bioihbjkbjnl/mcl2 huggingface dataset:
BEL114333, a Continuation Study of BEL113750 in Subjects With Systemic Lupus Erythematosus (SLE) in Northeast Asia, and in Japan Subjects Completing the Open-label Extension of HGS1006-C1115
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Belimumab
Intervention description: 10 mg/kg administered intravenously over 1 hour every 4 weeks
Intervention MeSH terms: Belimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 142.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: SELENA; belimumab; Lupus; systemic lupus erythematosus; PGA; BLys; SLE Flare Index; continuation; phase III; BILAG; extension; efficacy; SRI; B cell; SLEDAI; safety; Asia; B lymphocyte

Summary:

      This study provides subjects who complete the BEL113750 study and subjects who complete the
      open-label extension of HGS1006-C1115 (referred to as C1115) Study in Japan the option of
      continuing treatment with belimumab (10 mg/kg intravenously every 4 weeks) for those
      randomized to belimumab, or the option to begin treatment with belimumab for those randomized
      to placebo, as an add-on to their standard of care SLE therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have completed the BEL113750 Protocol in Northeast Asia through Week 48 OR have
             completed the open-label extension of C1115 in Japan.

          -  Be able to receive the first dose of belimumab for BEL114333 four weeks (minimum of 2
             weeks, maximum of 8 weeks) after the last dose in BEL113750 OR be able to receive the
             first dose of IV belimumab 1 week (plus a 1 week visit window) after the last dose of
             open-label SC belimumab in C1115..

        Exclusion Criteria:

          -  Have developed clinical evidence of significant, unstable or uncontrolled, acute or
             chronic diseases not due to SLE (i.e., cardiovascular, pulmonary, hematologic,
             gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases), or
             experienced an adverse event (AE) in the Phase 3 study that could, in the opinion of
             the principal investigator, put the subject at undue risk.

          -  Have developed any other medical diseases (e.g., cardiopulmonary), laboratory
             abnormalities, or conditions (e.g., poor venous access) that in the opinion of the
             principal investigator, makes the subject unstable for the study.
Phase 3 Study Evaluating Safety and Efficacy of OTX-TP in Subjects With OAG or OHT
Condition: Open Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Travoprost; Placebo Vehicle
Intervention MeSH terms: Travoprost
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 565.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of the study is to evaluate evaluate the safety and IOP lowering efficacy of
      OTX-TP, a sustained release travoprost drug product, placed in the canaliculus of the eyelid
      in the treatment of subjects with open-angle glaucoma or ocular hypertension
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented diagnosis of ocular hypertension with an open angle of Schaffer Grade 3 or
             greater or open-angle glaucoma without pseudoexfoliation or pigment dispersion or
             evidence of traumatic angle recession

          -  IOP is currently controlled as assessed by the Investigator

        Exclusion Criteria:

          -  Punctum size smaller than 0.4 mm or greater than 0.9 mm in either eye as measured
             using a standard punctum gauge

          -  A history of an inadequate response or no response to topical prostaglandin

          -  Known or suspected allergy and/or hypersensitivity to travoprost or any prostaglandin,
             fluorescein, or to any component of the study products
A Study of Intravenous Mircera in Dialysis Patients With Chronic Renal Disease and Anemia.
Condition: Anemia
MeSH terms: Anemia
Intervention: methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention description: 120, 200 or 360 micrograms iv monthly (starting dose)
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study will assess the efficacy, safety and tolerability of monthly
      intravenous Mircera for the maintenance of hemoglobin levels in dialysis patients with
      chronic renal disease, currently receiving epoetin alfa or beta. Patients will receive
      monthly intravenous injections of Mircera at a starting dose of 120, 200 or 360
      micrograms/month, depending on the dose of epoetin alfa or beta they were receiving in the
      week preceding study start. The anticipated time on study treatment is 3-12 months, and the
      target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  chronic renal anemia;

          -  hemodialysis or peritoneal dialysis, with same mode of dialysis for >=3 months before
             and throughout screening period;

          -  continuous maintenance epoetin alfa or beta therapy with the same dosing interval
             during the previous 2 months.

        Exclusion Criteria:

          -  transfusion of red blood cells during previous 2 months;

          -  poorly controlled hypertension requiring interruption of epoetin alfa or beta
             treatment in past 6 months;

          -  significant acute or chronic bleeding such as overt gastrointestinal bleeding;

          -  hemolysis;

          -  folic acid and vitamin B12 deficiency.
Safety and Efficacy of AN2728 Topical Ointment, 2% in Children, Adolescents, and Adults (Ages 2 Years and Older) With Atopic Dermatitis
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: AN2728 Topical Ointment, 2%; Matching vehicle control
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 763.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No
Keywords: atopic dermatitis

Summary:

      The purpose of this study is to investigate the safety and efficacy of AN2728 Topical
      Ointment, 2% in children, adolescents, and adults (ages 2 years and older) with atopic
      dermatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females 2 years and older

          -  Has a clinical diagnosis of AD according to the criteria of Hanifin and Rajka

          -  Has AD involvement ≥ 5% Treatable %BSA (excluding the scalp)

          -  Has an ISGA score of Mild (2) or Moderate (3) at Baseline/Day 1

          -  All female subjects of childbearing potential must use acceptable methods of
             contraception from the Screening Visit continuously until 30 days after stopping study
             drug

        Exclusion Criteria:

          -  As determined by the study doctor, a medical history that may interfere with study
             objectives

          -  Unstable AD or any consistent requirement for high potency topical corticosteroids

          -  History of use of biologic therapy (including intravenous immunoglobulin)

          -  Recent or anticipated concomitant use of systemic or topical therapies that might
             alter the course of AD

          -  Recent or current participation in another research study

          -  Females who are breastfeeding, pregnant, or with plans to get pregnant during the
             participation in the study

          -  Participation in a previous AN2728 clinical trial
Safety and Efficacy of a Hematinic Agent in the Treatment of Postpartum Patients
Condition: Postpartum Anemia
MeSH terms: Anemia
Intervention: Ferric Carboxymaltose (FCM); Ferrous Sulfate tablets
Intervention description: Up to a maximum cumulative dose of 2,500 mg administered IV based on iron-deficit calculations; the calculated dose was given in divided doses of up to 1,000 mg weekly.; 325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 291.0
Sex: Female
Healthy volunteers: No
Keywords: anemia; postpartum

Summary:

      The purpose of this study is to evaluate the efficacy, safety, and tolerability of VIT45
      compared to the current standard of care in postpartum patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female Subjects able to give consent

          -  Post partum patients

          -  Baseline Hgb < /= 10 g/dL

          -  Agree to practice birth control

        Exclusion Criteria:

          -  Participation in previous clinical trial of this investigational agent

          -  Known hypersensitivity reaction to active control

          -  Significant vaginal bleeding

          -  History of anemia other than iron deficiency anemia

          -  Anticipated need for surgery during the study

          -  Active severe infection or malignancy

          -  Known positive Hepatitis B antigen of Hepatitis C viral antibody

          -  Known HIV antibodies

          -  Received an investigational drug within 30 days of screening

          -  Alcohol abuse within past 6 months

          -  Hemochromatosis or other iron storage disorders

          -  Significant cardiovascular disease

          -  Any laboratory abnormality, medical condition or severe psychiatric disorder which in
             the opinion of the investigator woud put the subject's disease management at risk or
             may result in the subject being able to comply with the study requirements
Safety and Efficacy of Pasireotide Long Acting Release (LAR) vs. Octreotide LAR in Patients With Active Acromegaly
Condition: Acromegaly
MeSH terms: Acromegaly
Intervention: Pasireotide; Octreotide
Intervention description: Pasireotide LAR - intramuscular (i.m.) depot injection given once every 28 days.; Octreotide LAR - i.m. depot injection given once every 28 days.
Intervention MeSH terms: Octreotide; Pasireotide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 358.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acromegaly,; adult,; growth hormone,; insulin-like growth factor I,; somatostatin analogue

Summary:

      The patients received either Pasireotide LAR or Octreotide LAR for one year of treatment.

      The objective of this study was to compare the proportion of patients with a reduction of
      mean GH level to <2.5 µg/L and the normalization of IGF-1 to within normal limits (age and
      sex related) between the two treatment groups (pasireotide LAR and octreotide LAR) at 12
      months.

      Following one year of treatment patients could proceed into the study extension.

      Patients who did not respond to the treatment they were randomized to (based on month 12
      assessment results) were switched to the other treatment arm at month 13.
    

Eligibility criteria:

        Inclusion criteria:

          -  Patients with active acromegaly (based on elevated GH and IGF-1 levels)

          -  Patients who have undergone one or more pituitary surgeries, but have not been treated
             medically, or de-novo patients presenting a visible pituitary adenoma on MRI and who
             refuse pituitary surgery or for whom pituitary surgery is contraindicated

          -  Patients for whom written informed consent to participate in the study has been
             obtained prior to any study related activity

        Exclusion criteria:

          -  Patients who are being or were treated with octreotide, lanreotide, dopamine agonists
             or GH antagonists with the exception of a single dose of short-acting octrotide or
             short-acting dopamine agonists. In case of a single dose of short-acting octrotide,
             the dose should not be used to predict the response to the octretide treatment. The
             single dose of short-acting octreotide or short-acting dopamine agonists should not be
             administered in the 3 days prior to randomization

          -  Patients with compression of the optic chiasm causing any visual field defect

          -  Patients who have received pituitary irradiation within the last ten years prior to
             visit 1

          -  Poorly controlled diabetic patients

        Other protocol-defined inclusion/exclusion criteria may apply
Open Label Study to Evaluate Long Term Efficacy, Safety and Tolerability of Repeated Dosing in Subjects With Crohn's Disease and Who Participated and Successfully Completed M14-115
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Adalimumab
Intervention description: Adalimumab pre-filled syringe, administered by subcutaneous injection
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 252.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Crohn's Disease

Summary:

      The purpose of this study is to evaluate the long term efficacy, safety, and tolerability of
      repeated administration of adalimumab in participants with Crohn's disease.
    

Eligibility criteria:

        Inclusion Criteria:

        - Subject successfully enrolled in and completed Study M14-115 (NCT02185014), including the
        Week 12 ileocolonoscopy.

        Exclusion Criteria:

          -  If the Week 12 (Study M14-115; NCT02185014) colonoscopy shows evidence of dysplasia or
             malignancy.

          -  Subject is not in compliance with prior and concomitant medication requirements
             throughout M14-115 (NCT02185014).

          -  Subject who developed active Tuberculosis (TB) during M14-115 (NCT02185014), or
             subject who is non compliant with prophylaxis for latent tuberculosis (TB) initiated
             per M14-115 (NCT02185014) procedures.
Comparison Study of ISV-303 to DuraSite Vehicle in Cataract Surgery Subjects
Condition: Ocular Inflammation
MeSH terms: Cataract; Inflammation
Intervention: ISV-303; DuraSite Vehicle
Intervention description: Bromfenac in DuraSite; DuraSite Vehicle
Intervention MeSH terms: Bromfenac
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 268.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy of
      topical administration of ISV-303 compared with DuraSite Vehicle.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects age 18 or older scheduled for unilateral cataract surgery with
             posterior chamber intraocular lens implantation

          -  If a female is of childbearing potential, the subject must agree to and submit a
             negative pregnancy test before any protocol-specific procedures are conducted. The
             subject must use effective contraception for the duration of the study. Post
             menopausal is defined as having no menses for at least 12 consecutive months

          -  Signature of the subject on the Informed Consent Form

          -  Willing to avoid disallowed medication for the duration of the study.

          -  Willing and able to follow all instructions and attend all study visits

          -  Able to self-administer study drug (or have a caregiver available to instill all doses
             of study drug)

          -  Additional inclusion criteria also apply

        Exclusion Criteria:

          -  Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the
             study medications or any of the procedural medications

          -  Currently pregnant, nursing, or planning a pregnancy; or be a woman that has a
             positive pregnancy test

          -  Currently suffer from alcohol and/or drug abuse

          -  Prior (within 30 days of beginning study treatment) or anticipated concurrent use of
             an investigational drug or device

          -  A condition or a situation, which in the investigator's opinion may put the subject at
             increased risk, confound study data, or interfere significantly with the subject's
             study participation

          -  Additional exclusion criteria also apply
Geographic Atrophy Treatment Evaluation
Condition: Geographic Atrophy; Age-Related Macular Degeneration
MeSH terms: Macular Degeneration; Geographic Atrophy; Atrophy
Intervention: AL-8309B Ophthalmic Solution; AL-8309B Vehicle
Intervention description: Inactive ingredients used as placebo comparator
Intervention MeSH terms: Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 772.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No
Keywords: Geographic Atrophy; GA; Age-Related Macular Degeneration; AMD

Summary:

      The purpose of this study was to evaluate the safety and efficacy of AL-8309B Ophthalmic
      Solution versus Vehicle administered as a topical ocular drop for the treatment for
      geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing to give written informed consent, make required study visits, and follow
             instructions.

          -  Able to administer eye drops or have a caretaker to administer the eye drops.

          -  Study eye: Atrophy secondary to age-related macular degeneration, best corrected
             visual acuity (BCVA) of 35 letters (20/200 Snellen equivalent) or better, clear ocular
             media, and adequate pupillary dilation.

          -  Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  Pregnant, nursing, or not using adequate contraception.

          -  Ocular disease in the study eye, other than non-exudative AMD.

          -  History of cataract surgery in either eye within the past 3 months of screening.

          -  History or evidence of serious ocular trauma or intraocular surgery in either eye
             within the past 6 months of screening.

          -  Any medical condition that would make participation in the trial or adherence to the
             study schedule difficult or unlikely.

          -  Participation in an investigational drug or device study within 30 days of screening.

          -  Other protocol-defined exclusion criteria may apply.
SMART Study: A Study of Re-treatment With MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Failed on Anti-TNF Alfa Therapy
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: rituximab
Intervention description: Arm A: 1000 mg IV (one infusion) every 2 months \nArm B: 2 x 1000 mg IV (2 infusions) every 2 months
Intervention MeSH terms: Rituximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 224.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will compare the efficacy and safety of re-treatment with 2 doses of MabThera
      (rituximab) in patients with active rheumatoid arthritis (RA) who have previously experienced
      an inadequate response or intolerance to anti-tumor necrosis factor (anti-TNF) therapies
      etanercept, infliximab or adalimumab therapy. All patients will receive infusions of 1000 mg
      intravenous (IV) MabThera on Days 1 and 15; at Week 24 patients who have demonstrated a
      moderate or good response will be randomized to receive re-treatment with either 1 or 2
      additional infusions of 1000 mg IV MabThera. The anticipated time on study treatment is 2+
      years, and the target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients >18 years of age

          -  RA for >=6 months

          -  Receiving outpatient treatment

          -  Ongoing treatment with methotrexate for >=3 months, stable for >=1 month

          -  Inadequate response or intolerance to etanercept, infliximab or adalimumab

        Exclusion Criteria:

          -  Previous treatment with MabThera

          -  Concurrent treatment with any anti TNF-alfa therapy or biologic therapy

          -  Previous treatment with any investigational cell-depleting therapies
Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution in Adult and Geriatric Participants With Ocular Redness
Condition: Hyperemia
MeSH terms: Hyperemia; Erythema
Intervention: Brimonidine Tartrate; Vehicle; Sodium Fluorescein; Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP
Intervention description: Ophthalmic solution to be applied as directed.; Ophthalmic solution to be applied as directed.; For use as needed during the study for evaluating corneal damage.; For use as needed during the study for intraocular pressure and dilated ophthalmoscopy.
Intervention MeSH terms: Brimonidine Tartrate; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ocular redness

Summary:

      To compare the efficacy and safety of brimonidine tartrate ophthalmic solution 0.025% with
      its vehicle for the treatment of ocular redness in a population of adult and geriatric
      participants with ocular redness.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years of age.

          -  Have a history of redness relief drops use or expressed a desire to use drops for
             redness relief, within the last 6 months.

          -  Have ocular health within normal limits including a calculated best-corrected visual
             acuity of 0.3 logarithm of the minimum angle of resolution (logMAR) or better in each
             eye, as measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart.

        Exclusion Criteria:

          -  Any ocular/systemic health problems.

          -  Use of any disallowed medications.