bioihbjkbjnl/mcl2 huggingface dataset:
Evaluate the Effect of Omalizumab on Markers of Asthma Impairment in Patients With Persistent Allergic Asthma
Condition: Persistent Allergic Asthma
MeSH terms: Asthma
Intervention: Omalizumab; Placebo
Intervention description: Omalizumab was supplied as a lyophilized, sterile powder in a single-use, 5 mL vial. The vial was designed to deliver 150 mg (1.2 mL) of omalizumab for subcutaneous (s.c.) administration after reconstitution with 1.4 mL sterile water for injection. Doses of more than 150 mg were divided among multiple injection sites to limit injections to not more than 150 mg per site.; Placebo was supplied as a lyophilized, sterile powder in a single-use, 5 mL vial. The vial was designed to deliver 150 mg (1.2 mL) of placebo for subcutaneous (s.c.) administration after reconstitution with 1.4 mL sterile water for injection. Doses of more than 150 mg were divided among multiple injection sites to limit injections to not more than 150 mg per site.
Intervention MeSH terms: Omalizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 271.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Asthma; asthma management; asthma impairment ; Xolair ; omalizumab

Summary:

      This study will evaluate the effect of omalizumab on markers of impairment in patients with
      inadequately controlled persistent allergic asthma on Step 4 or above therapy as defined in
      the 2007 National Heart, Lung, and Blood Institute (NHBLI) Guidelines
    

Eligibility criteria:

        Inclusion Criteria:

          -  Total Asthma Control Test (ACT) score of ≤19 plus at least one of the following in the
             4 weeks preceding visit 1, on average:

               -  Symptoms > 2 days/week

               -  Night-time awakenings ≥1 time/week

               -  Short-acting beta2-agonist (SABA) use for symptom control >2 days/week forced
                  expiratory volume in 1 second (FEV1) ≤ 80% predicted

        Exclusion Criteria:

          -  History of intubation for asthma.

          -  An asthma exacerbation requiring treatment with systemic steroids within 4 weeks of
             screening (Visit 1).

          -  Less than 3 months of stable maintenance oral corticosteroid therapy for asthma

        Other protocol-defined inclusion/exclusion criteria applied
A Study of Basal Insulin Analog and Insulin Analog Mid Mixture in Chinese Participants With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Insulin Analog Mid Mixture; Basal Insulin Analog
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 814.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: mid mixture insulin analog; basal insulin analog

Summary:

      The purpose of this study is to compare the effectiveness of basal insulin analog and insulin
      analog mid mixture in Chinese participants with type 2 diabetes mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  have type 2 diabetes as defined by World Health Organization (WHO) criteria

          -  are taking oral anti-hyperglycemic medications (OAMs) and are judged as OAM failure by
             the investigator

          -  most recent HbA1c value ≥7.5% within 12 weeks of study entry

          -  in the opinion of the investigator, require to initiate premix analog or basal insulin
             analog treatment

          -  willing to start with insulin treatment

        Exclusion Criteria:

          -  have a diagnosis of type 1 diabetes

          -  have received any type of insulin within 24 months of study entry (except for
             intermittent use of insulin of less than 1 month each time)

          -  have serious preexisting medical or other conditions that, in the judgment of the
             investigator, would preclude participation in this study

          -  are pregnant or breastfeeding, or intend to become pregnant during the course of the
             study

          -  are currently enrolled or have participated, within the last 30 days in any other
             clinical trial involving an investigational product or any other type of medical
             research judged not to be scientifically or medically compatible
Propofol for Pediatric Tracheal Intubation With Deep Anesthesia During Sevoflurane Induction
Condition: Anesthesia Intubation Complication
Intervention: propofol
Intervention description: Initial dose: Propofol 2 mg/kg, then dose changes separately based on the last subject in the same age group and sevo time range
Intervention MeSH terms: Propofol
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Intervention model: Single Group Assignment
Intervention model description: This is a single study with 6 parallel groups as noted in the description. With Dixon's Up and Down Method for determining a 50th percentile of a dichotomous outcome, the number of patients required is not known prior to starting a study. Data from Paul and Fisher demonstrated that 6 "crossovers" (change in the dichotomous outcome from one patient to another, indicating change from increasing the dose of the study drug to decreasing it, or visa-versa). When choosing a meaningful starting point near the 50th percentile, the number required is typically 15-20 patients. With 6 study groups, the estimated number of patients required would be 90-120. Please Note: This is not a study where one can perform a power analysis and determine a required N.
Masking: None (Open Label)
Enrollment: 106.0
Sex: All
Minimum age: 1 Year
Maximum age: 11 Years
Healthy volunteers: No
Keywords: intubation of children without neuromuscular blockade

Summary:

      The purpose of this study is to determine the amount of propofol required to achieve 50% of
      patients obtaining a perfect ("excellent") intubation score of 5 on the Steyn modification of
      the Helbo-Hansen Intubation Score, when placing a tracheal tube in children 1-6 years and
      6-12 years (division of age groups at 6th birthday) of age, under a specific induction and
      ventilation sequence as specified in this study design.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent / assent

          -  Ages 1-11 years (12 - 132 months)

          -  American Society of Anesthesiology (ASA) physical status 1 or 2, which implies that
             the patient has no comorbidity that limits daily function.

          -  Scheduled for non-emergent surgery/ procedure under general anesthesia in which the
             anesthesia team intends to place an endotracheal tube

          -  Expected routine intubation according to physical exam and history

          -  Weight under 50 kg

        Exclusion Criteria:

          -  Requires neuromuscular blocking agents

          -  Emergent surgery / procedure

          -  Expected difficult intubation

          -  ASA physical status 3 or 4

          -  Weight over 50 kg

          -  Age under 12 months or over 132 months

          -  Allergy to study drugs to be used
Effects of Etanercept on the Heart, Veins and Thickness of Certain Major Arteries In Ankylosing Spondylitis Patients
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Intervention: etanercept
Intervention description: etanercept 50 mg/week
Intervention MeSH terms: Etanercept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: IMT evaluation in AS patients treated with etanercept

Summary:

      Study to assess whether etanercept therapy is able to increase flow-mediated vasodilatation
      in AS, and whether etanercept can modify the intima-media thickness (IMT) in these patients
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of AS, as defined by Modified New York Criteria for Ankylosing Spondylitis.

          2. AS with active disease as defined by Bath Ankylosing Spondylitis Disease Activity
             Index (BASDAI, see Attachment 4) >= 4 at screening visit.

          3. Patients capable, in the opinion of the investigator, of complying with the treatment
             schedule and doses throughout the 52 weeks

          4. Agreement by male subjects who are not surgically sterile and female subjects who are
             not surgically sterile or postmenopausal to use reliable methods of birth control for
             the duration of the study.

          5. Ability to self-inject drug or have a designee who can do so.

          6. Ability to store injectable test article at 2ºC to 8ºC.

        Exclusion Criteria:

        1. Pregnancy confirmed by test taken at screening in all women except those who were
        surgically sterile or at least 1 year postmenopausal. Sexually active women of childbearing
        potential participating in the study must use a medically acceptable form of contraception
        that needs to be continued for 15 days following discontinuation of the test article.
How Effective Are Antithrombotic Therapies in Primary Percutaneous Coronary Intervention
Condition: Acute ST Elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Intervention: unfractionated heparin; Bivalirudin
Intervention description: 70 units/kg body weight intravenous; intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour
Intervention MeSH terms: Heparin; Calcium heparin; Bivalirudin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1829.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ST elevation myocardial infarction; Primary percutaneous coronary intervention; Unfractionated heparin; Bivalirudin; primary angioplasty

Summary:

      The purpose of this study is to compare unfractionated heparin (UFH) and bivalirudin in the
      performance and subsequent outcomes of Primary percutaneous coronary intervention. This will
      be a pragmatic trial. Interventional procedures will be performed to reflect current and
      evolving standards, including predominant radial access. All patients will be treated with
      routine oral anti-platelet therapy pre-procedure. GP IIb/IIIa inhibitors will be reserved for
      'bail out' treatment only.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients presenting with a suspected myocardial infarction event with PPCI as the
             proposed index reperfusion strategy will be included in the trial

        Exclusion Criteria:

          -  ≤ 18 years of age

          -  Known intolerance, hypersensitivity or contraindication to any trial medication

          -  Active bleeding at presentation

          -  Artificial ventilation, reduced conscious level or other factors precluding the
             administration of oral antiplatelet therapy

          -  Previous enrolment in this trial
Evaluation of the Therapeutic Benefit of an Initial Intensified Dosing Regimen of Mycophenolate Sodium Versus a Standard Regimen in Renal Transplant Patients
Condition: Kidney Transplantation
Intervention: Enteric-coated mycophenolate sodium (Myfortic); Cyclosporine (Neoral); Prednisone
Intervention description: 1440 mg/day for the standard dose. 2880 mg/day for the initial intensified dosage, reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.; cyclosporine microemulsion in galenic form capsules starting at twice a day for a dose of 8-10 mg/kg/day adjusted if necessary to achieve protocol specific target levels; 20 mg orally per day reduced according to center practice for a minimum dose of 5 mg/day.
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Prednisone; Cyclosporins
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 313.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Keywords: Renal, Kidney, Intensified, Enteric-coated mycophenolate sodium, Transplant

Summary:

      The purpose of this study is to determine if an initial intensified enteric-coated
      mycophenolate sodium (Myfortic) dosing regimen administered during the first six weeks post
      renal transplantation provides improved efficacy, with a similar safety profile, compared to
      a standard regimen of Myfortic.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females, 18 to 65 years old

          -  First or second time kidney transplant patients

          -  For females capable of becoming pregnant, negative pregnancy test prior to entry into
             trial and effective birth control during trial and 3 months after stopping trial
             medication

        Exclusion Criteria:

          -  Previous graft loss due to immunological reasons in the 1st year after the 1st
             transplant

          -  Multi-organ recipients or previous transplant of another organ, different from the
             kidney

          -  Recipients from a non-heart-beating donor

          -  Known hypersensitivity to mycophenolic acid or cyclosporine

          -  HIV positive or Hepatitis B surface antigen positive

          -  History of malignancy (past 5 years)

          -  Pregnancy or planned pregnancy, lactating, or unwillingness to use effective
             contraception.

          -  Evidence of severe liver disease

        Other protocol-defined inclusion/exclusion criteria may apply.
EC PK in Women With Normal and Obese BMI
Condition: Contraception
Intervention: LNG-EC; UPA-EC
Intervention description: FDA-approved emergency contraceptive pill containing levonorgestrel 1.5mg; FDA-approved emergency contraceptive pill containing ulipristal acetate 30mg
Intervention MeSH terms: Contraceptive Agents; Levonorgestrel; Ulipristal acetate; Contraceptives, Postcoital
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Emergency contraception

Summary:

      A well-designed pharmacokinetics (PK) study may identify the physiologic basis for observed
      differences in levonorgestrel emergency contraception (LNG-EC) and ulipristal acetate
      emergency contraception (UPA-EC) failure rates in women with normal and obese BMI. The
      investigators propose a study to compare serum LNG and UPA levels after administration of a
      single-dose of LNG-EC or UPA-EC. The investigators hypothesize that there will be no
      difference in PK parameters between women with normal BMI and obese women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women aged 18-45 years

          -  English-speaking

          -  BMI 18.5-24.9 kg/m2 or obese BMI 30.0-39.9 kg/m2

          -  Regular menstrual cycles

          -  No use of medroxyprogesterone acetate at least 6 months prior to study enrollment,
             unless resumption of two menstrual cycles

          -  No use of levonorgestrel intrauterine system (levonorgestrel-IUS), etonogestrel
             implant or combined hormonal contraception at least one month prior to the study and
             resumption of one menstrual cycle

          -  Women who are postpartum or post-abortion will be included if they have had at least
             one menstrual cycle since their last pregnancy

        Exclusion Criteria:

          -  Prior allergic reaction to LNG-EC or UPA-EC

          -  Use of hormonal emergency contraception within the past month

          -  Women who are currently pregnant or who are currently breastfeeding

          -  History of cancer other than non-melanoma skin cancer

          -  Medical or surgical conditions or conditions requiring therapies known to impact sex
             steroid production or metabolism

               -  Use of HAART therapy for management of HIV infection

               -  Concomitant use of CYP3A4 inducers like rifampin, barbiturates, carbamazepine,
                  lamotrigine, bosentan, felbamate, griseofulvin, oxcarbazepine, phenytoin, St.
                  John's Wort and topiramate

          -  Current participation in any other trial of an investigational medicine or device in
             the three months leading up to this study
Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis
Condition: Conjunctivitis
MeSH terms: Conjunctivitis
Intervention: loteprednol etabonate and tobramycin; loteprednol etabonate; Tobramycin; Vehicle of Zylet
Intervention description: Topical ocular administration of loteprednol etabonate and tobramycin 4 times per day (QID) for 14 days.; Topical ocular administration of Lotemax (loteprednol etabonate) QID for 14 days.; Topical ocular administration of Tobramycin QID for 14 days.; Topical ocular administration of the vehicle of Zylet QID for 14 days.
Intervention MeSH terms: Loteprednol Etabonate; Tobramycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 137.0
Sex: All
Minimum age: 1 Week
Maximum age: 6 Years
Healthy volunteers: No
Keywords: Blepharokeratoconjunctivitis

Summary:

      The objective of this study is to evaluate the safety and effectiveness of Zylet in
      comparison with Lotemax, Tobramycin and the vehicle of Zylet for the treatment of
      blepharoconjunctivitis in pediatric subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  children 0-6 years of age.

          -  clinical diagnosis of blepharoconjunctivitis

          -  Parent/guardian must understand, be willing and able to comply with all treatment and
             follow-up procedures.

          -  Parent/guardian must understand, be willing and able to provide informed consent and
             Health Insurance Portability Accountability Act (HIPAA) authorization.

        Exclusion Criteria:

          -  Known hypersensitivity to corticosteroids, aminoglycosides, or any component of the
             study medication.

          -  Subjects who have a history of ocular surgery, including laser procedures, within the
             past 6 months.

          -  Subjects who are monocular.

          -  Subjects who have a history of any severe/serious ocular pathology or medical
             condition that could result in the subject's inability to complete the study.

          -  Subjects who have participated in an ophthalmic drug or device research study within
             30 days prior to entry in this study.
Equivalence of Calcium Acetate Oral Solution and Sevelamer Carbonate Tablets in Hemodialysis Patients
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Intervention: Calcium acetate oral solution (COS); Sevelamer carbonate
Intervention description: Each subject will undergo two separate treatment periods. Subjects will ingest either COS or sevelamer for 28 days (Treatment Period 1) and then switch to the other binder for 28 days (Treatment Period 2).; Each subject will undergo two separate treatment periods. Subjects will ingest either COS or sevelamer for 28 days (Treatment Period 1) and then switch to the other binder for 28 days (Treatment Period 2).
Intervention MeSH terms: Calcium; Sevelamer; Calcium acetate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Serum phosphorus levels

Summary:

      The purpose of this study is to demonstrate equivalence of calcium acetate oral solution and
      sevelamer carbonate in maintaining serum phosphorus levels

      This is a phase IV, multicenter, randomized, open-label, cross-over study to assess the
      equivalence of a liquid formulation of a calcium-based phosphate binder, COS, to sevelamer
      carbonate tablets, in hemodialysis dependent Chronic Kidney Disease subjects (CKD). The aim
      of the study is to maintain serum phosphorus level and establish equivalence between COS and
      sevelamer carbonate tablets.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects ≥18 years of age able to give written informed consent to the
             study

          -  Hemodialysis dependent chronic kidney disease stage 5D patients

          -  Taking sevelamer carbonate tablets or sevelamer hydrochloride as phosphate binder
             monotherapy

          -  Taking 3 or more sevelamer carbonate or sevelamer hydrochloride tablets per day

        Exclusion Criteria:

          -  Estimated life expectancy of less than 6 months and for cancer patients, an Eastern
             Cooperative Oncology Group (ECOG) Performance Status >1

          -  Active malignancy within the past 5 years. Basal or squamous cell skin cancer is not
             exclusionary. History of malignancy is not an exclusion

          -  Known hypersensitivity reaction to calcium-based phosphate binders

          -  Anticipated renal transplantation during the study

          -  Pregnant or sexually active female subjects who are of childbearing potential and who
             are not willing to use an acceptable form of contraception.