bioihbjkbjnl/mcl2 huggingface dataset:
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy Infants
Condition: Pneumococcal Disease
MeSH terms: Pneumococcal Infections
Intervention: 20-valent pneumococcal conjugate vaccine; 13-valent pneumococcal conjugate vaccine
Intervention description: 20-valent pneumococcal conjugate vaccine; 13-valent pneumococcal conjugate vaccine
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1258.0
Sex: All
Minimum age: 42 Days
Maximum age: 112 Days
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series
      in Healthy Infants
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female infants born at >36 weeks of gestation and 2 months of age at the time
             of consent.

          -  Healthy infants determined by clinical assessment, including medical history and
             clinical judgment, to be eligible for the study.

        Exclusion Criteria:

          -  History of severe adverse reaction associated with a vaccine and/or severe allergic
             reaction (eg, anaphylaxis).

          -  Major known congenital malformation or serious chronic disorder.

          -  Other acute or chronic medical or psychiatric condition or laboratory abnormality that
             may increase the risk associated with study participation or investigational product
             administration or may interfere with the interpretation of study results and, in the
             judgment of the investigator, would make the participant inappropriate for entry into
             this study.

          -  Previous vaccination with any licensed or investigational pneumococcal vaccine, or
             planned receipt through study participation.
An Efficacy and Safety Study of Ravulizumab in ALS Participants
Condition: Amyotrophic Lateral Sclerosis; ALS
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Intervention: Placebo; Ravulizumab
Intervention description: Single loading dose via intravenous infusion, followed by regular maintenance dosing, based on weight.; Single loading dose via intravenous infusion, followed by regular maintenance dosing, based on weight.
Intervention MeSH terms: Ravulizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 382.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ravulizumab; ALXN1210; Ultomiris; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; ALS

Summary:

      The purpose of the study is to assess the efficacy and safety of ravulizumab for the
      treatment of adult participants with ALS.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. A diagnosis of sporadic or familial ALS, defined by the El Escorial criteria
             (possible, laboratory-supported probable, probable, or definite ALS).

          2. ALS onset ≤ 36 months from Screening.

          3. Documented meningococcal vaccination not more than 3 years prior to, or at the time
             of, initiating study treatment.

          4. Upright slow vital capacity ≥ 65% predicted at Screening.

          5. If on riluzole, participant must be on a stable dose for 30 days; if on edaravone,
             participant must be on a stable dose for 60 days (2 cycles).

          6. Body weight ≥ 40 kilograms at Screening.

          7. Contraceptive use by men or women should be consistent with local regulations
             regarding the methods of contraception for those participating in clinical studies.

        Key Exclusion Criteria:

          1. History of Neisseria meningitidis infection.

          2. Human immunodeficiency virus (HIV) infection (evidenced by HIV 1 or HIV 2 antibody
             titer).

          3. Dependence on invasive or non-invasive mechanical ventilation.

          4. Previously or currently treated with a complement inhibitor.

          5. Exposure to an investigational drug or device within 30 days of Screening or 5 half
             lives of the study drug, whichever is greater.
Open-Label Extension Study to Evaluate Long Term Safety and Treatment Effect of DiaPep277®
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Intervention: DiaPep277®
Intervention description: 1 mg of DiaPep277® subcutaneously in the upper arm at 0, 3, 6, 9, 12, 15, 18, and 21 months, for a total of 8 administrations
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 47 Years
Healthy volunteers: No
Keywords: C peptide; beta cell function; immune modulation of type 1 diabetes; immune intervention in type 1 diabetes

Summary:

      This is an extension study to evaluate the safety and tolerability of long-term treatment
      with DiaPep277® and to determine the long-term treatment effect of DiaPep277® on parameters
      of metabolic control and on preservation of beta-cell function in subjects who have long
      exposure to DiaPep277®.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients with type 1 diabetes who participated in the 1001 study

          -  residual beta-cell function demonstrated by stimulated C-peptide ≥ 0.20 nmol/L.

        Exclusion Criteria:

          -  The subject has any significant ongoing diseases or conditions that is likely to
             affect the subject's response to treatment

          -  The subject has a history of any kind of malignant tumor.

          -  The subject has clinical evidence of any diabetes-related complication

          -  Subject has history of endogenous allergic reactivity:

          -  The subject has a known immune deficiency
A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Placebo and an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Condition: Chronic Plaque Psoriasis; Moderate to Severe Chronic Plaque Psoriasis; Psoriatic Arthritis
MeSH terms: Arthritis, Psoriatic; Psoriasis
Intervention: Bimekizumab; Ustekinumab; Placebo
Intervention description: Bimekizumab will be provided at pre-specified time intervals.; Ustekinumab will be provided as dose 1 for subjects weighing <=100 kg and as dose 2 for subjects weighing >100 kg at pre-specified time intervals.; Subjects will receive Placebo at pre-specified time points.
Intervention MeSH terms: Ustekinumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 567.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bimekizumab; PSO; Psoriasis

Summary:

      This is a study to compare the efficacy of bimekizumab versus placebo and an active
      comparator in the treatment of subjects with moderate to severe chronic plaque psoriasis
      (PSO).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be at least 18 years of age

          -  Chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening Visit

          -  Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO
             >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale

          -  Subject is a candidate for systemic PSO therapy and/or phototherapy

          -  Female subject of child bearing potential must be willing to use highly effective
             method of contraception

        Exclusion Criteria:

          -  Subject has an active infection (except common cold), a recent serious infection, or a
             history of opportunistic or recurrent chronic infections

          -  Subject has concurrent acute or chronic viral hepatitis B or C or human
             immunodeficiency virus (HIV) infection

          -  Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB
             infection, or has current or history of nontuberculous mycobacterium (NTMB) infection

          -  Subject has any other condition, including medical or psychiatric, which, in the
             Investigator's judgment, would make the subject unsuitable for inclusion in the study

          -  Presence of active suicidal ideation or positive suicide behavior

          -  Presence of moderately severe major depression or severe major depression

          -  Subject has any active malignancy or history of malignancy within 5 years prior to the
             Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell
             carcinoma, or in situ cervical cancer
Prophylactic Use of Maribavir for the Prevention of Cytomegalovirus (CMV) Disease in Stem Cell Transplant Recipients
Condition: Cytomegalovirus Infections
MeSH terms: Cytomegalovirus Infections
Intervention: maribavir; placebo
Intervention description: 100 mg twice daily for up to 12 weeks; twice daily for up to 12 weeks
Intervention MeSH terms: Maribavir
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 681.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: prevention; prophylaxis; Cytomegalovirus; CMV; allogeneic stem cell transplant; SCT

Summary:

      The purpose of this research study is to investigate whether or not maribavir is safe and
      effective for preventing CMV disease when taken by mouth for up to 12 weeks in patients who
      have had a stem cell transplant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Allogeneic stem cell transplant recipient

          -  Recipient or donor CMV seropositive

          -  Have transplant engraftment

          -  Able to swallow tablets

        Exclusion Criteria:

          -  CMV organ disease

          -  HIV infection

          -  Use of other anti-CMV therapy post-transplant
Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares
Condition: Gout
MeSH terms: Gout
Intervention: Rilonacept; Placebo; Allopurinol
Intervention description: Rilonacept 160 mg loading dose followed by Rilonacept 80 mg/2 mL injections qw for 52 weeks.; Placebo loading dose followed by placebo injections (2 mL) qw for 52 weeks.; Allopurinol 50 or 100 mg, orally daily for 52 weeks as background treatment.
Intervention MeSH terms: Rilonacept; Allopurinol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 220.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to determine the safety and tolerability of rilonacept for
      participants with gout who were initiating allopurinol.
    

Eligibility criteria:

        Inclusion Criteria:

        Key Inclusion criteria:

          -  Male or female participants aged 18 to 80 years;

          -  Previously met the preliminary criteria of the ARA for the classification of the acute
             arthritis of primary gout;

          -  Serum uric acid greater than or equal to 7.5 mg/dL at the screening visit;

          -  A self-reported history of at least 2 gout flares in the year prior to screening.

        Exclusion Criteria:

        Key Exclusion criteria:

          -  Pregnant or nursing, or planning to become pregnant or father a child within 3 months
             after receiving the last dose of study drug;

          -  Participants requiring dialysis;

          -  Participants who had had an organ transplant;

          -  Persistent chronic or active infections;

          -  Previous exposure to rilonacept;

          -  Use of allopurinol, benzbromarone, febuxostat, probenecid or sulfinpyrazone within 84
             days prior to the screening visit.
A Study of Dulaglutide in Japanese Participants With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: LY2189265; Insulin glargine; Sulfonylureas (SU); Biguanide (BG)
Intervention MeSH terms: Insulin Glargine; Dulaglutide; Biguanides
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 361.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Glucagon-like peptide-1 (GLP-1)

Summary:

      The purpose of this trial is to examine the efficacy and safety of once-weekly LY2189265
      (dulaglutide) in participants with type 2 diabetes mellitus taking an oral antihyperglycemic
      medication (OAM).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who have had a diagnosis of type 2 diabetes mellitus for at least 6
             months before screening

          -  Participants who have been taking sulfonylurea (glibenclamide, gliclazide, or
             glimepiride) and/or biguanide (metformin or buformin). The dose of the drug(s) during
             the 8 weeks before screening must be stable

          -  Participants who have a qualifying glycosylated hemoglobin (HbA1c) value of 7.0% to
             10.0% at screening

          -  Participants who have a body mass index (BMI) of 18.5 to 35.0 kilograms per meter
             squared (kg/m^2)

        Exclusion Criteria:

          -  Participants who have a diagnosis of type 1 diabetes

          -  Participants who have previously been treated with any other glucagon-like peptide 1
             (GLP-1) analog

          -  Participants who have received therapy with an alpha-glucosidase inhibitor (a-GI),
             thiazolidinedione (TZD), glinide, or dipeptidyl peptidase-IV (DPP-IV) inhibitor within
             3 months before screening

          -  Participants who have been currently taking insulin or have had previous insulin
             treatment within 3 months before screening

          -  Participants who have obvious clinical signs or symptoms of pancreatitis, a history of
             chronic pancreatitis, or acute pancreatitis at screening, as determined by the
             investigator. Participants who have a serum amylase concentration ≥ 3 times the upper
             limit of the reference range and/or a serum lipase concentration ≥ 2 times the upper
             limit of the reference range, as determined by the central laboratory at screening

          -  Participants who have self or family history of medullary C-cell hyperplasia, focal
             hyperplasia, or medullary thyroid carcinoma (MTC)
PALISADE Follow-on Study (ARC004)
Condition: Peanut Allergy
MeSH terms: Hypersensitivity; Peanut Hypersensitivity
Intervention: AR101
Intervention description: AR101 powder provided in capsules & sachets
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 388.0
Sex: All
Minimum age: 4 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: AR101; Characterized Peanut Allergen; CPNA (Characterized Peanut Allergen); OIT (oral immunotherapy); Peanut Allergy; Allergy; Peanut-Allergic Children; Peanut-Allergic Adults; Desensitization; PALISADE

Summary:

      The purpose of this study is to demonstrate the safety, tolerability, and efficacy of AR101
      through oral immunotherapy (OIT) in peanut-allergic children and adults who have completed
      the ARC003 study.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Completion of the ARC003 study

          -  Written informed consent and/or assent from subjects/guardians as appropriate

          -  Use of effective birth control by sexually active female subjects of child-bearing
             potential

        Key Exclusion Criteria:

          -  Early discontinuation from the ARC003 study

          -  Meets any longitudinally applicable ARC003 study exclusion criteria

          -  (Group 2 only) Failure to tolerate ≥ 443 mg cumulative of peanut protein with no or
             mild symptoms in the ARC003 study Exit DBPCFC

          -  Any other condition that, in the opinion of the Investigator, precludes participation
             for reasons of safety
A Study Comparing Cardiovascular Effects of Ticagrelor Versus Placebo in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Ticagrelor 60 mg; Ticagrelor placebo
Intervention description: Ticagrelor 60 mg bd taken orally as tablets; Ticagrelor placebo bd taken orally as tablets
Intervention MeSH terms: Ticagrelor
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 19271.0
Sex: All
Minimum age: 50 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Diabetes; Coronary artery disease; Outcome; Prevention; Antiplatelet

Summary:

      The purpose of this study is to compare the effect of ticagrelor versus placebo in patients
      with Type 2 Diabetes Mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

        Men or women ≥50 years of age with type 2 diabetes mellitus on treatment with a glucose
        lowering medication since at least 6 months, and either documented coronary artery
        occlusive disease or previous revascularization of a coronary artery.

        Key Exclusion Criteria:

        History of myocardial infarction or any stroke; planned treatment with agents inhibiting
        blood clotting; planned use of ASA/Aspirin at doses above 150 mg daily; planned coronary,
        cerebrovascular, or peripheral arterial revascularization; patients with known bleeding
        disorders and patients who need chronic oral anticoagulant therapy or chronic
        low-molecular-weight heparin; history of intracranial bleeding at any time, or a history of
        bleeding from the gastrointestinal tract within the last 6 months or a major surgery within
        the last 30 days; patients with known severe liver disease or with kidney failure requiring
        dialysis
Rivaroxaban Versus Aspirin in Secondary Prevention of Stroke and Prevention of Systemic Embolism in Patients With Recent Embolic Stroke of Undetermined Source (ESUS)
Condition: Stroke
MeSH terms: Stroke; Embolic Stroke; Embolism
Intervention: Rivaroxaban (Xarelto, BAY59-7939); Acetylsalicylic acid (Aspirin, BAY1019036); Rivaroxaban-Placebo; Aspirin-Placebo
Intervention description: 15 mg, once daily, orally, tablet; 100 mg, once daily, orally, tablet; Matching placebo, once daily, orally, tablet; Matching placebo, once daily, orally, tablet
Intervention MeSH terms: Aspirin; Rivaroxaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 7213.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Rivaroxaban; Xarelto; Aspirin; Acetylsalicylic acid (ASA); Oral Anticoagulant; Blood Thinner; Stroke; Ischemic Stroke; Cryptogenic Stroke; Embolic stroke of undetermined source; ESUS; Transient Ischemic Attack; Thromboembolism; Cerebrovascular Disease

Summary:

      This is a study in patients who recently had a brain attack (stroke) and in whom no clear
      cause of the stroke could be identified. These strokes are likely due to a blood clot and
      therefore, can be called embolic stroke of undetermined source. The abbreviation is ESUS. The
      study will compare 2 blood thinners. Patients will be randomly assigned to either Rivaroxaban
      15 mg or Aspirin 100 mg and the study is intended to show, if patients given rivaroxaban have
      fewer blood clots in the brain (stroke) or in other blood vessels.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recent ESUS (between 7 days and 6 months), defined as:

          -  Recent ischemic stroke (including transient ischemic attack with positive
             neuroimaging) visualized by brain imaging that is not lacunar, and

          -  Absence of cervical carotid atherosclerotic stenosis> 50% or occlusion, and

          -  No atrial fibrillation after ≥ 24-hour cardiac rhythm monitoring, and

          -  No intra-cardiac thrombus on either transesophageal or transthoracic echocardiography,
             and

          -  No other specific cause of stroke (for example, arteritis, dissection,
             migraine/vasospasm, drug abuse)

        Exclusion Criteria:

          -  Severely disabling stroke (modified Rankin score ≥4)

          -  Indication for chronic anticoagulation or antiplatelet therapy

          -  Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m^2
Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects Who Are Intolerant to Statins
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Intervention: Bococizumab (PF-04950615;RN316); Atorvastatin; Placebo for Bococizumab (PF-04950615;RN316); Placebo for atorvastatin
Intervention description: 150 mg every 2 weeks by subcutaneous injection for 24 weeks; Atorvastatin PO QD; 150 mg every 2 weeks by subcutaneous injection for 24 weeks; PO QD
Intervention MeSH terms: Atorvastatin; Bococizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 184.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hyperlipidemia; statin intolerance

Summary:

      This study is a multicenter, double blinded, active and placebo controlled randomized
      clinical trial to demonstrate a superior lipid lowering effect of Bococizumab (PF-04950615;
      RN316) compared to placebo in subjects who are statin intolerant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hyperlipidemia

          -  Statin Intolerant

          -  Fasting LDL-C > = 70 mg/dL Fasting TG < = 400 mg/dL

        Exclusion Criteria:

          -  Pregnant or breastfeeding females

          -  Cardiovascular or cerebrovascular event or procedure within 90 days

          -  Severe or life-threatening adverse events with past use of statins

          -  Poorly controlled hypertension