bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess Efficacy and Safety of Two Different Dose Regimens of Risankizumab Administered Subcutaneously in Japanese Subjects With Generalized Pustular Psoriasis or Erythrodermic Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: risankizumab
Intervention description: risankizumab administered by subcutaneous injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Generalized Pustular Psoriasis; Erythrodermic Psoriasis; risankizumab; Japanese

Summary:

      The purpose of this study is to investigate the safety and efficacy of two different dose
      regimens of risankizumab for Japanese subjects with generalized pustular psoriasis (GPP) or
      erythrodermic psoriasis (EP).
    

Eligibility criteria:

        Inclusion Criteria:

        For GPP

          -  Have a diagnosis of GPP for at least 60 days prior to informed consent based on the
             diagnostic criteria of the Japanese Dermatological Association (JDA). Subjects not
             fulfilling one of the diagnostic criteria i.e., "accompanying systemic symptoms
             including fever or malaise" at the time of screening can be entered.

          -  Subjects with an erythema area with pustules accounting for ≥ 10% of the body surface
             area (BSA), and with a severity assessment criteria score (JDA total score) specified
             by the JDA of less than 14.

          -  Must be candidates for systemic therapy or phototherapy for GPP, as assessed by the
             investigator.

        For EP

          -  Have a diagnosis of EP prior to informed consent.

          -  Subjects with an inflammatory erythema area accounting for ≥ 80% of the BSA at
             screening and at the time of the first administration of the study drug.

          -  Must be candidates for systemic therapy or phototherapy for EP, as assessed by the
             investigator.

        Exclusion Criteria:

          -  Previous exposure to risankizumab.

          -  Currently enrolled in another investigational study or less than 30 days (from
             screening) since completing another investigational study (participation in
             observational studies is permitted).

        For GPP

          -  Subjects with active ongoing inflammatory diseases other than GPP that might confound
             trial evaluations according to investigator's judgment.

        For EP

          -  Subjects with active ongoing inflammatory diseases other than EP that might confound
             trial evaluations according to investigator's judgment.

          -  Subject diagnosed with medication-induced or medication-exacerbated EP.
Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants (V114-033)
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Intervention: V114; PCV13
Intervention description: 15-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) present in PCV13 plus 2 additional serotypes (22F, 33F) in each subcutaneous 0.5 mL single dose.; 13-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) in each subcutaneous 0.5 mL single dose.
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 694.0
Sex: All
Minimum age: 2 Months
Maximum age: 6 Months
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this clinical study is to evaluate the safety and immunogenicity of a 4-dose
      schedule (3-dose primary series followed by a toddler dose) of V114 compared with
      Pneumococcal 13-valent Conjugate Vaccine (PCV13). The hypotheses are that: 1) V114 is
      non-inferior to PCV13 for the 13 shared serotypes between V114 and PCV13 based on the
      response rates at 30 days following dose 3; 2) V114 is non-inferior to PCV13 for the 2 unique
      V114 serotypes based on the response rate of the 2 unique V114 serotypes at 30 days following
      dose 3; 3) V114 is non-inferior to PCV13 for the 13 shared serotypes between V114 and PCV13
      based on anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG)
      geometric mean concentrations (GMCs) at 30 days following dose 3.
    

Eligibility criteria:

        Inclusion Criteria:

        - Japanese male or female

        Exclusion Criteria:

          -  Has a history of invasive pneumococcal disease (IPD)

          -  Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine
             (PCV), or any diphtheria toxoid containing vaccine

          -  Has a known or suspected impairment of immunological function

          -  Has a history of congenital or acquired immunodeficiency

          -  Has or his/her mother has a documented human immunodeficiency virus (HIV) infection

          -  Has or his/her mother has a documented hepatitis B surface antigen-positive test

          -  Has known or history of functional or anatomic asplenia

          -  Has a history of autoimmune disease

          -  Has a known neurologic or cognitive behavioral disorder

          -  Has received a dose of any pneumococcal vaccine prior to study entry

          -  Has received a blood transfusion or blood products, including immunoglobulins
Study to Assess if ABP 798 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis (RA) Compared to Rituximab
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: ABP 798; Rituximab (US); Rituximab (EU)
Intervention description: Supplied as a 10 mg/mL liquid concentrate for intravenous (IV) administration.; Supplied as a 10 mg/mL liquid concentrate for IV administration.; Supplied as a 10 mg/mL liquid concentrate for IV administration.
Intervention MeSH terms: Rituximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 311.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This trial is designed to determine what effects the human body has on the investigational
      medicine, ABP 798, and what effects the body has on the investigational medicine after you
      have been given it, and if this is comparable to what is seen for the licensed medicine,
      rituximab, in patients with moderate or severe RA.

      This study will also assess if the investigational medicine is safe and effective in treating
      moderate or severe RA compared to the licensed medicine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women ≥ 18 and ≤ 80 years old

          -  Subjects must be diagnosed with rheumatoid arthritis for at least 6 months before
             baseline

          -  Active RA defined as ≥ 6 swollen joints and ≥ 6 tender joints at screening and
             baseline and at least one of the following at screening:

               -  erythrocyte sedimentation rate (ESR) ≥ 28 mm/hr

               -  serum C-reactive protein (CRP) > 1.0 mg/dL

          -  Subjects must be taking methotrexate (MTX) for ≥ 12 consecutive weeks and on a stable
             dose of MTX 7.5 to 25 mg/week for ≥ 8 weeks prior to receiving the investigational
             product (IP), and be willing to remain on a stable dose throughout the study

          -  Subject has no known history of active tuberculosis

        Exclusion Criteria:

          -  Class IV RA, Felty's syndrome or history of prosthetic or native joint infection

          -  Major chronic inflammatory disease or connective tissue disease other than RA, with
             the exception of secondary Sjögren's syndrome

          -  Use of commercially available or investigational biologic therapies for RA as follows:

               -  anakinra, etanercept within 1 month prior to first dose of IP

               -  infliximab, abatacept, tocilizumab, golimumab, certolizumab within 3 months prior
                  to first dose of IP

               -  other experimental or commercially available biologic therapies for RA within 3
                  months or 5 half-lives (whichever is longer) prior to first dose of IP

          -  Previous receipt of rituximab or a biosimilar of rituximab

        Other Inclusion/Exclusion criteria may apply
Study of Safety and Efficacy of Brolucizumab 6 mg Dosed Every 4 Weeks Compared to Aflibercept 2 mg Dosed Every 4 Weeks in Patients With Retinal Fluid Despite Frequent Anti-VEGF Injections
Condition: Age-Related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: Brolucizumab; Aflibercept
Intervention description: 6 mg/0.05mL solution for intravitreal injection; 2 mg/0.05mL solution for intravitreal injection
Intervention MeSH terms: Aflibercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: multicenter, randomized, double-masked
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 535.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: neovascular age-related macular degeneration; nAMD; intravitreal injection; IVT; anti-VEGF; brolucizumab; aflibercept; EYLEA; double-masked; MERLIN; BEOVU

Summary:

      This clinical study was designed to compare the safety and efficacy of brolucizumab 6 mg
      dosed every 4 weeks to aflibercept 2 mg dosed every 4 weeks in those neovascular age-related
      macular degeneration (nAMD) patients with retinal fluid despite frequent anti-Vascular
      Endothelial Growth Factor (VEGF) injections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent

          -  Diagnosis of wet age-related macular degeneration (AMD)

          -  Currently receiving anti-VEGF injections

        Exclusion Criteria:

          -  Active infection or inflammation in either eye

          -  Significant fibrosis in the study eye

          -  Recent ocular surgery

          -  Uncontrolled glaucoma

          -  Use of medications as specified in the protocol

          -  Pregnant, nursing

          -  Of child-bearing potential unless using highly effective method of contraception
A Study to Assess the Long Term Effect, Safety and Metabolism of a Solifenacin Liquid Suspension in Participants 5 to 18 Years of Age With Neurogenic Detrusor Overactivity
Condition: Neurogenic Detrusor Overactivity
MeSH terms: Urinary Bladder, Overactive
Intervention: Solifenacin succinate
Intervention description: Oral suspension administered once a day via syringe.
Intervention MeSH terms: Solifenacin Succinate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 76.0
Sex: All
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Cognitive Function; Phase 3; Neurogenic Detrusor Overactivity; Pharmacokinetics; Ocular Accommodation; Urodynamics

Summary:

      The purpose of this study was to investigate a medicine for the treatment of symptoms and
      complications of neurogenic detrusor overactivity (NDO) in children and adolescents.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented diagnosis of NDO, confirmed by urodynamics

          -  Practicing clean intermittent catheterization (CIC)

          -  Currently on treatment with an antimuscarinic drug

        Exclusion Criteria:

          -  Known genitourinary condition (other than NDO) that may cause incontinence

          -  Bladder augmentation surgery

          -  Current Faecal impaction

          -  Electro-stimulation therapy within 2 weeks prior to screening and at any time during
             the study

          -  Subjects with the following gastro-intestinal problems: partial or complete
             obstruction, decreased motility like paralytic ileus, subjects at risk of gastric
             retention

          -  Reflux grade 3 or 4

          -  Current urinary tract infection (UTI)

          -  Subject has severe renal impairment (glomerular filtration rate < 30 ml/min)

          -  Subject has severe hepatic impairment (Child-Pugh score > 9).

          -  Subject has received intra-vesical botulinum toxin within 9 months prior to screening
Long-term Safety and Tolerability of Idalopirdine (Lu AE58054) as Adjunctive Treatment to Donepezil in Patients With Mild-moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Idalopirdine 60 mg
Intervention description: once daily, encapsulated tablets, orally
Intervention MeSH terms: (2-(6-fluoro-1H-indol-3-yl)-ethyl)-(3-(2,2,3,3-tetrafluoropropoxy)benzyl)amine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1463.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      To evaluate the long-term safety and tolerability of idalopirdine (Lu AE58054) as adjunctive
      therapy to donepezil in patients with mild-moderate Alzheimer's Disease (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  the patient has completed Visit 7 (Completion Visit) in the lead-in double-blind,
             placebo controlled clinical studies 14861A/NCT01955161 or 14862A/NCT02006641

        For patients in the OLEX-MEM:

          -  The patient has completed Visit 6 (Week 28) of the OLEX.

          -  The patient, according to the judgement of the investigator, requires initiation of
             treatment with memantine as per local label/SmPC/treatment guidelines.

        Exclusion Criteria:

          -  The patient has a moderate or severe ongoing adverse event from the lead-in study
             considered a potential safety risk by the investigator.

          -  The patient has experienced seizures before Completion Visit in the lead-in study.

          -  The patient has evidence of clinically significant disease.

          -  The patient's donepezil treatment is likely to be interrupted or discontinued during
             the study.

          -  The patient is receiving therapy with another acetylcholinesterase inhibitors (AChEI).

        Other protocol-defined inclusion and exclusion criteria may apply.
Double-Blind Efficacy and Safety of CD5789 (Trifarotene) 50µg/g Cream Versus Vehicle Cream in Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: CD5789 (trifarotene) 50µg/g Cream; Placebo Cream
Intervention description: CD5789 (Trifarotene) 50µg/g cream applied once daily during 12 weeks.; Placebo cream applied once daily during 12 weeks.
Intervention MeSH terms: Trifarotene
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1212.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No
Keywords: Efficacy; Safety; Acne vulgaris

Summary:

      Assessment of the efficacy and safety of CD5789 (Trifarotene) 50µg/g cream applied once daily
      for 12 weeks in subjects with acne vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The subject is a male or female, 9 years of age or older, at Screening visit.

          -  The Subject has moderate acne at Screening and Baseline.

          -  The subject is a female of non childbearing potential

          -  The subject is a female of childbearing potential with a negative pregnancy test and
             who is strictly abstinent or who agrees to use an effective and approved contraceptive
             method for the duration of the study and at least 1 month after the last study drug
             application.

        Exclusion Criteria:

          -  The subject has severe forms of acne (e.g., acne conglobate, acne fulminant) or
             secondary acne form (e.g.,chloracne, drug-induced acne, etc.).

          -  The subject has any uncontrolled or serious disease or any medical or surgical
             condition that may either interfere with the interpretation of the trial results
             and/or put the subject at significant risk (according to the Investigator's judgment)
             if the subject takes part to the trial.

          -  The subject has been exposed to excessive ultraviolet (UV) radiation within one month
             prior to the Baseline visit or the subject is planning intense UV exposure during the
             study (i.e., occupational exposure to the sun, sunbathing, tanning salon use,
             phototherapy, etc.)

          -  The subject is unwilling to refrain from use of prohibited medication during the
             clinical trial
Adjuvant Melatonin for Prevention of Lung Cancer Recurrence and Mortality
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Recurrence
Intervention: melatonin; placebo
Intervention description: 20 mgs ingested nightly; similar to experimental in all ways except for lack of active ingredient
Intervention MeSH terms: Melatonin
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 709.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: melatonin; natural health product (NHP); lung cancer; complementary and alternative medicine (CAM); randomized clinical trial

Summary:

      There is evidence to support the use of melatonin, a natural health product, as an additional
      treatment aid for cancer patients. This study is designed to see if the daily ingestion of 20
      milligrams of melatonin for one year can lower the incidence of developing lung cancer
      recurrence and/or death. Only patients with a diagnosis of non small cell lung cancer who are
      eligible for surgical resection can participate in the trial. The study will also be
      assessing for changes in quality of life, pain, fatigue, anxiety, sleep, and depression
      amongst the participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of non small cell lung cancer

          -  Eligible for surgical resection

          -  Willingness to adhere to randomized treatment

          -  Availability for follow-up schedule of visits

        Exclusion Criteria:

          -  Taking exogenous melatonin
Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation and Pain
Condition: Post Surgical Ocular Inflammation and Pain
MeSH terms: Inflammation
Intervention: KPI-121 1% Ophthalmic Suspension dosed BID; Vehicle of KPI-121 Ophthalmic Suspension dosed BID
Intervention MeSH terms: Loteprednol Etabonate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 520.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: postsurgical; postoperative; ocular; cataract; inflammation; pain; corticosteroid

Summary:

      The primary objective of the study is to investigate the efficacy and safety of KPI-121 1.0%
      ophthalmic suspension compared to placebo in subjects who have undergone cataract surgery.
    

Eligibility criteria:

        Inclusion Criteria:

        Candidates for routine, uncomplicated cataract surgery

        In Investigator's opinion, potential postoperative Snellen Distance VA by pinhole method of
        at least 20/200 in study eye.

        Exclusion Criteria:

          -  Known hypersensitivity/contraindication to study product(s) or components.

          -  History of glaucoma, intraocular pressure (IOP) >21 mmHg at the screening or
             randomization visits, or being treated for glaucoma in either eye.

          -  Diagnosis of: ongoing ocular infection; severe/serious ocular condition that in
             judgment of Investigator could confound study assessments or limit compliance;
             severe/serious systemic disease or uncontrolled medical condition that in judgment of
             Investigator could confound study assessments or limit compliance; or have been
             exposed to an investigational drug within the 30 days prior to screening or 18 days
             following surgery.

          -  In the opinion of Investigator or study coordinator, be unwilling or unable to comply
             with study protocol or unable to successfully instill eye drops.
A Study Of PF-05280586 (Rituximab-Pfizer) Or MabThera® (Rituximab-EU) For The First-Line Treatment Of Patients With CD20-Positive, Low Tumor Burden, Follicular Lymphoma (REFLECTIONS B328-06)
Condition: Follicular Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular
Intervention: PF-05280586; MabThera®
Intervention description: PF-05280586 (rituximab-Pfizer) concentrate for solution for infusion 375mg/m2 administered via IV infusion on Days 1, 8, 15, and 22; MabThera® (rituximab-EU) concentrate for solution for infusion 375mg/m2 administered via IV infusion on Days 1, 8, 15, and 22
Intervention MeSH terms: Rituximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 394.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: rituximab; follicular lymphoma; Non-Hodgkin lymphoma; Non-Hodgkin's lymphoma

Summary:

      This study will compare the safety and effectiveness of PF-05280586 versus rituximab-EU in
      patients with CD20-positive, low tumor burden follicular lymphoma. The primary hypothesis to
      be tested in this study is that the effectiveness of PF-05280586, as measured by the Overall
      Response Rate, is similar to that of rituximab-EU.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of low tumor burden, CD20-positive follicular lymphoma

          -  Ann Arbor Stage II, III, or IV

        Exclusion Criteria:

          -  Not a candidate for treatment with rituximab as a single-agent

          -  Evidence of transformation to a high grade or diffuse large B-cell lymphoma

          -  Any previous systemic therapy for B-cell NHL, including chemotherapy, immunotherapy,
             or steroids

          -  Any prior treatment with rituximab

          -  Active, uncontrolled infection