bioihbjkbjnl/mcl2 huggingface dataset:
Long-Term Effectiveness And Safety Of CP-690,550 For The Treatment Of Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: CP-690,550; CP-690,550
Intervention description: 5 mg PO BID open label; may increase to 10 mg PO BID to provide greater control of RA if no related AEs are present. May be off study drug temporarily for up to 28 days for mild to moderate AEs.; 10 mg PO BID open label; may decrease to 5 mg PO BID for mild to moderate AEs. May be off study drug temporarily for up to 28 days for mild to moderate AEs.
Intervention MeSH terms: Tofacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 4488.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: long-term; open-label; safety

Summary:

      The purpose of this study is to determine the long-term effectiveness and safety of
      CP-690,550 for the treatment of rheumatoid arthritis. Subjects are eligible for this study
      only after participating in another "qualifying" study of CP-690,550

      A sub-study will be conducted within the A3921024 study, this study will evaluate the immune
      response to pneumococcal and influenza vaccines in patients receiving CP-690,550
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who have participated in a randomized "qualifying" study of CP-690,550 for
             the treatment of rheumatoid arthritis

        Vaccine sub-study visit

          -  Subjects actively participating in Study A3921024 must have completed at least 3
             months of continuous 10 mg BID CP-690,550 treatment in A3921024 as defined by >80%
             compliance with prescribed dose consumption of CP-690,550 over the previous 3 months.

        Exclusion Criteria:

          -  Serious medical conditions that would make treatment with CP-690,550 potentially
             unsafe

        Vaccine sub-study visit

          1. Any documented influenza or pneumococcal infection within the last 3 months prior to
             randomization in this study

          2. Received any vaccine within 1 month prior to randomization in this study

          3. Received an influenza vaccine within 6 months or a pneumococcal vaccine within 5 years
             of randomization in this study.
CR845-CLIN3105: A Study to Evaluate the Safety and Effectiveness of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
Condition: Uremic Pruritus
MeSH terms: Pruritus
Intervention: CR845 0.5 mcg/kg
Intervention description: IV CR845 0.5 mcg/kg administered three times/week
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 222.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Hemodialysis; Pruritus; Uremic Pruritus; Dialysis; CR845; Chronic Itch; CKD; CKD-associated pruritus; CKD-aP; ESRD (end stage renal disease); difelikefalin; Itch; Itching; KALM; Chronic Kidney Disease; Kidney failure, chronic; Kidney dysfunction; Generalized pruritus

Summary:

      This is a multicenter, open-label study to evaluate the safety and effectiveness of
      intravenous (IV) CR845 at a dose of 0.5 mcg/kg administered after each dialysis session. The
      study includes an up to 12-week Treatment Period.
    

Eligibility criteria:

        Key Inclusion Criteria:

        To be eligible for inclusion into the study, a patient must meet the following criteria:

          -  Has end-stage renal disease (ESRD) and has been on hemodialysis 3 times per week for
             at least 3 months prior to the start of screening;

          -  Has at least 2 single-pool Kt/V measurements ≥1.2, or at least 2 urea reduction ratio
             measurements ≥65%, or 1 single pool Kt/V measurement ≥1.2 and 1 urea reduction ratio
             measurement ≥65% on different dialysis days during the 3 months period prior to
             screening;

          -  Prior to Treatment:

               -  Has completed at least 3 Worst Itching Intensity NRS questionnaires from the
                  start of the Run-in Period up to and including the pre-dose assessment on Day 1;

        Key Exclusion Criteria:

        A patient will be excluded from the study if any of the following criteria are met:

          -  Known noncompliance with dialysis treatment that in the opinion of the investigator
             would impede completion or validity of the study;

          -  Scheduled to receive a kidney transplant during the study;

          -  New or change of treatment received for itch including antihistamines and
             corticosteroids (oral, IV, or topical) within 14 days prior to screening;

          -  New or change of prescription for opioids, gabapentin, or pregabalin within 14 days
             prior to screening;

          -  Received another investigational drug within 30 days or five half-lives (whichever is
             longer) prior to the start of dosing or is planning to participate in another
             interventional clinical study while enrolled in this study;

          -  Has pruritus only during the dialysis session (by patient report);

          -  Is receiving ongoing ultraviolet B treatment and/or anticipates receiving such
             treatment during the study;

          -  Participated in a previous clinical study with CR845.
Safety and Efficacy of Oral Febuxostat in Subjects With Gout
Condition: Gout
MeSH terms: Gout
Intervention: Febuxostat; Allopurinol
Intervention MeSH terms: Allopurinol; Febuxostat
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 504.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Gout; Uric Acid; Xanthine oxidase; Febuxostat

Summary:

      The purpose of this study is to compare febuxostat allopurinol in subjects with gout.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hyperuricemia (serum urate ≥8.0 mg/dL) and gout by Chinese Rheumatism Association
             Criteria;

          -  Renal function defined as a serum creatinine level of < 2.0 mg/dL and creatinine
             clearance of > 20 milliliters per minute (mL/min) by Cockcroft and Gault formula;

          -  No gout flare 2 weeks beforehand during 2-week screening period.

        Exclusion Criteria:

          -  Pregnancy or lactation;

          -  Concurrent therapy with urate lowering agents, azathioprine, 6-mercaptopurine,
             thiazide diuretics, or medications containing aspirin (>325 mg) or other salicylates;

          -  Body Mass Index (BMI) >50 kilogram per meter²(kg/m²);

          -  A history of active liver disease, or hepatic dysfunction;

          -  A history of bronchial asthma;

          -  A history of renal calculi or thyroid disease;

          -  Secondary gout Joint diseases induced by rheumatoid arthritis, psoriatic arthritis and
             bone tumor;

          -  Intolerance to allopurinol and Ibuprofen;

          -  Alcohol intake of ≥ 14 drinks/week;

          -  Clinically significant medical condition.
Study of Modified Process Hib/Hep B Vaccine in Infants (V121-019)(COMPLETED)
Condition: Haemophilus Influenzae Type B; Hepatitis B
MeSH terms: Hepatitis A; Influenza, Human; Hepatitis B; Hepatitis
Intervention: Comparator: Modified Process Vaccine; Comparator: COMVAX™
Intervention description: Modified process vaccine HBsAg 5 ug/0.5 mL and PRP [OMPC] 7.5 ug/0.5 mL in a 3-dose regimen at 2, 4 & 12 months of age. Duration of treatment is 11 months.; COMVAX™ HBsAg 5 ug/0.5 mL and PRP [OMPC] 7.5 ug/0.5 mL in a 3-dose regimen at 2, 4, and 12 months of age. Duration of treatment is 11 months.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 546.0
Sex: All
Minimum age: 40 Days
Maximum age: 80 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Haemophilus Influenza, type b and Hepatitis B

Summary:

      To determine if there is an improvement in the immune response to HBsAg (hepatitis B virus)
      in healthy infants using a modified process in a combination Haemophilus Influenzae, type
      b/Hepatitis B vaccine and a currently licensed Haemophilus Influenzae, type b/Hepatitis B
      vaccine
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy 2-month-old full term infants born to non-HBs Ag (hepatitis B virus) carrier
             mothers

        Exclusion Criteria:

          -  Birth mother known to be a carrier of hepatitis B virus (HBsAg+) or known carriers
             ever living in close contact with the subject

          -  History of previous hepatitis B infection; history of vaccination with any hepatitis B
             vaccine

          -  Recent (<72 hours) history of febrile illness (rectal temperature >=38.1°C/>=100.5°F)

          -  Known or suspected hypersensitivity to any component of RECOMBIVAXHB™ or COMVAX™
             (e.g., aluminum, yeast)

          -  Recent administration (w/i 3 months prior to study start) of hepatitis B immune
             globulin (HBIg), serum immune globulin, or any other blood-derived product

          -  Receipt of investigational drugs or investigational vaccines within 3 months prior to
             study start or if planned within the study period;

          -  Known or suspected impairment of immunologic function or recent use (within 3 months
             prior to study start) of immunomodulatory medications (does not include topical and
             inhaled steroids);

          -  Any condition that, in the opinion of the investigator, might interfere with the
             evaluation of study objectives; or inability to comply with the study schedule and/or
             inability to attend all required study visits
Open-label Study to Evaluate Clearance of Superficial Basal Cell Carcinoma After Use of Imiquimod 5% Cream
Condition: Superficial Basal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Basal Cell
Intervention: Imiquimod 5% cream
Intervention description: Aldara (imiquimod) 5% cream - 250 mg / packet - once daily 7 days per week for 6 weeks
Intervention MeSH terms: Imiquimod
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 169.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Superficial Basal Cell Carcinoma; Aldara

Summary:

      An open-label study to evaluate the safety and the ability of Imiquimod 5% cream, applied
      topically, to clear superficial basal cell carcinoma and to keep it clear for 5 years of
      follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have at least 1 previously untreated superficial basal cell carcinoma tumor

          -  Minimum tumor size 0.5 cm2 and maximum diameter of 2.0 cm

        Exclusion Criteria:

          -  Evidence of clinically significant, unstable medical conditions

          -  Cannot have recent use of topical steroids or retinoids in the treatment area.
Xylitol Syrup for the Prevention of Acute Otitis Media in Otitis-prone Children
Condition: Acute Otitis Media
MeSH terms: Otitis; Otitis Media
Intervention: Xylitol syrup; Placebo
Intervention description: 7.5 mL (5 grams) by mouth three times daily; 7.5 mL by mouth three times daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 326.0
Sex: All
Minimum age: 6 Months
Maximum age: 5 Years
Healthy volunteers: No
Keywords: otitis media; ear infection

Summary:

      The primary objective of the proposed study is to determine the effectiveness and safety of
      orally administered viscous-adherent xylitol syrup given in a dose of five grams three times
      daily for 12 weeks in reducing the incidence of clinically-diagnosed acute otitis media (ear
      infection) in children with a history of recurrent acute otitis media.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Six months to five years of age

          -  General good health

          -  History of at least three episodes of AOM in previous 12 months, at least one of which
             occurred within the previous six months

          -  English or Spanish speaking

        Exclusion Criteria:

          -  History of tympanostomy tubes

          -  Intestinal malabsorption or chronic diarrhea

          -  Diabetes mellitus

          -  Any inborn error of metabolism

          -  Parent/guardian unreachable by telephone

          -  Known allergy to any of the study solution components (xylitol, sorbitol, sodium
             carboxymethylcellulose, potato starch, glycerin, potassium sorbate, natural berry
             flavoring).
A Trial Comparing Sequential Addition of Insulin Aspart Versus Further Dose Increase With Insulin Degludec/Liraglutide in Subjects With Type 2 Diabetes Mellitus, Previously Treated With Insulin Degludec/Liraglutide and Metformin and in Need of Further Intensification
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: insulin degludec/liraglutide; insulin aspart
Intervention description: Insulin degludec/liraglutide will be given subcutaneously (s.c., under the skin) once daily in combination with metformin.
Dose individually adjusted.; Dose titration of insulin aspart will be based on the respective pre-meal(s) and bedtime SMPG measured daily.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Liraglutide; Xultophy
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted globally. The aim of the trial is to compare sequential addition of
      insulin aspart versus further dose increase with insulin degludec/liraglutide in subjects
      with type 2 diabetes mellitus, previously treated with insulin degludec/liraglutide and
      metformin and in need of further intensification.

      This is an extension to trial NN9068-3952, NCT01952145 (DUAL™ V).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completion (Visit 28) of NN9068-3952 with insulin degludec/liraglutide + metformin

          -  HbA1c (glycosylated haemoglobin) above or equal to 7 percent at Visit 27 of
             NN9068-3952 trial

        Exclusion Criteria:

          -  Clinically significant diseases of the major organ systems

          -  Screening calcitonin above or equal to 50 ng/L
Palifermin for the Reduction of Oral Mucositis in Single-dose Evaluation (PROMISE)
Condition: Cancer; Lymphoma; Leukemia
MeSH terms: Mucositis; Stomatitis
Intervention: palifermin; Total Body Irradiation; Cyclophosphamide; Etoposide; Placebo
Intervention description: Administered as one daily intravenous bolus.; To be delivered before the administration of chemotherapy in 6, 8, or 10 fractions over 3 or 4 days.; Cyclophosphamide is administered at a total dose of 100 mg/kg given in 1 dose on Day -2; Etoposide may be administered (optional) as a single intravenous infusion over 4 hours on the day after the last fTBI fraction.; Administered as one daily intravenous bolus.
Intervention MeSH terms: Cyclophosphamide; Etoposide
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cancer; Oncology

Summary:

      To evaluate whether palifermin (rHuKGF) administered as a single dose is non-inferior to 3
      consecutive doses of palifermin in reducing the incidence of severe oral mucositis (World
      Health Organization [WHO] grade 3 and 4).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent

          -  Subjects with: non-Hodgkin's lymphoma, Hodgkin's disease, acute myelogenous leukemia,
             acute lymphoblastic leukemia, chronic myelogenous leukemia, chronic lymphocytic
             leukemia, or multiple myeloma

          -  Minimum of 1.5 x 10^6 CD34+ cells/kg cryopreserved and to be transplanted.

        Exclusion Criteria:

          -  Cancer other than those specified in inclusion criteria above (except: adequately
             treated basal cell carcinoma of the skin)

          -  Prior bone marrow or peripheral blood stem cell transplantation - Negatively selected
             (purged) stem cell product - Current active infection or oral mucositis

          -  Congestive heart failure as defined by New York Heart Association class III or IV.

          -  History of or current diagnosis of pancreatitis

          -  Inadequate renal function (serum creatinine greater than 1.5x the upper limit of
             normal per the institutional guidelines)

          -  Inadequate liver function (direct bilirubin greater than 1.5x the upper limit of
             normal, aspartate aminotransferase (AST) greater than 3x upper limit of normal and/or
             alanine aminotransferase (ALT) greater than 3x upper limit of normal per the
             institutional guidelines)

          -  Inadequate pulmonary function as measured by a corrected diffusion capacity of carbon
             monoxide (DLCO) less than 50% of predicted.

          -  Subject is currently enrolled in or has not yet completed at least 30 days since
             ending other investigational device or drug trial(s), or subject is receiving other
             investigational agent(s)
Trial Comparing Patching Versus Atropine for Amblyopia in 7 to < 13 Year Olds
Condition: Amblyopia
MeSH terms: Amblyopia
Intervention: Atropine; Patching; Near activities
Intervention description: Atropine 1% each weekend day in the sound eye; Patching 2 hours per day; near visual activities for at least one hour per day
Intervention MeSH terms: Atropine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 233.0
Sex: All
Minimum age: 7 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: Amblyopia; Atropine; Patching

Summary:

      The purpose of this study is:

        -  To compare the effectiveness of weekend atropine plus near activities and daily patching
           plus near activities for moderate amblyopia (20/40 to 20/100) and severe amblyopia
           (20/125 to 20/400) in improving vision in the amblyopic eye of 7 to <13 year olds.

        -  To determine the maximum improvement in vision of the amblyopic eye with each treatment.

        -  To determine whether amblyopia is associated with structural abnormalities of optic
           nerve fiber layer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 7 to 12 years old (inclusive)

          -  Amblyopia associated with strabismus, anisometropia, or both

          -  Visual acuity in the amblyopic eye 19 to 71 letters on Electronic Early Treatment
             Diabetic Retinopathy Study (E-ETDRS©) (20/40 to 20/400 inclusive)

          -  Visual acuity in the sound eye 79 letters or better on E-ETDRS© (20/25 or better)

          -  Interocular difference >=15 letters (3 lines)

          -  Spectacles, if needed, worn for at least 16 weeks or visual acuity documented to be
             stable

        Inclusion Criteria for Optional Ancillary Study:

          -  Enrolled into the main study

          -  Refractive error in both eyes between -0.25 and +5.00D, inclusive (to avoid the need
             to adjust for refractive error)

          -  Birth weight >1500 grams

          -  No history of Central Nervous System (CNS) disease (e.g. intraventricular hemorrhage
             (IVH), periventricular leukomalacia (PVL), meningitis, developmental abnormalities of
             the brain, hydrocephalus, cerebral palsy, hypoxic ischemic encephalopathy

        Exclusion Criteria:

          -  Amblyopia treatment (other than spectacles) in the last 6 months

          -  Myopia (more than -0.25D spherical equivalent) in either eye
Long-term Trial of OPA-15406 Ointment in Adult and Pediatric Patients With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: 0.3% OPA-15406 ointment; 1% OPA-15406 ointment
Intervention description: Twice daily; Twice daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 366.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No

Summary:

      To demonstrate the safety of 1% OPA-15406 ointment in adult patients with AD and of 0.3% and
      1% OPA-15406 ointments in pediatric patients with AD administered twice daily for 52 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age: At least 2 years (at time of obtaining informed consent)

          -  Diagnosis of AD based on the Japanese Dermatological Association's criteria

          -  Atopic dermatitis affecting ≥5% of body surface area (BSA, excluding scalp) at the
             screening and baseline examinations

        Exclusion Criteria:

        - Subjects who have an AD or contact dermatitis flare-up defined as a rapid intensification
        of AD, within 28 days prior to the baseline examination