bioihbjkbjnl/mcl2 huggingface dataset:
Altitude Sickness Prevention and Efficacy of Comparative Treatments
Condition: Acute Mountain Sickness
MeSH terms: Altitude Sickness
Intervention: Budesonide; Acetazolamide; Placebo
Intervention description: Inhaled Budesonide vs. PO Acetazolamide vs. Placebo for prevention of Acute Mountain Sickness; Inhaled Budesonide vs. PO Acetazolamide vs. Placebo for prevention of Acute Mountain Sickness; Placebo pill and sham inhaler
Intervention MeSH terms: Budesonide; Acetazolamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is designed to be the first to examine the novel drug budesonide for prevention of
      acute mountain sickness in comparison to acetazolamide and in the context of rapid ascent to
      high altitude. The investigators will accomplish these objectives with a prospective, double
      blinded view of a large population of hikers who are ascending at their own rate in a true
      hiking environment.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and Female

          2. Sea level-dwelling hikers

          3. Between ages 18-65

        Exclusion Criteria:

          1. History of allergy to acetazolamide or budesonide (or other corticosteroids)

          2. Taken NSAIDs, acetazolamide, or corticosteroids in the one week prior to study
             enrollment.

          3. Hazardous medical conditions which precludes the ability to moderately hike to high
             altitude including: sickle cell anemia, asthma, or COPD, severe anemia, or severe
             coronary arterial disease.

          4. Pregnancy or suspected pregnancy.

          5. Participants who are younger than 18 years of age and more than 65

          6. Sleep above 4'000 elevation in the preceding 1 week.

          7. History of asthma or COPD

          8. Current symptoms of an acute upper respiratory illness.

          9. Unable to complete a moderately strenuous hike at high altitude.
Long-Term Safety Study of TA-7284 in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: TA-7284-Low; TA-7284-High
Intervention description: TA-7284-Low; TA-7284-High
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1299.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: TA-7284; JNJ-28431754; Canagliflozin; Sodium Glucose Co-Transporter (SGLT2 inhibitor)

Summary:

      The purpose of this study is to evaluate the safety and efficacy of TA-7284 as monotherapy or
      combination therapy with other oral anti-hyperglycaemic agent in Japanese patients with Type
      2 diabetes mellitus on 52 weeks oral administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women age ≥20 years old

          -  Diagnosed with Type 2 diabetes mellitus at least 3 months before screening

          -  HbA1c of ≥7.0% and ≤10.0% (monotherapy group)

          -  HbA1c of ≥7.0% and ≤10.5% (combination therapy group)

        Exclusion Criteria:

          -  Type I diabetes mellitus, diabetes mellitus resulting from pancreatic disorder,
             secondary diabetes mellitus

          -  Past or current history of severe diabetic complications

          -  Fasting plasma glucose > 270 mg/dL before treatment start

          -  History of hereditary glucose-galactose malabsorption or primary renal glucosuria

          -  Patients requiring insulin therapy
Duloxetine Versus Placebo in Chronic Low Back Pain
Condition: Back Pain Without Radiation
MeSH terms: Back Pain; Low Back Pain
Intervention: Duloxetine; Placebo
Intervention description: 30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase; every day (QD), by mouth (PO), 13 weeks
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 236.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose of your participation in this study is to help answer the following
      research question, and not to provide you treatment for your condition.

      Whether duloxetine once daily can help patients with Chronic Low Back Pain.

      Patients who do not have their pain reduced by at least 30% by week 7 will be given 120 mg
      dose for the duration of the study. After the 13 week double blind period, patients
      randomized to placebo will switch to duloxetine 60 mg or 120 mg in the 41-week extension
      period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male/Female outpatients 18 years of age with chronic low back pain

          -  Females of child bearing potential must test negative on a pregnancy test at visit 1.

        Exclusion Criteria:

          -  Have a serious or unstable diseases of the heart or blood vessels, liver, kidney,
             lungs, or blood-related illness

          -  Problems with decreased blood flow to arms and legs (peripheral vascular disease), or
             other medical conditions

          -  Psychiatric conditions that, in the opinion of the investigator, would affect your
             participation or be likely to lead to hospitalization during the course of the study

          -  Have acute liver injury (such as hepatitis) or severe cirrhosis

          -  Have had previous exposure to duloxetine

          -  Have a body mass index (BMI) over 40

          -  Have a major depressive disorder

          -  Require daily narcotics

          -  Have suicidal risk

          -  Have a presence of any factors/conditions, medical or other, that in the judgment of
             the investigator may interfere with performance of study outcome measures
Randomized Evaluation of Strategic Intervention in Multidrug Resistant Patients With Tipranavir (RESIST)
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Tipranavir; Ritonavir(r); Comparator Protease Inhibitor (CPI)
Intervention MeSH terms: Ritonavir; HIV Protease Inhibitors; Tipranavir; Protease Inhibitors
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Parallel Assignment
Enrollment: 630.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Demonstrate the safety and efficacy of Tipranavir/Ritonavir versus an active treatment
      regimen in highly treatment experienced Human Immunodeficiency virus 1(HIV-1) infected
      patients.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients meeting the following criteria will be eligible for participation in th is study:

          1. Human Immunodeficiency virus 1 (HIV-1) infected males or females >=18 years of age.

          2. Screening genotypic resistance report indicating both of the following: at least one
             primary protease Inhibitor (PI) mutation at the following sites:

        30N, 46I/L, 48V, 50V, 82A/F/L/T, 84V or 90M, and no more than two protease mutations on
        codons 33, 82, 84, or 90.

        3. At least 3 consecutive months experience taking antiretrovirals (ARVs) from each of the
        classes of nucleoside reverse transcriptase inhibitors(NRTI(s)), non-nucleoside reverse
        transcriptase inhibitors(NNRTI(s)), and protease inhibitors (PIs) at some point in
        treatment history,with at least 2 protease inhibitor (PI)-based regimens, one of which must
        be the current regimen, and current protease inhibitor (PI)-based antiretroviral (ARV)
        medication regimen for at least 3 months prior to randomization.

        4. Human Immunodeficiency Virus 1 (HIV-1) viral load >=1,000 copies/mL at screening.

        Exclusion criteria:

        Patients with any of the following criteria are excluded from participation in t he study:

          1. Antiretroviral (ARV) medication naïve.

          2. Patients on recent drug holiday, defined as off antiretroviral (ARV) medications for
             at least 7 consecutive days within the last 3 months.

          3. alanine aminotransferase (ALT) >=3.0x upper limit of normal (ULN) and aspartate
             aminotransferase(AST) >=2.5x upper limit of normal (ULN) (>=Division of AIDS(DAIDS)
             Grade 1) at either screening visit.
Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the Southern Hemisphere 2015 Season
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Trivalent influenza subunit vaccine Influvac
Intervention description: "3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 "
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Vaccine; Committee for Medicinal Products for Human Use (CHMP) criteria

Summary:

      Influenza (flu) viruses change continuously, therefore also the parts of viruses used in
      influenza vaccines can vary from year to year. The current study is a phase III A clinical
      trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. The
      objective of this study is to investigate the immunogenicity and safety and tolerability of
      the changed influenza vaccine virus composition in two groups of subjects in good health:
      subjects aged >= 18 and <= 60 years and subjects >= 61 years of age (elderly).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing and able to give informed consent and able to adhere to all protocol required
             study procedures.

          -  Men and women aged ≥ 18 and ≤ 60 years or ≥ 61 years of age at the day of study
             vaccination.

          -  Being in good health as judged by medical history, physical examination (if needed)
             and clinical judgment of the Investigator

        Exclusion Criteria:

          -  Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of
             the vaccine.

          -  A serious adverse reaction after a previous (influenza) vaccination.

          -  Presence of any significant condition that may prohibit inclusion as determined by the
             investigator.

          -  Seasonal or pandemic influenza vaccination or laboratory confirmed seasonal or
             pandemic influenza infection within the previous six months before study vaccination
             or planned vaccination during the study period.

          -  A history of Guillain-Barré syndrome or active neurological disease.
Multicenter Study to Assess the Efficacy and Safety of Methyl Aminolevulinate Hydrochloride (MAL) 16.8% Cream (CD06809-41) Versus Vehicle Cream for Actinic Keratosis of the Face
Condition: Actinic Keratoses
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: MAL 16.8% cream; MAL Vehicle Cream
Intervention description: Day light photodynamic therapy with MAL 16.8% cream; Day light photodynamic therapy with MAL vehicle cream
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 557.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A Randomized, Double-Blind, Vehicle-Controlled, Multicenter Study to Assess the Efficacy and
      Safety of Methyl aminolevulinate hydrochloride (MAL) 16.8% cream (CD06809-41) versus vehicle
      cream in the treatment of thin and moderately thick, non-hyperkeratotic, non-pigmented
      actinic keratosis of the face and scalp when using daylight photodynamic therapy (DL-PDT).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants aged ≥ 18 years at the Screening visit.

          -  Participants had at least 4, but no more than 12, clinically-confirmed thin or
             moderately thick, non-hyperkeratotic, non-pigmented AKs located on the face (e.g.,
             forehead, cheek, chin), and balding scalp.

          -  Female Participants of non-childbearing potential.

          -  Participants fully understood and signed an ICF before any investigational
             procedure(s) are performed.

        Exclusion Criteria:

          -  Participants with pigmented AK in the treatment areas.

          -  Female participants who were pregnant, nursing, or planning a pregnancy during the
             study.

          -  Participants with a clinical diagnosis of a skin disease other than AK.

          -  Immunocompromised participants.

          -  Participants with any condition that may be associated with a risk of poor protocol
             compliance.
Assess the Long Term Efficacy and Safety of Ruxolitinib Cream in Participants With Vitiligo
Condition: Vitiligo
MeSH terms: Vitiligo
Intervention: ruxolitinib; Vehicle
Intervention description: ruxolitinib cream is a topical formulation applied as a thin film to affected areas BID.; Vehicle cream is a topical formulation applied as a thin film to affected areas.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Double Blind
Enrollment: 458.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: INCB018424

Summary:

      The purpose of this study is to evaluate the duration of response following withdrawal of
      ruxolitinib cream (Cohort A vehicle group), safety and maintenance of response with continued
      use of ruxolitinib cream in participants who have completed either Study NCT04052425 or
      NCT04057573 (parent studies) in which the participants will have been using ruxolitinib cream
      BID for the previous 28 to 52 weeks depending on their initial randomization in the parent
      study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Currently enrolled and receiving treatment in INCB 18424-306 (NCT04052425) or INCB
             18424-307 (NCT04057573) studies evaluating ruxolitinib cream in participants with
             vitiligo.

          -  Currently tolerating ruxolitinib cream in the parent study and no safety concerns per
             investigators judgment.

          -  Has demonstrated compliance, as assessed by the investigator, with the parent study
             protocol requirements.

          -  Willingness and ability to comply with scheduled visits, treatment plans, and any
             other study procedures indicated in this protocol.

          -  Male and female participants must be willing to take appropriate contraceptive
             measures to avoid pregnancy or fathering a child.

          -  Ability to comprehend and willingness to sign an ICF or written informed consent of
             the parent(s) or legal guardian and written assent from the participant when possible.

        Exclusion Criteria:

          -  Has been permanently discontinued from study treatment in the parent study for any
             reason.

          -  Participants with an uncontrolled intercurrent illness or any concurrent condition
             that, in the investigator's opinion, would jeopardize the safety of the participant or
             compliance with the Protocol.

          -  Pregnant or breastfeeding woman.

          -  Participants who live with anyone participating in any current Incyte-sponsored
             ruxolitinib cream study.
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Adults Aged >= 50 Years
Condition: Healthy
Intervention: 13vPnC
Intervention description: 13vPnC for both stratum
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 271.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Vaccines, Pneumococcal Conjugate Vaccine

Summary:

      The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the
      13-valent pneumococcal conjugate (13vPnC) vaccine in healthy Japanese adults aged >= 50
      years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese descent male and female adults who do not have the potential to bear children
             >= 50 years of age.

          -  Determined to be eligible for the study based on medical history, physical
             examination, and clinical judgment. Subjects with preexisting stable disease, defined
             as disease not requiring significant change in therapy or hospitalization for
             worsening disease 12 weeks before receipt of study vaccine, are eligible.

          -  Sexually active men must agree and commit to use a medically accepted form of
             contraception during the study and for at least 3 months after vaccination.

        Exclusion Criteria:

          -  History of severe adverse reaction associated with a vaccine.

          -  Receipt of any vaccine within 30 days before study vaccination, except influenza
             vaccine.

          -  Documented S pneumoniae infection within the past 5 years before study vaccination.
A Study to Evaluate Safety, Immunogenicity, and Lot-to-Lot Consistency of H5N1 Subunit Influenza Virus Vaccine in Healthy Adult Subjects ≥18 Years of Age
Condition: Avian Influenza
MeSH terms: Influenza, Human; Influenza in Birds
Intervention: aH5N1c; Placebo
Intervention description: Intramuscular (IM) administration, containing 7.5 mcg H5N1 hemagglutinin antigen (HA) + 0.25 mL MF59 (approximately 0.5 mL total volume).; Placebo: Saline injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 3196.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Vaccine; Flu; Avian; Pandemic; H5N1; MF59

Summary:

      This Phase 3 study evaluates the safety, immunogenicity and lot-to lot consistency of 3 lots
      of aH5N1c vaccine for pandemic avian influenza, in approximately 2394 healthy adults ≥18
      years of age receiving the vaccine and 797 healthy adults receiving placebo. Subjects were
      randomized in a 3:1 ratio to receive either aH5N1c vaccine or saline placebo. Enrollment was
      stratified by age: 18 to <65 years of age and ≥65 years of age, to allow adequate safety
      assessment of the entire age spectrum.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects ≥ 18 years of age, mentally competent, in good health as determined by
             medical history, physical examination and clinical judgment by the Investigator; able
             to comply with all study procedures, to be contacted, and to be available for study
             visits according to the protocol.

        Exclusion Criteria:

          -  Individuals who are pregnant or breastfeeding. Female subjects of childbearing
             potential must have a negative pregnancy test prior to study vaccines being
             administered.

          -  Females of childbearing potential who refuse to use an acceptable method of birth
             control from Day 1 (1st vaccination) to 3 weeks after the second study vaccination,
             and, if sexually active, who have not used a reliable birth control method for at
             least two months prior to study entry.

          -  Individuals with a body temperature ≥38.0 °C (≥100.4 °F) or any acute illness within 3
             days of intended study vaccination.

          -  Individuals who received any type of influenza vaccine (e.g., "seasonal") within 7
             days prior to enrolment in this study or who are planning to receive any type of
             influenza vaccine within 7 days (before or after) from the study vaccines.

          -  Individuals who received any other licensed vaccines within 14 days (for inactivated
             vaccines) or 28 days (for live vaccines) prior to enrollment in this study or who are
             planning to receive any (non-influenza) vaccine within 28 days (before or after) from
             the study vaccines.

          -  Individuals with known or suspected impairment of the immune system.