bioihbjkbjnl/mcl2 huggingface dataset:
Persistence Of Antibody Responses Among Children Who Previously Received Novartis MenACWY Conjugate Vaccine or Meningococcal C Conjugate Vaccine
Condition: Meningococcal Disease
MeSH terms: Meningococcal Infections
Intervention: MenACWY-CRM
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 205.0
Sex: All
Minimum age: 22 Months
Maximum age: 45 Months
Healthy volunteers: No
Keywords: Meningococcal; ACWY; Conjugate Vaccine; Meningitis; Toddlers; Children; Persistence; Boost

Summary:

      The primary purpose of this study is to evaluate the persistence of bactericidal antibodies
      in children of approximately 22 to 45 months of age previously enrolled in the V59P22 study
      (NCT00667602) who received Novartis MenACWY Conjugate Vaccine or Meningococcal C Conjugate
      Vaccine. This is measured by percentage of subjects with human Serum Bactericidal Assay
      (hSBA) titers ≥ 1:8 directed against Neisseria meningitidis serogroups A, C, W-135, and Y. In
      addition the response one month post an additional dose of Novartis MenACWY will be measured
      by percentage of subjects with hSBA titers ≥ 1:8 and GMTs.
    

Eligibility criteria:

        Inclusion Criteria:

        Children eligible to be enrolled in the study were those

          -  whose parents provide written informed consent;

          -  were in generally good health based on the clinical judgment of the investigators;

          -  subjects were 22-45 months of age at the time of enrollment into V59P22E1;

          -  subject who had participated in the parent V59P22 study.

        Exclusion Criteria:

        Main exclusion criteria:

          -  Subjects with serious, acute, or chronic illnesses

          -  Subjects who had received any other licensed vaccines within 28 days (Exception:
             Influenza vaccine was allowed up to 14 days prior to and no less than 14 days after
             the study immunization) prior to enrolment and any study visit

          -  Subjects who had received any Meningococcal vaccine since the study dose of MenACWY or
             Men C at 12 months of age in V59P22 trial.
A Study of Safety and Effectiveness of Golimumab in Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Golimumab; Methotrexate; Placebo
Intervention description: 2mg/kg or 4mg/kg will be administered as an IV infusion over 30 minutes; Active MTX capsules, filled with microcrystalline cellulose (Avicel PH 102) and a 2.5 mg MTX tablet, will be administered at the same dose as before the study entry.; Placebo solution will be administered through IV infusion in Group V and oral placebo capsules (sham MTX) filled with microcrystalline cellulose (Avicel PH 102) will be administered in Group II and IV.
Intervention MeSH terms: Golimumab; Methotrexate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 643.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid arthritis; Golimumab; Methotrexate; Tumor Necrosis Factor-alpha; Immunology

Summary:

      The purpose of this study is to assess the clinical effectiveness and safety of golimumab
      intravenous (IV) infusions every 12 weeks with or without Methotrexate (MTX), compared with
      MTX alone, in patients with active rheumatoid arthritis (RA) despite concurrent MTX
      treatment. In addition, the safety of subcutaneous (SC) golimumab injections following
      transition from IV golimumab infusions will also be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

        - Must have a diagnosis of active rheumatoid arthritis (RA) (according to the revised 1987
        criteria of the ARA (American Rheumatism Association) with at least 4 swollen and 4 tender
        joints for at least 3 months prior to screening - Have been treated with and tolerated
        methotrexate (MTX) at a dose of at least 15 mg per week for at least 3 months prior to
        screening - Have been on a stable MTX dose of greater than or equal to 15 mg per week and
        less than or eual to 25 mg per week for at least 4 weeks prior to screening - If using non
        steroidal anti-inflammatory agents (such as naproxen) or other pain relievers for RA, must
        be on a stable dose for at least 2 weeks prior to the first administration of study agent

        Exclusion Criteria:

        - Participants having known hypersensitivity (severe allergy) to human immunoglobulin
        proteins or other components of golimumab - Having known clinically serious adverse
        reaction to a biologic anti-TNF agent - Have had history of latent or active granulomatous
        infection, including tuberculosis, histoplasmosis, or coccidioidomycosis, prior to
        screening
Efficacy of Antibiotics in Children With Acute Sinusitis: Which Subgroups Benefit?
Condition: Sinusitis; Respiratory Tract Infections
MeSH terms: Respiratory Tract Infections; Sinusitis
Intervention: Amoxicillin-clavulanate; Placebo
Intervention description: Amoxicillin-clavulanate (90/6.4 mg/kg/d in 2 divided dosed for 10 days); placebo made to match the study antibiotic given twice a day orally for 10 days
Intervention MeSH terms: Amoxicillin; Clavulanic Acid; Clavulanic Acids; Amoxicillin-Potassium Clavulanate Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 515.0
Sex: All
Minimum age: 2 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: pediatrics; antibiotics; placebo

Summary:

      The objective of this trial is to determine whether certain subgroups of children with acute
      sinusitis exist in whom antibiotic therapy can be appropriately withheld.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets criteria for "persistent" or "worsening" presentations of sinusitis

          -  Baseline score ≥9 on the Pediatric Rhinosinusitis Symptom Scale

        Exclusion Criteria:

          -  Severe presentation (≥3 days of colored nasal discharge and fever ≥39°C

          -  Asthma/allergic rhinitis explains symptoms

          -  Allergy to amoxicillin-clavulanate

          -  Immotile cilia syndrome

          -  Cystic fibrosis

          -  Immunodeficiency

          -  Parental inability to read/write English or Spanish

          -  Other concurrent infection (e.g., pneumonia, acute otitis media, streptococcal
             pharyngitis)

          -  Systemic toxicity

          -  Wheezing on exam

          -  Antibiotic use within 15 days
Long-Term, Open Label Atomoxetine Study
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: atomoxetine
Intervention description: 0.5-1.8 mg/kg/day, by mouth (PO), for up to 5 years
Intervention MeSH terms: Atomoxetine Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1553.0
Sex: All
Minimum age: 6 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      To learn about the safety and any side effects of atomoxetine when given to children and
      adolescents for about 5 years (long-term) and to learn whether atomoxetine can help children
      and adolescents with attention-deficit/hyperactivity disorder (ADHD) who take the drug for
      about 5 years (long-term).

      Study participants can be atomoxetine naive, atomoxetine experienced whose therapy has been
      interrupted or, atomoxetine experienced on a known stable dose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be at least 6 years old but less than 18 years old when enrolled in first
             atomoxetine study

          -  Must meet the study criteria for ADHD

          -  Must be willing to have blood drawn and to complete other test required for this study

        Exclusion Criteria:

          -  allergic to more than 1 kind of medicine or have had multiple bad reactions to any
             drug

          -  taking certain medicines that could interact with atomoxetine

          -  plan to move too far away from a doctor participating in this study in the next 5
             years

          -  current or past history of any of the following: alcohol or drug abuse within the past
             3 months, bipolar I or II disorder, high blood pressure, organic brain disease or
             seizures, psychosis, other disorders or conditions diagnosed by a doctor that might
             make you unsuitable to participate in this study
FOLFOX6m Plus SIR-Spheres Microspheres vs FOLFOX6m Alone in Patients With Liver Mets From Primary Colorectal Cancer
Condition: Colorectal Cancer Metastatic
MeSH terms: Colorectal Neoplasms
Intervention: FOLFOX6m; SIR-Spheres microspheres
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 209.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: colon; rectum; metastatic colorectal cancer; liver metastases

Summary:

      This study is a randomized, multi-center study that will compare the efficacy and safety of
      selective internal radiation therapy (SIRT) using SIR-Spheres microspheres plus a standard
      chemotherapy regimen of FOLFOX6m versus FOLFOX6m alone as first-line therapy in patients with
      non-resectable liver metastases from primary colorectal carcinoma.

      Treatment with the biologic agent bevacizumab, if part of the standard of care at
      participating institutions, is allowed within this study at the discretion of the
      Investigator.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years or older

          -  Willing and able to provide written informed consent

          -  Unequivocal and measurable CT evidence of liver metastases which are not treatable by
             surgical resection or local ablation

          -  Limited extra-hepatic metastases in the lung and/or lymph nodes are permitted (Lung: 5
             lesions total, < 1 cm, or 1 single lesion of up to 1.7 cm; Lymph nodules in one single
             anatomic area (pelvis, abdomen or chest): any number, < 2 cm)

          -  All imaging evidence used as part of the screening process must be within 28 days

          -  Suitable for either treatment regimen

          -  WHO performance status 0-1

          -  Adequate hematological, renal and hepatic function

          -  Life expectancy of at least 3 months without any active treatment

        Exclusion Criteria:

          -  Evidence of ascites, cirrhosis, portal hypertension, main portal or venous involvement
             or thrombosis as determined by clinical or radiologic assessment

          -  Previous radiotherapy delivered to the liver

          -  Non-malignant disease that would render the patient unsuitable for treatment according
             to the protocol

          -  Peripheral neuropathy > grade 2 (NCI-CTC)

          -  Dose-limiting toxicity associated with previous adjuvant 5-FU or oxaliplatin
             chemotherapy

          -  Prior non-adjuvant chemotherapy for any malignancy. Adjuvant chemotherapy for
             colorectal cancer is permitted provided that it was completed more than 6 months
             before entry into the study

          -  Pregnant or breast feeding

          -  Concurrent or prior history of cancer other than adequately treated non-melanoma skin
             cancer or carcinoma in situ of the cervix

          -  Allergy to contrast media that would preclude angiography of the hepatic arteries
A Study of ALKS 3831 in Adults With Acute Exacerbation of Schizophrenia (the ENLIGHTEN-1 Study)
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: ALK3831; Olanzapine; Placebo
Intervention description: Daily dosing; Daily dosing; Daily dosing
Intervention MeSH terms: Olanzapine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 403.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Alkermes; ALKS 3831; Samidorphan; Schizophrenia; Acute Exacerbation of Schizophrenia

Summary:

      This study will evaluate the efficacy of ALKS 3831 in adult subjects with acute exacerbation
      of schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a body mass index (BMI) of 18.0 - 40.0 kg/m^2

          -  Meets criteria for the diagnosis of schizophrenia

          -  Resides in a stable living situation when not hospitalized

          -  Is willing and able to provide government-issued identification

          -  Additional criteria may apply

        Exclusion Criteria:

          -  Has had a psychiatric hospitalization for more than 30 days during the 90 days before
             screening

          -  Subject initiated first antipsychotic treatment within the past 12 months, or <1 year
             has elapsed since the initial onset of active-phase of schizophrenia symptoms

          -  Subject poses a current suicide risk

          -  Subject has a history of treatment resistance

          -  Subject has a history of poor or inadequate response to treatment with olanzapine

          -  Subject requires or has had electroconvulsive therapy (ECT) treatment in the 2-month
             period prior to screening

          -  Subject has a diagnosis of moderate or severe alcohol or drug use disorder

          -  Subject has a positive urine drug screen for opioids, amphetamine/methamphetamine,
             phencyclidine, or cocaine at screening

          -  Additional criteria may apply
Efficacy of Nalmefene in Patients With Alcohol Dependence
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Intervention: Placebo; Nalmefene
Intervention description: as-needed use, tablets, orally, 6 months; 18.06 mg, as-needed use, tablets, orally, 6 months. 18.06 mg nalmefene equals 20 mg nalmefene hydrochloride.
Intervention MeSH terms: Nalmefene
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 678.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pharmacologic Actions; Alcohol-Related Disorders; Alcoholism; Mental Disorders; Central Nervous System Agents

Summary:

      The purpose of the study is to evaluate the efficacy, safety and tolerability of nalmefene in
      the treatment of alcohol dependence.
    

Eligibility criteria:

        Inclusion Criteria:

        In- and outpatients who:

          -  had a primary diagnosis of alcohol dependence according to Diagnostic and Statistical
             Manual of Mental Disorders - text revision (DSM-IV-TR) criteria

          -  had had ≥6 HDDs in the 4 weeks preceding the Screening Visit

          -  had had an average alcohol consumption at WHO medium risk level or above in the 4
             weeks preceding the Screening Visit

        Exclusion Criteria:

        The patient:

          -  had a DSM-IV Axis I disorder other than alcohol dependence or nicotine dependence

          -  had an antisocial personality disorder

          -  had risk of suicide evaluated by the suicidality module of the Mini-International
             Neuropsychiatric Interview (MINI)

          -  had a history of delirium tremens or alcohol withdrawal seizures

          -  reported current or recent (within 3 months preceding screening) treatment with
             disulfiram, acamprosate, topiramate, naltrexone or carbimide, or with any opioid
             antagonists

          -  reported current or recent treatment with antipsychotics or antidepressants

          -  was pregnant or breast-feeding

        Other protocol-defined inclusion and exclusion criteria may apply.
A Study of Paclitaxel With or Without Ramucirumab (IMC-1211B) in Metastatic Gastric Adenocarcinoma
Condition: Gastric Cancer
MeSH terms: Adenocarcinoma
Intervention: Ramucirumab (IMC-1211B) DP; Placebo; Paclitaxel
Intervention description: 8 milligrams/kilogram (mg/kg) intravenous (IV) infusion on Days 1 and 15 of every 4-week cycle; Ramucirumab placebo IV infusion on Days 1 and 15 of every 4-week cycle; Paclitaxel 80 milligrams per square meter (mg/m²) IV infusion on Days 1, 8, and 15 of every 4-week cycle
Intervention MeSH terms: Paclitaxel; Ramucirumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 665.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastatic Adenocarcinoma; Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma

Summary:

      This is a Phase III randomized multicenter double-blind, placebo controlled trial evaluating
      the safety and efficacy of paclitaxel plus ramucirumab (IMC-1211B) drug product (DP) compared
      to paclitaxel plus placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent

          -  histologically or cytologically confirmed gastric or gastroesophageal junction
             adenocarcinoma

          -  Metastatic disease or locally advanced, unresectable disease

          -  Disease progression during or within 4 months after the last dose of the first-line
             therapy (platinum/fluoropyrimidine doublet with or without anthracycline)

          -  Organs are functioning well (liver, kidney, blood)

          -  Good performance status Eastern Cooperative Oncology Group (ECOG) Performance Status
             (PS) 0 to 1

        Exclusion Criteria:

          -  First line chemotherapy for metastatic gastric cancer other than
             platinum/fluoropyrimidine doublet with or without anthracycline

          -  Previous systemic therapy with other anti-angiogenic drugs

          -  Uncontrolled high blood pressure

          -  Symptomatic or poorly controlled heart disease or had a heart attack or stroke within
             the last 6 month

          -  Evidence of central nervous system (CNS) metastasis at baseline
Study to Evaluate Efficacy of Odanacatib (MK-0822) on Bone Mineral Density (BMD) and Bone Micro-architecture and Overall Safety in Postmenopausal Women (MK-0822-031)
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: Odanacatib; Placebo; Vitamin D3; Calcium supplement
Intervention description: Odanacatib 50 mg tablets, taken orally once weekly for 24 months.; Matching placebo tablets to odanacatib taken orally once weekly for 24 months.; Vitamin D3 tablets (5600 IU) taken orally once weekly for 24 months.; Calcium supplement 500 mg tablet taken orally once daily (up to ~1200 mg total) for 24 months.
Intervention MeSH terms: Calcium, Dietary; Vitamin D; Cholecalciferol; Calcium Carbonate; Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 214.0
Sex: Female
Minimum age: 45 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and treatment effect of 50 mg odanacatib (MK-0822) with
      Vitamin D versus placebo with Vitamin D in postmenopausal women with low bone density. The
      primary efficacy hypothesis is that odanacatib will increase aBMD at the lumbar spine
      compared to placebo at 12 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has been postmenopausal for 3 years

          -  Participant has BMD t-score at the total hip, hip trochanter, femoral neck, or lumbar
             spine ≥ -1.5 but > -3.5

          -  Participant has 2 hips that are evaluable by dual-energy X-ray absorptiometry (DXA)
             and quantitative computed tomography (QCT), e.g. contain no hardware from orthopedic
             procedures

          -  Participant is ambulatory

        Exclusion Criteria:

          -  Participant has had a previous hip fracture

          -  Participant has had >1 prior clinical vertebral fracture AND is a candidate for
             osteoporosis therapy

          -  Participant has been treated with oral bisphosphonates, strontium, parathyroid hormone
             (PTH) or other agents with an effect on bone

          -  Participant has had metabolic bone disorder other than osteoporosis

          -  Participant has renal stones, Parkinson's disease, multiple sclerosis (MS) or active
             parathyroid disease.
Evaluation of New or Worsening Lens Opacifications in Men With Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss
Condition: Cancer; Cataract; Low Bone Mineral Density; Osteopenia; Osteoporosis; Prostate Cancer
MeSH terms: Prostatic Neoplasms; Osteoporosis; Bone Diseases, Metabolic; Cataract
Intervention: Denosumab; Placebo
Intervention description: Prefilled syringe for subcutaneous (SC) injection administered at a dose of 60 mg; Prefilled syringe for subcutaneous (SC) injection
Intervention MeSH terms: Denosumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 769.0
Sex: Male
Minimum age: 30 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: Lens Opacification; Bone Loss; Androgen Deprivation Therapy; Non-metastatic prostate cancer

Summary:

      This is a phase 3, randomized, double-blind, placebo-controlled study to evaluate new or
      worsening lens opacifications in men with non-metastatic prostate cancer receiving denosumab
      for bone loss due to androgen deprivation therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men ≥ 30 years of age with non-metastatic prostate cancer, having undergone bilateral
             orchiectomy or initiated androgen deprivation therapy (ADT) with
             gonadotropin-releasing hormone (GnRH) agonists and is expected to continue on ADT for
             at least 12 months

          -  Adequate visual accuracy allowing eye testing

          -  Bone Mineral Density (BMD) requirements: Osteopenia if under 70 years of age;
             Osteopenia or normal BMD if over 70 years of age

          -  Signed informed consent

        Exclusion Criteria:

          -  Previous surgery for cataracts in both eyes, current diagnosis of cataracts, cataracts
             surgery foreseen in the near future, or ocular disease leading to visual loss

          -  Diagnosis of osteoporosis