bioihbjkbjnl/mcl2 huggingface dataset:
Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia
Condition: Hyperlipidemia and Mixed Dyslipidemia
MeSH terms: Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias
Intervention: Evolocumab; Standard of Care
Intervention description: Administered by subcutaneous injection either every 2 weeks or once a month (patient preference) using a prefilled autoinjector pen; Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes
Intervention MeSH terms: Evolocumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3681.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: High cholesterol; Raised cholesterol; Cholesterol; Elevated Cholesterol

Summary:

      This study will contribute to the evaluation of long-term safety, tolerability and efficacy
      of evolocumab (AMG 145) in adults with hyperlipidemia and adults with mixed dyslipidemia.
    

Eligibility criteria:

        Inclusion Criteria:

        - Complete a qualifying evolocumab (AMG 145) parent study (ie, Study 20110114
        [NCT01763827], 20110115 [NCT01763866], 20110116 [NCT01763905], 20110117 [NCT01763918],
        20110109 [NCT01516879], 20120122 [NCT01953328], 20120332 [NCT01984424], 20120348
        [NCT01849497], or 20120356 [NCT01879319]).

        Exclusion Criteria:

          -  Experienced a treatment-related serious adverse event that led to study drug
             discontinuation in the parent study

          -  Have an unstable medical condition, in the judgment of the investigator

          -  Known sensitivity to any of the products to be administered during dosing

          -  Currently enrolled in another investigational device or drug study (excluding
             evolocumab (AMG 145) parent study), or less than 30 days since ending another
             investigational device or drug study(s),or receiving other investigational agent(s)
Tedizolid Phosphate (TR-701 FA, MK-1986) vs Linezolid for the Treatment of Nosocomial Pneumonia (MK-1986-002)
Condition: Pneumonia
MeSH terms: Pneumonia; Healthcare-Associated Pneumonia
Intervention: Tedizolid phosphate; Linezolid
Intervention description: Tedizolid phosphate IV 200 mg once daily; Linezolid IV 600 mg twice daily
Intervention MeSH terms: Linezolid; Tedizolid; Tedizolid 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: 726.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a 1:1 ratio, randomized, double-blind, double-dummy, multicenter, global Phase 3
      study of tedizolid phosphate (TR-701 FA) 200 mg intravenous (IV) once daily for 7 days versus
      linezolid (Zyvox®, Zyvoxid®, etc) 600 mg IV every 12 hours for 10 days for the treatment of
      ventilated participants with presumed gram-positive hospital-acquired bacterial pneumonia
      (HABP) or ventilator-associated bacterial pneumonia (VABP), collectively referred to as
      ventilated nosocomial pneumonia (VNP). Participants with concurrent gram-positive bacteremia
      are to receive 14 days of active therapy in either treatment arm.

      The primary objective is to determine the noninferiority (NI) in all-cause mortality (ACM)
      within 28 days after randomization of IV tedizolid phosphate compared with IV linezolid in
      the Intent to Treat (ITT) Analysis Set (NI is declared when the lower bound of the 95% CI >
      -10).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Requires IV antibiotic therapy with diagnosis of ventilated nosocomial pneumonia

          -  Gram-positive bacteria on respiratory Gram stain

        Exclusion Criteria:

          -  Pneumonia of community, viral, fungal or parasitic etiology

          -  Structural lung abnormalities

          -  Immunosuppression

          -  Previous antibiotics for > 24 hours

          -  Expected survival of < 72 hours
A Phase III Study of a 2-dose Regimen of a Multivalent Human Papillomavirus (HPV) Vaccine (V503), Administered to 9 to 14 Year-olds and Compared to Young Women, 16 to 26 Years Old (V503-010)
Condition: Human Papillomavirus Infection
MeSH terms: Papillomavirus Infections
Intervention: V503 (9-valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] vaccine)
Intervention description: V503, a 9-valent HPV (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1518.0
Sex: All
Minimum age: 9 Years
Maximum age: 26 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This was a 37-month safety and immunogenicity study conducted in boys and girls 9 to 14 years
      of age and in young women 16 to 26 years of age. From this study, the goal was to establish
      that the investigational 2-dose regimens (0, 6 months and 0, 12 months) studied in boys and
      girls 9 to 14 years of age are generally safe and immunogenic, with an antibody response that
      is not inferior to that observed in young women 16 to 26 years of age who received the
      standard 3-dose regimen of V503 (i.e., the population and dose regimen used to establish V503
      efficacy).
    

Eligibility criteria:

        Inclusion Criteria:

        All Participants:

        -Judged to be in good physical health on the basis of medical history, physical examination
        and laboratory results

        Boys and Girls 9 to 14 Years:

        -Must not have had coitarche and does not plan on becoming sexually active during the
        vaccination period

        Women 16 to 26 Years:

          -  Has never had a Papanicolaou (Pap) test or only had normal Pap test results

          -  A lifetime history of 0 to 4 male and/or female sexual partners

        Exclusion Criteria:

        All Participants:

          -  Known allergy to any vaccine component

          -  History of severe allergic reaction that required medical intervention

          -  Thrombocytopenia or any coagulation disorder

          -  Females only: participant is pregnant or expecting to donate eggs during day 1 through
             month 7

          -  Currently immunocompromised, or been diagnosed with immunodeficiency

          -  Had a splenectomy

          -  Receiving or has received immunosuppressive therapies within the last year

          -  Received any immunoglobulin product or blood-derived product within 3 months

          -  Received a marketed HPV vaccine or has participated in an HPV vaccine clinical trial
Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: SM-13496 (lurasidone HCl); SM-13496 (lurasidone HCl); Placebo; Risperidone
Intervention description: Lurasidone HCl: 40 mg/day; Lurasidone HCl: 80 mg/day
Intervention MeSH terms: Risperidone; Lurasidone Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 460.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No

Summary:

      The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients
      with schizophrenia.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Patient meets DSM-IV criteria for schizophrenia.

          -  Patient is 18 or older but younger than 75 years of age on the day of signing informed
             consent.

          -  Patient understands the objectives, nature, and other aspects of the study and
             voluntarily agrees to participate in the study by providing written informed consent.

        Main Exclusion Criteria:

          -  Patient has a history of neuroleptic malignant syndrome, water intoxication, or
             paralytic ileus.

          -  Patient has Parkinson's disease.

          -  Patient has a history or complication of malignancy.
Open-Label Extension Study of the Phase 3 VRX-RET-E22-302 Double-Blind Trial. 115097
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Retigabine (INN), Ezogabine (USAN)
Intervention description: Film-coated tablets containing 50 mg, 100 mg, or 300 mg of retigabine per tablet. Dosage and frequency will be specific to each patient so long as the patients receives between 600 and 1200 mg of retigabine per day. The duration will be until the completion of the trial, or until the patient withdraws from the trial.
Intervention MeSH terms: Ezogabine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 376.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Partial Seizures; Epilepsy; RTG115097; Complex Partial Seizures; Anticonvulsant; Potassium Channels; Epilepsies, Partial

Summary:

      This Phase 3 trial is an open-label extension study of the placebo-controlled, double-blind
      VRX-RET-E22-302 trial. Patients who have completed the VRX-RET-E22-302 trial and who meet
      inclusion and exclusion criteria will be treated with 600-1200 mg/day of retigabine as an
      adjunct therapy to their current antiepileptic drugs (AEDs) or vagal nerve stimulation.
      Treatment will be continued until the subject withdraws from the study or until the program
      is discontinued. Patients will be recruited from 55-60 sites in Europe, Israel, Australia,
      and South Africa. The primary objective of the study is to evaluate the safety and
      tolerability of long-term therapy with retigabine administered as adjunctive therapy in adult
      epilepsy patients with partial-onset seizures, who completed the double-blind Study
      VRX-RET-E22-302. Secondary objectives are: to evaluate efficacy of long-term treatment with
      retigabine and patient quality of life and to evaluate whether retinal pigmentation,
      unexplained vision loss, pigmentation of non-retinal ocular tissue, and discoloration of
      nails, lips, skin or mucosa change over time after discontinuation of retigabine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has successfully completed the Maintenance and Transition phases of Study
             VRX-RET-E22-302 for the treatment of partial-onset seizures

          -  Patient is expected to benefit from participation in the study in the opinion of the
             Investigator.

        Exclusion Criteria:

          -  Patient meets any of the withdrawal criteria in the previous VRX-RET-E22-302 study or
             is experiencing an ongoing serious adverse event.

          -  Patient is receiving any investigational drug or using any experimental device in
             addition to Retigabine for treatment of epilepsy or any other medical condition.

          -  Patient has any other condition that would prevent compliance with the study
             procedures or proper reporting of adverse events.
Study of Efficacy and Safety of Canakinumab in Japanese Patients With SJIA
Condition: Systemic Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Intervention: Canakinumab
Intervention description: canakinumab was provided as a 150 mg/1 mL solution for subcutaneous injection and administered at 4mg/kg every 4 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 2 Years
Maximum age: 19 Years
Healthy volunteers: No
Keywords: ACZ885; canakinumab; Juvenile Rheumatoid arthritis (JRA) chronic; systemic inflammatory disorder; painful joints; inflammation of the synovial membrane; auto-immune rheumatoid disease; reactive rheumatoid arthritis; Systemic Juvenile Rheumatoid arthritis (SJRA); Japanese patients

Summary:

      This was a phase III study designed to provide efficacy and safety data for canakinumab
      administered for at least 48 weeks as subcutaneous (s.c.) injection every 4 weeks (q4wk) in
      Japanese patients with Systemic Juvenile Idiopathic Arthritis (SJIA). Interim analysis (IA)
      data at Week 28 and 48 from this study supported a registration submission of canakinumab in
      the indication of SJIA in Japan.
    

Eligibility criteria:

        Inclusion Criteria

        - Confirmed diagnosis of SJIA as per International League Against Rheumatism (ILAR)
        definition (Petty, et al. 2004) that must have occurred at least 3 months prior to
        enrollment with an onset of disease < 16 years of age: Arthritis in one or more joints,
        with or preceded by fever of at least 2 weeks duration that is documented to be
        daily/quotidian for at least 3 days and accompanied by one or more of the following: Rash
        due to SJIA, lymphadenopathy, Hepatomegaly/Splenomegaly, Serositis

          -  Active disease at the time of baseline defined as follows:

          -  At least 2 joints with active arthritis

          -  Documented spiking, intermittent fever (body temperature > 38°C) for at least 1 day
             during the screening epoch and within 1 week before first canakinumab dose

          -  C-Reactive Protein (CRP) > 30 mg/L(3 mg/dL) (normal range < 10 mg/L(1 mg/dL))

          -  Negative TB screen (Chest X-ray and T-SPOT test)

        Exclusion Criteria:

          -  With active or recurrent bacterial, fungal or viral infection at the time of
             enrollment, including patients with evidence of Human Immunodeficiency Virus (HIV)
             infection, Hepatitis B and Hepatitis C infection. Patients with resolved/previous
             hepatitis B infection (a negative HBs antigen, but a positive anti-HBs antibody and/or
             anti-HBc antibody).

          -  With underlying metabolic, renal, hepatic, infectious or gastrointestinal conditions
             which in the opinion of the investigator immunocompromises the patient and /or places
             the patient at unacceptable risk for participation.

          -  With neutropenia (absolute neutrophil count < 1500/mm3) at screening.
HOPE-B: Trial of AMT-061 in Severe or Moderately Severe Hemophilia B Patients
Condition: Hemophilia B
MeSH terms: Hemophilia A; Hemophilia B
Intervention: AAV5-hFIXco-Padua; Factor IX (FIX)
Intervention description: Single intravenous infusion of AAV5-hFIXco-Padua (AMT-061); During the lead-in phase, which lasted for a minimum of 26 weeks (i.e., ≥6 months), subjects recorded their use of FIX replacement therapy and bleeding episodes in their dedicated e-diary.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: The reference therapy is prophylactic factor IX replacement therapy used during the lead-in phase prior to treatment with AAV5-hFIXco-Padua (AMT-061).
Masking: None (Open Label)
Enrollment: 67.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Gene therapy; FIX; factor IX; Bleeding; Viral vector; Padua; hemophilia; AAV (adeno-associated virus); serotype 5 AAV (adeno-associated virus); serotype 5

Summary:

      This is an open-label, single-dose, multi-center, multinational trial to demonstrate the
      efficacy of AMT-061 and to further describe its safety profile.

      The study drug is identified as AAV5-hFIXco-Padua (AMT- 061). AMT-061 is a recombinant
      adeno-associated viral vector of serotype 5 (AAV5) containing the Padua variant of a
      codon-optimized human FIX complementary deoxyribonucleic acid (cDNA) under the control of a
      liver-specific promoter. The pharmaceutical form of AMT-061 is a solution for intravenous
      infusion administered at a dose of 2 x 10^13 gc/kg.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male

          2. Age ≥18 years

          3. Subjects with congenital hemophilia B, classified as severe or moderately severe, and
             are currently on factor IX prophylaxis

          4. >150 previous exposure days of treatment with factor IX protein

        Exclusion Criteria:

          1. History of factor IX inhibitors

          2. Positive factor IX inhibitor test at screening

          3. Select screening laboratory value >2 times upper limit of normal

          4. Positive human immunodeficiency virus (HIV) test at screening, not controlled with
             anti-viral therapy

          5. Active infection with hepatitis B or C virus at screening

          6. History of Hepatitis B or C exposure, currently controlled by antiviral therapy at the
             end of the lead-in phase

          7. Previous gene therapy treatment

          8. Receipt of an experimental agent within 60 days prior to screening

          9. Current participation or anticipated participation within one year after study drug
             administration in this trial in any other interventional clinical trial involving
             drugs or devices
Extension Study of Eculizumab in Patients With Transfusion Dependent Paroxysmal Nocturnal Hemoglobinuria (PNH)
Condition: Paroxysmal Hemoglobinuria, Nocturnal
MeSH terms: Hemoglobinuria; Hemoglobinuria, Paroxysmal
Intervention: eculizumab
Intervention MeSH terms: Eculizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 187.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: transfusion dependent; paroxysmal nocturnal hemoglobinuria; hemolytic

Summary:

      The purpose of this study is to evaluate the long-term safety of eculizumab in patients with
      transfusion dependent hemolytic PNH.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have fully completed the TRIUMPH, SHEPHERD, or X03-001 studies

          -  TRIUMPH patients who have discontinued receiving investigational drug prior to the
             last visit of the study due to lack of efficacy or exacerbation of symptoms of PNH and
             have completed all monthly safety and efficacy procedures

          -  Patient must be willing and able to give written informed consent

          -  Patient must avoid conception during the trial

        Exclusion Criteria:

          -  Patients who have terminated early from the SHEPHERD or X03-001 studies

          -  Patients who have terminated early from the TRIUMPH study due to an adverse event

          -  Female who is pregnant, breast feeding, or intending to conceive during the course of
             the study

          -  Any condition that could increase the patient's risk by participating in the study or
             could confound the outcome of the study
Orantinib In Combination With Transcatheter Arterial Chemoembolization In Patients With Unresectable Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: Orantinib (TSU-68); Placebo
Intervention description: 200 mg (1 tablet) of Orantinib was administered orally twice per day after meals, morning and evening.; 1 tablet was administered orally twice per day after meals, morning and evening.
Intervention MeSH terms: Orantinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 888.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the overall survival (OS) for Orantinib in
      combination with transcatheter arterial chemoembolization (TACE) versus placebo in
      combination with TACE in patients with unresectable hepatocellular carcinoma (HCC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be diagnosed as HCC.

          -  Patients has no indications for treatment with curative hepatic resection or curative
             percutaneous local therapy.

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.

          -  Patients are able to receive oral medication.
Treat & Extend Treatment With 0.5mg Ranibizumab vs Monthly Treatment With 0.5mg Ranibizumab
Condition: Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: 0.5 mg ranibizumab
Intervention description: Subject will receive drug (ranibizumab) via intravitreal injections (IVT) at every visit.
Intervention MeSH terms: Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Age related; Macular; sub retinal fluid; Age related Macular degeneration

Summary:

      TREX is a phase IIIb, multicenter, randomized, controlled clinical study. Subjects will be
      randomized 1:2 to "monthly" (control arm) or "treat and extend" protocol (comparator arm)
      respectively. TREX assess the safety, tolerability and efficacy of intravitreal injections
      (IVT) of 0.5mg ranibizumab given monthly for up to 100 weeks followed by pro re nata (PRN)
      treatment for 56 weeks compared to a Treat and Extend protocol for 156 weeks in patients with
      wet age-related macular degeneration (AMD). Subjects treated in a treat and extend protocol
      receive 3 consecutive IVT 0.5 mg ranibizumab (visits 2, 4 and 5). Starting at week 8, if a
      subject has achieved a "dry" macula; signs of active exudation have resolved will begin a
      Treat and Extend protocol (visits lengthened by 2 week intervals every visit a dry macular is
      maintained). At the beginning of the 104-week endpoint subjects initially randomized to the
      TREX cohort will transition to PRN re-treatment when there is no exudative disease activity
      at the 12-week interval.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability to provide written informed consent and comply with study assessments for the
             full duration of the study

          -  Age > 50 years

          -  Ability and willingness to return for all scheduled visits and assessments

          -  Any CNVM lesion (Occult, Minimally Classic or Classic) (i.e., leakage on fluorescein
             angiography or subretinal, intraretinal activity on SDOCT) secondary to age-related
             macular degeneration.

        Best corrected visual acuity in the study eye, using ETDRS testing, between 20/32 and
        20/400 (Snellen equivalent), inclusive.

        -The total area of subretinal hemorrhage and fibrosis must comprise less than 50% of the
        total lesion. Clear ocular media and adequate pupillary dilation to permit good quality
        fundus imaging.

        Exclusion Criteria:

          -  Subretinal hemorrhage in the study eye that involves the center of the fovea, if the
             size of the hemorrhage is either > 50% of the total area of the lesion or > 1 disc
             area (2.54 mm2) in size

          -  Subfoveal fibrosis or atrophy in the study eye

          -  CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or
             pathologic myopia