bioihbjkbjnl/mcl2 huggingface dataset:
Cervical Ripening for Obese Women: A Randomized, Comparative Effectiveness Trial
Condition: Obesity; Labor Induction; Cesarean Delivery
Intervention: Vaginal Misoprostol; Foley Balloon + Vaginal Misoprostol
Intervention MeSH terms: Misoprostol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 236.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Obese pregnant women (BMI ≥ 30 kg/m2) are more likely than their normal-weight counterparts
      to require induction of labor because of increased rates of obstetric complications including
      pregnancy related hypertensive disorders, diabetes, and prolonged gestations. Several studies
      have shown that obese women experience increased labor duration and oxytocin needs when
      compared to normal-weight women. This in turn results in increased rates for unplanned
      cesarean delivery (CD) as a result of failed induction of labor (IOL), arrest disorders and
      non-reassuring fetal heart rate tracing, that is dose-dependent with increasing class of
      obesity. The investigators hypothesize that obese pregnant women and unfavorable cervix
      (Bishop score ≤ 6), IOL ≥ 24 weeks gestation using the Foley balloon plus vaginal misoprostol
      will result in reduced cesarean delivery rates when compared to vaginal misoprostol alone.
    

Eligibility criteria:

        Inclusion Criteria

          -  Nulliparous women aged 18 or above

          -  BMI ≥ 30 at the time of labor induction

          -  Singleton gestation

          -  Cephalic presentation (includes successful external cephalic version)

          -  Intact fetal membranes

          -  Unfavorable cervix (Bishop score of ≤ 6)

          -  Gestational age ≥ 32 weeks

        Exclusion Criteria

          -  Patient not candidate for IOL with misoprostol as deemed by the treating physician

          -  Multiple gestation

          -  Major fetal anomalies

          -  Fetal demise
Safety and Pharmacokinetic Study of EMBEDA in Children Ages 7-17 With Pain
Condition: Moderate-severe Pain
Intervention: Ages 7-11; ages 12-17
Intervention description: Oral/Capsule, once per day or twice per day dosing; Treatment duration consists of a 1 to 4 week Conversion/Titration Phase leading to a 2 to 6 week Maintenance Treatment duration.; Oral/Capsule, once per day or twice per day dosing; Treatment duration consists of a 1 to 4 week Conversion/Titration Phase leading to a 2 to 6 week Maintenance Treatment duration.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 7 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Pediatric; pain indication; controlled release morphine

Summary:

      Safety and pharmacokinetics of an abuse-deterrent, extended-release formulation of morphine
      sulfate with a sequestered naltrexone core in children 7-17 with moderate-severe pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children 7-17 with moderate to severe pain requiring around the clock treatment with
             an opioid analgesic.

          -  Be an experienced opioid user, defined as any subject treated with opioid therapy,
             equivalent or equal to >20 mg per day of morphine, for a period of 3 consecutive days
             immediately prior to first day of dosing.

        Exclusion Criteria:

          -  Columbia-Suicide Severity Rating Scale (C-SSRS) for suicidal ideation and behavior in
             past year.

          -  Hypersensitivity to morphine, naltrexone.

          -  A life expectancy (assessed by investigator) of less than 6 months or is no longer
             capable of taking medication orally.

          -  Undergone surgery within 3 days prior to the first day of dosing.
Evaluation of Quality of Life (QoL) in Subjects With Highly Active Relapsing Multiple Sclerosis (MS) (CLARIFY MS)
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Mavenclad®
Intervention description: Participants with Relapsing Multiple Sclerosis (RMS) received Mavenclad® 3.5 milligram per kilogram (mg/kg) of body weight over 2 years, administered as 1 treatment course of 1.75 mg/kg per year. Each treatment course consisted of 2 treatment weeks, one at the beginning of the first month and one at the beginning of the second month of the respective year.
Intervention MeSH terms: Cladribine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 485.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multiple sclerosis; Mavenclad®; Cladribine; Health-related Quality of Life

Summary:

      The main purpose of the study was to assess the health-related quality of life (HRQoL)
      through the Multiple Sclerosis Quality of Life-54 Questionnaire (MSQoL-54) scale in
      highly-active relapsing multiple sclerosis (RMS) particpants treated with Mavenclad® for 2
      years (24 months).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Highly active RMS as defined by:

          -  One relapse in the previous year and at least 1 T1 Gadolinium (Gd)+ lesion or 9 or
             more T2 lesions, while on therapy with other disease modifying drugs (DMDs).

          -  Two or more relapses in the previous year, whether on DMD treatment or not.

          -  Expanded Disability Status Scale (EDSS) score less than equals to (<=) 5.0.

          -  Other protocol defined inclusion criteria could apply.

        Exclusion Criteria:

          -  Positive hepatitis C or hepatitis B surface antigen test and/or core antibody test for
             immunoglobulin G (IgG) and/or immunoglobulin M (IgM).

          -  Current or previous history of immune deficiency disorders including a positive human
             immunodeficiency virus (HIV) result.

          -  Currently receiving immunosuppressive or myelosuppressive therapy with, for example,
             monoclonal antibodies, methotrexate, cyclophosphamide, cyclosporine or azathioprine,
             or chronic use of corticosteroids.

          -  History of tuberculosis, presence of active tuberculosis, or latent tuberculosis

          -  Presence of Progressive Multifocal Leukoencephalopathy (PML) in Magnetic Resonance
             Imaging (MRI).

          -  Active malignancy.

          -  Other protocol defined exclusion criteria could apply.
The Effects of Dexamethasone on Low Dose Interscalene Brachial Plexus Block
Condition: Shoulder Surgery; Nerve Block
Intervention: Systemic Dexamethasone; Perineural dexamethasone
Intervention description: Intravenous infusion of dexamethasone (4mg); Perinerual administration of dexamethasone (4mg)
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Dexamethasone 21-phosphate; BB 1101
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 182.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A standard interscalene nerve block is performed with long acting local anesthetic
      (bupivacaine or ropivacaine in concentrations varying from 0.25% to 0.75%). The purpose of
      this study is to investigate the effect of the addition of perineural dexamethasone (4mg) to
      a standard ropivacaine solution (0.5%) on analgesic duration of low dose interscalene block
      compared to ropivacaine alone for interscalene block with systemic dexamethasone.

      Ropivacaine is not an intervention as a local anesthetic is pre-requisite to performing a
      nerve block.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients undergoing arthroscopic shoulder surgery at Sunnybrook Health Sciences
             Centre, Toronto Western Hospital and Women's College Hospital.

          2. ASA functional status class I to III

          3. Age 18 to 80 years

          4. BMI ≤ 35 kg/m2

        Exclusion Criteria:

          1. Lack of patient consent

          2. Allergy to dexamethasone or ropivacaine

          3. BMI > 35 kg/m2

          4. Contraindications to low dose dexamethasone including peptic ulcer disease, systemic
             infection, glaucoma, active varicella/herpetic infections, diabetes mellitus

          5. Contraindications to ISB including severe Chronic Obstructive Pulmonary Disease
             (Forced expiratory volume < 40% predicted), coagulopathy, pre-existing neurologic
             deficit in ipsilateral upper extremity, localized infection

          6. Pregnant or nursing females

          7. Chronic opioid use defined as > 30mg oral morphine or equivalent per day

          8. Unable to take acetaminophen or celecoxib
An Evaluation of the Fixed Combination Brimonidine Tartrate 0.2%/ Timolol Maleate 0.5% to Latanoprost 0.005% in Glaucoma or Ocular Hypertension Subjects
Condition: Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Hypertension
Intervention: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution; latanoprost 0.005%
Intervention description: 1 drop of study medication taken approximately 12 hours apart, dosed 2 times a day; 1 drop of study medication taken once daily
Intervention MeSH terms: Timolol; Brimonidine Tartrate; Ophthalmic Solutions; Latanoprost
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 148.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A three-month evaluation comparing the safety and efficacy of a fixed combination of 0.2%
      brimonidine tartrate/0.5% timolol maleate with that of latanoprost 0.005%, a prostaglandin
      analogue in glaucoma or ocular hypertension subjects
    

Eligibility criteria:

        Inclusion Criteria:

          1. Be at least 18 years of age;

          2. Give written informed consent;

          3. Be in good general health as determined by your doctor;

          4. Have a diagnosis of unilateral or bilateral glaucoma or ocular hypertension;

          5. If you are a female of child bearing potential, you must be willing to practice
             effective contraception for the duration of the study (i.e., abstinence, spermicide,
             condoms, or birth control pills);

          6. Understand the study instructions, and be able to follow the study instructions; and

          7. Be likely to complete the entire study period (12 weeks), including all regularly
             scheduled study visits.

        Exclusion Criteria:

          1. Have any active ocular disease other than glaucoma or ocular hypertension that would
             interfere with study interpretation;

          2. Any systemic disease or clinical evidence of any condition which would make the
             subject, in the opinion of the investigator, unsuitable for the study or could
             potentially confound the study results; and

          3. Concurrent participation or prior participation in any investigational drug or device
             study within the last 30 days prior to the Screening Visit
A Study To Evaluate An Interaction Between Maraviroc And Raltegravir In Healthy Subjects
Condition: Healthy
Intervention: Maraviroc; Maraviroc; Raltegravir; Raltegravir
Intervention description: 300 milligrams(mg) every 12 hours Days 6-11; Days 12-14: Raltegravir 400 milligrams(mg) every 12 hours, maraviroc 300 milligrams(mg) every 12 hours (AM doses only on Day 14); Days 12-14: Raltegravir 400 milligrams(mg) every 12 hours, maraviroc 300 milligrams(mg) every 12 hours (AM doses only on Day 14); 400 milligrams(mg) every 12 hours Days 1-3 Followed by washout Days 4-5
Intervention MeSH terms: Raltegravir Potassium; Maraviroc
Phase: Phase 4
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: maraviroc; raltegravir; drug interaction study; healthy volunteers

Summary:

      An open label study to evaluate an interaction between maraviroc and raltegravir in healthy
      subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and/or female subjects between 18 and 55 years of age.

        Exclusion Criteria:

          -  Evidence or history of clinically significant disease or clinical findings at
             screening
Greater Occipital Nerve Block Versus Metoclopramide
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Greater occipital nerve block with bupivacaine; Metoclopramide
Intervention description: This is a type of peripheral nerve block. 3cc of 0.5% bupivacaine will be injected adjacent to the greater occipital nerve block blaterally; Metoclopramide 10mg IV will be administered over 15 minutes
Intervention MeSH terms: Metoclopramide; Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double dummy design with IV placebo and placebo nerve block
Enrollment: 99.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      We are comparing a type of nerve block called greater occipital nerve block versus standard
      therapy among patients who present to an emergency department for acute migraine. This is a
      randomized, double-blind, double dummy study. The greater occipital nerve block will be
      performed bilaterally with bupivacaine 0.5%. Standard therapy is metoclopramide 10mg IV.
    

Eligibility criteria:

        Inclusion Criteria:

        Eligible patients are adults who present with an acute moderate or severe headache meeting
        migraine headache criteria, as defined by the International Classification of Headache
        Disorders-3β (1.1, migraine without aura). Patients who meet criteria for Probable Migraine
        without Aura (1.5.1) will also be included, provided they have had at least one similar
        attack previously.

        Exclusion Criteria:

        Patients will be excluded if informed consent cannot be obtained, if there is concern for a
        secondary cause of headache, if the maximum documented temperature is greater than 100.3
        degrees, for a new objective neurologic abnormality, skull defect, suspected infection
        overlying injection site, known bleeding disorder, ongoing use of anti-platelet agents
        including P2Y12 platelet inhibitors (clopidogrel, prasugrel, ticagrelor), heparins,
        warfarin, or 10a inhibitors (rivaroxaban, apixaban, edoxaban, fondaparinux), prior
        treatment with a greater occipital nerve block, allergy to the investigational medications,
        pheochromocytoma, seizure disorder, Parkinson's disease, use of MAO inhibitors, and use of
        anti-rejection transplant medications.
Pharmacokinetics of Immediate-Release vs. Delayed-Release Omeprazole in Gastroparesis
Condition: Gastroparesis; Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Gastroparesis
Intervention: Immediate-release omeprazole; Delayed-release omeprazole
Intervention description: Immediate-release omeprazole 40 mg qam for 7 days; Delayed-release omeprazole 40 mg qam for 7 days
Intervention MeSH terms: Omeprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Gastroparesis; Gastroesophageal reflux disease; heartburn

Summary:

      The purpose of this study is to compare the blood drug levels of two prescribed medications,
      immediate-release omeprazole 40 mg powder and delayed-release omeprazole 40 mg capsule to
      determine which drug is better absorbed in patients with a slow stomach emptying
      (gastroparesis). Delayed-release omeprazole has a protective coating to prevent the drug
      omeprazole from being neutralized by stomach acid. Immediate-release omeprazole has sodium
      bicarbonate (antacid) which neutralizes the stomach acid, eliminating the need for a
      protective coating. Immediate-release omeprazole suspension may have a more rapid
      pharmacokinetic profile and greater overall drug absorption in gastroparesis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Symptoms of heartburn >2 days per week off antireflux therapy, defined by "a burning
             feeling rising from the stomach or lower chest up towards the neck"

          -  Symptoms of gastroparesis >1 month in duration, defined by nausea, vomiting, bloating,
             dyspepsia, early satiety, or effortless regurgitation.

          -  Prior abnormal 4-hour gastric emptying scan within the past 3 years

        Exclusion Criteria:

          -  History of esophageal or gastric surgery

          -  Severe gastroparesis with any of the following: vomiting with dehydration requiring IV
             hydration, hospitalization, weight loss >10 % pre-illness weight, requiring feeding
             jejunostomy tubes

          -  Presence of gastric electrical stimulator

          -  Symptoms of retching with vomiting more than 2 days per week

          -  Diagnosis of diabetes

          -  Disorders of small bowel motility (such as pseudo-obstruction or dumping syndrome)

          -  Disorders of small bowel absorption

          -  Diagnosis of gastric outlet, small bowel or colon mechanical obstruction

          -  Diagnosis of acid hypersecretory syndrome

          -  Disorders affecting proton pump inhibitor metabolism (such as liver failure)

          -  Known allergy or side effects to proton pump inhibitor

          -  Non-ambulatory patients: bed-ridden, nursing home resident, etc.

          -  Pregnancy
A Study to Assess the Immunogenicity and Safety of CSL's 2013/2014 Formulation of Enzira® Vaccine in Healthy Volunteers
Condition: Influenza, Human
MeSH terms: Influenza, Human
Intervention: Enzira® vaccine
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a study to assess the immune (antibody) response and safety of the 2013/2014
      formulation of Enzira® vaccine in healthy adult volunteers aged 18 years or older.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females aged 18 years or older at the time of vaccination.

          -  Females of child-bearing potential (i.e., ovulating, pre-menopausal, not surgically
             sterile) must be abstinent or be willing to use a medically accepted contraceptive
             regimen for the duration of the study. Females of child-bearing potential must return
             a negative urine pregnancy test result prior to vaccination with the vaccine.

        Exclusion Criteria:

          -  Known hypersensitivity to a previous vaccination with influenza vaccine or allergy to
             eggs, ovalbumin, chicken protein, neomycin, polymyxin, or any components of the
             vaccine.

          -  Clinical signs of an active infection.

          -  A clinically significant medical condition.

          -  Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months
             preceding study entry.

          -  Females who are pregnant or lactating.
The Effects of General Anesthetics on Upper Airway Collapsibility in Healthy Subjects
Condition: Airway Complication of Anaesthesia; Healthy
Intervention: Propofol; Sevoflurane
Intervention description: Propofol administration for induction of general anesthesia. Administration will be performed IV, using a Target Controlled Induction Pump.; Sevoflurane will be administered via mask inhalation to achieve anesthesia.
Intervention MeSH terms: Propofol; Sevoflurane
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: apnea; airway collapsibility; healthy; hypercapnia; general anesthesia; breathing-swallow coordination; aspiration

Summary:

      The investigators hypothesize that propofol, when compared to sevoflurane, causes the upper
      airway to collapse more easily and causes less activity in the tongue muscle. Additionally,
      the investigators hypothesize that, under increased carbon dioxide concentrations of the air
      inhaled, the upper airway will be less likely to collapse under anesthesia and there will be
      increased activity in the tongue muscle under both propofol and sevoflurane, when compared to
      breathing normal concentrations of carbon dioxide, as in room air. Furthermore the
      investigators hypothesize that anesthesia disrupt the breathing swallow coordination, an
      effect additionally altered by increased carbon dioxide through increased respiratory drive.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologists (ASA) class I

          -  Age between 18 and 45

          -  BMI 18-28 kg/m^2

        Exclusion Criteria:

          -  Concurrent significant medical illness (heart disease including untreated
             hypertension, Clinically significant kidney disease, liver disease, or lung disease,
             History of myasthenia gravis or other muscle and nerve disease)

          -  Anxiety disorder requiring treatment

          -  Concurrent medications known to affect anesthesia, upper airway muscles or respiratory
             function (e.g., gabaergic anxiolytics, antipsychotics)

          -  Individuals with a history of allergy or adverse reaction to lidocaine, propofol, or
             sevoflurane

          -  For women: pregnancy

          -  Suggestion of obstructive sleep apnea (OSA) or any other sleep disorder (e.g.
             witnessed apneas, gasping or choking during sleep, unexplained excessive daytime
             sleepiness)

          -  History of drug or alcohol abuse

          -  Acute intermittent porphyria