bioihbjkbjnl/mcl2 huggingface dataset:
Study to Assess in Home Use of Evolocumab (AMG 145) Administration Using Either an Automated Mini-doser or a Prefilled Autoinjector/Pen
Condition: Primary Hypercholesterolemia; Mixed Dyslipidemia
MeSH terms: Hypercholesterolemia; Dyslipidemias
Intervention: Evolocumab AMD; Evolocumab AI/pen
Intervention description: Evolocumab subcutaneous injection using a single use, disposable AMD containing 3.5 mL deliverable volume.; Evolocumab subcutaneous injection using a handheld mechanical (spring-based) prefilled AI/Pen, each containing 1.0 mL deliverable volume.
Intervention MeSH terms: Evolocumab; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 164.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: LDL-C, triglycerides, high cholesterol

Summary:

      The primary objective of this study was to assess users' ability to administer a full dose of
      evolocumab in a home-use setting using either an automated mini-doser (AMD) or
      autoinjector/pen (AI/pen).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Fasting LDL-C at screening > 85 mg/dL

          -  Fasting triglycerides less than or equal to 400 mg/dL (4.5 mmol/L)

        Exclusion Criteria:

          -  New York Heart Association (NYHA) III or IV heart failure

          -  Uncontrolled cardiac arrhythmia

          -  Uncontrolled hypertension

          -  Type 1 diabetes or poorly controlled type 2 diabetes

          -  Uncontrolled hypothyroidism or hyperthyroidism
Randomised Placebo-controlled Duloxetine-referenced Efficacy and Safety Study of 2.5, 5 and 10 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Placebo; Vortioxetine (Lu AA21004); Vortioxetine (Lu AA21004); Vortioxetine (Lu AA21004); Duloxetine
Intervention description: capsules; daily; orally; 2.5 mg/day; encapsulated tablets; orally; 5 mg/day; encapsulated tablets; orally; 10 mg/day; encapsulated tablets; orally; 60 mg/day; encapsulated capsules; orally
Intervention MeSH terms: Duloxetine Hydrochloride; Vortioxetine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 766.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Major depressive disorder; Placebo-controlled; Active reference; Multicenter study; Randomised study; Acute treatment

Summary:

      The purpose of the study is to evaluate the efficacy and the tolerability of three fixed
      doses of Vortioxetine in order to establish the appropriate clinical effective dose range in
      the treatment of Major Depressive Disorder (MDD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  MDE as primary diagnosis according to DSM-IV-TR criteria (classification code 296.xx)

          -  Moderate to severe depression

          -  Current MDE duration of at least 3 months

        Exclusion Criteria:

          -  Any current psychiatric disorder other than MDD as defined in the DSM-IV TR

          -  Any substance disorder within the previous 6 months

          -  Female patients of childbearing potential who are not using effective contraception

          -  Use of any psychoactive medication 2 weeks prior to screening and during the study

        Other protocol-defined inclusion and exclusion criteria may apply.
Lurasidone HCl - A Long Term Safety Phase 3 Study of Patients With Clinically Stable Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: Lurasidone HCl; Risperidone
Intervention description: 40 - 120mg per day; Risperidone
Intervention MeSH terms: Risperidone; Lurasidone Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 629.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Lurasidone; Schizophrenia; Latuda

Summary:

      Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This
      clinical study is designed to test the hypothesis that lurasidone is safe and tolerable long
      term among clinically stable patients. The study will also assess the long term effectiveness
      of lurasidone as compared to an active comparator.
    

Eligibility criteria:

        Main Inclusion Criteria:

        To be eligible to enter the study, each patient must comply with the following inclusion
        criteria:

          -  Subject is 18 to 75 years on the day of signing the consent form (age parameters may
             be restricted further per local requirements without protocol amendment).

          -  Subject meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition
             (DSM-IV) criteria for a primary diagnosis of schizophrenia (including disorganized
             (295.10), paranoid (295.30), undifferentiated (295.90), catatonic (295.20), or
             residual (295.60) or schizoaffective disorder (295.70) subtypes.

          -  Subject is not pregnant or nursing, and is not planning pregnancy within the projected
             duration of the study.

          -  Subject will comply with the study procedures and outpatient visit requirements in the
             opinion of the investigator.

          -  Subject voluntarily agrees to participate in the study by giving written informed
             consent.

        Main Exclusion Criteria:

        To be excluded from entering this study if they fulfil any of the criteria below:

          -  Subject has a chronic organic disease of the central nervous system (other than
             schizophrenia).

          -  Subject has current clinically significant or history of, alcohol abuse/alcoholism or
             drug abuse/dependence within the last 6 months.

          -  In the opinion of the investigator, the subject has any condition, therapy, laboratory
             abnormality, or other circumstance that might confound the results of the study, or
             interfere with the subject's participation for the full duration of the study.

          -  Subject has participated in a study with an investigational compound or device within
             30 days of signing informed consent.
A Study to Compare the Efficacy and Safety of CT-P43 to Stelara in Patients With Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: CT-P43; Stelara
Intervention description: 45mg or 90mg dose subcutaneous administration; 45mg or 90mg dose subcutaneous administration
Intervention MeSH terms: Ustekinumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 509.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study is a randomized, active-controlled, double-blind, phase 3 study to compare the
      efficacy and safety of CT-P43 to Stelara in patients with moderate to severe plaque
      psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

        - Patient has had diagnosis of plaque-type psoriasis for at least 24 weeks.

        Exclusion Criteria:

          -  Patients diagnosed with forms of psoriasis other than plaque-type.

          -  Patients previously received ustekinumab or a biosimilar of ustekinumab.

          -  Patient who has allergies to the active substance or any of the excipients of
             ustekinumab or study drug, or patients with a hypersensitivity to immunoglobulin
             products or natural rubber and latex.
MSB11022 in Moderate to Severe Rheumatoid Arthritis
Condition: Moderate to Severe Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: MSB11022; EU-Humira
Intervention description: Participants received MSB11022 (modified buffer and stabilizer) subcutaneously at dose of 40 milligram (mg) every other week from Day 1 up to Week 48.; Participants received EU-Humira subcutaneously at dose of 40 mg every other week from Day 1 up to Week 48.
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 288.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the efficacy, safety and immunogenicity of MSB11022
      and Humira® in adult participants with rheumatoid arthritis (RA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of rheumatoid arthritis based on 2010 American College of
             Rheumatology/European League Against Rheumatism (ACR/EULAR) criteria

          -  At least 6 tender (of 68 assessed) and 6 swollen (of 66 assessed) joints at screening
             and baseline

          -  Must have received methotrexate for at least 12 weeks and been on a stable dose for at
             least 4 weeks prior to the first study dose

          -  Other protocol defined inclusion criteria could apply

        Exclusion Criteria:

          -  Evidence of untreated or inadequately treated latent or active Tuberculosis

          -  Evidence of uncontrolled, clinically significant diseases

          -  Any second disease-modifying antirheumatic drugs must be washed out prior to the first
             study dose

          -  Other protocol defined exclusion criteria could apply
Travatan Z in Ocular Surface Health in Patients With Open-Angle Glaucoma or Ocular Hypertension
Condition: Open-angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®); Latanoprost ophthalmic solution 0.005% (XALATAN®)
Intervention description: Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 90 days. Referred to as travoprost.; Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 90 days. Referred to as latanprost.
Intervention MeSH terms: Travoprost; Pharmaceutical Solutions; Latanoprost; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 726.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to compare two ophthalmic solutions in patients with open-angle
      glaucoma or ocular hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years or older.

          -  Ocular Surface Disease Index (OSDI) score and corneal fluorescein staining score as
             specified in protocol.

          -  Diagnosis of open-angle glaucoma or ocular hypertension in at least one eye.

          -  Intraocular pressure (IOP) controlled with latanoprost 0.005% (XALATAN®) for at least
             one continuous month prior to Visit 1.

          -  Willing and able to discontinue use of any topical ocular medication other than the
             study medication for the duration of the study, including artificial tears.

          -  Best corrected visual acuity of -0.6 logarithm of the Minimum Angle of Resolution
             (logMAR) or better in each eye.

          -  Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  Any medical condition (systemic or ophthalmic) that may preclude safe administration
             of the test article.

          -  Use of contact lenses within 30 days of Visit 1.

          -  Use of contact lenses during the study.

          -  Participation in an investigational drug or device study within 30 days of entering
             this study.

          -  Other protocol-defined exclusion criteria may apply.
Assess the Efficacy and Safety of Personalized Prophylaxis Human-cl rhFVIII in Patients With Severe Haemophilia A
Condition: Severe Haemophilia A
MeSH terms: Hemophilia A
Intervention: Human cl rhFVIII
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The rationale of this study is to further fine-tune and individualize prophylactic treatment
      of patients with severe Haemophilia A with the goal of keeping the trough FVIII level above
      1% between doses. Because trough FVIII levels are likely to be important predictors of the
      efficacy of prophylaxis, the focus of this study is on pharmacokinetic (PK) data.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Severe Haemophilia A (FVIII:C < 1%)

          -  Male patients >= 18 years of age

          -  Previous treatment with a FVIII concentrate for at least 150 EDs

          -  Good documentation regarding dosing and bleeding frequency in the 6 months preceding
             study start

          -  Immunocompetence (CD4+ count > 200/uL)

        Exclusion Criteria:

          -  Any coagulation disorder other than Haemophilia A

          -  Present of past FVIII inhibitor activity

          -  Severe liver or kidney disease
Trial to Reduce Cardiovascular Events With Aranesp® Therapy (TREAT)
Condition: Kidney Disease; Diabetes Mellitus; Anemia
MeSH terms: Kidney Diseases
Intervention: Placebo; darbepoetin alfa
Intervention description: Volume and dose frequency changes resembling dosing in the active treatment group; Starting dose : 0.75 mcg/kg subcutaneous (SC) every two weeks (Q2W); subsequent doses titrated to achieve hemoglobin (Hb) target of 13.0 g/dL
Intervention MeSH terms: Darbepoetin alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 4038.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the impact of treatment of anemia with darbepoetin
      alfa to a hemoglobin target of 13 g/dL on (1) all-cause mortality and nonfatal cardiovascular
      events, and (2) progression to end-stage renal disease or death, in subjects with chronic
      kidney disease and type 2 diabetes mellitus.

      Academic PI/Executive Committee Chairman: Marc Pfeffer, MD, PhD
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hemoglobin less than or equal to 11 g/dL

          -  History of Chronic Kidney Disease

          -  eGFR (estimated glomerular filtration rate) greater than or equal to 20 mL/min/1.73 m2
             and less than or equal to 60 mL/min/1.73 m2

          -  Tsat (transferrin saturation) greater than 15%

        Exclusion Criteria:

          -  Uncontrolled hypertension

          -  Erythropoietic protein use within 12 weeks of randomization
Long-term Safety of SPD422 in Japanese Adults With Essential Thrombocythaemia
Condition: Essential Thrombocythemia (ET)
MeSH terms: Thrombocytosis; Thrombocythemia, Essential
Intervention: SPD422 (anagrelide hydrochloride)
Intervention description: Subjects will be continued on the dose of anagrelide that controlled their platelet levels in Study 308 and titrated if necessary.
Intervention MeSH terms: Anagrelide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to provide SPD422 to subjects who completed Study SPD422 308
      and, in the opinion of the Investigator, will continue to benefit from treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have completed Study SPD422 308
Study of Efficacy and Safety of Xolair® (Omalizumab) in Chinese Patients With Chronic Spontaneous Urticaria
Condition: Chronic Spontaneous Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Intervention: Omalizumab; Placebo
Intervention description: injection of 150mg or 300 mg; Injection of placebo
Intervention MeSH terms: Omalizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 418.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Chronic spontaneous urticaria; ISS7; UAS7; omalizumab; China

Summary:

      The purpose of this study was to demonstrate the efficacy and safety of omalizumab, compared
      with placebo, as an add-on to H1 antihistamines (H1AH) therapy in adult patients suffering
      from Chronic Spontaneous Urticaria (CSU) who remained symptomatic despite H1AH therapy.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Symptomatic CSU patients with CSU diagnosis for at least 6 months.

          -  Patients must have been on an approved dose of an H1AH for CSU for at least the 3
             consecutive days immediately prior to the Day -14 screening visit

          -  Patients must have documented current use on the day of the initial screening visit

        Main Exclusion Criteria

          -  Clearly defined underlying etiology for chronic urticarias other than CSU (main
             manifestation being physical urticaria)

          -  Other skin disease associated with itch Urticarial vasculitis, urticaria pigmentosa,
             erythema multiforme, mastocytosis, hereditary or acquired angioedema, lymphoma,
             leukemia, or generalized cancer
Comparison of Two Basal Insulins for Patients With Type 2 Diabetes Taking Oral Diabetes Medicines and Exenatide
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Insulin Lispro Protamine Suspension; Insulin Glargine
Intervention description: Administered subcutaneously once a day at bedtime; Administered subcutaneously once a day at bedtime
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Lispro; Protamines
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 339.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No

Summary:

      This study will compare insulin lispro protamine suspension (ILPS) and insulin glargine in
      combination with the patient's oral diabetes medications and exenatide, for their ability to
      control blood sugar in patients with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have type 2 diabetes

          -  Must be at least 18 years of age and less than 75 years of age

          -  Must be taking exenatide 10 micrograms twice a day (BID) for at least 3 months

          -  Must be taking one of the following oral diabetes medication regimens for at least 3
             months: (1) metformin (2) metformin + sulfonylurea (3) metformin + thiazolidinedione
             (TZD). Doses must be at or above the following: Metformin--1500 mg/day,
             Sulfonylurea--1/2 the maximum daily dose according to the product label, TZD--30
             mg/day pioglitazone

          -  Must have a hemoglobin A1C greater than or equal to 7.0% and less than or equal to
             10.0%

        Exclusion Criteria:

          -  Must not have used insulin on a regular basis during the past 2 years

          -  Must not have taken any glucose-lowering medications not included in the inclusion
             criteria in the past 3 months

          -  Must not have had more than one episode of severe hypoglycemia in the past 6 months

          -  Must not have clinically significant hematologic, oncologic, renal, cardiac, hepatic,
             or gastrointestinal disease

          -  Must not be pregnant or intend to get pregnant during the course of the study
Evaluation of Inter-reader Reliability Using Images From Subjects With Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI)
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: florbetapir F 18
Intervention description: IV injection, 370MBq (10mCi), single dose (intervention for Study A05 participants, source of scans for this study)
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: Single
Enrollment: 40.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Amyloid imaging; Positron Emission Tomography; 18F-AV-45; florbetapir F 18; Diagnostic imaging

Summary:

      Re-read of brain amyloid scans acquired in previous AV-45 clinical studies by readers trained
      using updated reading methodology. The scans in this study came from subjects who had
      Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI).
    

Eligibility criteria:

        Participants:

          -  Inclusion Criteria AD:

               -  Male or female >=50 years of age

               -  Meet National Institute of Neurological and Communicative Disorders and Stroke
                  (NINCDS) criteria for probable AD with Mini-Mental State Examination (MMSE) score
                  of 10-24

          -  Inclusion Criteria MCI:

               -  Male or female >=50 years of age

               -  Have a Clinical Dementia Rating (CDR) of 0.5

               -  MMSE >24

          -  Exclusion Criteria:

               -  Have a history or current diagnosis of other neurologic disease

               -  Have had or currently have a diagnosis of other neurodegenerative disease

               -  Have participated in experimental therapy targeted to amyloid plaque

        Readers:

        •Private nuclear medicine physicians with no prior training in reading florbetapir-PET
        scans