bioihbjkbjnl/mcl2 huggingface dataset:
Study of Nivolumab (BMS-936558) vs. Everolimus in Pre-Treated Advanced or Metastatic Clear-cell Renal Cell Carcinoma (CheckMate 025)
Condition: Advanced or Metastatic (Medically or Surgically Unresectable) Clear-cell Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: Nivolumab; Everolimus
Intervention MeSH terms: Nivolumab; Everolimus
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 821.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to compare the clinical benefit, as measured by duration of
      overall survival, of Nivolumab vs. Everolimus in subjects with advanced or metastatic
      clear-cell renal cell carcinoma who have received prior anti-angiogenic therapy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men & women ≥18 years of age

          -  Histologic confirmation of renal cell carcinoma (RCC) with clear-cell component

          -  Advanced/metastatic RCC

          -  Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
             criteria

          -  Received 1 or 2 prior anti-angiogenic therapy regimens in advanced or metastatic
             setting

          -  No more than 3 total prior systemic treatment regimens in the advanced or metastatic
             setting, and evidence of progression on or after last treatment regimen received and
             within 6 months of enrollment

          -  Karnofsky Performance Score ≥70%

        Exclusion Criteria:

          -  Any Central Nervous System (CNS) metastases or history of CNS metastases

          -  Prior therapy with an Mammalian target of rapamycin (mTOR) inhibitor

          -  Any active known or suspected autoimmune disease

          -  Uncontrolled adrenal insufficiency

          -  Active chronic liver disease

          -  Prior malignancy active within past 3 years, except for locally curable cancers

        Other protocol-defined inclusion/exclusion criteria apply
Extension in AS: Sustainability of Benefits, Safety and Tolerability
Condition: Spondylitis, Ankylosing
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Intervention: Secukinumab; Placebo (Pbo)
Intervention description: Group 1: secukinumab 75 mg plus placebo 150 mg or Group 2 secukinumab 150 mg plus placebo 75m dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only secukinumab 75 mg or 150 mg were dosed. Secukinumab in PFS for s.c. self-administration Q4W; Group 1: secukinumab 75 mg plus placebo 150 mg or Group 2 secukinumab 150 mg plus placebo 75m dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only secukinumab 75 mg or 150 mg were dosed. Secukinumab in PFS for s.c. self-administration Q4W
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 274.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: AIN457, ankylosing spondylitis, chronic inflammatory disease, inflammatory back pain, PFS, pre-filled syringe, secukinumab, self-injection

Summary:

      This 3-year extension study aims at making available the treatment with secukinumab in
      prefilled syringes (PFS) to patients with ankylosing spondylitis who took part in phase III
      study CAIN457F2305, defined as "core study", as well as to generate additional data on the
      sustainability of clinical benefits, safety and tolerability during long-term administration
      of secukinumab.
    

Eligibility criteria:

        Inclusion Criteria: patients having completed the "core study" CAIN457F2305, indication for
        treatment extension. -- Exclusion Criteria: history of hypersensitivity to secukinumab or
        to any drug of similar chemical classes, use of any investigational drug other than
        secukinumab during the "core study" CAIN457F2305.
A Follow-up Extension Study to Evaluate the Persistence of Immune Response to GSK Biologicals' HPV Vaccine in Healthy Chinese Female Subjects Who Received Three Doses of the Vaccine in the HPV-058 Study
Condition: Cervical Intraepithelial Neoplasia
MeSH terms: Uterine Cervical Dysplasia
Intervention: Blood sampling for antibody determination
Intervention description: In order to assess the persistence of immune responses seven to eight years after the last vaccine dose against HPV-16/18, a blood sample (~5 mL) will be taken from all the subjects, at Day 1.
Intervention MeSH terms: Antibodies
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 228.0
Sex: Female
Minimum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Immune response; Cervarix; Persistence; Chinese; Human papillomavirus

Summary:

      The purpose of this study is to evaluate the persistence of immune response in subjects who
      received the HPV-16/18 vaccine, seven to eight years after the last dose of primary
      vaccination in the HPV-058 study. No new subjects will be enrolled in this extension study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects/subject's parents/legally acceptable representative(s) [LAR(s)] who, in the
             opinion of the investigator, can and will comply with the requirements of the
             protocol.

          -  Written informed consent obtained from the subject or subject's parents/LAR(s) prior
             to performing any study specific procedure.

          -  Written informed assent obtained from the subjects below the legal age of consent.

          -  Subjects who received all three doses of the HPV-16/18 vaccine in the HPV-058 study.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine which may have
             an impact on the study objectives) during the period starting 30 days (Day 29 to Day
             1) before the study visit.

          -  Concurrently participating in another clinical study, in which the subject has been or
             will be exposed to an investigational or a non-investigational vaccine/product
             (pharmaceutical product or device).

          -  Previous vaccination against HPV outside the HPV-058 study.

          -  Subjects with contraindications related to blood draw such as blood disorders and
             anticoagulants use.
A Study of Reslizumab in Patients 12 Years of Age and Older With Severe Eosinophilic Asthma
Condition: Eosinophils, Asthma
MeSH terms: Asthma; Pulmonary Eosinophilia
Intervention: reslizumab
Intervention description: Reslizumab was provided in a pre-filled syringe.
Intervention MeSH terms: Reslizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 391.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This is a multicenter, open-label (OL) extension study to obtain additional long-term safety
      data for subcutaneous (sc) administration of reslizumab treatment administered at a fixed
      dose of 110 mg in patients 12 years of age and older with severe eosinophilic asthma who
      completed the treatment period of a placebo-controlled Phase 3 trial of sc reslizumab. The
      study consists of a screening/baseline visit followed by a 36-week OL treatment period and a
      15-week follow-up period.
    

Eligibility criteria:

        Inclusion Criteria:

        • Patient with eosinophilic asthma who completed the treatment period of a double-blind,
        placebo controlled sc reslizumab study (Study C38072-AS-30025 or C38072-AS-30027)

        ~~ Additional criteria apply, please contact the investigator for more information

        Exclusion Criteria:

          -  Patient has received any reslizumab administration in any previous clinical trial
             other than Studies C38072-AS-30025 and C38072-AS-30027.

          -  The patient has any clinically significant, uncontrolled medical condition

          -  The patient has another confounding underlying lung disorder

          -  The patient has a known/diagnosed hypereosinophilic syndrome.

          -  The patient has a diagnosis of malignancy within 5 years of the screening visit,
             except for treated and cured non-melanoma skin cancers.

          -  The patient is a pregnant or lactating woman

          -  The patient is a current smoker (ie, has smoked within the last 6 months before
             screening) or has a smoking history ≥10 pack-years.

          -  The patient is currently using any systemic immunosuppressive or immunomodulatory
             agents other than OCS

          -  The patient has a history of allergic reaction or hypersensitivity to any component of
             the study drug.

          -  The patient has a history of an immunodeficiency disorder including human
             immunodeficiency virus (HIV).

               -  Additional criteria apply, please contact the investigator for more information
A Long Term Extension Study of Ixekizumab (LY2439821) in Participants With Axial Spondyloarthritis
Condition: Axial Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis; Axial Spondyloarthritis
Intervention: Ixekizumab; Placebo
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Ixekizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 773.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate, in participants having achieved a state of
      sustained remission, if the ixekizumab treatment groups are superior to the placebo group in
      maintaining response during the randomized withdrawal-retreatment period in participants with
      axial spondyloarthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have completed the final study visit in Study RHBV (NCT02696785), RHBW (NCT02696798),
             or RHBX (NCT02757352).

        (Note: Participants from Study RHBX are not eligible if they permanently discontinued
        ixekizumab and were receiving a tumor necrosis factor [TNF] inhibitor).

          -  Must agree to use a reliable method of birth control.

        Exclusion Criteria:

          -  Have significant uncontrolled disorders or abnormal laboratory values that, in the
             opinion of the investigator, pose an unacceptable risk to the participant if
             investigational product continues to be administered.

          -  Have a known hypersensitivity to ixekizumab or any component of this investigational
             product.

          -  Had investigational product permanently discontinued during a previous ixekizumab
             study.

          -  Had temporary investigational product interruption at any time during or at the final
             study visit of a previous ixekizumab study and, in the opinion of the investigator,
             restarting ixekizumab poses an unacceptable risk for the participant's participation
             in the study.

          -  Have any other condition that, in the opinion of the investigator, renders the
             participant unable to understand the nature, scope, and possible consequences of the
             study or precludes the participant from following and completing the protocol.

          -  Are currently enrolled in any other clinical trial involving an investigational
             product or any other type of medical research judged not to be scientifically or
             medically compatible with this study.
Fluoride Release,Compressive Strength and Clinical Performance of a Bioactive Restorative Material in ART
Condition: Dental Caries
MeSH terms: Dental Caries
Intervention: Fuji IX EXTRA; ACTIVA KIDS bioactive restorative material
Intervention description: High-viscosity glass ionomer (Fuji IX EXTRA); Modified composite (ACTIVA KIDS)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 110.0
Sex: All
Minimum age: 4 Years
Maximum age: 8 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioactive Restorative Material , ART

Summary:

      The study will be two parallel group, triple blinded randomized controlled clinical trial
      that based on CONSORT (consolidated standards of reporting trials) guideline .The selected
      participants according to inclusion and exclusion criteria will be randomly allocated in two
      groups using (Research Randomizer Program) .
    

Eligibility criteria:

        Inclusion Criteria:

          1. Children aged from 4 to 8 years old, in good general health

          2. Children classified as class 3 or 4 based on Frankel et al. classification. (26)

          3. The children have at least one primary molar with class I carious lesion.

          4. Asymptomatic teeth (without spontaneous pain)

        Exclusion Criteria:

          1. Medically compromised patient

          2. Presence of pulp exposure, pain, mobility

          3. Presence of swelling, abscess or fistula near the tooth

          4. Not accessible carious lesion to hand instruments
Study to Evaluate Psoriasis Severity and Its Psychosocial Impact Using the Simplified Psoriasis Index (SPI), as Well as Long-term Safety, Tolerability and Efficacy of Secukinumab Administered Subcutaneously in Patients With Moderate to Severe Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Secukinumab
Intervention description: weekly sub cutaneous injections of 300 mg during the first month and then monthly until week 52 plus extension until 03/11/2016.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: This was an open label single-arm study; therefore treatment blinding was not necessary.
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Psoriasis; Secukinumab; Simplified Psoriasis Index; CAIN457A; AIN457AFR01; AIN457A; Skin condition; skin disease; itching condition; psoriasis vulgaris; relapsing/remitting psoriasis; immune-mediated systemic disease; skin lesions; red skin lesions; scaly patches; papules; plaques; itching

Summary:

      Evaluate psoriasis severity and its psychosocial impact using a novel Patient Reported
      Outcome (the Simplified Psoriasis Index SPI) at 16 weeks, as well as long-term safety,
      tolerability and efficacy of secukinumab administered subcutaneously during 52 weeks (plus
      extension) in patients with moderate to severe psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients with a history of chronic, moderate to severe plaque psoriasis (PASI ≥12; BSA
             (body surface area) ≥10 and IGA mod 2011 (Investigator's Global Assessment) ≥3) for at
             least 6 months

          -  patient candidates for systemic therapy.

          -  informed consent.

        Exclusion Criteria:

          -  previous treatment with agent targeting IL-17 (interleukine-17) or IL-17 receptor.

          -  recent treatment with topical treatment (2 weeks), systemic agents (4 weeks for
             methotrexate, Ciclosporine A; systemic retinoids and other systemic treatment), TNF
             (tumor necrosis factor) inhibitors (3 months) or IL-12/23 inhibitors (6 months).
A Study to Evaluate Leuprolide Acetate 45 mg 6-Month Formulation in Children With Central Precocious Puberty (CPP)
Condition: Central Precocious Puberty (CPP)
MeSH terms: Puberty, Precocious
Intervention: Leuprolide Acetate (LA)
Intervention description: Administered intramuscularly as an injection
Intervention MeSH terms: Leuprolide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 2 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Central Precocious Puberty (CPP); Leuprolide Acetate (LA)

Summary:

      The primary objective of the study is to assess the safety and efficacy of a leuprolide
      acetate (LA) 45 mg 6-month depot formulation for the treatment of CPP in children who are
      either naïve to treatment with a gonadotropin-releasing hormone agonist (GnRHa) or who have
      been previously treated with a GnRHa.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children with CPP who are naïve to treatment with a gonadotropin-releasing hormone
             agonist (GnRHa) (females 2 - 8 years of age, or males 2 - 9 years of age) or who have
             been on standard GnRHa therapy for at least 6 months (females 2 - 10 years of age, or
             males 2 - 11 years of age).

          -  No history of clinically significant medical conditions or any other reason that the
             investigator determines would make the participant an unsuitable candidate to receive
             study drug.
Efficacy and Safety Study of Ozanimod in Relapsing Multiple Sclerosis
Condition: Relapsing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Ozanimod; Ozanimod placebo; Interferon beta-1a; Interferon beta-1a placebo
Intervention description: Oral capsule, daily for 24 months; Oral capsule, daily for 24 months; Intramuscular injection, 30 µg, weekly for 24 months; Intramuscular injection, weekly for 24 months
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a; Ozanimod
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1320.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      This study is a two-part trial consisting of Part A (see NCT01628393) and Part B, presented
      within this record.

      The primary objective of Part B is to assess whether the clinical efficacy of ozanimod
      (RPC1063) is superior to interferon beta-1a (IFN β-1a; Avonex®) in reducing the rate of
      clinical relapses at the end of Month 24 in patients with relapsing multiple sclerosis (RMS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Multiple sclerosis as diagnosed by the revised 2010 McDonald criteria

          -  Expanded Disability Status Scale (EDSS) score between 0 and 5.0 at baseline

        Exclusion Criteria:

          -  Primary progressive multiple sclerosis
Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis
Condition: Chronic Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Roflumilast 0.3% cream; Vehicle Cream
Intervention description: Roflumilast 0.3% cream for topical application.; Vehicle cream for topical application.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 439.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No

Summary:

      This is a double-blind, parallel group, vehicle-controlled study to assess the safety and
      efficacy of roflumilast (ARQ-151) 0.3% cream vs vehicle (placebo) cream for treatment of
      chronic plaque psoriasis (CPP) in adult participants with 2 to 20% body surface area (BSA) of
      CPP.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants legally competent to sign and give informed consent and if appropriate
             assent as required by local laws

          -  Males and females ages 2 years and older (inclusive)

          -  Clinical diagnosis of psoriasis vulgaris of at least 6 months duration (3 months for
             children) as determined by the Investigator

          -  Females of childbearing potential (FOCBP) must have a negative pregnancy test at
             Screening (Visit 1) and Baseline (Visit 2). In addition, sexually active FOCBP must
             agree to use at least one form of highly effective contraception throughout the trial.

          -  In good health as judged by the Investigator, based on medical history, physical
             examination, serum chemistry labs, hematology values, and urinalysis.

          -  Subjects considered reliable and capable of adhering to the Protocol and visit
             schedule, according to the judgment of the Investigator.

        Exclusion Criteria:

          -  Planned excessive exposure of treated area(s) to either natural or artificial
             sunlight, tanning bed or other LED.

          -  Females who are pregnant, wishing to become pregnant during the study, or are
             breast-feeding.

          -  Previous treatment with ARQ-151 or its active ingredient

          -  Subjects with any serious medical condition or laboratory abnormality that would
             prevent study participation or place the subject at significant risk, as determined by
             the Investigator.

          -  Subjects with a history of chronic alcohol or drug abuse within 6 months of initiation
             of investigational product

          -  Subjects who are unable to communicate, read or understand the local language, or who
             display another condition, which in the Investigator's opinion, makes them unsuitable
             for clinical study participation