bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Olopatadine HCl Nasal Spray in 6-11 Year Old Patients
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Olopatadine Hydrochloride Nasal Spray 0.6%; Vehicle
Intervention description: Olopatadine HCl 1 or 2 sprays per nostril twice daily; Vehicle 1 or 2 sprays per nostril twice daily
Intervention MeSH terms: Olopatadine Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2388.0
Sex: All
Minimum age: 6 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: allergic rhinitis; allergies; seasonal allergies

Summary:

      A study to demonstrate the superiority of test article nasal spray relative to vehicle nasal
      spray for the treatment of seasonal allergic rhinitis for a 2 week period in patients aged 6
      to 11 years with a history of seasonal allergic rhinitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female; minimum of 6 years of age and less than 12 years

          -  2 year history of seasonal allergic rhinitis

        Exclusion Criteria:

          -  Concurrent disease that might interfere with the investigation or evaluation of te
             study medication

          -  Confirmed diagnosis of chronic rhinosinusitis within the last year

          -  Asthma, with the exception of mild intermittent asthma

          -  Anatomical nasal deformity

          -  Nasal obstruction

          -  Known non-responder to antihistamines for symptoms of Seasonal Allergic Rhinitis (SAR)

          -  Chronic or intermittent use of of inhaled, oral, intramuscular intravenous
             corticosteroids ot topical steroids

          -  Ocular disorder other that allergic conjunctivitis
Actual Use Trial of Atorvastatin Calcium 10 mg
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Atorvastatin calcium 10 mg
Intervention description: Atorvastatin calcium 10 mg tablet to be administered orally every day
Intervention MeSH terms: Atorvastatin; Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Masking: None (Open Label)
Enrollment: 1311.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: atorvastatin; Hypercholesterolemia

Summary:

      The purpose of this actual use study is to simulate the over the counter use of atorvastatin
      calcium 10 mg.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years of age (19 in Alabama).

          -  Provide written informed consent.

          -  Never participated in a study about cholesterol medicines.

        Exclusion Criteria:

          -  Females subjects who are pregnant or breastfeeding.

          -  Subjects with active liver disease.

          -  Subjects taking cyclosporine.

          -  Subjects with a known allergy to atorvastatin calcium.
A Phase 3 Rollover Study of Lumacaftor in Combination With Ivacaftor in Subjects 12 Years and Older With Cystic Fibrosis
Condition: Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Lumacaftor Plus Ivacaftor Combination; Ivacaftor
Intervention description: Fixed dose combination tablet, oral use; Film-coated tablet, oral use
Intervention MeSH terms: Ivacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1164.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy and safety of long-term treatment with
      lumacaftor in combination with ivacaftor in people 12 years and older with Cystic Fibrosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent form (ICF), and where appropriate, signed assent form.

          -  Participants entering the Part A Treatment Cohort: Completed 24 weeks of study drug
             treatment in Study 103 or Study 104 and elect to enroll in Part A treatment cohort.

          -  Participants entering the Part B Treatment Cohort: Completed 56 days of study drug
             treatment in Cohort 4 of Study 102 and elect to enroll in Part B treatment cohort.

          -  Participants entering the Part A Observational Cohort: Completed 24 weeks of study
             drug treatment in Study 103 or Study 104, but do not elect to enroll in the Part A
             Treatment Cohort or do not qualify to enroll in Part A treatment cohort.

          -  Willing to remain on a stable CF medication regimen through the end of study (Part A
             and Part B Treatment Cohorts only).

        Exclusion Criteria:

          -  Any comorbidity or laboratory abnormality that, in the opinion of the investigator,
             might confound the results of the study or pose an additional risk in administering
             study drug to the participant (e.g., cirrhosis with portal hypertension).

          -  Pregnant and nursing females. Females of childbearing potential must have a negative
             pregnancy test at the Day 1 Visit.

          -  History of drug intolerance in the prior study that would pose an additional risk to
             the participant in the opinion of investigator or Vertex.

          -  History of poor compliance with study drug and/or procedures in the previous study as
             deemed by the investigator.

          -  Participation in an investigational drug trial (including studies investigating
             lumacaftor and/or ivacaftor, or studies requiring blood collections with or without
             administration of study drug)
Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT)
Condition: Otitis Media With Effusion in Children; Otitis Media Recurrent
MeSH terms: Otitis; Otitis Media; Otitis Media with Effusion
Intervention: EXE844 Sterile Otic Suspension, 0.3%; Tympanostomy Tube Insertion
Intervention description: Surgical procedure for treating pediatric cases of recurrent or chronic otitis media
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 470.0
Sex: All
Minimum age: 6 Months
Maximum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate EXE844 plus tympanostomy tubes compared to
      tympanostomy tubes only based on sustained clinical cure at end-of-therapy (EOT).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recurrent acute otitis media (RAOM) or chronic otitis media with effusion (COME) and
             eligible for bilateral myringotomy and tympanostomy tube insertion.

          -  Suspected bacterial infection at time of surgery in at least 1 ear.

          -  Willing to refrain from water immersion of the ears following surgery without the use
             of adequate ear protection during swimming, bathing, showering and other water-related
             activities.

          -  Legally Authorized Representative (LAR) must read and sign the informed consent.

          -  Parent or caregiver must agree to comply with the requirements of the study and
             administer study medication as directed, complete required study visits, and comply
             with the protocol.

          -  Other protocol-specified inclusion criteria may apply.

        Exclusion Criteria:

          -  Previous otologic or otologic-related surgery within the past 30 days or ongoing
             complications.

          -  Middle ear pathology in either ear other than otitis media.

          -  Current acute otitis externa (AOE), malignant otitis externa (MOE) or other conditions
             which could interfere with evaluation of the study drug.

          -  Any systemic disease or disorder, complicating factor or structural abnormality that
             would negatively affect the conduct or outcome of the study based upon assessment by
             the Investigator.

          -  Known or suspected allergy or hypersensitivity to quinolones or other active or
             inactive ingredients present in the medications to be used in the study.

          -  Other protocol-specified exclusion criteria may apply.
International, Multicenter, Study of One-year, Open-label, Titrated Oral Tolvaptan Tablet Administration in Patients With Chronic Hyponatremia
Condition: Hyponatremia
MeSH terms: Hyponatremia
Intervention: Tolvaptan
Intervention description: Once Daily
Intervention MeSH terms: Tolvaptan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 111.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hyponatremia

Summary:

      This study will assess the safety of long-term tolvaptan use in patients previously enrolled
      in shorter-term Phase 3 studies and gather information on the natural history of hyponatremia
      in the context of tolvaptan therapy and underlying disease states.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age greater than or equal to 18 years.

          2. Ability to provide informed consent or assent.

          3. Prior successful participation in a tolvaptan hyponatremia trial termination with
             evidence of continued need or desire for therapy.

        Exclusion Criteria:

          -  A current medical condition where long-term treatment with an aquaretic agent may
             present an undue risk to the patient.

          -  Hyponatremia which is acute, reversible, artifactual or due to conditions not
             associated with vasopressin excess or likely to respond to aquaretic therapy.

          -  Hyponatremia due to reversible medical condition or therapy

          -  Conditions associated with an independent imminent risk of morbidity and mortality

          -  Conditions which confound the assessment of endpoints.
A Study Evaluating Lurasidone for The Treatment of Schizophrenia or Schizoaffective Disorder in Subjects Switched From Other Antipsychotic Agents
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: Lurasidone HCl
Intervention description: Lurasidone tablets, 40 mg/daily, 80 mg/daily, 120 mg/daily for 6 weeks
Intervention MeSH terms: Lurasidone Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 244.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lurasidone; Schizophrenia; Latuda

Summary:

      Lurasidone (lurasidone HCl) is a novel psychotropic agent that is being developed as a
      potential new antipsychotic treatment for patients with schizophrenia. Switching between
      antipsychotic medications is common in the treatment of schizophrenia. The current study is
      designed to evaluate the effectiveness, safety, and tolerability of switching clinically
      stable, but symptomatic outpatients with schizophrenia or schizoaffective disorder from their
      preswitch antipsychotic medication to lurasidone, over a period of 6 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject ≥ 18 years of age.

          -  Subject meets DSM-IV criteria for a primary diagnosis of schizophrenia or
             schizoaffective disorder.

          -  Subject must be judged by the investigator to be an appropriate candidate for
             switching current antipsychotic medication due to insufficient efficacy and/or safety
             or tolerability concerns.

        Exclusion Criteria:

          -  Presence of an Axis I or Axis II disorder other than schizophrenia or schizoaffective
             disorder that is the primary focus of treatment prior to screening.

          -  Subject has experienced persistent lack of improvement in psychotic symptoms despite
             adequate trials (at least 6 weeks at standard doses), of two or more antipsychotic
             agents in the 12 months prior to screening.

          -  Subject is considered by the investigator to be at imminent risk of suicide or harm to
             self, others, or property. Subject has suicidal ideation at baseline or has attempted
             suicide within 90 days prior to randomization (even without hospitalization).
Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Relapser Genotype 2 Hepatitis C Infected Patients
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: MP-424 (generic name:Telaprevir); Ribavirin; Peginterferon alfa-2b
Intervention description: 750mg q8h for 12 weeks; 400 - 1000 mg/day based on body weight for 24 weeks; 1.5mcg/kg/week for 24 weeks
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 108.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Genotype 2

Summary:

      This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b and
      Ribavirin (RBV) in patients with genotype 2 hepatitis C, who relapsed after previous
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Genotype 2, chronic hepatitis C

          -  Relapsers (patient who relapsed after previous treatment)

          -  Able and willing to follow contraception requirements

        Exclusion Criteria:

          -  Cirrhosis of the liver or hepatic failure

          -  Hepatitis B surface antigen-positive or HIV antibodies-positive

          -  History of, or concurrent hepatocellular carcinoma

          -  History of, or concurrent depression, schizophrenia,; or suicide attempt in the past

          -  Pregnant, lactating, or suspected pregnant patients, or male patients whose female
             partner is pregnant
(ARTEMIS-IPF) Randomized, Placebo-Controlled Study to Evaluate Safety and Effectiveness of Ambrisentan in IPF
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Intervention: Ambrisentan; Placebo
Intervention description: Ambrisentan (5mg or 10 mg tablet) was administered orally once daily.; Placebo to match ambrisentan was administered orally once daily.
Intervention MeSH terms: Ambrisentan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 494.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: idiopathic pulmonary fibrosis; interstitial lung disease; ambrisentan

Summary:

      The ARTEMIS-IPF study was conducted to determine if ambrisentan was effective in delaying
      disease progression and death in participants with idiopathic pulmonary fibrosis (IPF), to
      evaluate its safety, and to evaluate its effect on development of pulmonary hypertension,
      quality of life, and dyspnea (shortness of breath) symptoms in this participant population.
      Participants were randomized in a 2:1 ratio to receive ambrisentan or placebo, respectively.
      Participation in the study was to be up to 4 years, depending on how long it would take to
      enroll participants and observe study events. After randomization, visits to the clinic took
      place every 3 months, and laboratory procedures were performed every month.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or females from 40 to 80 years of age

          -  Diagnosis of IPF

          -  Honeycombing (fibrosis in the lung) on high-resolution computerised tomography (HRCT)
             scan of less than or equal to 5%

          -  Willing and able to have 2 right heart catheterizations performed

          -  Willing to have monthly lab tests to monitor liver function

          -  Able to perform the 6 minute walk test (indicated adequate physical function)

          -  Must have meet lung function requirements

          -  Normal liver function tests

          -  Negative serum pregnancy test

          -  Willing to use at least 2 reliable methods of contraception

          -  Able to understand and willing to sign informed consent form

        Exclusion Criteria:

          -  No restrictive lung disease (other than usual interstitial pneumonia or IPF)

          -  No obstructive lung disease

          -  No recent or active respiratory exacerbations

          -  No recent hospitalization for an IPF exacerbation

          -  No recent history of alcohol abuse

          -  Chronic sildenafil (or same drug class) use for pulmonary hypertension

          -  Chronic treatment with certain medications for IPF within 30 days of randomization

          -  No other serious medical conditions
Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation
Condition: Stroke; Atrial Fibrillation; Embolism
MeSH terms: Atrial Fibrillation; Embolism
Intervention: warfarin tablets; Edoxaban tablets (high dose regimen-60mg); Edoxaban tablets (low dose regimen-30mg); placebo warfarin; placebo edoxaban
Intervention description: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months; Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months; Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months; placebo warfarin; placebo edoxaban
Intervention MeSH terms: Warfarin; Edoxaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 21105.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Systemic embolic events

Summary:

      This study is to demonstrate the safety and efficacy profile, in two different dose regimens
      of Edoxaban (DU-176b), (an investigational new drug being tested for the prevention of
      stroke/systemic embolic events (SEE)), in individuals with atrial fibrillation. Patients will
      be randomized to one of three treatment groups: High Dose Regimen, Low Dose Regimen, &
      Warfarin. The expected duration of the study is 24 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  21 years of age or older; male or female.

          -  Able to provide written informed consent.

          -  History of documented AF within the prior 12 months

          -  A moderate to high risk of stroke, as defined by CHADS2 index score of at least 2

        Exclusion Criteria:

          -  Transient atrial fibrillation secondary to other reversible disorders

          -  Subjects with moderate or severe mitral stenosis, unresected atrial myxoma, or a
             mechanical heart valve

          -  Subjects with any contraindication for anticoagulant agents;

          -  Subjects with conditions associated with high risk of bleeding or have known or
             suspected hereditary or acquired bleeding disorders

          -  Females of childbearing potential including the following:

               -  Females with a history of tubal-ligation

               -  Females less than 2 years post-menopausal
[SOCRATES -Acute Stroke Or Transient IsChaemic Attack TReated With Aspirin or Ticagrelor and Patient OutcomES]
Condition: Acute Ischaemic Stroke; Transient Ischaemic Attack
MeSH terms: Stroke; Ischemic Stroke; Ischemic Attack, Transient; Ischemia
Intervention: ticagrelor; Acetylsalicylic acid (ASA)
Intervention description: ticagrelor, 180 mg (two tablets of 90 mg) loading dose on Day 1 followed by 90 mg twice daily.; ASA, 300 mg (three tablets of 100 mg) on Day 1, followed by 100 mg once daily.
Intervention MeSH terms: Aspirin; Ticagrelor
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 13307.0
Sex: All
Minimum age: 40 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Acute ischaemic stroke.; Transient ischaemic attack.

Summary:

      The primary objective of the study is to compare the effect of 90-day treatment with
      ticagrelor (180 mg [two 90 mg tablets] loading dose on Day 1 followed by 90 mg twice daily
      maintenance dose for the remainder of the study) vs acetylsalicylic acid (ASA)-aspirin (300
      mg [three 100 mg tablets] loading dose on Day 1 followed by 100 mg once daily maintenance
      dose for the remainder of the study) for the prevention of major vascular events (composite
      of stroke, myocardial infarction [MI], and death) in patients with acute ischaemic stroke or
      transient ischaemic attack (TIA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women equal or elder 40 years of age

          -  Either acute ischaemic stroke or high-risk TIA as defined here and randomisation
             occurring within 24 hours after onset of symptoms

        Key Exclusion Criteria:

          -  Planned use of antithrombotic therapy in addition to study medication including
             antiplatelets (eg, open label ASA, GPIIb/IIIa inhibitors, clopidogrel, ticlopidine,
             prasugrel, dipyridamole, ozagrel, cilostazol) and anticoagulants (eg, warfarin, oral
             thrombin and factor Xa inhibitors, bivalirudin, hirudin, argatroban, unfractionated
             and low molecular weight heparins). - Any history of atrial fibrillation, ventricular
             aneurysm or suspicion of cardioembolic pathology for TIA or stroke. - Planned carotid,
             cerebrovascular, or coronary revascularisation that requires halting study medication
             within 7 days of randomisation. - Receipt of any intravenous or intra-arterial
             thrombolysis or mechanical thrombectomy within 24 hours prior to randomisation -
             History of previous symptomatic non-traumatic intracerebral bleed at any time
             (asymptomatic microbleeds do not qualify), gastrointestinal (GI) bleed within the past
             6 months, or major surgery within 30 days.