bioihbjkbjnl/mcl2 huggingface dataset:
STeroids to REduce Systemic Inflammation After Infant Heart Surgery
Condition: Congenital Heart Disease in Children; Inflammatory Response
MeSH terms: Heart Diseases; Heart Defects, Congenital; Inflammation
Intervention: Methylprednisolone; Isotonic saline
Intervention description: IV Steroid pre-operative and intra-operative; Isotonic saline pre-operative and intra-operative
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1263.0
Sex: All
Maximum age: 12 Months
Healthy volunteers: No

Summary:

      This study's objective is to determine the pharmacokinetics (PK)/pharmacodynamics (PD),
      safety and efficacy of methylprednisolone in infants undergoing heart surgery with
      cardiopulmonary bypass. This is a prospective, double blind, multi-center, placebo-controlled
      safety and efficacy study. Blood samples will be collected from a subset of enrolled study
      participants to evaluate multiple dose methylprednisolone PK/PD. Participants will be
      randomized in a 1:1 fashion to intravenous methylprednisolone versus placebo. Study
      drug/placebo will be administered 8 to 12 hours before the anticipated start time of surgery
      and in the operating room at the time of initiation of cardiopulmonary bypass. Patients will
      be followed for primary and secondary outcomes for the duration of their hospitalization.
      Serious study drug-related adverse events will be collected for 7 days after the last dose of
      study drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age < 1 year at the time of surgery

          -  Undergoing heart surgery with CPB as part of standard clinical care

          -  Availability and willingness of the parent/legally authorized representative to
             provide written informed consent

        Exclusion Criteria:

          -  < 37 weeks adjusted gestational age at time of surgery

          -  Any oral or intravenous steroid treatment within two days of surgery

          -  Any patient receiving any of the following medications within 2 days of surgery:

        Amphotericin B, aminoglutethimide, anticholinesterases, warfarin, P450 3A4 inducers
        including (but not limited to) carbamazepine, phenobarbital, phenytoin, rifampin, bosentan
        and nafcillin or P450 3A4 inhibitors including (but not limited to) clarithromycin,
        voriconazole, itraconazole, ketoconazole, ciprofloxacin, diltiazem, fluconazole,
        erythromycin and verapamil.

          -  Infection contraindicating steroid use

          -  Preoperative mechanical circulatory support or active resuscitation at the time of
             randomization

          -  Emergent surgery precluding steroid administration 8-12 hours before surgery
Suprachoroidal Injection of CLS-TA in Subjects With Macular Edema Associated With Non-infectious Uveitis
Condition: Uveitis; Uveitis, Posterior; Uveitis, Anterior; Uveitis, Intermediate; Panuveitis
MeSH terms: Macular Edema; Uveitis; Panuveitis; Uveitis, Posterior; Uveitis, Intermediate; Pars Planitis; Uveitis, Anterior
Intervention: 4mg CLS-TA Suprachoriodal Injection; Sham Procedure
Intervention description: CLS-TA, 40 mg/mL (4 mg in 100 µL), administered as a single injection at 2 timepoints; Sham procedure administered at 2 timepoints
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 160.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Uveitis; UME; Posterior Uveitis; Anterior Uveitis; Intermediate Uveitis; Panuveitis; Non-infectious Uveitis; Triamcinolone; Choroid; Choroidal Injection; Suprachoroidal; Microneedle; Microinjection; Triamcinolone acetonide

Summary:

      The study is designed to evaluate the safety and efficacy of suprachoroidally administered
      triamcinolone acetonide, CLS-TA, in subjects with macular edema associated with
      non-infectious uveitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of non-infectious uveitis (pan, anterior, intermediate and posterior)

          -  Diagnosis of macular edema associated with non-infectious uveitis (retinal thickness ≥
             300 microns)

          -  Visual Acuity score of ≥ 5 letters read (20/800 Snellen equivalent) and ≤ 70 letters
             read (20/40 Snellen equivalent), in the study eye

        Exclusion Criteria:

          -  Any active ocular disease or infection in the study eye other than uveitis

          -  Intraocular pressure > 22 mmHg or uncontrolled glaucoma in the study eye; subjects are
             not excluded if IOP ≤ 22 mmHg with no more than 2 IOP lowering medications.

          -  Any uncontrolled systemic disease that, in the opinion of the Investigator, would
             preclude participation in the study

          -  Any topical ocular corticosteroid in the 10 days prior to baseline; intraocular or
             periocular corticosteroid injections in the 2 months prior to baseline; an OZURDEX
             implant in the 6 months prior to baseline; RETISERT or ILUVIEN implant in the 3 years
             prior to baseline.
Endometrial Safety of a Low Dose of Vagifem® in Postmenopausal Women With Atrophic Vaginitis
Condition: Menopause; Postmenopausal Vaginal Atrophy
MeSH terms: Vaginitis; Atrophic Vaginitis
Intervention: estradiol, 10 mcg
Intervention description: Tablets, administered intravaginally twice weekly
Intervention MeSH terms: Estradiol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 336.0
Sex: Female
Minimum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This trial is conducted in Europe. The purpose of this study is to evaluate endometrial
      safety of intravaginal estradiol (Vagifem®) in healthy postmenopausal women having atropic
      vaginitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal women whose last menstruation was at least two years prior to the time
             of screening

          -  At least 1 urogenital symptom (vaginal dryness, vaginal and/or vulvar
             irritation/itching, vaginal soreness, dysuria, dyspareunia and vaginal bleeding
             associated with sexual activity

          -  Generally healthy

        Exclusion Criteria:

          -  Exposure to exogenous sex steroid hormones (estrogen and/or progestin hormone
             replacement therapy) within past 3 months
Follow-On Study of Pitavastatin Versus Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia
Condition: Type II Diabetes Mellitus; Dyslipidemia
MeSH terms: Diabetes Mellitus; Dyslipidemias; Diabetes Mellitus, Type 2
Intervention: Pitavastatin; Atorvastatin
Intervention description: Pitavastatin 4 mg QD; Atorvastatin 40 mg
Intervention MeSH terms: Atorvastatin; Pitavastatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 214.0
Sex: All
Healthy volunteers: No
Keywords: Pitavastatin; Type II Diabetes Mellitus; Combined Dyslipidemia

Summary:

      This is a sixteen-week double-blind active-controlled follow-on and 28-week single-blind
      extension study for patients who participated in study NK-104-305.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type II diabetes mellitus

          -  Combined dyslipidemia

          -  Completed NK-104-305 (NCT00309751)

        Exclusion Criteria:

          -  Withdrawal from NK-104-305 (NCT00309751)
A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain
Condition: Endometriosis
MeSH terms: Endometriosis
Intervention: elagolix; placebo
Intervention description: oral tablet; oral tablet
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 872.0
Sex: Female
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: No
Keywords: Gonadotropin-Releasing Hormone Antagonist; Endometriosis associated pain; Dysmenorrhea (DYS); Non-Menstrual Pelvic Pain (NMPP); Elagolix

Summary:

      A randomized study evaluating the safety and efficacy of elagolix in the management of
      moderate to severe endometriosis-associated pain in adult premenopausal female participants.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Premenopausal female, between 18 and 49 years of age, inclusive, at the time of
             signing consent.

          2. Clinical diagnosis of endometriosis (laparoscopy or laparotomy) performed within 10
             years of entry into Washout (if applicable) or Screening.

          3. Agrees to use required birth control methods during the entire length of participation
             in the study.

          4. Subject has a Composite Pelvic Signs and Symptoms Score total score of ≥ 6 at
             Screening with a score of at least 2 for dysmenorrhea AND at least 2 for non-menstrual
             pelvic pain. 5. Subjects must have at least two menstrual cycles 24 to 38 days within
             the Screening Period, prior to Day 1

        Exclusion Criteria:

          1. Subject is pregnant or breast feeding or is planning a pregnancy within the next 24
             months or is less than 6 months postpartum, post-abortion, or post-pregnancy at the
             time of entry into the Screening Period.

          2. Subject has a history of previous non-response to Gonadotropin-releasing hormone
             (GnRH) agonists, GnRH antagonists, Depot Medroxyprogesterone Acetate, or aromatase
             inhibitors as assessed by subject report of no improvement in dysmenorrhea or
             non-menstrual pelvic pain (subject report of partial response to or side effects from
             these agents is not exclusionary).

          3. Subject has chronic pelvic pain that is not caused by endometriosis that requires
             chronic analgesic or other chronic therapy, or that would interfere with the
             assessment of endometriosis related pain.

          4. Clinically significant gynecologic condition identified on Screening transvaginal
             ultrasound or endometrial biopsy.

          5. Subject has a history of osteoporosis or other metabolic bone disease.

          6. Subject has a current history of undiagnosed abnormal genital bleeding.
Grazoprevir (MK-5172) and Elbasvir (MK-8742) Combination for Chronic Hepatitis C Virus (HCV) Genotypes 1, 4, and 6 (MK-5172-065)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: Grazoprevir + Elbasvir; Placebo
Intervention description: FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken once daily by mouth.; Placebo tablets matching grazoprevir + elbasvir FDC tablets taken once daily by mouth.
Intervention MeSH terms: Grazoprevir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 159.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, multi-site, placebo-controlled trial of a fixed dose combination (FDC)
      of grazoprevir (MK-5172) 100 mg + elbasvir (MK-8742) 50 mg in participants with chronic
      Hepatitis C Virus (HCV) genotype (GT) 1, GT4 or GT6 with inherited blood disorders. The
      primary hypothesis is that the proportion of participants treated with grazoprevir+elbasvir
      achieving Sustained Virologic Response (SVR) 12 weeks after the end of all study therapy
      (SVR12) will be greater than the reference rate of 40%.
    

Eligibility criteria:

        Inclusion Criteria:

          -  has HCV GT1, GT4, or GT6 with sickle cell anemia, thalassemia, or hemophilia/von
             Willebrand disease

          -  has cirrhosis or is non-cirrhotic

          -  is human immunodeficiency virus (HIV) coinfected or not infected with HIV

          -  is a female of non childbearing potential, or is male or female and uses an acceptable
             method(s) of contraception

        Exclusion Criteria:

          -  has evidence of decompensated liver disease

          -  is coinfected with hepatitis B

          -  has had a malignancy ≤5 years prior to signing informed consent except for adequately
             treated basal cell or squamous cell skin cancer or in situ cervical cancer

          -  has hepatocellular carcinoma (HCC) or is under evaluation for HCC

          -  has clinically-relevant drug or alcohol abuse within 12 months of screening
Clinical Outcomes of ACL Reconstruction Augmented by an Injectable Osteoconductive/Osteoinductive Compound
Condition: ACL Injury
MeSH terms: Anterior Cruciate Ligament Injuries
Intervention: OOC
Intervention description: The OOC will be mixed with autologous 5cc of platelet rich plasma (PRP), and then injected using a syringe into both tibia and femoral tunnels
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The goal of this study is to determine whether the use of injectable
      osteoinductive/osteoconductive compounds (OOC) during Anterior Cruciate Ligament (ACL)
      reconstructive surgery, combined with an accelerated rehabilitation protocol (ARP) provides
      clinical outcomes superior to those attained via traditional ACL reconstruction and delayed
      rehabilitation protocols.
    

Eligibility criteria:

        Inclusion Criteria:

          -  any adult undergoing a surgical procedure for hamstring ACL reconstruction

        Exclusion Criteria:

          -  Adults unable to consent

          -  Individuals who are not yet adults (infants, children, teenagers)

          -  Pregnant women

          -  Prisoners
Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants (V114-033)
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Intervention: V114; PCV13
Intervention description: 15-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) present in PCV13 plus 2 additional serotypes (22F, 33F) in each subcutaneous 0.5 mL single dose.; 13-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) in each subcutaneous 0.5 mL single dose.
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 694.0
Sex: All
Minimum age: 2 Months
Maximum age: 6 Months
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this clinical study is to evaluate the safety and immunogenicity of a 4-dose
      schedule (3-dose primary series followed by a toddler dose) of V114 compared with
      Pneumococcal 13-valent Conjugate Vaccine (PCV13). The hypotheses are that: 1) V114 is
      non-inferior to PCV13 for the 13 shared serotypes between V114 and PCV13 based on the
      response rates at 30 days following dose 3; 2) V114 is non-inferior to PCV13 for the 2 unique
      V114 serotypes based on the response rate of the 2 unique V114 serotypes at 30 days following
      dose 3; 3) V114 is non-inferior to PCV13 for the 13 shared serotypes between V114 and PCV13
      based on anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG)
      geometric mean concentrations (GMCs) at 30 days following dose 3.
    

Eligibility criteria:

        Inclusion Criteria:

        - Japanese male or female

        Exclusion Criteria:

          -  Has a history of invasive pneumococcal disease (IPD)

          -  Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine
             (PCV), or any diphtheria toxoid containing vaccine

          -  Has a known or suspected impairment of immunological function

          -  Has a history of congenital or acquired immunodeficiency

          -  Has or his/her mother has a documented human immunodeficiency virus (HIV) infection

          -  Has or his/her mother has a documented hepatitis B surface antigen-positive test

          -  Has known or history of functional or anatomic asplenia

          -  Has a history of autoimmune disease

          -  Has a known neurologic or cognitive behavioral disorder

          -  Has received a dose of any pneumococcal vaccine prior to study entry

          -  Has received a blood transfusion or blood products, including immunoglobulins
Vaniprevir Administered With Pegylated-interferon and Ribavirin in Japanese Treatment-Naïve Chronic Hepatitis C Participants (MK-7009-043)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: vaniprevir; Placebo to vaniprevir; Peg-IFN; ribavirin
Intervention description: Capsules containing 150 mg vaniprevir, orally, two in the morning and two in the evening for 12 or 24 weeks; Placebo to vaniprevir, capsules, orally, twice daily for 12 weeks or 24 weeks; Peg-IFN 1.5 μg/kg once per week, subcutaneously (SC) for 24 or 48 weeks; Capsules containing 200 mg RBV orally, 3 to 5 capsules, dosage based on the participant's weight (600 mg/day to 1000 mg/day), for 24 or 48 weeks
Intervention MeSH terms: Ribavirin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 294.0
Sex: All
Minimum age: 20 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety, tolerability, and efficacy of vaniprevir
      given in combination with pegylated interferon alfa-2b (peg-IFN) and ribavirin (RBV) versus
      treatment with peg-IFN and RBV alone in Japanese treatment-naïve participants with chronic
      hepatitis C (CHC) genotype (GT)1. The primary efficacy hypothesis is that the percentage of
      participants achieving sustained virologic response 24 weeks after completion of all study
      therapy (SVR24) in at least one of the vaniprevir arms is superior to the percentage of
      participants achieving SVR24 in the control arm.
    

Eligibility criteria:

        Inclusion criteria:

          -  Japanese participant diagnosed with compensated CHC GT 1

          -  Absence of ascites, bleeding esophageal varices, hepatic encephalopathy, or other
             signs or symptoms of advanced liver disease.

          -  IFN treatment naive

          -  No evidence of cirrhosis

        Exclusion criteria:

          -  Co-infection with human immunodeficiency virus (HIV)

          -  Positive hepatitis B surface antigen or other evidence of active hepatitis B infection

          -  Any other condition that is contraindicated or for which caution is required for
             treatment with peg-IFN or RBV

          -  Any condition or pre-study laboratory abnormality, or history of any illness, that, in
             the opinion of the investigator, might confound the results of the study or pose
             additional risk in administering the study drugs, peg-IFN and RBV, to the participant.
A Study of Combination Therapy With PEGASYS (Pegylated Interferon Alfa-2a (40KD)) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 2 or 3 Who Do Not Achieve a Rapid Viral Response
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: peginterferon alfa-2a; Ribavirin
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 235.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of peginterferon alfa-2a 40KD + ribavirin
      combination therapy given for 24 weeks versus 48 weeks in patients with chronic hepatitis C,
      genotype 2/3.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  serological evidence of chronic hepatitis C (CHC);

          -  CHC genotype 2 or 3;

          -  receiving PEGASYS + Copegus according to local standard of care and no rapid viral
             response (RVR);

          -  compensated liver disease.

        Exclusion Criteria:

          -  pegylated interferon, standard interferon or ribavirin therapy at any time prior to
             initiation of current therapy with PEGASYS + Copegus;

          -  coinfection with hepatitis A or B, or human immunodeficiency virus (HIV);

          -  history or other evidence of decompensated liver disease.
A Study of MabThera/Rituxan (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis and Inadequate Response to DMARD Therapy
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: rituximab [MabThera/Rituxan]; methotrexate; methylprednisolone
Intervention description: 1000 mg iv Days 1 and 15; 10 - 25 mg/week; iv administration on Day 1 and 15 prior to MabThera/Rituxan infusion
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Rituximab; Methotrexate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of MabThera/Rituxan plus methotrexate in
      patients with active rheumatoid arthritis who have had an inadequate response to at least 1
      DMARD treatment. All patients will receive MabThera (1000mg iv infusion) on days 1 and 15,
      and methotrexate (10-25mg po) weekly. The anticipated time on study treatment is 3-12 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, 18-80 years of age;

          -  rheumatoid arthritis after inadequate response to >=1 DMARD treatment;

          -  active disease;

          -  DMARDs other than methotrexate withdrawn for at least 4 weeks prior to start of study
             treatment.

        Exclusion Criteria:

          -  autoimmune disease other than rheumatoid arthritis;

          -  bone/joint surgery within 8 weeks prior to screening, or joint surgery planned within
             24 weeks of MabThera infusion;

          -  concurrent treatment with any DMARD or antiTNF-alfa;

          -  intra-articular or parenteral corticosteroids within 4 weeks prior to screening.