bioihbjkbjnl/mcl2 huggingface dataset:
Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004)
Condition: Cervical Cancer; Vulvar Cancer; Vaginal Cancer; Genital Warts; Human Papillomavirus Infection
MeSH terms: Papillomavirus Infections; Condylomata Acuminata; Vulvar Neoplasms; Vaginal Neoplasms
Intervention: V503
Intervention description: V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1212.0
Sex: Female
Minimum age: 16 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will assess the safety and immunogenicity of GARDASIL®9 (V503) in 16- to
      45-year-old women. The primary hypothesis of the study states that anti-HPV 16, 18, 31, 33,
      45, 52, and 58 geometric mean titers (GMTs) at 4 weeks postdose 3 are non-inferior in adult
      women as compared with GMTs in young adult women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  good physical health

        Exclusion Criteria:

          -  history of an abnormal Pap (Papanicolaou) test or abnormal cervical biopsy results

          -  history of HPV-related condition

          -  history of known prior vaccination with an HPV vaccine

          -  pregnant

          -  user of recreational or illicit drugs

          -  history of severe allergic reaction, including known allergy to any vaccine component

          -  immunocompromised

          -  history of certain medications or is currently taking or has taken certain medications
             (details will be discussed at the time of consent)

          -  has thrombocytopenia or other coagulation disorder

          -  concurrently enrolled in a clinical study of investigational agent
Safety and Efficacy of Sugammadex (Org 25969, MK-8616) in Participants With or Having a Past History of Pulmonary Disease (19.4.308) (P05932) (MK-8616-017)
Condition: Anesthesia, General
Intervention: Sugammadex; Rocuronium
Intervention description: Sugammadex solution for injection.; Rocuronium bromide solution for injection.
Intervention MeSH terms: Rocuronium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 86.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the trial is to research the safety and to show faster recovery after
      administration of 2.0 mg/kg or 4.0 mg/kg sugammadex (Org 25969, MK-8616) given as a reversal
      agent for 0.6 mg/kg (0.15 mg/kg maintenance dose) rocuronium (Zemuron®) in participants
      diagnosed with or having a history of pulmonary disease. All drug administration will be via
      the intravenous (IV) route.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologists (ASA) Class 1 to 3;

          -  Has been diagnosed with or having a past history of pulmonary disease;

          -  Is scheduled for elective surgical procedure under general anesthesia requiring
             neuromuscular block with the use of rocuronium;

          -  Is scheduled for surgery in supine position;

          -  Has given written informed consent;

        Exclusion Criteria:

          -  Is expected to have a difficult intubation due to anatomical malformations;

          -  Has known or suspected of having neuromuscular disorders impairing neuromuscular
             blockade and/or significant renal dysfunction;

          -  Has known or suspected of having a (family) history of malignant hyperthermia;

          -  Has known or suspected of having an allergy to narcotics, muscle relaxants or other
             medications used during surgery;

          -  Is receiving medication known to interfere with neuromuscular blocking agents such as
             anticonvulsants, antibiotics and Mg2+;

          -  Is a female who is pregnant or breast-feeding;

          -  Is a female of childbearing potential not using an acceptable method of birth control
             [condom or diaphragm with spermicide, vasectomized partner (> 6 months), IUD,
             abstinence] or using only hormonal contraception as birth control;

          -  Has already participated in a sugammadex trial including Protocol 19.4.308;

          -  Has participated in another clinical trial, not pre-approved by Organon, within 30
             days of entering into Protocol 19.4.308.
BOTOX® Open-Label Treatment in Pediatric Lower Limb Spasticity
Condition: Pediatrics; Muscle Spasticity; Cerebral Palsy
MeSH terms: Muscle Spasticity; Cerebral Palsy
Intervention: Botulinum Toxin Type A
Intervention description: Participants received intramuscular injections of botulinum toxin Type A into the lower limb muscles and/or upper limb muscles at a minimum of 12 weeks apart for a maximum of 5 treatments.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 370.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This study will evaluate the long-term safety of BOTOX® (botulinum toxin Type A) for the
      treatment of pediatric lower limb spasticity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Minimum weight of 10 kilograms (kg)/22 pounds (lb)

          -  Cerebral palsy with dynamic muscle contracture of the ankle

        Exclusion Criteria:

          -  Muscular dystrophy, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral
             sclerosis, or mitochondrial disease

          -  Uncontrolled epilepsy

          -  Botulinum Toxin therapy of any serotype for any condition within the last 3 months

          -  History of surgical intervention of the lower study leg within 1 year, or planned
             surgery of any limb during the study
Darbepoetin Alfa MDS Companion Protocol
Condition: Myelodysplastic Syndrome (MDS)
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome
Intervention: Darbepoetin Alfa
Intervention description: The first dose of darbepoetin alfa was the same as that administered at the last dosing visit of the active treatment period in Study 20090160. Doses could be increased up to a maximum of 500 μg every two weeks (Q2W).
Intervention MeSH terms: Darbepoetin alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Myelodysplastic Syndrome (MDS); Darbepoetin alfa; low risk MDS; intermediate-1 risk MDS; International Prognostic Scoring System (IPSS)

Summary:

      The primary objective of the study was to provide required access of investigational product
      (darbepoetin alfa) beyond the end of the active treatment period (EOATP) of the darbepoetin
      alfa MDS 20090160 (NCT01362140) study for patients who had continued demonstration of benefit
      from darbepoetin alfa treatment and to describe the safety of longer-term use in this patient
      population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject or subject's legally acceptable representative has provided informed consent
             prior to any study-specific activities/ procedures being initiated;

          -  Subject must continue long term follow up within parent study (20090160);

          -  Subject must have an ongoing clinically relevant erythroid response as assessed by the
             Investigator using current response criteria (ie, International Working Group (IWG)
             response criteria);

        Exclusion Criteria:

          -  Transfusion dependence defined as receiving a total of ≥ 4 units of red blood cell
             (RBC) transfusion in the previous 8-week period prior to enrolment;

          -  Known diagnosis of acute myelogenous leukemia (AML) or marrow collagen fibrosis;

          -  Known refractory anaemia with excess blast-2 (RAEB-2);

          -  Known diagnosis of intermediate-2 or high risk MDS per International Prognostic
             Scoring System (IPSS);

          -  Subjects received thrombopoiesis-stimulating factors (eg, eltrombopag, romiplostim) in
             the MDS 20090160 study or planning to receive such agents during the study;

          -  Other protocol defined inclusion and exclusion criteria may apply.
Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Participants With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Cariprazine; Placebo
Intervention description: Cariprazine capsules, oral administration, once daily.; Matching placebo capsules, oral administration, once daily.
Intervention MeSH terms: Cariprazine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 587.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      1. To evaluate the efficacy and safety of cariprazine at a target dose of 4.5 milligram per
           day (mg/d) compared with placebo in prevention of relapse in patients with schizophrenia

        2. To evaluate the efficacy and safety of cariprazine at a target dose of 3.0 mg/d compared
           with placebo in prevention of relapse in patients with schizophrenia who were initially
           stabilized on a target dose of 4.5 mg/d
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of schizophrenia for a minimum of 1 year before Visit 1 (Screening).

          -  Ability to follow study instructions, complete study assessment tools with minimal
             assistance and no alteration to the assessment tools, and likely to complete all
             required visits.

          -  Participant meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition
             (DSM-5) criteria for schizophrenia as determined by Structured Clinical Interview for
             DSM-5 (SCID-5).

          -  Positive and Negative Syndrome Scale (PANSS) total score >= 70 and <= 120 at Visit 1
             and Visit 2 (Day 1).

          -  Rating of at least 4 (moderate) on at least 2 of the following 4 PANSS positive
             symptoms; P1: delusions; P2: conceptual disorganization; P3: hallucinatory behaviour;
             P6: suspiciousness/persecution at Visit 1 and Visit 2.

        Exclusion Criteria:

          -  Currently meeting DSM-5 criteria for any of the following:

          -  Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders

          -  Bipolar I and II disorder

          -  Autism spectrum disorder, intellectual development disorder, delirium, major/minor
             neurocognitive disorder

          -  History of meeting DSM-5 criteria for substance-related disorders (excluding
             caffeine-related and tobacco-related disorders) within the prior 3 months before Visit
             1.

          -  Prior participation in any clinical trials involving experimental or investigational
             drugs within 6 months before Visit 1 or planned during the study.

          -  Female Participants who are pregnant, planning to become pregnant during the course of
             the study, or are currently lactating.
Reduced Clavulanate Formulation of Amoxicillin-Clavulanate in Children 6-23 Months With Acute Otitis Media
Condition: Acute Otitis Media
MeSH terms: Otitis; Otitis Media
Intervention: Amoxicillin-Clavulanate potassium
Intervention MeSH terms: Amoxicillin; Clavulanic Acid; Clavulanic Acids; Amoxicillin-Potassium Clavulanate Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 112.0
Sex: All
Minimum age: 6 Months
Maximum age: 23 Months
Healthy volunteers: No
Keywords: ear infections; antibiotics; antibiotic resistance; pediatrics; infants; children; amoxicillin-clavulanate

Summary:

      To evaluate the safety profile of amoxicillin-clavulanate potassium containing a reduced
      concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered
      at 90/3.2 mg/kg/day (formulation 1) or at 80/2.85 mg/kg/day (formulation 2) in two divided
      doses for 10 days. Investigators will focus on the proportion of subjects who develop
      protocol-defined diarrhea and proportion who develop diaper dermatitis that occasions the
      prescription of antifungal medication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age range: 6 to 23 months

          -  Evidence of AOM

          -  Recent (within 48 hours) onset of signs and symptoms.

          -  Middle ear effusion evidenced by the presence of at least 2 of the following:
             decreased or absent mobility of the tympanic membrane (TM), yellow of white
             discoloration of the TM, and/or opacification of the TM

          -  Acute inflammation evidenced by one of the following: 1+ bulging of the TM with either
             intense erythema or otalgia or 2+ or 3+ bulging of the TM

        Exclusion Criteria:

          -  Toxic appearance (capillary refill >3 seconds, systolic blood pressure <60 mm Hg)

          -  Inpatient hospitalization

          -  Clinical or anatomical characteristics that might obscure response to treatment (e.g.,
             tympanostomy tubes in place, cleft palate, Down syndrome)

          -  Sensorineural hearing loss (unilateral or bilateral)

          -  Allergy to amoxicillin or amoxicillin clavulanate

          -  Recent treatment of AOM within the last 14 days
An Efficacy and Safety Study of Ravulizumab in Adult Participants With NMOSD
Condition: Neuromyelitis Optica; Neuromyelitis Optica Spectrum Disorder
MeSH terms: Neuromyelitis Optica
Intervention: Ravulizumab
Intervention description: Participants will receive a weight-based loading dose of ravulizumab via IV infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until end of the Long-Term Extension Period.
Intervention MeSH terms: Ravulizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: External Placebo-Controlled, Open-Label Design
Masking: None (Open Label)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Neuromyelitis Optica; Neuromyelitis Optica Spectrum Disorder; Devic's Disease; Transverse Myelitis; Optic Neuritis; Relapse; Ravulizumab; Ultomiris; ALXN1210; CNS Autoimmune Disorders; Demyelinating Disorders; NMO; NMOSD

Summary:

      The primary purpose of this study is to evaluate the efficacy and safety of ravulizumab for
      the treatment of adult participants with NMOSD.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Anti-aquaporin-4 antibody-positive and a diagnosis of NMOSD as defined by the 2015
             international consensus diagnostic criteria.

          2. At least 1 attack or relapse in the last 12 months prior to the Screening Period.

          3. Expanded Disability Status Scale score ≤7.

          4. Participants who enter the study receiving supportive immunosuppressive therapy must
             be on a stable dosing regimen of adequate duration prior to Screening.

          5. Body weight ≥40 kilograms.

          6. Contraceptive use by men or women should be consistent with local regulations
             regarding the methods of contraception for those participating in clinical studies.

        Exclusion Criteria:

          1. History of neisseria meningitidis infection.

          2. Human immunodeficiency virus (HIV) infection (evidenced by HIV-1 or HIV-2 antibody
             titer).

          3. Previously or currently treated with a complement inhibitor.

          4. Use of rituximab or mitoxantrone within 3 months prior to Screening.

          5. Use of IV immunoglobulin within 3 weeks prior to Screening.
Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri®
Condition: Relapsing-Remitting Multiple Sclerosis (RRMS)
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Intravenous (IV) infusions
Intervention description: Intravenous (IV) infusions of a dose of 300mg, every 4 weeks with a total of 12 doses
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 265.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      This is a multi-center, randomized, parallel arm, double-blind study with a total duration of
      subjects' participation of 48 weeks. Approximately 260 participants with relapsing-remitting
      multiple sclerosis will be randomized to receive 12 doses of either PB006 or EU-licensed
      Natalizumab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients (age ≥18 to 60 years), with relapsing-remitting multiple
             sclerosis (RRMS) defined by the 2010 revised McDonald criteria

          -  At least 1 documented relapse within the previous year and either ≥1 GdE T1-weighted
             brain lesions or ≥9 T2-weighted brain lesions at Screening

          -  Kurtzke Expanded Disability Status Scale (EDSS) score from 0 to 5 (inclusive) at
             Screening

        Exclusion Criteria:

          -  Manifestation of multiple sclerosis (MS) other than relapsing-remitting multiple
             sclerosis (RRMS)

          -  Relapse within the 30 days prior Screening and until administration of the first dose
             of study drug

          -  Prior treatment with natalizumab, alemtuzumab, ocrelizumab, daclizumab, rituximab,
             cladribine, or other B- and T-cell targeting therapies

          -  Prior total lymphoid irradiation or bone marrow or organ transplantation

          -  Patients with John Cunningham Virus (JCV) index >1.5 at Screening

          -  Past or current Progressive Multi-focal leukoencephalopathy (PML) diagnosis

          -  Severe renal function impairment as defined by serum creatinine values >120 micromol
             per litre
Comparison of Sugammadex (Org 25969) With Neostigmine as Reversal Agents for Rocuronium or Vecuronium at Reappearance of T2 (P05960)
Condition: Anesthesia, General
Intervention: Sugammadex; Neostigmine
Intervention description: After the last dose of rocuronium or vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was to be administered; After the last dose of rocuronium or vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was to be administered
Intervention MeSH terms: Glycopyrrolate; Neostigmine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 198.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to demonstrate in adult participants faster recovery from a
      neuromuscular block induced by either rocuronium or vecuronium after reversal at reappearance
      of T2 (the amplitude of the first response of second twitch to train of four (TOF)
      stimulation, expressed as percentage of control first twitch, T1) by 2.0 mg/kg sugammadex
      (Org 25969) compared to 50 ug/kg neostigmine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is of American Society of Anesthesiologists (ASA) 1 - 4;

          -  Is above or equal to the age of 18;

          -  Scheduled for surgical procedures with a general anesthesia with the use of rocuronium
             or vecuronium for endotracheal intubation and maintenance of neuromuscular block;

          -  Scheduled for surgical procedure in supine position;

          -  Given written informed consent.

        Exclusion Criteria:

          -  Participants in whom a difficult intubation because of anatomical malformations was
             expected;

          -  Is known or suspected to have neuromuscular disorders impairing neuromuscular block
             (NMB) and/or significant renal dysfunction;

          -  Is known or suspected to have a (family) history of malignant hyperthermia;

          -  Is known or suspected to have an allergy to narcotics, muscle relaxants or other
             medication used during general anesthesia;

          -  Is receiving medication in a dose and/or at a time point known to interfere with
             neuromuscular blocking agents such as antibiotics, anticonvulsants and Mg2+;

          -  Participants in whom the use of neostigmine and/or glycopyrrolate may be
             contraindicated;

          -  Had already participated in a sugammadex trial;

          -  Had participated in another clinical trial, not pre-approved by NV Organon, within 30
             days of entering into P05960.

          -  Females who are pregnant:

          -  Females of childbearing potential not using any method of birth control: condom or
             using only hormonal contraception as birth control;

          -  Females who were breast-feeding.
Efficacy, Safety and Tolerability Study of Agile AG200-15 Transdermal Contraceptive Delivery System
Condition: Healthy
Intervention: AG200-15
Intervention description: Transdermal contraceptive delivery system
Intervention MeSH terms: Contraceptive Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2032.0
Sex: Female
Healthy volunteers: Accepts Healthy Volunteers
Keywords: prevention of pregnancy

Summary:

      Study of the efficacy of a contraceptive patch in 2100 healthy women for up to one year.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy, sexually active woman at risk for pregnancy seeking to use hormonal
             contraception for at least 1 year

          -  Ability to demonstrate willingness to participate and adhere to study protocol

        Exclusion Criteria:

          -  Known or suspected pregnancy

          -  Lactating women

          -  Anticipates use of condoms or any other form of back-up contraception during the study

          -  History of dermal sensitivity to medicated patches (nicotine) or to bandages, surgical
             tape, etc.

          -  Has a contraindication to combined estrogen-progestin contraceptive use

          -  Any disease that may worsen under hormonal treatment (cardiovascular, liver,
             metabolic)

          -  Smoker who is 35 years old or over