal Varices in Liver Cirrhosis (PPIs: Proton Pump Inhibitors)
Condition: Liver Cirrhosis; Hypertension, Portal
MeSH terms: Liver Cirrhosis; Hypertension, Portal; Fibrosis
Intervention: Proton Pump Inhibitors; Placebo
Intervention description: Pantoprazole 40mg per day intravenously or orally for 2 weeks after endoscopic treatment.; Placebo 40mg per day intravenously or orally for 2 weeks after endoscopic treatment.
Intervention MeSH terms: Proton Pump Inhibitors
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 106.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Gastroesophageal varices; Hemorrhage

Summary:

      This study is aimed at investigating the effect of PPIs on gastroesophageal varices in liver
      cirrhosis. Half of participants will receive PPI, while the other half will receive a
      placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of cirrhosis

          -  GEVs was diagnosed by endoscopy

        Exclusion Criteria:

          -  Acute gastrointestinal bleeding need emergency surgery

          -  Acid-related disease, such as peptic ulcer disease or gastroesophageal reflux diseases
             (GERD)

          -  Hepatocellular carcinoma (HCC) or other malignant tumor

          -  History of esophagus, stomach or liver surgery

          -  Child-Pugh C and can't be improved to Child-Pugh A or B

          -  Preparing to be pregnant, pregnant or breast feeding

          -  Allergic to PPIs(proton pump inhibitors) or intolerable

          -  Cannot provide informed consent
Assessing Efficacy of Intravenous Acetaminophen for Perioperative Pain Control for Oocyte Retrieval
Condition: Infertility, Female; Pain, Postoperative
MeSH terms: Infertility; Infertility, Female; Pain, Postoperative
Intervention: IV Acetaminophen; PO Acetaminophen; Placebo IV Acetaminophen; Placebo PO Acetaminophen
Intervention description: IV Acetaminophen for pain control during procedure; PO Acetaminophen for pain control during procedure; Placebo IV Acetaminophen; Placebo PO Acetaminophen
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 161.0
Sex: Female
Minimum age: 18 Years
Maximum age: 44 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: in vitro fertilization; oocyte retrieval; acetaminophen; postoperative pain control

Summary:

      In this research study we want to learn more about how effective certain medications are at
      reducing pain after oocyte (egg) retrieval surgery and how effective they are at reducing the
      time between the retrieval and discharge from the hospital. We will compare three types of
      pre-operative medications: intravenous (IV) acetaminophen, oral (PO) acetaminophen, and
      placebo (no medication), which is the current typical care.
    

Eligibility criteria:

        Inclusion Criteria:

        [ ] Patient is 18 years or over, undergoing oocyte retrieval. [ ] Patient is
        English-speaking.

        Exclusion Criteria:

        [ ] Allergy/hypersensitivity to acetaminophen or opiates. [ ] Any history of liver disease,
        history of alcohol depending, or renal impairment as reported in the electronic health
        record.

        [ ] Any history chronic opiate use or chronic pain disorder reported in the electronic
        health record.

        [ ] Weight less than 50kg as reported in the medical record.
Comparison of Albuterol for Status Asthmaticus
Condition: Status Asthmaticus
MeSH terms: Status Asthmaticus
Intervention: preservative free albuterol
Intervention description: Preservative free albuterol for nebulization
Intervention MeSH terms: Albuterol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This study is designed to compare the length of continuous albuterol administration between
      two different albuterol formulations, BAC containing albuterol versus preservative free
      albuterol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients will be included in the study if they are admitted to the 5th floor of Norton
             Children's Hospital for the treatment of an acute asthma exacerbation, initiated on
             continuous albuterol inhalation therapy, and are between 5 and 17 years of age.

        Exclusion Criteria:

          -  Patients will be excluded from the study if they are transferred from the 5th floor to
             the Pediatric Intensive Care Unit (PICU), admitted for any indication other than acute
             asthma exacerbation, or removed from the inpatient asthma protocol for any given
             reason.
ProvodineTM Decreases Hand Contamination
Condition: Hand Hygiene
Intervention: Provodine Hand Sanitizer
Intervention description: Intervention with Provodine
Intervention MeSH terms: Hand Sanitizers
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Intervention model description: Anesthesia providers will serve as their own controls
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 22 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hand hygiene; Provodine; Hand contamination

Summary:

      The purpose of this study is to see whether Provodine, an FDA approved product, provides
      long-lasting protection on the hands of staff who provide anesthesia for patients. If this
      product does provide long-lasting protection, it could be used for hand hygiene in the
      operating room and it could help prevent infections after operations. Fifteen anesthesia
      providers (15 main operating room [MOR] and 5 ambulatory surgery center [ASC]) who agree to
      participate will participate in the pre-intervention and intervention periods. During the
      pre-intervention or baseline period, the investigators will do bag broth cultures of
      anesthesia providers' hands just before the start of their first case of the day . The
      participants will then rinse and dry their hands to remove the culture medium. The
      investigators will also obtain cultures after the first case of the day, and after the second
      case. During the intervention period (ProvodineTM; usual hand hygiene practice), the
      investigators obtain hand cultures from the same anesthesia providers at the beginning of the
      day. The participants will then then do a hand scrub with ProvodineTM. The investigators will
      obtain a second hand culture at this point and participants will rinse and dry their hands to
      remove the culture medium and then apply a small amount of ProvodineTM as a hand rub. The
      investigators will obtain cultures after the first case of the day, and after the second case
      of the day. If participants are still providing anesthesia to their second case 6 hours after
      they applied ProvodineTM, the participants will apply a small of ProvodineTM amount as a hand
      rub at this time.

      For anesthesia providers in the ASC, the investigators will use the same protocol with the
      following exception. Because cases are likely to be shorter, the investigators will obtain
      the final cultures after the last case of the day or after the case that ends closest to 6
      hours after ProvodineTM was applied in the morning.
    

Eligibility criteria:

        Inclusion Criteria:

        - Must be an anesthesia provider at The University of Iowa Hospitals and Clinics

        Exclusion Criteria:

        - Are not an anesthesia provider at The University of Iowa Hospitals and Clinics