bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Effect of Erenumab on Blood Pressure When Given Concomitantly With Subcutaneous Sumatriptan
Condition: Healthy Subjects
Intervention: Placebo; Sumatriptan; Erenumab
Intervention description: Administered by intravenous infusion; Administered by two 6 mg subcutaneous injections 1 hour apart on day 2 and day 5; Administered by intravenous infusion
Intervention MeSH terms: Sumatriptan; Erenumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this study was to assess the effects of subcutaneous sumatriptan
      alone and the effects of a single dose of erenumab (AMG 334) intravenous (IV) and sumatriptan
      concomitant therapy on resting blood pressure in healthy adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and female subjects ≥ 18 to ≤ 55 years old

          -  Good general health

          -  Laboratory results within range

          -  Other Inclusion Criteria May Apply

        Exclusion Criteria:

          -  Female subjects pregnant or breastfeeding

          -  An unstable medical condition

          -  History of cancer

          -  Active liver disease

          -  Positive Hepatitis B or Hepatitis C

          -  Unwilling or unable to limit alcohol consumption

          -  Unable to refrain from strenuous exercise

          -  Other Exclusion Criteria May Apply
Effect of a Proton Pump Inhibitor on the PK of Tepotinib
Condition: Healthy
Intervention: Tepotinib; Omeprazole
Intervention description: Participants received single oral dose of 500 mg Tepotinib in Treatment A, B and C.; Participants received omeprazole alone on Day 1 to 4 and co-administration of omeprazole with Tepotinib on Day 5 in Treatment B and C.
Intervention MeSH terms: Tepotinib; Omeprazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Proton Pump Inhibitor; Omeprazole; Tepotinib; Non-small cell lung cancer (NSCLC); Pharmacokinetics

Summary:

      This study was investigated in healthy participants (i) the effect of omeprazole (proton pump
      inhibitor) co-administration on the single dose pharmacokinetics (PK) of tepotinib under fed
      conditions, and (ii) the effect of food on the single dose PK of tepotinib after
      co-administration of omeprazole and tepotinib. Furthermore, the study assessed the safety and
      tolerability of tepotinib alone and upon co-administration of omeprazole.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy participants of non-child bearing potential

          -  Body mass index (BMI) between 18.5 and 29.9 kilogram per meter square (kg/m^2)

          -  Body weight between 50 to 100 kilogram (kg)

          -  Other protocol defined inclusion criteria could apply

        Exclusion Criteria:

          -  Participation in a clinical study within 60 days prior to first drug administration

          -  Whole blood donation or loss of greater than (>) 450 milliliter (mL) within 60 days
             prior to first drug administration

          -  Any surgical or medical condition, or any other significant disease that could
             interfere with the study objectives, conduct, or evaluation

          -  Other protocol defined exclusion criteria could apply
Safety Study of Enzalutamide (MDV3100) in Patients With Incurable Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: enzalutamide; anastrozole; exemestane; fulvestrant; enzalutamide; exemestane
Intervention description: 80 mg (2 capsules) or 160 mg (4 capsules) taken orally daily.; 1 mg/day; The exemestane dose is 25mg daily.; 500 mg every 28 days; 160 mg (4 capsules) taken orally daily.; The exemestane dose is 50 mg daily.
Intervention MeSH terms: Fulvestrant; Anastrozole; Exemestane
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)
Enrollment: 101.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: enzalutamide; MDV3100; breast cancer

Summary:

      The purpose of this study is to determine the safety, tolerability and pharmacokinetics of
      enzalutamide alone and in combination with anastrozole, or exemestane, or fulvestrant in
      patients with incurable breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed breast cancer with accompanying pathology report;

          -  Submit unstained representative tumor specimen, either as a paraffin block (preferred)
             or ≥ 10 unstained slides

          -  Received at least 2 lines of systemic therapy in the advanced setting (for
             enzalutamide alone arm only);

          -  Eastern Cooperative Oncology Group performance (ECOG) status of 0 or 1;

          -  Estimated life expectancy of at least 3 months

        Exclusion Criteria:

          -  Severe concurrent disease, infection, or comorbidity that, in the judgment of the
             Investigator, would make the patient inappropriate for enrollment;

          -  Pregnant or lactating;

          -  Known or suspected brain metastasis or leptomeningeal disease;

          -  History of another malignancy within the previous 5 years other than curatively
             treated in situ carcinomas;

          -  For patients who are enrolled to receive enzalutamide plus anastrozole or exemestane
             or fulvestrant must not have received tamoxifen or any medication known to be a potent
             CYP3A4 inducer or inhibitor.
A Study to Compare the Effects of a Test and Reference Formulation of LY900014 in Healthy Participants
Condition: Healthy
Intervention: LY900014
Intervention description: Administered SC
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study of healthy participants evaluated the concentration of a test LY900014 and a
      reference LY900014 formulation in the bloodstream and how it affected the blood sugar levels.
      The whole study, including screening, took up to 8 weeks to complete.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female participants who can potentially get pregnant:

               -  Must have a negative pregnancy test at the time of screening

               -  Agree to continue to use a reliable method of birth control until the end of the
                  study

          -  Have a body mass index (BMI) of 18.0 to 30.0 kilogram per meter square (kg/m²),
             inclusive, at screening

          -  Are nonsmokers, have not smoked for at least 2 months before entering the study

        Exclusion Criteria:

          -  Are currently enrolled in a clinical trial involving an investigational product or any
             other type of medical research judged not to be scientifically or medically compatible
             with this study

          -  Have known allergies to insulin lispro, related compounds, or any components of the
             formulation

          -  Have significant history of or current cardiovascular, respiratory, hepatic, renal,
             gastrointestinal, endocrine, hematological, or neurological disorders capable of
             significantly altering the absorption, metabolism, or elimination of drugs

          -  Intend to use over-the-counter or prescription medication within 7 and 14 days,
             respectively, before dosing (apart from vitamin/mineral supplements, occasional
             paracetamol, hormonal contraception, or thyroid-replacement therapy)

          -  Have used systemic glucocorticoids within 3 months prior to entry into the study

          -  Have donated blood of more than 450 milliliters (mL) or more in the last 3 months or
             provided any blood donation within the last month before screening
Study of the Bioequivalence of Two Tablet Forms of MK0431 (0431-027)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Sitagliptin phosphate anhydrous formulation; Comparator: sitagliptin phosphate monohydrate form
Intervention description: Single dose sitagliptin 100 mg tablets (anhydrous form) in one of two treatment periods.; Single dose sitagliptin 100 mg tablets [monohydrate Final Market Image (FMI) form] in one of two treatment periods.
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will establish that the MK0431 100 mg anhydrous formulation tablets are
      bioequivalent to the MK0431 100 mg monohydrate final market image (FMI) tablets.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is in good health

          -  Female subjects must have a negative pregnancy test

          -  Subject is within 30% of ideal body weight

          -  Subject does not smoke

          -  Subject agrees to follow the study guidelines

        Exclusion Criteria:

          -  Subject has a history of any illness that might confound the results of the study or
             make participation unsafe for the subject

          -  Subject has a history of hypoglycemia

          -  Subject has a history of any hepatic disease

          -  Subject is taking any oral, parenteral, topical or implantable contraceptives
A Study to Determine the Pharmacokinetics (PK) of Single Intravenous (IV) Dose of Vedolizumab 300 Milligram (mg) in Healthy Adult Chinese Participants
Condition: Colitis, Ulcerative; Crohn Disease
MeSH terms: Crohn Disease; Colitis, Ulcerative
Intervention: Vedolizumab
Intervention description: Vedolizumab intravenous infusion.
Intervention MeSH terms: Vedolizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Drug therapy

Summary:

      The purpose of this study is to assess the PK of vedolizumab following a single intravenous
      infusion in healthy adult Chinese participants.
    

Eligibility criteria:

        Inclusion Criteria:

        1. The participant weighs at least 50 kilogram (kg) and has a body mass index (BMI) from
        19.0 to 26.0 kilogram per square meter (kg/m^2) inclusive at Screening.

        Exclusion Criteria:

          1. Has one or more positive response on the progressive multifocal leukoencephalopathy
             (PML) subjective symptoms checklist at Screening or before dosing on Day 1.

          2. Has had a surgical procedure requiring general anesthesia within 30 days before the
             initial Screening Visit or is planning to undergo a surgery that requires general
             anesthesia during the study period (through Final Visit/Day 127).

          3. For participants who are negative for hepatitis B surface antigen (HBsAg) but are
             positive for either surface antibodies and/or core antibodies, hepatitis B virus
             Deoxyribonucleic Acid (DNA) polymerase chain reaction will be performed and any result
             that meets or exceeds detection sensitivity will be excluded.

          4. Has poor peripheral venous access.

          5. Has a QT interval with Fridericia correction method (QTcF) greater than (>) 430
             millisecond (ms) (males) or >450 ms (females) or PR outside the range 120 to 220 ms,
             confirmed with 1 repeat testing within a maximum of 5 minutes, at the Screening Visit
             or Check-in (Day -1).
Persistence-Targeted Smoking Cessation
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Intervention: Persistence Targeted Smoking Cessation; Clearing The Air; Nicotine lozenge
Intervention description: 8-weeks of smoking cessation counseling ("Persistence Targeted Smoking Cessation"); 8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air; 12-weeks 4mg nicotine lozenge
Intervention MeSH terms: Nicotine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: tobacco; smoking cessation; nicotine dependence

Summary:

      The investigators propose to develop a theory-based smoking cessation intervention (called
      Persistence-targeted smoking cessation; PTSC). PTSC includes 8 weekly individual counseling
      sessions and use of nicotine lozenge for 12 weeks. The investigators will test the
      feasibility and preliminary efficacy of the intervention (i.e., cigarettes per day and
      prolonged abstinence).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be between 18 - 64 years old

          -  Must smoke at least 10 cigarettes per day for past 6-months

          -  Expired breath carbon monoxide (CO) > 7

          -  Must have a working cellular phone

        Exclusion Criteria:

          -  Must not be currently receiving tobacco dependence treatment counseling

          -  Must not currently be taking varenicline, bupropion, or any nicotine preparations
             (gum, lozenge, patch, spray, inhaler)

          -  Must have no contraindications to using nicotine lozenge
A Study Investigating the Influence of Hepatic Insufficiency on the Pharmacokinetics of Vaniprevir (MK-7009-005)
Condition: Hepatitis C
MeSH terms: Hepatitis C; Hepatic Insufficiency; Liver Failure
Intervention: Vaniprevir 300 mg; Vaniprevir 200 mg
Intervention description: single dose administration of 300 mg oral tablet; single dose administration of 200 mg oral tablet
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 45 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This was a 3-part study comparing the pharmacokinetics after administration of vaniprevir
      (MK-7009) for participants with mild, moderate or severe hepatic insufficiency with healthy
      matched control participants. The primary hypothesis is that the area under the curve (AUC)
      (0 to infinity) of vaniprevir for participants with mild, moderate, or severe hepatic
      insufficiency is similar to that observed in healthy matched controlled participants.
    

Eligibility criteria:

        Inclusion Criteria:

        Hepatic Participants:

          -  Females of reproductive potential test negative for pregnancy and agree to use an
             appropriate method of contraception during the study

          -  Apart from hepatic insufficiency, is in good general health

          -  Has a diagnosis of chronic stable hepatic insufficiency

          -  Score on the Child-Pugh scale ranged from 5 to 6 (mild hepatic insufficiency); from 7
             to 9 (moderate hepatic insufficiency); from 10 to 15 (severe hepatic insufficiency).
             Moderate and Severe participants must have had a 50% score of 2 or higher on at least
             one of the laboratory parameters (i.e., albumin, prothrombin time, bilirubin) at the
             prestudy visit.

        Healthy Matched Participants:

          -  Females of reproductive potential test negative for pregnancy and agree to use an
             appropriate method of contraception during the study

          -  Is in good health

        Exclusion Criteria:

          -  Female is pregnant, lactating, expecting to become pregnant or donate eggs

          -  Has a history of stroke or seizures

          -  Has a history of cancer

          -  Is unable to refrain from the use of any prescription or non-prescription medication

          -  Consumes excessive amounts of alcohol or caffeinated beverages daily

          -  Has had surgery, donated blood or participated in another investigational study with
             in the last 4 weeks

          -  Is a regular user or past abuser of any illicit drug including alcohol
A Study To Evaluate The Abuse Potential Of Single Oral Doses Of Dimebon (Latrepirdine) In Healthy Recreational Polydrug Users
Condition: Alzheimer's Disease; Huntington's Disease
MeSH terms: Alzheimer Disease; Huntington Disease
Intervention: dimebon; dimebon; dimebon; placebo; alprazolam; alprazolam
Intervention description: Oral tablet; 20 mg dimebon, single dose; Oral tablet; 40 mg dimebon, single dose; Oral tablet; 60 mg dimebon, single dose; Oral tablet or capsule; placebo, single dose; Oral capsule; 1 mg alprazolam, single dose; Oral capsule; 3 mg alprazolam, single dose
Intervention MeSH terms: Alprazolam
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: oral single-dose 6-way crossover recreational drug users abuse potential pharmacodynamics safety

Summary:

      Dimebon will not exhibit abuse potential when compared to placebo or a positive control
      (alprazolam).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and/or female subjects between the ages of 18 and 55 years.

          -  Recreational polydrug user with a history of CNS depressant use.

        Exclusion Criteria:

          -  History of clinically significant neurologic condition(s), such as seizures,
             convulsions, epilepsy, or significant head injury, as judged by the investigator or
             designee.

          -  A known history of hypersensitivity or previous intolerance to dimebon or other
             antihistamines.

          -  Self-reported history of drug or alcohol dependence (except nicotine or caffeine) in
             the 2 years prior to screening, or drug or alcohol dependence as defined by the
             (DSM-IV-TR) in 12 months prior to screening, including subjects who have ever been in
             a substance rehabilitation program (other than treatment for smoking cessation).

          -  History of clinically significant psychiatric disorder(s), as judged by the
             investigator or qualified designee.
Understanding Dexmedetomidine in Neonates After Open Heart Surgery
Condition: Tetrology of Fallot; Heart Ventricle; Hypoplastic Left Heart
MeSH terms: Hypoplastic Left Heart Syndrome; Tetralogy of Fallot
Intervention: Dexmedetomidine
Intervention description: Dosage Level 1=0.25mcg/kg loading dose, 0.2 mcg/kg/hr infusion Dosage Level 1A= 0.35mcg/kg loading dose, 0.3 mcg/kg/hr infusion Dosage Level 2= 0.5mcg/kg loading dose, 0.4 mcg/kg/hr infusion
Intervention MeSH terms: Dexmedetomidine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 1 Hour
Maximum age: 30 Days
Healthy volunteers: No
Keywords: Precedex; Open Heart Surgery; Dexmedetomidine; Sedation

Summary:

      The purpose of this study is to determine what happens to dexmedetomidine in the body after
      it has been given to a newborn after heart surgery. We want to learn how long the drug stays
      in the body, how the drug is metabolized by the body, and how well the medicine works at a
      particular dose or amount.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be less than or equal to 1 month old.

          -  Postconceptual age must be > or equal to 37 weeks on the day of surgery.

          -  Postoperative from cardiac surgery with tracheal intubation/mechanical ventilation in
             the immediate post-op period.

          -  Planned tracheal extubation within 24 hrs post-op.

          -  Adequate renal function (serum creatine < or equal to 1.5mg/dL)

          -  Adequate liver function (ALT < or equal to 165 U/L)

          -  Isolated heart surgery

          -  Informed consent

        Exclusion Criteria:

          -  Patients who have received another investigational drug since birth.

          -  Patients receiving continuous infusions of muscle relaxants in the post-op setting.

          -  Pateints who have a positive blood culture without a subsequent negative culture of
             other evidence of ongoing serious infection.

          -  Patients who show signs and symptoms of elevated intracranial pressure.

          -  Post-op hypotension defined by post conceptual age.

          -  Pre-existing bradycardia defined by age

          -  Heart block

          -  Weight < 2kg

          -  Patients who, in the opinion of the investigator, are not appropriate candidates for
             an investigational drug study