bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV Vaccine in Young Males.
Condition: Infections, Papillomavirus
Intervention: Cervarix vaccine; Engerix-B vaccine
Intervention description: All subjects received an intramuscular injection into the deltoid of the non-dominant arm according to a 0, 1 and 6-month schedule.; All subjects received an intramuscular injection into the deltoid of the non-dominant arm according to a 0, 1 and 6-month schedule
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 270.0
Sex: Male
Minimum age: 10 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main aim of this vaccine is to prevent cervical cancer in women. However, it could also
      be relevant to vaccinate selected groups of males. Therefore, this study is designed to
      evaluate the safety and immunogenicity of the HPV vaccine in pre-teen and adolescent male
      subjects aged 10-18 years.
    

Eligibility criteria:

        Inclusion criteria:

          -  A male between, and including, 10 and 18 years of age at the time of the first
             vaccination.

          -  Written informed consent obtained from the subject prior to enrolment

          -  For subjects below the legal age of consent, a written informed consent must be
             obtained from the subject's parent/guardian. In addition, a written informed assent
             must be obtained from the subject.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  Free of obvious health problems as established by medical history and clinical
             examination before entering into the study.

        Exclusion criteria:

          -  Previous vaccination against Human Papillomavirus (HPV).

          -  Previous vaccination against Hepatitis B, known clinical history of Hepatitis B
             infection.

          -  Cancer or autoimmune disease under treatment.
Beta-blockers in Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: Carvedilol; Placebo
Intervention description: Beta-adrenergic receptor blocker; Placebo
Intervention MeSH terms: Carvedilol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The investigators will conduct a, randomized, phase 2, placebo-controlled, double-blinded,
      crossover trial of carvedilol in 26 PAH patients with World Health Organization functional
      class II or III symptoms and RV ejection fraction (EF) < 45% for 6 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 18 years

          -  WHO category 1 pulmonary arterial hypertension (Nice 2013)

          -  WHO functional class II-III

          -  RVEF by cardiac MRI < 45%

          -  Stable on PAH-specific therapy as defined by no change in PAH-specific treatment and
             functional class in the past 3 months. Patient can be on either mono or combination
             PAH-specific therapy

        Exclusion Criteria:

          -  Subjects will be excluded from participation in the study if any of the following
             conditions exist:

          -  Significant persistent bradycardia (resting heart rate < 60 bpm) without a permanent
             pacemaker

          -  Second or third degree AV block without a permanent pacemaker

          -  Significant sinus tachycardia (resting heart rate > 110 bpm)

          -  Use of anti-arrhythmic drugs

          -  Hypotension defined as systolic blood pressure < 100 mmHg at the time of enrollment

          -  Significant illness in the past 30 days requiring hospitalization

          -  Acute decompensated right heart failure within past 30 days

          -  Known allergy or intolerance to carvedilol or other β blockers

          -  Cardiac index < 2 l/min/m2 or right atrial pressure > 15 mm Hg by right heart
             catheterization within last 3 months

          -  Asthma

          -  Positive pregnancy test in patients of child bearing-potential
Long-term Efficacy, Safety and Tolerability of ACZ885 in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Canakinumab
Intervention description: Canakinumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 115.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis; Anti-interleukin-1 beta; ACZ885

Summary:

      This study will assess the long-term safety and tolerability of ACZ885 in patients with
      rheumatoid arthritis, as well as long-term efficacy, long-term preservation and/or
      improvement of joint structure and bone mineral density, and long term maintenance of
      health-related quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients (male and non-pregnant, non-lactating females) who completed the core
             CACZ885A2204, CACZ885A2206, or CACZ885A2207 study without serious or severe
             drug-related adverse effects may enter the extension study upon signing informed
             consent

        Exclusion Criteria:

          -  Patients for whom continued treatment in the extension is not considered appropriate
             by the treating physician.

          -  Patients who were non-compliant or who demonstrated a major protocol violation in the
             core study.

          -  Patients who did not complete / discontinued from the core study.

          -  Patients with drug related serious adverse events or severe adverse events.

        Other protocol-defined inclusion/exclusion criteria may apply.
Tiagabine to Enhance Slow Wave Sleep in Patients With Sleep Apnea
Condition: Sleep Apnea, Obstructive
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Intervention: Tiagabine; Placebo
Intervention description: GABA reuptake inhibitor; Placebo comparator
Intervention MeSH terms: Tiagabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: arousal threshold; phenotype; tiagabine; slow wave sleep

Summary:

      Obstructive sleep apnea (OSA) is common and has major health implications but treatment
      options are limited. Interestingly, the severity of OSA is profoundly reduced in deep sleep
      (called "slow wave sleep"), potentially via an increase in the stimulus required to arouse
      from sleep. Here the investigators test the idea that the medication called "tiagabine"
      improves slow wave sleep and reduces OSA severity. The investigators will also test whether
      tiagabine raises the arousal threshold (more negative esophageal pressure), and whether
      detailed OSA "phenotyping" characteristics can predict the improvement in OSA severity with
      this intervention.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed OSA (moderate-to-severe; apnea hypopnea index >15 events/hr)

        Exclusion Criteria:

          -  History of seizures
A Pilot Study of Rituximab for the Anticoagulation Resistant Manifestations of Antiphospholipid Syndrome
Condition: Antiphospholipid Syndrome
MeSH terms: Antiphospholipid Syndrome; Syndrome
Intervention: Rituximab
Intervention description: Rituximab 1000mg IV on Days 0 and 15
Intervention MeSH terms: Rituximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: antiphospholipid syndrome

Summary:

      RITuximab AntiphosPholipid Syndrome (RITAPS) Study is designed to evaluate whether a
      medication called rituximab would reduce the signs and symptoms of antiphospholipid antibody
      (aPL) -related certain clinical problems.
    

Eligibility criteria:

        Inclusion Criteria:

          -  - Positive aPL profile defined as:

               -  Positive lupus anticoagulant test as defined by the International Society on
                  Thrombosis and Haemostasis, on two or more occasions, at least 12 weeks apart
                  and/or

               -  Positive anticardiolipin antibody (aCL) immunoglobulin G(Ig)G/M/A isotype,
                  present in > 40U, on two or more occasions, at least 12 weeks apart and/or

               -  Positive anti-β2-glycoprotein-I (aβ2GPI) IgG/M/A isotype, present in > 40U, on
                  two or more occasions, at least 12 weeks apart

        AND

        - Clinical features attributable to aPL that are resistant to warfarin and/or heparin:

          -  Persistent thrombocytopenia and/or

          -  Persistent autoimmune hemolytic anemia and/or

          -  Cardiac valve disease and/or

          -  Chronic skin ulcers and/or

          -  Renal thrombotic microangiopathy and/or

          -  Cognitive dysfunction with/without white matter changes

        Exclusion Criteria (selected):

          -  > 4/11 American College of Rheumatology Classification Criteria for SLE

          -  Acute thrombosis

          -  History of stroke (only for patients with cognitive dysfunction)

          -  Positive Hepatitis B or C serology

          -  History of positive HIV

          -  Acute or chronic pancreatitis

          -  Treatment with any investigational agent within 4 weeks of screening

          -  Receipt of a live vaccine within 4 weeks prior to randomization

          -  Previous Treatment with Rituximab (MabThera® / Rituxan®)

          -  Previous treatment with Natalizumab (Tysabri®)

          -  Known active bacterial, viral fungal mycobacterial, or other infection

          -  Pregnancy

          -  Concomitant malignancies or previous malignancies, with the exception of adequately
             treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the
             cervix

          -  History of psychiatric disorder that would interfere with normal participation in this
             protocol

          -  Significant cardiac or pulmonary disease
A Study to Assess the Safety, Tolerability and Effectiveness of MT-0814 for the Treatment of Age-related Macular Degeneration
Condition: Age-related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: MT-0814; Placebo
Intervention description: Randomly assigned dose; Placebo manufactured to mimic MT-0814
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 13.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Exudative; Wet; AMD; Age-related macular degeneration; Age related macular degeneration

Summary:

      Age-related macular degeneration (AMD) is the leading cause of blindness among adults in
      North America. The current standard of care for patients with exudative ("wet") AMD is
      anti-vascular endothelial growth factor (anti-VEGF) therapy which must be administered by an
      injection into the eye every 4-8 weeks. MT-0814 is being developed for the treatment of
      patients with exudative AMD, and could offer an alternative, safer and less burdensome
      therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must agree to sign informed consent form, and to comply with protocol requirements,
             including study visits.

          -  Must have clear optic media in the study eye that is capable of producing high-quality
             fundus images.

        Exclusion Criteria:

          -  Has active CNV due to causes other than AMD in the study eye.

          -  Has retinal vascular disease or retinal degeneration other than AMD in the study eye.

          -  Has had intraocular surgery, cataract surgery or LASIK surgery on the study eye within
             90 days prior to the study.

          -  Has had yttrium aluminum garnet (YAG) laser capsulotomy on the study eye within 30
             days prior to the study.

          -  Has active inflammation, infection, or other severe ocular disease in either eye.

          -  Has aphakia in the study eye.

          -  Has uncontrolled glaucoma or a history of previous glaucoma filter surgery in either
             eye.

          -  Is a contact lens wearer and is unable to discontinue their use in both eyes for the
             duration of the study.

          -  Has a serious allergy to, or experienced a prior significant adverse reaction to
             fluorescein angiography (FA) or indocyanine green angiography (ICGA).

          -  Has participated in any other clinical trial and/or has taken any investigational drug
             or product within 90 days prior to the study.

        Other protocol-defined inclusion/exclusion criteria could apply.
Phase II Trial of Adjuvant Cisplatin and Radiation With Pembrolizumab in Resected Head and Neck Squamous Cell Carcinoma
Condition: Head and Neck Cancer
MeSH terms: Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Intervention: Pembrolizumab; Surgery; Radiation Therapy; Cisplatin
Intervention description: Pembrolizumab administered one week prior to surgery and then every three weeks in the adjuvant setting for a total of 7 doses.; gross total surgical resection; 60-66 Gy over 6 weeks; Weekly during radiation therapy for 6 doses only for patients with high risk pathological features
Intervention MeSH terms: Pembrolizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 96.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to test the safety and the benefit of adding
      pembrolizumab (a therapy that activates the immune system to fight cancer) to standard of
      care treatment for head and neck cancer. The standard of care treatment will include surgery
      followed by radiation for 6 weeks. Some patients may also receive cisplatin as standard of
      care once a week for 6 weeks if the cancer is found to be "high risk". High risk includes
      cancer that was not completely removed (positive margins) or cancer that has invaded through
      the outer lining of your lymph nodes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients eligible for resection with one or more of the following

               1. Any T stage with ≥ N2 disease;

               2. T4 disease, any N stage;

               3. T3 Oral Cavity, any N stage; or

               4. Clinical evidence of extra-capsular extension on scans.

          -  Must be willing to undergo definitive resection with neck dissection.

          -  Performance status 0 or 1 on Eastern Cooperative Oncology Group Performance Scale.

          -  Adequate labs

          -  Appropriate staging imaging.

        Exclusion Criteria:

          -  Diagnosis of immunodeficiency or receiving systemic steroid therapy or
             immunosuppressive therapy within 7 days prior to planned first dose of trial
             treatment.

          -  Nasopharyngeal or sinonasal carcinoma

          -  Confirmed metastatic disease

          -  Human Papillomavirus (HPV)+ disease of the oropharynx

          -  Known history of active tuberculosis (TB), autoimmune disease, pneumonitis, infection,
             HIV, Hepatitis B, or Hepatitis C
A Study of Prexasertib (LY2606368) in Participants With Extensive Stage Disease Small Cell Lung Cancer
Condition: Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Intervention: Prexasertib
Intervention description: Administered IV
Intervention MeSH terms: Prexasertib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 133.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: SCLC; LY2606368; CHK1

Summary:

      The purpose of this study is to evaluate the safety and efficacy of prexasertib when given to
      participants with extensive stage disease small cell lung cancer (ED-SCLC). The study will
      evaluate how the body processes the drug and how the drug affects the body. The study will
      also evaluate the association between tumor response and the participant's perceived quality
      of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have ED-SCLC and have received a prior platinum-based regimen

          -  Participants in Cohort 1 and in the addendum must have had an objective response to
             prior platinum-based therapy with subsequent progression ≥90 days after the last dose
             of platinum

          -  Participants in Cohort 2 must have either not had an objective response to prior
             platinum based therapy or had progression <90 days after the last dose of platinum

          -  Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group scale

        Exclusion Criteria:

          -  Have received more than 2 prior therapies for ED-SCLC (including immunotherapy,
             targeted therapies, or chemotherapy)

          -  Have symptomatic central nervous system (CNS) malignancy or metastasis. Asymptomatic
             participants with treated CNS metastases are eligible for this study if they are not
             currently receiving corticosteroids to treat CNS metastases

          -  Have previously completed or withdrawn from this study or any other study
             investigating prexasertib or a checkpoint kinase I (CHK1) inhibitor or have shown
             hypersensitivity to any of the components of the prexasertib formulation

          -  Have a serious cardiac condition
Milk Protein Feeding After Aerobic Exercise in Older Adults With Pre-diabetes Taking the Biguanide Metformin
Condition: Physical Activity
MeSH terms: Prediabetic State
Intervention: Metformin; Placebo; Carbohydrate Beverage; Protein Beverage
Intervention description: Daily administration of Metformin will begin as one 500 mg tablet for the first week and will increase by 500 mg/day/week until reaching 2000 mg/day by week 4 during a 12 week exercise training program.; Daily administration of matching placebo during a 12 week exercise training program.; Supervised aerobic exercise 3 days per week followed by a carbohydrate drink; Supervised aerobic exercise 3 days per week followed by a protein drink
Intervention MeSH terms: Metformin
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were assigned to either Metformin-Protein, Metformin-Carbohydrate, Placebo-Protein, and Placebo-Carbohydrate.
Masking: Double (Participant, Investigator)
Enrollment: 56.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The investigators propose that post-exercise milk protein feeding will enhance the
      mitochondrial protein synthesis (biogenesis) response to an exercise-training program. In
      addition, the investigators propose that this stimulatory effect of protein feeding will
      overcome the potential blunting effect of metformin on exercise responses. The investigators
      will investigate these outcomes over a 12-week exercise-training program in older adults with
      pre-diabetes with or without metformin treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  55 years or older

          -  Individuals with Prediabetes defined as impaired fasting glucose (100 to 126 mg/dl),
             HbA1c (5.7-6.4%), and/or impaired glucose tolerance defined as 2 hour postprandial
             blood glucose of 140 to 200 mg/dl.

        Exclusion Criteria:

          -  Medications contraindicated with Metformin (Dofetilide, Lamotrigine, Pegvisomant,
             Somatropin, Trimethoprim, Trospium, Gatifloxacin, Cephalexin, Cimetidine,
             Dalfampridine)

          -  Recent (less than 6 weeks) or planned imaging that requires IV contrast,

          -  Renal dysfunction creatinine ≥ 1.3 mg/dL in men or ≥ 1.2 mg/dL in women

          -  Alanine Aminotransferase (ALT) levels exceed 52 IU/L

          -  Heart, Kidney or Liver Disease

          -  Type I or Type II Diabetes

          -  Anti-coagulant therapy (warfarin/heparin)

          -  Lung/respiratory dysfunction

          -  Medications affecting primary outcomes

          -  Lactose Intolerant

          -  Tobacco Use

          -  Heavy Alcohol Use

          -  Cancer

          -  Lidocaine Allergy