bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Arformoterol Tartrate Inhalation Solution in Subjects With Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease; Bronchitis; Emphysema
MeSH terms: Bronchitis; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
Intervention: Arformoterol tartrate inhalation solution; Arformoterol 25 ųg BID; Formoterol 12 ųg BID; Placebo
Intervention description: Arformoterol 15 ųg BID by nebulization; Arformoterol 25 ųg BID by nebulization; Formoterol fumarate 12 ųg BID via aerolizer/DPI; Placebo nebule or placebo aerolizer
Intervention MeSH terms: Formoterol Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 443.0
Sex: All
Minimum age: 35 Years
Healthy volunteers: No
Keywords: COPD; chronic bronchitis; emphysema

Summary:

      To evaluate the long-term safety and monitor the long-term efficacy of arformoterol over a
      period of 6 months in subjects with chronic obstructive pulmonary disease (COPD).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male and female subjects must be at least 35 years old at the time of consent

          -  Subjects must have a pre-established, documented primary clinical diagnosis of
             non-asthmatic COPD or are referred for diagnosis of non-asthmatic COPD

          -  Subjects must have a >=15 pack-year smoking history and a baseline breathlessness
             severity grade of >=2 (Modified Medical Research Council [MMRC] Dyspnea Scale Score)
             at Visits 1 and 2

          -  Female subjects <=65 years of age must have a negative serum pregnancy test, females
             of childbearing potential must be using an acceptable method of birth control

          -  Subjects must be in general good health.

        Key Exclusion criteria:

          -  Subjects with a history of asthma, with the exception of asthma diagnosed in childhood

          -  Subjects with a blood eosinophil count >5% of total white blood cell count

          -  Subjects have had a febrile illness within 72 hours (3 days) before Screening Visit 1

          -  Subjects with a chest x-ray that suggests a diagnosis other than COPD (e.g.,
             diagnostic of pneumonia, other infection, atelectasis, or pneumothorax or other
             active/ongoing pulmonary conditions)
A Phase III Study of A01016 in Subjects With Symptomatic Vitreomacular Adhesion
Condition: Symptomatic Vitreomacular Adhesion
MeSH terms: Tissue Adhesions
Intervention: Ocriplasmin; Sham injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 251.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Vitreomacular Adhesion; Vitreomacular Traction; Vitreomacular Traction Syndrome; Vitrectomy; Central Visual Field Defect; Blind Spot; Intravitreal Injection; Macula; Retina; Decreased Visual Acuity; Visual Complaint; SD-OCT; Macular Hole

Summary:

      The purpose of this study is to evaluate the superiority regarding vitreomacular adhesion
      (VMA) resolution of a single intravitreal injection of A01016 (Ocriplasmin) compared to
      sham-injection in subjects with symptomatic VMA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Symptomatic vitreomacular adhesion (VMA) which, in the opinion of the Investigator, is
             related to decreased visual function;

          -  Best corrected visual acuity (BCVA) of 20/25 or worse in the study eye;

          -  BCVA of 20/800 or better in the non-study eye;

          -  Provide written informed consent;

          -  Follow specified instructions during study period;

          -  Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  Evidence of proliferative retinopathy, exudative age-related macular degeneration, or
             retinal vein occlusion in the study eye;

          -  Vitreous hemorrhage or other opacification;

          -  High myopia in the study eye;

          -  Ocular surgery, laser photocoagulation treatment, or intravitreal injection(s) in the
             study eye in the prior 3 months;

          -  Uncontrolled glaucoma in the study eye;

          -  History of retinal detachment in either eye;

          -  Active infection in either eye;

          -  Pregnant or of child-bearing potential and not utilizing acceptable form of
             contraception;

          -  Participation in another investigational drug study within 30 days prior to this
             study;

          -  Other protocol-defined exclusion criteria may apply.
Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS)
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Intervention: Secukinumab; Placebo
Intervention description: Secukinumab 300mg every 2 or every 4 weeks; Placebo 300mg every 2 or every 4 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 545.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: acne inversa; Hidradenitis suppurativa; maladie de Verneuil; inflammatory disease; AIN457; AIN457M; secukinumab; HS; lumps; skin; lesions

Summary:

      The purpose of this study was to demonstrate superiority of secukinumab at Week 16, based on
      Hidradenitis Suppurativa Clinical Response (HiSCR) rates versus placebo, along with the
      maintenance of efficacy of secukinumab at Week 52 in subjects with moderate to severe HS.
      Moreover, this study assessed the safety and tolerability of secukinumab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  -Written informed consent must be obtained before any assessment is performed.

          -  Male and female patients ≥ 18 years of age.

          -  Diagnosis of HS ≥ 1 year prior to baseline.

          -  Patients with moderate to severe HS defined as:

          -  A total of at least 5 inflammatory lesions, i.e. abscesses and/or inflammatory nodules
             AND

          -  Inflammatory lesions should affect at least 2 distinct anatomic areas

          -  Patients agree to daily use of topical over-the-counter antiseptics on the areas
             affected by HS lesions while on study treatment.

        Exclusion Criteria:

          -  Total fistulae count ≥ 20 at baseline.

          -  Any other active skin disease or condition that may interfere with assessment of HS.

          -  Active ongoing inflammatory diseases other than HS that require treatment with
             prohibited medications.

          -  Use or planned use of prohibited treatment. Washout periods detailed in the protocol
             have to be adhered to.

          -  History of hypersensitivity to any of the study drug constituents.

          -  History of lymphoproliferative disease or any known malignancy or history of
             malignancy of any organ system treated or untreated within the past 5 years,
             regardless of whether there is evidence of local recurrence or metastases (except for
             skin Bowen's disease, or basal cell carcinoma or actinic keratoses that have been
             treated with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the
             cervix or non-invasive malignant colon polyps that have been removed).

          -  Pregnant or lactating women.
Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Fingolimod; Placebo
Intervention description: Fingolimod capsules for oral administration; Matching placebo capsules for oral administration.
Intervention MeSH terms: Fingolimod Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1083.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: fingolimod; FTY720; relapsing-remitting multiple sclerosis; MS; RRMS

Summary:

      This study assessed the safety, tolerability and efficacy of two doses of oral fingolimod
      compared to placebo on efficacy parameters in patients with relapsing-remitting multiple
      sclerosis (RRMS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients between ages 18-55 with a diagnosis of multiple sclerosis

          -  Patients with a relapsing-remitting disease course

          -  Patients with expanded disability status scale (EDSS) score of 0-5.5

        Exclusion Criteria:

          -  Patients with other chronic disease of the immune system, malignancies, acute
             pulmonary disease, cardiac failure, etc.

          -  Pregnant or nursing women

        For inclusion in the extension phase patients should complete the 24 month core study with
        or without 24 months on study drug. If a patient discontinued study drug during the core
        study due to an adverse event, serious adverse event, laboratory abnormality etc. they
        would be excluded from the Extension Phase.

        Other protocol-defined inclusion/exclusion criteria may apply.
Study To Compare On-Demand Treatment To A Prophylaxis Regimen Of BeneFIX In Subjects With Moderately Severe to Severe Hemophilia B
Condition: Hemophilia B
MeSH terms: Hemophilia A; Hemophilia B
Intervention: Nonacog alfa; Nonacog alfa
Intervention description: Period 1: During on-demand period, dosing at the discretion of investigator.; Period 2: During the prophylaxis period, 100 IU/kg once weekly
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: Male
Minimum age: 12 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Hemophilia B; on-demand; prophylaxis; nonacog alfa; BeneFIX; FIX

Summary:

      The purpose of this study will be to determine if a once-weekly prophylaxis regimen of
      BeneFIX in subjects with moderately severe to severe Hemophilia B is safe and effective.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented history of moderately-severe to severe hemophilia B (FIX activity </=2%).

          -  Male subjects, aged 12 years to 65 years.

          -  Subjects with at least 100 exposure days (EDs) to factor IX products.

          -  Subjects with a minimum of 12 bleeding episodes, 6 of which must be joint bleeds, in
             the 12-month period before the Screening visit.

        Exclusion Criteria:

          -  Subjects who have received FIX as a primary or secondary prophylaxis regimen within
             the last 12 months prior to the Screening visit.

          -  Subjects who have had major surgery or an orthopedic surgical procedure within the
             past 3 months prior to Screening visit.

          -  Subjects for which major surgery or orthopedic surgery is planned within the duration
             of study participation.

          -  Subjects with a past history of, or current FIX inhibitor, defined as >ULN (upper
             limit of normal) of the reporting laboratory.

          -  Subjects with a known hypersensitivity to any FIX product or hamster protein.
Safety and Immunogenicity of Two Trivalent Subunit Influenza Vaccines in Healthy Adult Subjects
Condition: Prophylaxis: Influenza
MeSH terms: Influenza, Human
Intervention: TIVc_LOT A; TIVc_LOT B; TIVc_LOT C; TIVf
Intervention description: Single IM (Intramuscular) administration dose of 0.5 mL of TIVc; Single IM administration dose of 0.5 mL of TIVc; Single IM administration dose of 0.5 mL of TIVc; Single IM administration dose of 0.5 mL of TIVf
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1561.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the immunologic equivalence of three consecutive
      lots of a cell based trivalent subunit influenza vaccine (TIVc), and to assess
      immunogenicity, safety and tolerability of the vaccine and an egg based trivalent subunit
      influenza vaccine (TIVf).

      The study comprised 1 vaccination, 2 clinic visits, 3 reminder calls and 2 blood draws.
      Female subjects of childbearing potential were tested for pregnancy before the administration
      of the vaccine and included only if using and agreeing to continue to use contraception
      during the course of the study.

      The total study participation time per subject is about 3 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females 18 through 49 years of age.

          -  Subjects having provided informed consent.

          -  Individuals in good health

        Exclusion Criteria:

          -  Chronic or acute illness that would interfere with the subject's safety and/or could
             interfere with the evaluation of study vaccine, including known history of
             anaphylaxis, serious vaccine reactions or hypersensitivity, known immunodeficiency or
             receiving immunosuppressive therapy.

          -  Female of childbearing potential not using acceptable contraceptive methods, pregnant
             or breastfeeding.
Efficacy and Safety Study of GK530G Versus CD0271 0.1% Gel and CD1579 2.5% Gel in the Treatment of Acne Vulgaris.
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: GK530G; CD0271; CD1579
Intervention MeSH terms: Adapalene; Benzoyl Peroxide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 417.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Acne Vulgaris

Summary:

      This study is to demonstrate the superiority in efficacy of the GK530G (fixed combination of
      CD0271 0.1% and CD1579 2.5%) versus each of the monads (CD0271 0.1% and CD1579 2.5%) in the
      treatment of acne vulgaris for up to 12 weeks, in the Japanese patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women at the age of 12 or older at the Screening visit.

          -  Those with clinical diagnosis of acne vulgaris with more than 20 noninflammatory
             lesions (open and closed comedones) and 12 to 100 (inclusive) inflammatory lesions
             (papules, pustules and nodules) on the face (forehead, both cheeks, nose and chin).

        Exclusion Criteria:

          -  Those with more than two nodular acne lesions or any cysts.

          -  Those with the diagnosis of any acne conglobata, any acne fulminans, any chloracne, or
             any drug induced acne.

          -  Those who have clinically significant abnormal findings or conditions on skin other
             than acne such as atopic dermatitis, perioral dermatitis, or rosacea that potentially
             interfere with study assessments according to Investigator's judgment.
Comparison of NN1250 With Insulin Glargine in Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: insulin degludec; insulin degludec; insulin glargine
Intervention description: Injected s.c. (under the skin) once daily (alternative regimen). Dose was individually adjusted.; Injected s.c. (under the skin) once daily. Dose was individually adjusted.; Insulin glargine injected s.c. (under the skin) once daily. Dose was individually adjusted.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin, Long-Acting
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 687.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Africa, Asia, Europe and South America. The aim of this clinical
      trial is to compare NN1250 (insulin degludec (IDeg) with insulin glargine (IGlar) in patients
      with type 2 diabetes. Subjects treated with oral antidiabetic drug(s) (OAD(s)) should
      continue their current OAD treatment at the stable, prerandomisation dose level and dosing
      frequency.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months

          -  Current treatment: oral anti-diabetic drug(s) (OAD(s)) alone, basal insulin alone or
             the combination of OAD(s) and basal insulin. Allowed OADs are: Metformin, insulin
             secretagogues (sulphonylureas (SU) or glinides), pioglitazone with unchanged dosing
             for at least 3 months prior to Visit 1

          -  HbA1c: OADs only users 7.0-11.0 % (both inclusive), basal insulin with/without OADs
             users 7.0-10.0% (both inclusive) by central laboratory analysis

          -  Body Mass Index (BMI) below or equal to 40.0 kg/m^2

        Exclusion Criteria:

          -  Cancer and medical history of cancer hereof

          -  Use within the last 3 months prior to Visit 1 of: glucagon-like peptide-1(GLP-1)
             receptor agonist (exenatide, liraglutide), rosiglitazone, dipeptidyl peptidase IV
             (DPP-IV) inhibitors, alpha-glucosidase-inhibitors

          -  Cardiovascular disease, within the last 6 months prior to Visit 1, defined as: stroke;
             decompensated heart failure New York Heart Association (NYHA) class III or IV;
             myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or
             angioplasty

          -  Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least
             180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)

          -  Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate
             contraceptive measures according to local requirements

          -  Cancer and medical history of cancer hereof (except basal cell skin cancer and
             squamous cell skin cancer)
A Multi-Center Open-Label Evaluation of the Safety of Sarecycline Tablets in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Sarecycline
Intervention description: Administered based on participant's body weight.
Intervention MeSH terms: Sarecycline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 490.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No

Summary:

      Open-label study will evaluate the safety of an approximate 1.5 mg/kg/day dose of oral
      sarecycline in the long-term treatment of participants with moderate to severe facial acne
      vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Successfully completed participation in Phase 3 study of sarecycline (SC1401 or
             SC1402)

          -  Signed informed consent or assent form

          -  Body weight between 33 kg and 136 kg, inclusive

          -  Negative urine pregnancy test for females of childbearing potential

          -  Agrees to use effective method of contraception throughout study, if applicable.

          -  Able to fulfill protocol requirements, indicated willingness to participate in study
             and agrees to all study procedures by providing written informed consent/assent and
             authorization to disclose (personal health information)

        Exclusion Criteria:

          -  Currently participating in another clinical study, unless it is a pharmacokinetic
             sarecycline study and participation approved by medical monitor; has received
             investigational medication (except sarecycline) within 30 days of enrollment.

          -  Discontinued participation in a Phase 3 study with sarecycline for any reason

          -  Had poor compliance wtih study requirements/study drug dosing in a Phase 3 study with
             sarecycline

          -  Is receiving/planning to receive any systemic acne medication, systemic retinoids,
             systemic corticosteroids or any androgen/anti-androgenic therapy (eg, testosterone,
             spironolactone)

          -  Is pregnant, lactating or planning a pregnancy during the study period

          -  Has a significant intercurrent illness (including clinically significant abnormality
             in clinical laboratory tests), psychiatric disorder, or other factors that, in the
             opinion of the Investigator or Medical Monitor, precludes participation in the study

          -  Is judged by the Investigator to be unsuitable for any reason