bioihbjkbjnl/mcl2 huggingface dataset:
Pediatric Study to Evaluate the Efficacy and Safety of Ezetimibe Monotherapy in Children With Primary Hypercholesterolemia (P05522)
Condition: Primary Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: ezetimibe; Placebo
Intervention description: oral tablets: ezetimibe 10 mg once daily for 12 weeks; oral tablets: placebo to match ezetimibe 10 mg; administered once daily during the 5-week, single-blind, placebo run-in and diet stabilization period and 12-week double-blind treatment period
Intervention MeSH terms: Ezetimibe
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 138.0
Sex: All
Minimum age: 6 Years
Maximum age: 10 Years
Healthy volunteers: No
Keywords: heterozygous familial hypercholesterolemia; nonfamilial hypercholesterolemia

Summary:

      The purpose of this study is to determine the effect of ezetimibe 10 mg/day compared to
      placebo on the reduction of low-density lipoprotein cholesterol (LDL-C) from baseline to 12
      weeks of treatment in children >=6 to <=10 years old with primary hypercholesterolemia. The
      study will also evaluate the effect of ezetimibe on total cholesterol (TC), apolipoprotein B
      (Apo B), high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and triglycerides (TG). The
      safety of ezetimibe in this subject population will also be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Each subject may be of either sex and of any race/ethnicity, and must be >=6 and <=10
             years of age, with a diagnosis of primary hypercholesterolemia (heterozygous familial
             or nonfamilial) despite being on a lipid-lowering diet for at least 3 months with a
             LDL-C of >159mg/dL

          -  Each subject's parent/guardian must be willing to give written informed consent on
             his/her behalf.

        Exclusion Criteria:

        Each subject must not:

          -  Have known hypersensitivity or any contraindication to ezetimibe.

          -  Have use of any investigational drugs within 30 days of study entry.

          -  Be a member or a family member of the personnel of the investigational or sponsor
             staff directly involved with this trial.

          -  Be a female of child-bearing potential who is pregnant, intends to become pregnant, or
             is nursing

          -  Have known congenital cardiac disorder.

          -  Have documented or laboratory values consistent with homozygous familial
             hypercholesterolemia (HoFH).

          -  Be known to be human immunodeficiency virus (HIV) positive.
Carotid and Vertebral Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)
Condition: Cerebral Arterial Diseases
MeSH terms: Cerebral Arterial Diseases
Intervention: Dotarem; TOF MRA
Intervention description: Each subject will receive one injection of Dotarem 0.2ml/kg; Each subject will undergo a Time Of Flight Magnetic Resonance Angiography (TOF MRA)
Intervention MeSH terms: Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 211.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: carotid or vertebral artery disease; Contrast agent; MRA

Summary:

      The study will evaluate the efficacy and safety of Dotarem enhanced MRA in patients suffering
      from carotid or vertebral arterial disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, aged more than 18 years

          -  Strongly suspected of having carotid or vertebral arterial disease

          -  Scheduled (or to be scheduled) to undergo computed tomography angiography (CTA)
             examination

        Exclusion Criteria:

          -  Known grade IV or V chronic kidney disease (GFR<30 mL/min/1.73m²)

          -  Contraindication to MRI

          -  Acute renal dysfunction within the 6 months preceding Dotarem®-enhanced MRA
             examination
Efficacy and Safety of Adalimumab and Methotrexate (MTX) Versus MTX Monotherapy in Subjects With Early Rheumatoid Arthritis
Condition: Early Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Adalimumab; Methotrexate; Adalimumab placebo; Methotrexate placebo
Intervention MeSH terms: Adalimumab; Methotrexate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 799.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Early Rheumatoid Arthritis

Summary:

      The purpose of the study is to assess the safety and efficacy of adalimumab in combination
      with methotrexate in patients with recent onset rheumatoid arthritis (RA), and to assess the
      long-term safety and maintenance of efficacy after treatment with adalimumab for up to 10
      years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject was age 18 or older and in good health (Investigator discretion) with a recent
             stable medical history.

          -  Diagnosis of rheumatoid arthritis (RA) as defined by the 1987-revised American College
             of Rheumatology (ACR) criteria, with a disease duration less than 3 years, at least 8
             swollen joints out of the 66 joints assessed, at least 10 tender joints out of the 68
             joints assessed, at least 1 joint erosion or rheumatoid factor (RF) positivity,
             erythrocyte sedimentation rate (ESR) >= 28 mm/1h or C-reactive protein (CRP) >= 1.5
             mg/dl

        Exclusion Criteria:

          -  Chronic arthritis diagnosed before the age of 16

          -  Preceding treatment with MTX, cyclophosphamide, cyclosporin, azathioprine or more than
             2 other disease-modifying anti-rheumatic drugs (DMARDs)

          -  Subject previously received anti-tumor necrosis factor (TNF) therapy

          -  Permanently wheelchair-bound or bedridden patients

          -  Subject considered by the investigator, for any reason, to be an unsuitable candidate
             for the study

          -  Female subject who is pregnant or breast-feeding or considering becoming pregnant
MK0431 Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-040)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: sitagliptin phosphate; Comparator: placebo
Intervention description: Sitagliptin 100 mg administered as one oral tablet once daily before the morning meal for up to 18 weeks.; placebo to match Sitagliptin 100 mg administered as one oral tablet once daily before the morning meal for up to 18 weeks
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 530.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a clinical study to determine the safety and efficacy of an investigational drug in
      patients with type 2 diabetes mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients have Type 2 Diabetes Mellitus and have laboratory results that are within the
             values established by the study such as an Hemoglobin A1c (HbA1c) >=7.5% and <=11% and
             a Fasting Plasma Glucose (FPG) >=130 mg/dL and <=280 mg/dL

        Exclusion Criteria :

          -  Patients have Type 1 Diabetes Mellitus or required insulin therapy within the past 12
             months
MSB11022 in Moderate to Severe Chronic Plaque Psoriasis
Condition: Psoriasis; Plaque Type Psoriasis; Moderate to Severe Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: MSB11022; Humira®
Intervention description: Participants received MSB11022 drug subcutaneously MSB11022 (Core Treatment Period), MSB11022 (Extended Treatment Period) and EU-Humira/MSB11022 arm.; Participants received EU-Humira subcutaneously in EU-Humira, EU-Humira/EU-Humira and EU-Humira/MSB11022 arm.
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 443.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Adalimumab; MSB11022; Psoriasis; Phase III

Summary:

      The purpose of this study was to compare the efficacy, safety and immunogenicity of MSB11022
      and Humira® in adult subjects with moderate to severe chronic plaque type psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participants greater than or equal to (>=) 18 years old with a clinical
             diagnosis of stable moderate to severe plaque psoriasis (defined by Psoriasis Area and
             Severity Index [PASI] score >=12, Physician Global Assessment [PGA] score >=3, and
             >=10% of body surface area affected at Screening and Baseline [Day 1 of Week 1]) who
             have a history of receipt of or are candidates for systemic therapy or phototherapy
             for active plaque-type psoriasis despite topical therapy

          -  Participants must not have received more than 1 biologic therapy

          -  Other protocol-defined inclusion criteria could apply

        Exclusion Criteria:

          -  Participants was excluded if they have erythrodermic, pustular, guttate, or
             medication-induced forms of psoriasis or other active skin diseases/infections that
             may interfere with the evaluation of plaque psoriasis

          -  Participants must not have received adalimumab or an investigational or licensed
             biosimilar of adalimumab; topical therapies for the treatment of psoriasis or
             ultraviolet B phototherapy within 2 weeks of investigational medicinal product (IMP)
             administration or plan to take such treatment during the trial; or psoralen combined
             with ultraviolet A phototherapy or nonbiological systemic therapies for psoriasis
             within 4 weeks prior to IMP administration

          -  Participants was excluded if they have a history of an ongoing, chronic, or recurrent
             infectious disease (except for latent tuberculosis [TB]); history of active TB; or a
             history of hypersensitivity to any component of the IMP formulation, comparable drugs,
             or latex

          -  Other protocol-defined exclusion criteria could apply
Efficacy and Safety of RTH258 Versus Aflibercept - Study 2
Condition: Neovascular Age-Related Macular Degeneration; Choroidal Neovascularization
MeSH terms: Macular Degeneration; Wet Macular Degeneration; Choroidal Neovascularization; Neovascularization, Pathologic
Intervention: Brolucizumab ophthalmic solution; Aflibercept ophthalmic solution
Intervention description: Ophthalmic solution for IVT injection administered as a 6 mg/50 µL dose; Ophthalmic solution for IVT injection administered as a 2 mg/50 µL dose
Intervention MeSH terms: Aflibercept; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1048.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: AMD; CNV; IVT

Summary:

      The purpose of this study is to compare brolucizumab (RTH258) ophthalmic solution for
      intravitreal (IVT) injection (6 mg) to aflibercept ophthalmic solution for IVT injection (2
      mg) in subjects with untreated active choroidal neovascularization (CNV) secondary to
      age-related macular degeneration (AMD) in the study eye.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Provide written informed consent;

          -  Active CNV lesions secondary to AMD that affected the central subfield in the study
             eye at Screening;

          -  Total area of CNV > 50% of the total lesion area in the study eye at Screening;

          -  Intraretinal and/or subretinal fluid affecting the central subfield of the study eye
             at Screening;

          -  Best corrected visual acuity (BCVA) between 78 and 23 letters, inclusive, in the study
             eye at Screening and Baseline using Early Treatment Diabetic Retinopathy Study (ETDRS)
             testing.

        Key Exclusion Criteria:

          -  Any active intraocular or periocular infection or active intraocular inflammation in
             either eye at Baseline;

          -  Central subfield of the study eye affected by fibrosis or geographic atrophy or total
             area of fibrosis ≥ 50% of the total lesion in the study eye at Screening;

          -  Subretinal blood affecting the foveal center point and/or ≥ 50% of the lesion of the
             study eye at Screening;

          -  Any approved or investigational treatment for neovascular age-related macular
             degeneration (nAMD) in the study eye at any time;

          -  Retinal pigment epithelial rip/tear in the study eye at Screening or Baseline or
             current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within
             4 weeks prior to Baseline;

          -  Pregnant or nursing women; women of child-bearing potential;

          -  Stroke or myocardial infarction in the 6-month period prior to Baseline.
A Study to Evaluate the Efficacy and Tolerability of Rizatriptan for Treatment of Acute Migraine (0462-087)
Condition: Acute Migraine
MeSH terms: Migraine Disorders
Intervention: rizatriptan; Comparator: Placebo; Comparator: Sumatriptan
Intervention description: Single dose of 10 mg orally disintegrating tablet at onset of migraine attack; Placebo to Rizatriptan; single dose of generic sumatriptan 100 mg at onset of migraine attack
Intervention MeSH terms: Sumatriptan; Rizatriptan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 109.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Treatment of acute migraine with or without aura in adults

Summary:

      A study to provide evidence supporting the benefit of Rizatriptan in patients who have an
      inadequate response to sumatriptan.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has a history of migraine with or without aura for 1 year or more with 2-8
             moderate or severe migraine attacks per month

          -  Patient generally does not respond to treatment with sumatriptan

          -  Patient of reproductive potential agrees to remain abstinent or use one method of
             highly effective birth control (i.e. IUD, condoms, hormonal contraceptive, diaphragm,
             vasectomy) for the duration of the study

          -  Patient is able to complete paper diary

        Exclusion Criteria:

          -  Patient is pregnant or breast feeding or excepts to become pregnant during the study

          -  Patient has history of mild migraine attacks or migraines that usually resolve
             spontaneously in less than 2 hours

          -  Patient has basilar or hemiplegic migraines

          -  Patient is unable to distinguish between migraine attacks from other types of
             headaches

          -  Patient has more than 15 headache-days per month

          -  Patient was greater than 50 years old at age of migraine onset

          -  Patient has failed to respond to 3 or more triptans

          -  Patient has a repeated history of failing to respond to or tolerate rizatriptan

          -  Patient uses opioids as primary migraine therapy

          -  Patient uses daily opioids

          -  Patient has a history of Cerebrovascular Accident (CVA) or other significant
             cardiovascular disease

          -  Patient has uncontrolled hypertension

          -  Patient has a history of neoplastic disease

          -  Patient is taking a serotonin reuptake inhibitor (SSRI or SNRI) where the dose has
             changed 3 months prior to screening

          -  Patient has a history of drug or alcohol abuse
A Study to Evaluate Upadacitinib in Adolescents and Adults With Moderate to Severe Atopic Dermatitis (Measure Up 2)
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Placebo for Upadacitinib; Upadacitinib
Intervention description: Tablets taken orally once a day; Tablets taken orally once a day
Intervention MeSH terms: Upadacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 912.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Atopic Dermatitis; Upadacitinib; ABT-494; Measure Up 2

Summary:

      The objective of this study is to assess the efficacy and safety of upadacitinib for the
      treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD)
      who are candidates for systemic therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body weight of ≥ 40 kg at Baseline Visit for participants ≥ 12 and < 18 years of age

          -  Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to
             Baseline and subject meets Hanifin and Rajka criteria

          -  Active moderate to severe AD defined by Eczema Area and Severity Index (EASI) ≥ 16,
             validated Investigator's Global Assessment (vIGA) ≥ 3, body surface area (BSA)
             affected by AD ≥ 10%, and weekly average of daily Worst Pruritus numerical rating
             scale (NRS) score ≥ 4.

          -  Candidate for systemic therapy or have recently required systemic therapy for AD

          -  Documented history (within 6 months prior to Baseline) of inadequate response to
             topical corticosteroid (TCS) or topical calcineurin inhibitor (TCI) or documented
             systemic treatment for AD or for whom topical treatments are otherwise medically
             inadvisable due to side effects or safety risks

        Exclusion Criteria:

          -  Prior exposure to any Janus kinase (JAK) inhibitor

          -  Unable or unwilling to discontinue current AD treatments prior to the study

          -  Requirement of prohibited medications during the study

          -  Other active skin diseases or skin infections requiring systemic treatment or would
             interfere with appropriate assessment of atopic dermatitis lesions

          -  Female subject who is pregnant, breastfeeding, or considering pregnancy during the
             study
Efficacy, Safety and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
Condition: Agitation in Patients With Dementia of the Alzheimer's Type
MeSH terms: Dementia; Alzheimer Disease; Psychomotor Agitation
Intervention: AVP-786; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Sequential parallel comparison design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 387.0
Sex: All
Minimum age: 50 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Agitation; Dementia; Alzheimer's disease

Summary:

      Participants with agitation secondary to dementia of the Alzheimer's type. The diagnosis of
      probable Alzheimer's disease (AD) was to be based on the "2011 Diagnostic Guidelines for
      Alzheimer's Disease" issued by the National Institute on Aging (NIA)-Alzheimer's Association
      (AA) workgroups.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National
             Institute on Aging-Alzheimer's Association (NIA-AA) working groups criteria

          -  The participant has clinically significant, moderate/severe agitation at the time of
             screening and for at least 2 weeks prior to randomization

          -  The diagnosis of agitation must meet the International Psychogeriatric Association
             (IPA) provisional definition of agitation

          -  Either out patients or residents of an assisted-living facility or a skilled nursing
             home

          -  Clinical Global Impression of Severity of Illness (CGIS) score assessing Agitation is
             >= 4 (moderately ill) at screening and baseline

          -  Mini-Mental State Examination (MMSE) score is between 6 and 26 (inclusive) at
             screening and baseline

          -  Caregiver who is able and willing to comply with all required study procedures. In
             order to qualify as a reliable informant (i.e., caregiver) capable of assessing
             changes in participant's condition during the study, the individual must spend a
             minimum of 2 hours per day for 4 days per week with the participant.

        Exclusion Criteria:

          -  Participant has dementia predominantly of non-Alzheimer's type (e.g., vascular
             dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)

          -  Participants with co-existent clinically significant or unstable systemic diseases
             that could confound the interpretation of the safety results of the study (e.g.,
             malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable
             pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated
             cardiomyopathy, or unstable valvular heart disease)

          -  Participant with myasthenia gravis