bioihbjkbjnl/mcl2 huggingface dataset:
Study to Characterize the Pharmacokinetics of a Single Dose of SC Abatacept 125 mg Using the BD Autoinjector or the Prefilled Syringe
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Abatacept
Intervention MeSH terms: Abatacept
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 356.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose of the protocol is to describe the pharmacokinetics of a single dose of
      Abatacept 125 mg in Rheumatoid Arthritis patients delivered via the autoinjector device or
      the approved prefilled syringe.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Subjects ≥18 years of age

          -  Diagnosis of Rheumatoid Arthritis confirmed by participant's physician

          -  Disease activity under control

        Key Exclusion Criteria:

          -  Change in disease-modifying antirheumatic drug (DMARD) therapy within 3 months of
             enrollment

          -  Exposure to investigational drug within 4 weeks or 5 half lives whichever is longer

          -  Current or prior use of Rituximab ≤6 months

          -  Current or prior use of the following within 4 weeks or 5 half lives whichever is
             longer: biologic DMARDS, Tofacitinib, Cyclophosphamide, Mycophenolate Mofetil &
             d-Penicillamine
Study of Saxagliptin, 5-Hydroxy Saxagliptin, and Metformin Concentrations/Levels in Pediatric Subjects With T2DM
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Metformin immediate release (IR); Saxagliptin; Metformin IR; Saxagliptin/Metformin XR FDC; Metformin XR
Intervention description: Tablet, Oral, 1000 mg, twice daily, 1 day; Tablet, Oral, 5 mg, single-dose, 1 day; Tablet, Oral, 1000 mg, twice daily, 5 days; Tablet, Oral, 2.5 mg Saxagliptin/1000 mg Metformin extended release (XR), Single-dose of 2 tablets. Fixed dose combination (FDC).; Tablet, Oral, 500 mg, Single-dose of 4 tablets
Intervention MeSH terms: Metformin; Saxagliptin
Phase: Phase 1
Study type: Interventional
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the pharmacokinetics of Saxagliptin, 5-hydroxy
      Saxagliptin, and Metformin in pediatric subjects with Type 2 diabetes mellitus (T2DM)
      following oral administration of Saxagliptin and Metformin XR fixed dose combination tablet
      and co-administration of Saxagliptin and Glucophage® (Metformin) IR tablets
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of T2DM

          -  Male and female subjects ages 10-17

          -  Body weight ≥50 kg

          -  Glycosylated hemoglobin (HbA1c) 6.5 to 10%

        Exclusion Criteria:

          -  Fasting plasma glucose (FPG) > 240 mg/dL at screening

          -  Abnormal renal function

          -  Active liver disease and/or significant abnormal liver function
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Velpatasvir in Participants With Chronic HCV Infection
Condition: Chronic Hepatitis C Virus
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: Velpatasvir; Placebo
Intervention description: Tablets administered orally; Tablets administered orally
Intervention MeSH terms: Velpatasvir
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Hepatitis C; HCV; Genotype 1; Genotype 2; Genotype 3; Genotype 4; Genotype 5; Genotype 6; Liver Disease

Summary:

      The primary objective of the study is to evaluate the safety, tolerability, and antiviral
      activity of velpatasvir (formerly GS-5816) in HCV treatment naive participants with genotypes
      1-6.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  HCV treatment-naive adult participants (18-65 years of age) with chronic HCV infection
             and plasma HCV RNA ≥ 5 log10 IU/mL at screening

          -  Agree to use protocol defined precautions against pregnancy

        Key Exclusion Criteria:

          -  Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease,
             α1 antitrypsin deficiency, cholangitis)

          -  Evidence of cirrhosis

          -  Evidence of current drug abuse

          -  Screening laboratory results outside the protocol specified requirements

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Metronidazole Pharmacokinetics (PK) in Premature Infants
Condition: Serious Systemic Infections; Necrotizing Enterocolitis
MeSH terms: Sepsis; Enterocolitis; Enterocolitis, Necrotizing; Premature Birth
Intervention: Metronidazole
Intervention description: Metronidazole will be administered intravenously to premature infants as a 15 mg/kg loading dose followed by maintenance doses of 7.5 mg/kg every 12 hours for infants with >=14 postnatal days and every 24 hours for infants <14 postnatal days.
Intervention MeSH terms: Metronidazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Maximum age: 90 Days
Healthy volunteers: No
Keywords: Metronidazole; Neonate; Premature; Sepsis; Necrotizing enterocolitis

Summary:

      Yearly in the United States over 500,000 newborns are delivered prematurely. This population
      is at high risk of catastrophic bowel disease known as necrotizing enterocolitis. Infants
      with necrotizing enterocolitis are at high risk of death, and survivors are at increased risk
      of mental retardation. Metronidazole is an antibiotic that is often administered to infants
      with suspected or confirmed necrotizing enterocolitis. Unfortunately, the appropriate dose of
      metronidazole in premature infants has not been established and it is likely to be different
      from older children and adults.

      The investigators will investigate the appropriate metronidazole dose in very premature
      infants by: 1) determining how premature infants eliminate metronidazole from the body and 2)
      determining the safest and most effective dose of metronidazole in premature infants.

      The investigators hypothesis are: 1) The rate of removal of metronidazole will increase with
      infant maturity and 2) an appropriate metronidazole dosing regimen will result in necessary
      drug levels to treat bacteria involved in necrotizing enterocolitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Gestational age <32 weeks at the time of enrollment.

          -  Postnatal age <91 days at the time of enrollment.

          -  Sufficient venous access to permit administration of study medication.

          -  Infant suspected to have a serious infection and from whom a blood culture has been
             obtained within 96 hours of study entry.

        Exclusion Criteria:

          -  History of anaphylaxis to metronidazole or other nitroimidazole derivatives (e.g.,
             tinidazole).

          -  Previous exposure to metronidazole in the week prior to study.

          -  Previous participation in the study.
A Study of LY3337641 in Japanese and Caucasian Healthy Participants
Condition: Healthy
Intervention: LY3337641; Placebo
Intervention description: Administered orally.; Administered orally.
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 36.0
Sex: All
Minimum age: 20 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purpose of this study is to evaluate the safety and tolerability of LY3337641 in
      healthy Japanese and Caucasian participants. The study will also investigate how the body
      processes LY3337641 and the effect of LY3337641 on the body. The study will last up to 4
      weeks for each participant. Screening may occur within 28 days prior to first dose of study
      drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy Japanese or Caucasian

          -  Body mass index (BMI) 18.0 - 32.0 kilograms per square meter (kg/m²)

        Exclusion Criteria:

          -  Are currently enrolled in a clinical trial involving an investigational product or
             off-label use of a drug or device or are concurrently enrolled in any other type of
             medical research judged not to be scientifically or medically compatible with this
             study

          -  Have participated, within the last 30 days, in a clinical trial involving an
             investigational product. If the previous investigational product has a long half-life,
             3 months or 5 half-lives (whichever is longer, if known) should have passed

          -  Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the
             investigator, increases the risks associated with participating in the study or
             affects or confounds the QTc analysis or have Fridericia-corrected QT interval (QTcF)
             >450 milliseconds (msec) for males and >470 msec for females

          -  Have had symptomatic herpes zoster within 3 months of screening

          -  Have active or latent tuberculosis (TB) based on a positive medical history,
             examination, and/or TB test results.

          -  Have received live vaccine(s) within 1 month of screening or intend to during the
             study

          -  Are immunocompromised

          -  Have a history of constipation or have had acute constipation within 3 weeks prior to
             admission
Evaluation of Omarigliptin (MK-3102) in Obese Participants and in Participants With Type 2 Diabetes (MK-3102-004)
Condition: Type 2 Diabetes (T2D)
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Omarigliptin; Placebo
Intervention description: Once-weekly 50 mg capsule; Once-weekly placebo capsule
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 32.0
Sex: All
Minimum age: 45 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Type 2 diabetes (T2D)

Summary:

      This study will test the safety and tolerability of omarigliptin. It is hypothesized that
      administration of once-weekly omarigliptin in obese but otherwise healthy participants, and
      in obese participants with Type 2 diabetes (T2D) will be sufficiently safe and well tolerated
      to permit continued clinical investigation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  obese (body mass index [BMI] ≥30 kg/m² and ≤40 kg/m²) male participants and female
             participants of non-childbearing potential

          -  has been diagnosed with T2D (Panel B)

          -  is not actively participating in a weight loss program

        Exclusion Criteria:

          -  has a history of clinically-significant disease (other than T2D)

          -  has a history of cancer

          -  has estimated creatinine clearance ≤60 mL/min

          -  is unable to refrain from or anticipates the use of any prescription or
             non-prescription medication

          -  consumes excessive amounts of alcohol or caffeine

          -  has participated in a previous omarigliptin study
In Vivo Optical Spectroscopy Monitoring in a New Model of Muscular Compartment Syndrome
Condition: Human Volunteers
MeSH terms: Compartment Syndromes
Intervention: Tourniquet; INVOS assessment; EMG assessment
Intervention description: Inflation of a tourniquet (pressure equal to the mean arterial pressure) obtaining a model of slight venous congestion and arterial hypoperfusion; Near Infraread spectroscopy, non invasive; Electromyography, non invasive
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: Male
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Human volunteers

Summary:

      Muscular compartment syndrome (MCS) is consecutive to an increase in intramuscular
      compartment pressures, and is a rare but serious postoperative complication.

      The INVOS (In Vivo Optical Spectroscopy) monitors tissular oxygenation continuously and
      non-invasively.

      The objective is to develop a model mimicking the physiopathology of MCS to assess the
      interest of the INVOS in this case.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy volunteers

          -  >18yr

          -  Informed consent

          -  Male

        Exclusion Criteria:

          -  Neuropathies

          -  Vascular pathology

          -  Actual pain

          -  Anti-platelet or anticoagulant therapy

          -  Ipsilateral history of fracture
A Study of Tralokinumab When Delivered Subcutaneously at Different Flow Rates to Healthy Volunteers
Condition: Asthma; Healthy Subjects or Volunteers
MeSH terms: Asthma
Intervention: Tralokinumab 300 mg
Intervention description: Participants will receive 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at different flow rates.
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 19 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Asthma; Healthy Subjects or Volunteers; Tralokinumab; CAT-354

Summary:

      The primary objective of this study is to evaluate the pharmacokinetics (PK) and tolerability
      of tralokinumab when delivered subcutaneously at different flow rates to healthy volunteers.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Healthy males and females ages 19-65 years

          -  Body mass index of 19.0-30.0 kilogram per meter square (kg/m^2)

          -  No clinically significant abnormality

          -  Vital signs, electrocardiogram (ECG), and laboratory parameters within normal range

          -  Negative alcohol and drug screens

          -  Females of childbearing potential who are sexually active with a nonsterilized male
             partner must use highly effective contraception

          -  Nonsterilized males who are sexually active with a female partner of childbearing
             potential must use highly effective contraception.

        Key Exclusion Criteria:

          -  Concurrent enrollment in another clinical study where the subject is receiving an
             investigational product

          -  Receipt of any marketed or investigational biologic agent within 4 months or 5
             half-lives prior to screening, whichever is longer

          -  Receipt of any investigational nonbiologic agent within 3 months or 5 half-lives prior
             to screening, whichever is longer

          -  Current use of regular pain-modifying, anti-depressant, anxiolytic, or hypnotic
             medication

          -  History of thrombocytopenia or bleeding disorder or use of anticoagulants

          -  History of any immunodeficiency disorder or use of immunosuppressive medication.

          -  History of a clinically significant infection

          -  History of cancer

          -  Positive Hepatitis B or C

          -  Positive HIV
Oral Nitrite and Nitrate in Healthy Normal Volunteer Adults
Condition: Focus of Study of Healthy Adults
Intervention: 15Nitrogen(15N)-labeled sodium nitrite; 15Nitrogen(15N)-labeled sodium nitrate
Intervention description: 15Nitrogen(15N)-labeled sodium nitrite 20 mg once; 15Nitrogen(15N)-labeled sodium nitrate 1,000 mg once
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This proposal hypothesizes that oral supplementation with sodium nitrite or nitrate will
      result in in vivo conversion of nitrate to nitrite and nitrite to nitric oxide with limited
      toxicity in the doses proposed in healthy adult normal volunteers. We utilize a powerful in
      vivo technique (pharmacokinetic testing) and are the first to design inorganic nitrate and
      nitrite capsules for cardiovascular disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-60 years

          -  Systolic blood pressure ≤130 and diastolic blood pressure ≤85 mm Hg

        Exclusion Criteria:

          -  Positive urine pregnancy test or breastfeeding

          -  Concurrent use of medications affecting glucose or lipid metabolism

          -  Recent addition or change in dosing of hormonal contraceptive medications (oral
             contraceptive pill, intrauterine device, DepoProvera)

          -  Current use of ≥2 anti-hypertensive agents regardless of blood pressure control or
             normotensive on a single agent

          -  Current use of phosphodiesterase 5 inhibitors or organic nitrates

          -  Not stable on treatments for the prior three months or not planning to remain on
             current dose of medications for blood pressure, contraception, etc

          -  Known chronic psychiatric or medical conditions including diabetes, liver or kidney
             disease or obesity syndromes

          -  Smoker
Phase 1 Study to Determine the Effects of Food on the Pharmacokinetic Profile of PBT2
Condition: Healthy Volunteers
Intervention: Fed Cohort PBT2; Fasted Cohort PBT2
Intervention description: PBT2 250 mg is administered orally following a period of fasting for 10 hours and a high fat breakfast.; PBT2 250 mg is administered orally after a period of fasting of 10 hours and without food
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is designed to determine the pharmacokinetic (PK) profile of a single oral dose of
      PBT2 administered to healthy volunteers in the presence and absence of food.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male or females with a BMI between 19 and 30kg/m2

          -  No clinically significant abnormalities

        Exclusion Criteria:

          -  Exposure to medications/drugs that interfere with metabolism of PBT2 including drugs
             that inhibit or induce CYP1A2)

          -  Use of caffeine-containing beverages, supplements or alcohol within 72 hours of study
             entry

          -  Significant history of depression or other psychiatric illness

          -  Surgical or medical conditions which could significantly alter drug absorption,
             distribution, metabolism or excretion

          -  unable to swallow capsules
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-925 in Healthy Volunteers and Participants With Narcolepsy
Condition: Healthy Participants; Narcolepsy
MeSH terms: Narcolepsy
Intervention: TAK-925; Placebo
Intervention description: TAK-925; TAK-925 Placebo
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to investigate the safety, tolerability, pharmacokinetics, and
      pharmacodynamics of TAK-925 when administered to healthy participants and narcolepsy
      participants.
    

Eligibility criteria:

        Inclusion Criteria:

        Healthy adult participants and Healthy elderly participants:

        • Participant weighs at least 50 kg (Healthy adults participants) / 40 kilogram (kg)
        (Healthy elderly participants) and has a body mass index (BMI) from 18.5 to 30 kilogram per
        square meter (kg/m^2), inclusive at Screening.

        Narcolepsy participants:

          -  Participants weighs at least 40 kg inclusive at Screening (>=50 kg is required for
             Cohort B4).

          -  A diagnosis of narcolepsy, as defined by the International Classification of Sleep
             Disorders, Third Edition (ICSD-3).

          -  At Day -1, Epworth sleepiness scale (ESS) score >=10

        Exclusion Criteria:

        All Participants:

          -  Participants consume excessive amounts, defined as greater than 6 servings (1 serving
             is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy
             drinks, or other caffeinated beverages per day.

          -  Participants have a moderate to severe substance use disorder.

          -  Participants have a risk of suicide according to endorsement of item 4 or 5 with
             Screening/Baseline visit C-SSRS (Columbia Suicide Severity Rating Scale) or has made a
             suicide attempt in the previous 6 months.

          -  Participants have a lifetime history of major psychiatric disorder, such as bipolar
             disorder or schizophrenia.

          -  Participants experienced sleep wake cycle disturbance with external factors such as
             irregular work hours.