bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults
Condition: Meningococcal Infections; Meningococcal Meningitis
MeSH terms: Meningococcal Infections; Meningitis, Meningococcal; Meningitis
Intervention: MenACWY CRM; Meningococcal ACWY Conjugate vaccine
Intervention description: One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.; One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 3539.0
Sex: All
Minimum age: 11 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Meningococcal; meningitis; vaccine; adolescents; adults

Summary:

      This study will evaluate the lot to lot consistency, safety and immune response of the
      Novartis Meningococcal ACWY conjugate vaccine in healthy US adolescents and adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy subjects who are 11-55 years of age inclusive and who have given appropriate
             written assent and/or consent

        Exclusion Criteria:

          -  Subjects with a previous or suspected disease caused by N. meningitidis

          -  previous immunization with a meningococcal vaccine or vaccine containing meningococcal
             antigen(s)

          -  previous or suspected disease caused by N. meningitidis

          -  Any serious acute, chronic or progressive disease

          -  Pregnant or breastfeeding
Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas
Condition: Indolent Non-Hodgkin's Lymphomas
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: Idelalisib; Rituximab; Bendamustine; Placebo
Intervention description: 150 mg tablet administered orally twice daily; 375 mg/m^2 single-use vials administered intravenously every 4 weeks (up to a total of 6 infusions); 90 mg/m^2 single-use vials administered intravenously for two consecutive days every 4 weeks (up to a total of 4-6 cycles as tolerated); Tablet administered orally twice daily
Intervention MeSH terms: Rituximab; Bendamustine Hydrochloride; Idelalisib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 475.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: iNHL; indolent NHL; follicular lymphoma; CAL-101; rituximab; bendamustine; small lymphocytic lymphoma; lymphoplasmacytoid lymphoma; Waldenstrom macroglobulinemia; LPL; WM; Marginal zone lymphoma; MZL; SLL; FL; GS-1101; PI3K inhibitor; idelalisib

Summary:

      The primary objective of this study is to evaluate the addition of idelalisib to
      bendamustine/rituximab on progression-free survival (PFS) in adults with previously treated
      indolent non-Hodgkin lymphoma (iNHL).

      An increased rate of deaths and serious adverse events (SAEs) among participants with
      front-line chronic lymphocytic leukemia (CLL) and early-line iNHL treated with idelalisib in
      combination with standard therapies was observed by the independent data monitoring committee
      (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data
      and terminated this study in agreement with the DMC recommendation and in consultation with
      the US Food and Drug Administration (FDA).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Histologically confirmed diagnosis of B-cell iNHL, with histological subtype limited
             to the following

               1. Follicular lymphoma (FL) Grade 1, 2, or 3a

               2. Small lymphocytic lymphoma (SLL)

               3. Lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM)

               4. Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal)

        Key Exclusion Criteria:

          -  History of lymphoid malignancy other than those allowed per inclusion criteria.

          -  Ongoing drug-induced liver injury, active hepatitis C, active hepatitis B, alcoholic
             liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic
             obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension.

          -  Prior treatment with bendamustine that was not effective.

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
An Extention Study of Safety of Canakinumab in Japanese Patients With Periodic Fever Syndromes
Condition: Periodic Fevers Syndrome
MeSH terms: Familial Mediterranean Fever; Amyloidosis; Syndrome; Fever; Hyperthermia
Intervention: Canakinumab (AIN457)
Intervention description: Canakinumab solution for subcutaneous injection in vial which contained 150mg/mL canakinumab in 1 mL solution
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Healthy volunteers: No
Keywords: Canakinumab,; interleukin-1; Periodic Fevers Syndrome; TRAPS; HIDS; crFMF; auto-inflammatory diseases; extension study

Summary:

      The primary objective of this study was to evaluate safety and tolerability of ACZ885 in this
      extension study. This extension study offered the opportunity for participants who completed
      Epoch 4 of the preceding CACZ885N2301 (NCT02059291) study to continue to be treated with
      ACZ885 until approval in Japan of the drug in Periodic Fever Syndromes or until development
      of ACZ885 in Periodic Fever Syndromes was suspended.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed Epoch 4 of the CACZ885N2301 study in Japan before the approval of
             canakinumab in Japan

          -  Written informed consent. Parent or legal guardian's written informed consent and
             child's assent, if appropriate, are required before any assessment is performed for
             patients < 20 years of age

        Exclusion Criteria:

          -  Any conditions or significant medical problems in which the investigator judges the
             patient should not enter this extension study
Long-term Safety Study of Glycopyrronium in Subjects With Primary Axillary Hyperhidrosis
Condition: Hyperhidrosis
MeSH terms: Hyperhidrosis
Intervention: Glycopyrronium Topical Wipes
Intervention description: Glycopyrronium Topical Wipes
Intervention MeSH terms: Glycopyrrolate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 564.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No

Summary:

      This is an open-label, long-term safety study of glycopyrronium topical wipes, enrolling up
      to 660 subjects with primary axillary hyperhidrosis who participated in either the DRM04-HH04
      or DRM04-HH05 studies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed Day 28 of either the DRM04-HH04 or DRM04-HH05 study with at least 80%
             treatment compliance

          -  Male or females

        Exclusion Criteria:

          -  Subject has a clinically significant abnormality on physical exam, vital signs or ECG
             at the Week 4 visit of DRM04-HH04 or DRM04-HH05 study that would make further
             treatment with glycopyrronium contraindicated

          -  Male with a history of urinary retention requiring catheterization due to prostatic
             hypertrophy or severe obstructive symptoms of prostatic hypertrophy

          -  Any other condition which, in the judgement of the Investigator, would put the subject
             at unacceptable risk for participation in the study
A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis
Condition: Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Intervention: 1% SPL7013 Gel; Placebo
Intervention description: Vaginal gel, daily for 7 days; Vaginal gel, daily for 7 days
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 250.0
Sex: Female
Minimum age: 12 Years
Healthy volunteers: No
Keywords: SPL7013; VivaGel; bacterial vaginosis; BV

Summary:

      The primary objective of the study is to assess the efficacy of 1% SPL7013 Gel compared to
      placebo gel for the treatment of bacterial vaginosis (BV).

      After screening eligible participants will be randomized to receive either 1% SPL7013 Gel or
      hydroxyethyl cellulose (HEC) placebo gel at a dose of 5g administered vaginally at bedtime
      for 7 consecutive days. Participants will be assessed for BV (both by Amsel criteria and
      Nugent score) at screening/Baseline, after last application (End of Treatment, EOT, Day 9-12)
      and at the final study visit approximately 2-3 weeks after last dose (Test of Cure, TOC, Day
      21-30).
    

Eligibility criteria:

        Key eligibility criteria:

          -  Post-menarchal females, aged 12 years or more

          -  Diagnosis of BV by Amsel criteria (ie all four of the following signs/symptoms:
             presence of white to grey homogeneous discharge; positive whiff test indicating an
             amine (fishy) odor with addition of potassium hydroxide; vaginal pH greater than 4.5;
             and presence at least 20% clue cells of total epithelial cells

          -  Nugent score of at least 4

          -  Otherwise healthy, as determined by medical history, physical examination

          -  normal Pap smear at or documented within 24 months of screening
A Long-term Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: DE-114 ophthalmic solution
Intervention MeSH terms: Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Enrollment: 130.0
Sex: All
Minimum age: 12 Years

Summary:

      Safety and efficacy of DE-114 ophthalmic solution will be evaluated in patients with allergic
      conjunctivitis, in an open-label, multicenter study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provided signed, written informed consent.

          -  Has a positive result from a Type I allergy test.

          -  If a subject is a female of childbearing potential, she must utilize reliable
             contraceptive throughout the study, and must have a negative urine pregnancy test
             prior to enrollment into this study.

        Exclusion Criteria:

          -  Females who are pregnant, nursing or planning a pregnancy, or females of childbearing
             potential who are not using a reliable method of contraception.

          -  Presence of any abnormality or significant illness that could be expected to interfere
             with the study.
Use Of Fragmin In Hemodialysis
Condition: Chronic Renal Failure
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic
Intervention: Fragmin
Intervention description: variable dosing regimen
Intervention MeSH terms: Dalteparin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 152.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Fragmin; dalteparin; hemodialysis; anticoagulation; Renal Failure

Summary:

      The study will determine if the Fragmin dose can be adjusted to suit the clinical needs of
      patients during dialysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  chronic renal failure on hemodialysis

        Exclusion Criteria:

          -  significant comorbidities that would prevent a patient from completing the trial
A Long Term Extension Study of Ixekizumab (LY2439821) in Participants With Axial Spondyloarthritis
Condition: Axial Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis; Axial Spondyloarthritis
Intervention: Ixekizumab; Placebo
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Ixekizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 773.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate, in participants having achieved a state of
      sustained remission, if the ixekizumab treatment groups are superior to the placebo group in
      maintaining response during the randomized withdrawal-retreatment period in participants with
      axial spondyloarthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have completed the final study visit in Study RHBV (NCT02696785), RHBW (NCT02696798),
             or RHBX (NCT02757352).

        (Note: Participants from Study RHBX are not eligible if they permanently discontinued
        ixekizumab and were receiving a tumor necrosis factor [TNF] inhibitor).

          -  Must agree to use a reliable method of birth control.

        Exclusion Criteria:

          -  Have significant uncontrolled disorders or abnormal laboratory values that, in the
             opinion of the investigator, pose an unacceptable risk to the participant if
             investigational product continues to be administered.

          -  Have a known hypersensitivity to ixekizumab or any component of this investigational
             product.

          -  Had investigational product permanently discontinued during a previous ixekizumab
             study.

          -  Had temporary investigational product interruption at any time during or at the final
             study visit of a previous ixekizumab study and, in the opinion of the investigator,
             restarting ixekizumab poses an unacceptable risk for the participant's participation
             in the study.

          -  Have any other condition that, in the opinion of the investigator, renders the
             participant unable to understand the nature, scope, and possible consequences of the
             study or precludes the participant from following and completing the protocol.

          -  Are currently enrolled in any other clinical trial involving an investigational
             product or any other type of medical research judged not to be scientifically or
             medically compatible with this study.
Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS).
Condition: Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: dimethyl fumarate
Intervention description: Initial oral dose for 7 days with maintenance dose thereafter
Intervention MeSH terms: Dimethyl Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 218.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Tecfidera; DMF; dimethyl fumarate

Summary:

      The primary objective of the study is to evaluate the effect of BG00012 on lymphocyte subset
      counts during the first year of treatment in subjects with relapsing-remitting multiple
      sclerosis (RRMS). A secondary objective is to evaluate the pharmacodynamic effect on absolute
      lymphocyte counts (ALCs) and immunoglobulins (Igs) during the first year of treatment.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Subjects of childbearing potential (including female subjects who are post-menopausal
             for less than 1 year) must practice effective contraception during the study and be
             willing and able to continue contraception for 30 days after their last dose of study
             treatment.

          -  Must have a confirmed diagnosis of RRMS according to the revised McDonald criteria
             (2010) [Polman 2011]

        Key Exclusion Criteria:

          -  History of or positive test result at Screening for:

          -  human immunodeficiency virus

          -  hepatitis C virus antibody

          -  hepatitis B infection

          -  Drug or alcohol abuse within 1 year prior to Screening.

          -  Prior treatment with any of the following:

          -  cladribine

          -  mitoxantrone

          -  total lymphoid irradiation

          -  alemtuzumab

          -  T-cell or T-cell receptor vaccination

          -  any therapeutic monoclonal antibody, with the exception of natalizumab or daclizumab

          -  Treatment with any of the following medications or procedures within 6 months prior to
             Baseline (Day 1):

          -  DMF (given as Fumaderm®) or BG00012; enrollment will be limited to no more than 40
             subjects (out of 200) with prior DMF exposure

          -  cyclosporine

          -  azathioprine

          -  methotrexate

          -  mycophenolate mofetil

          -  intravenous (IV) Ig

          -  plasmapheresis or cytapheresis

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Study to Test Rizatriptan in the Early Treatment of Acute Migraine (0462-081)
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Comparator: rizatriptan benzoate; Comparator: Placebo
Intervention description: Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack; Matching placebo; one dose, treatment of a single migraine attack
Intervention MeSH terms: Rizatriptan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 207.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to test the effectiveness of rizatriptan benzoate in the early
      treatment of an acute migraine attack.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Greater than one year history of migraine

          -  Attacks typically mild when they begin and progress to moderate or severe

          -  Experience 1-4 migraine attacks per month

        Exclusion Criteria:

          -  More than 15 headache days per month

          -  Heart disease

          -  Uncontrolled high blood pressure
An Effectiveness and Safety Study for Levofloxacin in Chronic Prostatitis
Condition: Prostatitis
MeSH terms: Prostatitis
Intervention: levofloxacin; levofloxacin; levofloxacin
Intervention description: 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.; 750mg tablet once daily for 3 weeks followed by 1 week of placebo.; 500mg tablet once daily for 4 weeks.
Intervention MeSH terms: Levofloxacin; Ofloxacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 242.0
Sex: Male
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Chronic Prostatitis; Prostatitis; levofloxacin; Levaquin

Summary:

      The purpose of this study is to compare the safety and effectiveness of levofloxacin 750 mg
      for 2 weeks or 750 mg for 3 weeks, compared to levofloxacin 500 mg for 4 weeks in the
      treatment of chronic prostatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males 40 years of age or older

          -  A clinical diagnosis of chronic prostatitis as evidenced by the following two
             criteria: 1. Clinical signs and symptoms of prostatitis including a soft, tender
             prostate without noticeable nodularity with one or more of the following signs or
             symptoms: painful or difficult urination, suprapubic discomfort, painful ejaculation,
             low back pain, perineal discomfort, urinary frequency, urinary urgency or hesitancy,
             decreased urinary stream, urinary retention, pain on digital rectal examination,
             perineal tenderness or pain, fever, chills. 2. A history of chronic prostatitis as
             defined as: symptomatic prostatitis - a clinical diagnosis of prostatitis having been
             made for at least one previous episode that lasted four weeks, or two or more episodes
             during the previous twelve months.

        Exclusion Criteria:

          -  Any condition which may interfere with the evaluation of study drug including
             transurethral prostatectomy within six months of enrollment, the presence of a
             permanent transurethral catheter or a history of cystostomy or nephrostomy

          -  Taking hormone therapy

          -  Known prostatic carcinoma

          -  Allergy to levofloxacin, ofloxacin, ciprofloxacin, or other members of the quinolone
             class of antibacterials.
Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Intervention: olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ) tablets; olmesartan medoxomil (OM)/ hydrochlorothiazide (HCTZ) 20mg/25mg
Intervention description: olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ)tablets 40mg/25mg + 20mg/25mg matching placebo tablets once daily for 8 weeks; olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ)20mg/25mg tablet + 40mg/25mg matching placebo tablet once a day for 8 weeks
Intervention MeSH terms: Hydrochlorothiazide; Olmesartan; Olmesartan Medoxomil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1011.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Moderate-to-Severe Hypertension; Essential Hypertension; Combination Therapy; Fixed-Combination Dose

Summary:

      The study will evaluate the blood pressure lowering effects of two different dosages of the
      combination of olmesartan and hydrochlorothiazide in patients with moderate or severe high
      blood pressure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female Europeans aged 18 years or older with moderate to severe HTN, defined
             as follows (conventional BP measurements)

        Exclusion Criteria:

          -  Female patients of childbearing potential pregnant, lactating or planning to become
             pregnant during the trial period.

          -  Patients with serious disorders which may limit the ability to evaluate the efficacy
             or safety of the study medication, including cerebrovascular, cardiovascular, renal,
             respiratory, hepatic, gastrointestinal, endocrine or metabolic, haematological or
             oncological, neurological and psychiatric diseases.

          -  Patients having a history of the following within the last six months:

               -  myocardial infarction,

               -  unstable angina pectoris,

               -  percutaneous coronary intervention,

               -  severe heart failure,

               -  hypertensive encephalopathy, cerebrovascular accident (stroke) or

               -  transient ischaemic attack.

          -  Patients with clinically significant abnormal laboratory values at screening.

          -  Patients with secondary HTN.