bioihbjkbjnl/mcl2 huggingface dataset:
SPY-X: A Study to Assess the Feasibility of Using SPY Alone for Sentinel Node Localization for Melanoma or Breast Cancer
Condition: Sentinel Lymph Node; Melanoma (Skin); Breast Cancer
MeSH terms: Breast Neoplasms; Melanoma
Intervention: IC-Green KIT
Intervention description: fluorescence lymphangiography with the use of IC-Green
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this study is to determine if fluorescence lymphangiography can be used
      alone to localize sentinel nodes in patients with melanoma or breast cancer. The hypothesis
      is that sentinel nodes can be identified using only indocyanine green (ICG) and fluorescence
      lymphangiography, without the need for technetium99 and a gamma probe.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with melanoma or breast cancer who meet criteria for and consent to sentinel
             node biopsy.The melanoma should be located on the upper extremity between and
             including the wrist and shoulder, or the lower extremity between and including the
             ankle and groin.

        Exclusion Criteria:

          -  Melanoma located on the trunk, head or neck. Patients with an allergy to indocyanine
             green or sodium iodide. Pregnant and nursing women. Patients who have had a prior
             sentinel node biopsy in the same nodal basin.
Does Seasonal Influenza Vaccination Affect the Incidence of pH1N1 Influenza?
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Fluviral influenza vaccine, 2009-2010; Normal saline
Intervention description: 0.5 mL intramuscular; 0.5 mL intramuscular
Phase: Phase 3
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 468.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: influenza; vaccine; observer blind

Summary:

      Since the onset of the 2009 pandemic, several observational public health investigations in
      Canada have identified evidence that suggests that adults, particularly younger adults, who
      have previously received seasonal influenza vaccine are at increased risk of infection with
      the 2009 pandemic strain of H1N1 (pH1N1). Investigations in Australia, the United States and
      the United Kingdom have not identified this effect. While it is not possible to have an
      answer to whether this affect is real prior to the second wave of the 2009 pandemic, it
      remains vital to future influenza vaccination programs that the hypothesis that, in 2009,
      seasonal vaccine increases or decreases the risk of pH1N1 infection be confirmed or refuted.

      The objective of this study is to determine whether Ontario adults aged 18-60 years who
      receive the 2009 seasonal influenza vaccine will be at a 2 fold or greater increased risk of
      infection with influenza pH1N1 during the second or third wave of the 2009 pandemic.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18 to 60 years old, inclusive, as of September 1st, 2009;

          2. understand the study, agree to its provisions, and give written informed consent prior
             to entry;

          3. available for follow-up during the study period;

          4. have convenient access to a computer with internet access and basic skills for use of
             the internet;

        Exclusion Criteria:

          1. planning to spend more than two consecutive weeks outside of Canada from October 1,
             2009 to April 15th 2010.

          2. received immunoglobulin within six months of study entry;

          3. has already received a 2009 seasonal influenza vaccine (southern or northern
             hemisphere)

          4. has had laboratory-confirmed infection with 2009 H1N1 influenza

          5. is participating in a clinical trial that would result in the receipt of
             investigational medication during the study period;

          6. allergic to eggs, to influenza vaccine, or any components of the seasonal influenza
             vaccine

          7. has had a previous severe adverse event associated with an influenza vaccine

          8. has a significant chronic underlying illness that would warrant seasonal influenza
             vaccine in a usual year, or is known to be pregnant.
Study of Safety and Efficacy of an Oral Contraceptive
Condition: Contraception
Intervention: Norethindrone acetate/ethinyl estradiol
Intervention description: one tablet per day
Intervention MeSH terms: Ethinyl Estradiol; Norethindrone; Norethindrone Acetate; Estradiol
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1683.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Contraception

Summary:

      This is a non-comparative study. The primary objective of the study is to assess the efficacy
      of a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are
      to assess the incidence of intracyclic bleeding; and to assess the safety and tolerability of
      the product.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy Women

          -  Age 18-45

          -  At risk for pregnancy

          -  History of regular cycles

        Exclusion Criteria:

          -  Contraindications for use of hormonal contraception

          -  Conditions which affect the absorption or metabolism of steroid hormones

          -  BMI > 35
Extension Study for Patients Entered Into Study Infacort 003
Condition: Adrenal Insufficiency
MeSH terms: Adrenal Insufficiency
Intervention: Infacort®
Intervention description: Infacort® is a dry granule formulation of hydrocortisone stored in capsules available in different strengths (0.5, 1.0, 2.0 and 5.0 mg).
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 1 Month
Maximum age: 6 Years
Healthy volunteers: No

Summary:

      A Phase 3, open-label, single-group, non-randomised, observational study of the safety and
      biochemical disease control of Infacort® in neonates, infants and children with adrenal
      insufficiency and congenital adrenal hyperplasia who had completed study Infacort 003. All
      subjects who had satisfactorily completed study Infacort 003 were offered the opportunity to
      take part in Infacort 004.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects successfully completing study Infacort 003, whose inclusion criteria were:

          1. Male and female children less than 6 years of age.

          2. A diagnosis of adrenal insufficiency (AI) as confirmed by an inappropriately low
             cortisol usually with other supporting tests.

          3. Receiving appropriate adrenocortical replacement therapy (hydrocortisone with/without
             fludrocortisone).

          4. Adequately hydrated and nourished. In addition, the parents/carers must be able to
             understand and give written Informed Consent for this extension study.

        Exclusion Criteria:

          1. Clinically evident acute AI (adrenal crisis) (Note: the subject can be re-evaluated
             for eligibility once the episode is over)

          2. Inability of the child to take oral therapy

          3. Subjects with clinical signs of acute infection or fever on inclusion (Note: the
             subject can be re-evaluated for eligibility once the episode is over)

          4. Any surgical or medical condition that in the opinion of the Investigator may place
             the subject at higher risk from his/her participation in the study

          5. Parents/carers of subjects unwilling to consent to saving and propagation of
             pseudonymised medical data for study reasons

          6. Subjects who are in a dependent relationship with the Investigator or the Sponsor
A Study to Evaluate Hormone Patterns and Ovarian Follicular Activity With DR-1021
Condition: Healthy
Intervention: DR-1021; Mircette®; Kariva®
Intervention description: Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus seven 10 μg EE tablets.; Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus two placebo tablets plus five 10 μg EE tablets.; Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus two placebo tablets plus five 10 μg EE tablets.
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Ethinyl Estradiol; Desogestrel; Oviol; Estradiol; Polyestradiol phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 61.0
Sex: Female
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a multi-center study to evaluate hormone levels with the oral contraceptive regimen
      DR-1021.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Premenopausal

          -  Weight <200 lbs

          -  Currently taking or willing to be treated with an oral contraceptive with a standard
             21/7 regimen for one cycle prior to starting Study Cycle 1

          -  Others as dictated by protocol

        Exclusion Criteria:

          -  Any contraindication to the use of oral contraceptives

          -  Breast feeding

          -  Smoking > 10 cigarettes per day

          -  Use of drugs that require simultaneous use of contraceptives (e.g., isotretinoin
             [Accutane])

          -  Others as dictated by protocol
Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: botulinum toxin Type A (200U); botulinum toxin Type A (300U); Normal Saline (Placebo); botulinum toxin Type A (200U); Normal Saline (Placebo); botulinum toxin Type A (300U)
Intervention description: botulinum toxin Type A 200 U (tx 1) followed by botulinum toxin Type A 200 U (tx 2); injections into detrusor, at > 12 weeks interval; botulinum toxin Type A 300 U (tx 1) followed by botulinum toxin Type A 300 U (tx 2); injections into detrusor, at > 12 weeks interval; Placebo (tx 1) followed by botulinum toxin Type A 200 U (tx 2); injections into detrusor, at > 12 weeks interval; Placebo (tx 1) followed by botulinum toxin Type A 300 U (tx 2), injections into detrusor, at > 12 weeks interval
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 416.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A
      in treating overactive bladder in spinal cord injury or multiple sclerosis patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord
             injury or multiple sclerosis

          -  Inadequate response to anticholinergic medication used to treat overactive bladder

        Exclusion Criteria:

          -  History of evidence of pelvic or urologic abnormality

          -  Previous or current diagnosis of bladder or prostate cancer

          -  Urinary tract infection at time of enrollment
The CLEVER Study - Coreg And Left Ventricular Mass Regression
Condition: Hypertrophy, Left Ventricular
MeSH terms: Hypertrophy, Left Ventricular; Hypertrophy
Intervention: carvedilol MR; atenolol; lisinopril
Intervention description: Study drug; Comparator; Comparator
Intervention MeSH terms: Atenolol; Carvedilol; Lisinopril
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 287.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: left ventricular hypertrophy (LVH); echocardiogram; left ventricular mass regression; cardiac MRI; left ventricular mass index (LVMI)hypertension

Summary:

      This study is designed to compare the effects of COREG MR (carvedilol modified release
      formulation) to atenolol on indices of left ventricular dimensions when added to standardized
      angiotensin converting enzyme (ACE) inhibition, and to the effect of ACE inhibition alone.
      Subjects with LVH (left ventricular hypertrophy) and hypertension will be studied. The
      primary endpoint will be the change in left ventricular mass index (LVMI) characterized by
      magnetic resonance imaging (MRI) following 12 months of treatment. Secondary endpoints
      include the change in LV (left ventricular) mass, LV wall thickness, diastolic left
      ventricular filling parameters, and left ventricular ejection fraction by echocardiographic
      methods at Treatment Month 12. Composite outcomes and individual event data will also be
      evaluated by treatment group.
    

Eligibility criteria:

        Inclusion criteria:

          -  Stage 1 or Stage 2 hypertension.

          -  Left ventricular hypertrophy.

        Exclusion criteria:

          -  In atrial fibrillation.

          -  Takes beta-blocker for MI (myocardial infarction) or arrhythmia.

          -  Has uncontrolled diabetes, uncontrollable or symptomatic arrhythmias, unstable angina,
             second or third degree heart block, history of MI, COPD (chronic obstructive pulmonary
             disease), liver or kidney disease.

          -  Uses beta-2-agonists.

          -  Unable to undergo MRI (magnetic resonance imaging).

          -  Females of childbearing potential.
GORE Embolic Protection With Reverse Flow
Condition: Carotid Artery Stenosis
MeSH terms: Carotid Stenosis
Intervention: GORE Flow Reversal System (GFRS)
Intervention description: Carotid artery angioplasty and stenting with embolic protection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 245.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: carotid artery stenosis; embolic protection device; GORE Neuro Protection System; GORE Flow Reversal System; reverse flow; proximal occlusion device; GNPS; Parodi; EMPiRE; distal embolization; minimizing risks of CAS; PAES

Summary:

      To compare the 30-day safety and efficacy of the GORE Flow Reversal System when used with
      approved carotid stents to an Objective Performance Criterion derived from distal embolic
      protection studies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Carotid stenosis requiring revascularization and indicating either symptomatic status,
             with carotid stenosis ≥ 50% OR asymptomatic status with carotid stenosis ≥ 80%

          -  Target lesion is located in one of the following:(a) internal carotid artery (ICA) (b)
             bifurcation (c) common carotid artery (CCA) proximal to the bifurcation

          -  At Anatomic risk for adverse events from CEA (e.g. restenosis after a prior CEA) OR at
             Co-morbid risk for adverse events from CEA (e.g., unstable angina with ECG changes)

        Exclusion Criteria:

          -  Recent surgical procedure within 30 days before or after the stent procedure

          -  Uncontrolled sensitivity to contrast media

          -  Renal Insufficiency

          -  Recent evolving, acute stroke within 21 days of study evaluation

          -  Myocardial infarction within 72 hours prior to stent procedure

          -  History of a prior major ipsilateral stroke with residual neurological deficits likely
             to confound the neurological assessments (e.g., NIHSS)

          -  Neurological deficits not due to stroke likely to confound the neurological
             assessments (e.g., NIHSS)

        Angiographic Exclusion Criteria:

          -  Isolated ipsilateral hemisphere leading to subject intolerance to reverse flow

          -  Total occlusion of the ipsilateral carotid artery

          -  Pre-existing stent in the ipsilateral carotid artery OR the contralateral carotid
             artery that extends into the aortic arch

          -  Presence of a filling defect, thrombus, occlusion or "string sign" in the target
             vessel

          -  Severe lesion calcification restricting stent deployment

          -  Carotid stenosis located distal to target stenosis that is more severe than target
             stenosis

          -  > 50% stenosis of the CCA proximal to target vessel

          -  Known mobile plaque in the aortic arch
A Study Investigating the Effect of Montelukast in Patients With Seasonal Allergic Rhinitis (MK-0476-192)(COMPLETED)
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: montelukast sodium; Comparator: loratadine; Comparator: placebo
Intervention description: montelukast 10 mg tablet, taken orally once daily at bed time for 2 weeks; loratadine 10 mg tablet, taken orally once daily at bed time for 2 weeks; placebo tablet, taken orally once daily at bed time for 2 weeks
Intervention MeSH terms: Loratadine; Montelukast
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 829.0
Sex: All
Minimum age: 15 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      A study of the ability of montelukast to improve signs and symptoms of seasonal allergic
      rhinitis compared with placebo. Loratadine is included in the study as an active control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has a documented clinical history of seasonal allergic rhinitis symptoms that
             become worse during the study season

          -  Patient is a non-smoker

          -  Patient is in good mental and physical health

        Exclusion Criteria:

          -  Patient is hospitalized

          -  Patient is a woman who is <8 weeks postpartum or is breast feeding

          -  Patient intends to move or vacation away during the study

          -  Patient is a current or past abuser of alcohol or illicit drugs
Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Acute Otitis Externa
Condition: Acute Otitis Externa
MeSH terms: Otitis; Otitis Externa
Intervention: DF289 plus DF277; DF289; DF277
Intervention description: 1 vial into the affected ear twice daily for 7 days; 1 vial into the affected ear twice daily for 7 days; 1 vial into the affected ear twice daily for 7 days
Intervention MeSH terms: Anti-Bacterial Agents; Antibiotics, Antitubercular
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 493.0
Sex: All
Minimum age: 6 Months
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if a combination of an antibiotic plus a
      corticosteroid is safe and effective in treating AOE
    

Eligibility criteria:

        Inclusion Criteria:

          -  Uncomplicated AOE of less tan 21 days, defined as a total symptom score of at least 2
             for otalgia, 2 for edema and 1 for otorrhea

          -  Brighton Grading of II or III

          -  Culture-based diagnosis of acute bacterial otitis externa

          -  Willingness to refrain from swimming through end of the study

        Exclusion Criteria:

          -  Previous episode of AOE within 4 weeks prior to enrollment, or 2 or more episodes of
             AOE within 6 months prior to the enrollment.

          -  Tympanic membrane perforation

          -  Any condition or situation likely to cause the patient to be unable or unwilling to
             comply with study treatment or attend all study visits

          -  Any condition in the patient or parent/guardian that, in the judgment of the principal
             investigator, could compromise patient safety, limit the patient's ability to complete
             the study, and/or compromise the objectives of the study
Extension Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis
Condition: Juvenile Idiopahtic Arthritis
MeSH terms: Arthritis
Intervention: etanercept
Intervention description: Subjects aged <18 years and less than or equal to 62 kg will receive etanercept SC at a dose of 0.8 mg/kg QW (up to a maximum dose of 50 mg QW).
Subjects aged greater than or equal to 18 years or >62 kg will receive etanercept SC at a dose of 50 mg QW.
Intervention MeSH terms: Etanercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Masking: None (Open Label)
Enrollment: 109.0
Sex: All
Minimum age: 2 Years
Maximum age: 30 Years
Healthy volunteers: No
Keywords: Use of etanercept to treat pediatric subjects with extended oligoarticular JIA; enthestitis related arthritis (ERA); or psoriatic arthritis (PsA).

Summary:

      This is a 8-year extension study in pediatric subjects who have been diagnosed with one of 3
      subtypes of Juvenile Idiopathic Arthritis (JIA) [extended oligoarticular JIA, enthestitis
      related arthritis (ERA), or psoriatic arthritis (PsA)] who have completed approximately 96
      weeks of participation in study 0881A1-3338 (B1801014). The study contains an active
      treatment period, withdrawal/re-treatment period and a observational period (non-treatment).
    

Eligibility criteria:

        Inclusion Criteria:

        Receipt of at least 1 dose of investigational product (etanercept) and participation for
        approximately 96 weeks in study 0881A1-3338 (B1801014)

        Personally signed and dated informed consent document (and assent document, as applicable)
        indicating the subject (or legally representative/guardian) has been informed of all
        pertinent aspects of the study.

        Exclusion Criteria:

        Exclusion criteria for subject planning to continue investigational product:

        withdrawal from investigational product in study 0881A1-3338 for any reason (safety or
        non-safety).

        History of maliginancy other than squamous cell, basal cell carcinoma or cervical carcinoma
        in situ.