bioihbjkbjnl/mcl2 huggingface dataset:
Evaluating Effect of the Study Drug Praluent (Alirocumab) on Neurocognitive Function When Compared to Placebo
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Praluent (Alirocumab); Placebo
Intervention MeSH terms: Alirocumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2176.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders

Summary:

      The main purpose of this study is to evaluate the effect on mental state (known as
      "neurocognitive function") with use of Praluent.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Men and women ≥ age 40 years and ≤ age 85 years

          -  Patients with heterozygous familial hypercholesterolemia (heFH) or with non-familial
             hypercholesterolemia (non-FH) patients at high or very high cardiovascular risk

          -  Patients with history of coronary heart disease (CHD) not having adequate control of
             their hypercholesterolemia with LDL-C ≥70 mg/dL, or all other patients with LDL-C ≥100
             mg/dL and be on maximally-tolerated dose of statin (unless they are statin-intolerant)

          -  Patients must have successfully completed the Motor Screening Task

          -  Patients must be willing and able to comply with clinic visits and study related
             procedures

          -  Patients must provide signed informed consent

        Key Exclusion Criteria:

          -  Patients with known Alzheimer's disease or other dementia, schizophrenia, bipolar
             disorder, severe depression, cognitive impairment, or patients with a sleep disorder
             requiring daily pharmacological treatment

          -  Recent (within 3 months prior to the screening visit) myocardial infarction, unstable
             angina leading to hospitalization, coronary artery bypass graft surgery, percutaneous
             coronary intervention, uncontrolled cardiac arrhythmia, carotid surgery or stenting,
             stroke, transient ischemic attack, carotid revascularization, endovascular procedure
             or surgical intervention for peripheral vascular disease

          -  Certain laboratory findings obtained during the screening visit as defined in the
             protocol

          -  Any condition or situation, including other significant mental or neurological
             disorders that, in the investigator's opinion, may confound the study results, or may
             interfere significantly with the patient's participation in the study

          -  Pregnant or breastfeeding women

          -  A positive human immunodeficiency virus (HIV) test

        NOTE: Other protocol defined Inclusion/Exclusion Criteria apply
Continuous Infusion Piperacillin-tazobactam for the Treatment of Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Piperacillin-tazobactam combination product
Intervention description: 400 mg/kg/day as either intermittent or continuous infusion
Intervention MeSH terms: Tazobactam; Piperacillin; Piperacillin, Tazobactam Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 6.0
Sex: All
Minimum age: 8 Years
Healthy volunteers: No
Keywords: piperacillin; tazobactam; pseudomonas aeruginosa; cystic fibrosis; pulmonary exacerbation; continuous infusion; beta lactam

Summary:

      Cystic fibrosis is an inherited disorder leading to chronic pulmonary inflammation and
      infection. A majority of people with cystic fibrosis have large quantities of bacteria
      residing in their lungs. One of the most common and harmful bacteria is called Pseudomonas
      aeruginosa.

      Patients with cystic fibrosis require frequent therapy with intravenous (I.V.) antibiotics to
      treat lung infections thought to be caused by Pseudomonas aeruginosa. One of the antibiotics
      frequently used to treat this bacteria is piperacillin-tazobactam. Piperacillin-tazobactam is
      thought to be the most effective when there is a constant level of drug in the body. The
      standard way to administer piperacillin-tazobactam is to give several grams 4 times each day
      as a 30 minute infusion. An alternative way to give piperacillin-tazobactam is by a
      continuous infusion; a continuous infusion will make it more likely that drug will remain at
      a constant level in the body. The objective of this study is to determine if administering
      piperacillin-tazobactam as a continuous infusion is more effective at treating people having
      a pulmonary exacerbation of cystic fibrosis than a standard 30 minute infusion, 4 times a
      day.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of cystic fibrosis

          2. 8 years of age or greater

          3. Chronic or intermittent infection with Pseudomonas aeruginosa as defined by the Leeds
             Criteria

          4. Pulmonary exacerbation as defined by Fuchs et al.

        Exclusion Criteria:

          1. Admission for greater than 48 hours prior to enrollment

          2. Isolation of Burkholderia spp. in a respiratory tract culture in the prior 12 months

          3. Current treatment for allergic bronchopulmonary aspergillosis

          4. Pregnant or breast feeding

          5. History of solid organ transplantation

          6. Renal impairment at time of randomization (< 40 mL/min as calculated by the
             Cockcroft-Gault equation24 ¬for adults or the Schwartz equation45 for those < 18 years
             of age) or receipt of hemodialysis

          7. Allergy to study medication
A Study to Investigate the Use of Hydrogel Vehicle in Maintaining the Skin Barrier in Persons With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Hydrogel vehicle; Eucerin Lotion
Intervention description: Each morning and evening, gently wash the target area with warm water and gently pat dry with soft towel. Once dry place a small amount of Hydrogel vehicle onto the tip of your finger. Place a dab of the Hydrogel vehicle on either the left or right side of the body as instructed. (Do not use Hydrogel vehicle and Eucerin lotion on the same side of the body.); Each morning and evening, gently wash the area with warm water and pat dry with a soft towel. Once dry, place a small amount of Eucerin lotion to the target area on either the left or right side of the body as instructed. (Do not use Eucerin and Hydrogel vehicle on the same side of the body.)
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 20.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Transepidermal water loss; Epidermal barrier; Skin hydration

Summary:

      While the repair of the epidermal barrier in atopic dermatitis is of major importance in the
      treatment of atopic dermatitis, most of the vehicles used may actually cause a worsening of
      an impaired epidermal barrier. Hydrogel vehicle is anecdotally known to be moisturizing and
      hydrating.This study will compare the use of Hydrogel vehicle and Eucerin Lotion in
      maintaining the epidermal barrier in subjects with atopic dermatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Definitive diagnosis of atopic dermatitis as characterized by Hanifin and Rajka
             criteria:

          -  3 out of 4 major characteristics

          -  At least 3 minor characteristics

          -  Mild to moderate disease score of 2 or 3 by Investigator Global Assessment

          -  Minimum 5% Body Surface Area at Baseline

          -  Uniformly bilateral signs and symptoms of atopic dermatitis

          -  Able to understand and comply with the requirements of the study and sign Informed
             Consent/HIPAA forms. Subjects under the legal age of consent must also have written
             informed consent of the parent or legal guardian.

        Exclusion Criteria:

          -  Allergy or sensitivity to any component of the test articles.

          -  Subjects who have not complied with the proper washout periods for prohibited
             medications.

          -  Significant coagulation disorder or any medical condition that, in the opinion of the
             investigator, contraindicates the subject's participation in the study.

          -  Recent alcohol or drug abuse is evident.

          -  History of poor cooperation, non-compliance with medical treatment or unreliability

          -  Participation in an investigational drug study within 30 days of the Baseline Visit.
Performance and Acceptance of Optive Versus Hylocomod Eyedrops in Patients With Dry Eye Symptoms
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Intervention: A sterile solution containing sodium carboxymethylcellulose and glycerin, preserved with PURITE®; Sodium hyaluronate
Intervention description: Eyedrops as required, but at least 3 times per day; Eyedrops as required, but at least 3 times per day
Intervention MeSH terms: Carboxymethylcellulose Sodium; Hyaluronic Acid; Glycerol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study evaluates the performance and acceptance of Optive versus Hylocomod eyedrops, when
      administered for one month to patients with mild to moderate dry eye symptoms, with and
      without contact lenses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years or over

          -  Contact lens wearer, spectacle wearer or non-spectacle wearer

          -  Mild to severe dry eye symptoms, defined as OSDI score 13 to 100

          -  Mild to moderate conjunctival staining in each eye and/or mild to moderate corneal
             staining in each eye

          -  Best corrected visual acuity of 6/9 in each eye

        Exclusion Criteria:

          -  Previously used Hylocomod or Optive eyedrops

          -  Systemic allergy or eye allergy

          -  Systemic disease which might have an ocular component and/or interfere with contact
             lens wear

          -  Autoimmune disease which might have an ocular component and/or interfere with contact
             lens wear

          -  Systemic medication which might have eye side effects and or interfere with contact
             lens wear

          -  Eye infection or use of eye medication
Comparison of the Blood Sugar Lowering Effect and Safety of Two Insulin Treatments in Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: insulin detemir; insulin aspart; insulin aspart
Intervention description: Treat-to-target dose titration scheme (individually adjusted dose) for a once daily injection s.c. (under the skin); Administered 1 - 3 times daily, at largest prandial increment, injection s.c. (under the skin); Administered 1 - 3 times daily, at largest meals, injection s.c. (under the skin)
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Insulin Detemir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 296.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Europe, Africa and the United States of America (USA).

      The aim of this trial is to compare the safety and efficacy of two different insulin
      treatments, the "basic" and the "advanced" treatment in type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes mellitus for more than 6 months

          -  HbA1c (glycosylated haemoglobin A1c) between 7.5 % and 10.0% at trial initiation
             (screening)

          -  BMI (Body Mass Index) less than 40 kg/m2

          -  Basal insulin treatment for at least 3 months (NPH once or twice daily, insulin
             glargine or detemir once daily)

          -  Treatment with one to 3 OADs

        Exclusion Criteria:

          -  Known or suspected allergy to trial products or related products

          -  Women who are pregnant, are breast-feeding or intend to become pregnant within the
             next 48 weeks

          -  Previous participation in any trial including this for the last 6 months

          -  Use of more than 1 U/kg of basal insulin daily at trial initiation (screening)
Treatment of Early Aggressive Rheumatoid Arthritis (TEAR)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: methotrexate; sulfasalazine; hydroxychloroquine; etanercept
Intervention description: varies; varies; varies; varies
Intervention MeSH terms: Hydroxychloroquine; Sulfasalazine; Etanercept; Methotrexate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 755.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: RA; painful joints; swollen joints

Summary:

      The purpose of this study is to 1)to determine if it is better to treat all early RA patients
      with methotrexate in combination with hydroxychloroquine plus sulfasalazine or in combination
      with etanercept or reserve this treatment for patients who do not appropriately respond to
      methotrexate alone and 2) to determine which combination of methotrexate therapy is better
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis of RA for less than or equal to 3 years

          -  Be 18 years of age or older at the time of diagnosis

        Exclusion Criteria:

          -  Pregnant or lactating women

          -  History of chronic infection, such as hepatitis, pneumonia, or chronic skin infections

          -  Active TB or evidence of latent TB
Comparing Effects of Two Fixed Combinations Ophthalmic Solutions on Ocular Blood Flow
Condition: Glaucoma
MeSH terms: Glaucoma
Intervention: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution; fixed combination of dorzolamide hydrochloride timolol maleate ophthalmic solution
Intervention description: 1 drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks; 1 drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks
Intervention MeSH terms: Timolol; Brimonidine Tartrate; Dorzolamide; Pharmaceutical Solutions; Ophthalmic Solutions; Maleic acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 15.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No

Summary:

      A 10 week evaluation, crossover design study including a 3 week washout period between
      treatments, to determine the effects of Combigan® (fixed combination brimonidine tartrate
      0.2%/timolol maleate 0.5%) and Cosopt® (fixed combination dorzolamide hydrochloride-timolol
      maleate ophthalmic solutions) on ocular blood flow as measured by retrobulbar blood flow.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age: 30 years or older.

          2. Primary open-angle glaucoma (POAG) or ocular hypertensive in at least one eye.

          3. Best corrected visual acuity at least 20/40 in at least one eye.

        Exclusion Criteria:

          1. History of acute angle-closure or a narrow, occludable anterior chamber angle by
             gonioscopy.

          2. History of chronic or recurrent inflammatory eye diseases (e.g., scleritis, uveitis).

          3. History or signs of intraocular trauma.

          4. Any abnormality preventing reliable applanation tonometry.

          5. Current use of any ophthalmic or systemic steroid which may interfere with this
             investigation.

          6. Severe, unstable or uncontrolled cardiovascular, renal, or pulmonary disease.
Comparison Between Systemic Exposure to Ciclesonide Nasal Spray, Ciclesonide HFA Nasal Aerosol and Orally Inhaled Ciclesonide (BY9010/M1-422)
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Intervention: Ciclesonide
Intervention MeSH terms: Ciclesonide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Allergic rhinitis

Summary:

      The purpose of this study is to compare the systemic des-ciclesonide exposure of OMNARIS™
      (ciclesonide) nasal spray, ciclesonide HFA nasal aerosol, and orally inhaled ciclesonide
      HFA-metered-dose inhaler (MDI). The administration of the study medication will be as
      follows: three single doses, separated by a wash-out period. The study will provide further
      data on the safety and tolerability of ciclesonide.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Written informed consent and HIPAA

          -  Body weight as indicate by a Body Mass Index (BMI) between ≥ 18 and ≤ 28 kg/m², and a
             body weight >50 kg

          -  General good health

          -  Ability to use oral inhaler

        Main Exclusion Criteria:

          -  Pregnancy, breast feeding, intention to become pregnant during the course of the study
             or lack of safe contraception in pre-menopausal women

          -  Participation in any investigational drug trial within the 30 days before Screening
             Visit and thereafter

          -  History or current clinically relevant allergies or idiosyncrasy to drugs or food

          -  History of allergic reactions to any corticosteroids including ciclesonide or any
             excipients of the formulations

          -  Any contraindication to nasally administered corticosteroids

          -  History of a respiratory infection or disorder [including, but not limited to
             bronchitis, pneumonia, acute or chronic sinusitis, flu, severe acute respiratory
             syndrome (SARS)] within the 30 days before Screening Visit, or development of a
             respiratory infection during the Screening Period

          -  History or current evidence of any other relevant allergic, cardiovascular, pulmonary,
             hepatic, renal, gastrointestinal, hematological, endocrine, metabolic, neurological,
             psychiatric, or other disease within the last 2 years

          -  Non-vaccinated exposure to or active infection with, chickenpox or measles within the
             21 days preceding Screening Visit
Nebulized Magnesium Sulfate in Children With Moderate to Severe Asthma Exacerbation
Condition: Asthma
MeSH terms: Asthma
Intervention: Nebulized magnesium sulfate
Intervention description: 15 mg albuterol in 22 ml of magnesium sulfate solution (880 mg) via nebulizer over one hour
Versus
15 mg albuterol in 22 ml of normal saline via nebulizer over one hour
Intervention MeSH terms: Magnesium Sulfate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 7 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Magnesium sulfate; Childhood asthma; Emergency department

Summary:

      The purpose of this study is to evaluate the effectiveness of nebulized magnesium sulfate as
      a vehicle for albuterol in children with moderate to severe asthma exacerbation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients age ≥ seven years

          -  Previous diagnosis of asthma or previous episode of wheezing treated with beta-agonist
             medication

          -  Able to complete bedside spirometry

          -  FEV1 < 70% predicted

        Exclusion Criteria:

          -  Known allergy to magnesium sulfate

          -  Known contra-indication to albuterol

          -  Respiratory distress occurring as a result of bedside spirometry

          -  History of neuromuscular disease, cardiac disease, renal disease, or underlying
             chronic lung disease

          -  Pregnancy

          -  Use of oral steroid medication within 72 hours of presentation

          -  Radiographic evidence of pneumonia at presentation

          -  Intubation during the current encounter prior to study enrollment

          -  Administration of intravenous magnesium sulfate prior to study enrollment

          -  Prior participation in this study
Effects of Levosimendan in Patients Eligible for Aortic Valve Replacement With Left Ventricular Hypertrophy
Condition: Diastolic Dysfunction; Left Ventricular Hypertrophy
MeSH terms: Hypertrophy, Left Ventricular; Hypertrophy
Intervention: levosimendan; placebo drug
Intervention description: Intravenous infusion, 0,1ug/kg/min, duration 4 hours prior to operation and until the end of operation.; Intravenous infusion, colour identical to levosimendan
Intervention MeSH terms: Simendan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 30 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: levosimendan; heart failure; inotropics; diastolic dysfunction; left ventricular hypertrophy; aortic valve stenosis

Summary:

      This is a clinical, randomised, double-blinded study in which patients eligible for aortic
      valve replacement are enrolled. Patients receive infusion of either levosimendan or placebo 4
      hours prior to surgery and until the end of surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eligible for aortic valve replacement

          -  EF > 45%

          -  Left ventricular posterior wall > 12mm

          -  Sinus rhythm

        Exclusion Criteria:

          -  Concomitant bypass operation

          -  Severe mitral insufficiency

          -  Active endocarditis

          -  Insufficient ultrasound opportunity

          -  Systolic blood pressure < 100 mmHg

          -  moderate-severe renal failure

          -  allergy to levosimendan

          -  lack of patient consent Pregnancy or status of lactating

          -  Fertile women who do not use relevant anticonception