bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Tolerability Study of N6022 in Healthy Subjects
Condition: Healthy
Intervention: N6022; Placebo
Intervention description: This is an injectible formulation which will be given at 5, 15 & 45 mg over 1, 3 and 9 minutes respectively, in single ascending doses.; This will be 0.9% normal saline given over 1, 3, or 9 minutes IV bolus.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the safety and tolerability of N6022 in healthy
      subjects.
    

Eligibility criteria:

        Inclusion:

          -  Subject is healthy

        Exclusion:

          -  Subject is a current alcohol abuser and/or has a history of illicit drug abuse within
             six months of entry.

          -  Subject has donated blood (> 500 mL) or blood products within 56 days prior to Day -1
A Study of Flortaucipir PET in Healthy Volunteers and Cognitively Impaired Subjects
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Flortaucipir F18; Brain PET scan
Intervention description: IV injection, 370 MBq (10 mCi), two doses up to four weeks apart; positron emission tomography (PET) scan of the brain at 80-100 and 110-130 minutes after injection
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will test if two flortaucipir PET scans up to 4 weeks apart in healthy volunteers,
      MCI and AD subjects provide the same results.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy Volunteers

               -  Male or female subjects ≥ 50 years of age

               -  Mini-mental state examination (MMSE) ≥ 29

          -  MCI Subjects

               -  Male or female subjects ≥ 50 years of age

               -  MMSE ≥ 24

               -  Have MCI consistent with National Institute on Aging-Alzheimer's Association
                  (NIA-AA) working group's diagnostic guidelines for AD

               -  Have a study partner that can report on subject's activities of daily living

          -  Probable AD Subjects

               -  Male or female subjects ≥ 50 years of age

               -  MMSE > 10

               -  Meet clinical criteria for probable AD based on the NIA-AA working group's
                  diagnostic guidelines for AD

               -  Have a study partner that can report on subject's activities of daily living

        Exclusion Criteria:

          -  Current clinically significant psychiatric disease

          -  Evidence of structural brain abnormalities

          -  Evidence of dementing illness other than AD

          -  Current clinically significant cardiovascular disease or ECG abnormalities, or
             additional risk factors for Torsades de Pointes

          -  Current clinically significant infectious disease, endocrine or metabolic disease,
             pulmonary, renal or hepatic impairment, or cancer

          -  History of alcohol or substance abuse or dependence

          -  Females of childbearing potential who are not surgically sterile, not refraining from
             sexual activity or not using reliable methods of contraception

          -  Have received or participated in a trial with investigational medications in the past
             30 days

          -  have had a non-study related radiopharmaceutical imaging or treatment procedure within
             7 days prior to the study imaging session.
A Study of 18F-AV-45 in Healthy Volunteers
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Intervention: florbetapir F 18
Intervention description: IV injection, 370MBq (10mCi), single dose
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Amyloid imaging; Positron Emission Tomography; 18F-AV-45; florbetapir F 18; Diagnostic imaging

Summary:

      This study will determine how florbetapir F 18 (18F-AV-45) radioactivity is distributed
      throughout the body.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to lie still on the imaging table for periods up to 1 hour

        Exclusion Criteria:

          -  Radiation exposure for experimental purposes within the last year

          -  Claustrophobic or otherwise unable to tolerate the imaging procedure

          -  Medical condition or surgical history that would confound evaluation

          -  Current clinically significant cardiovascular disease

          -  Received an investigational medication within the last 30 days
A Study To Evaluate The Effect Of CP-690,550 On Measures Of Kidney Function In Patients With Active Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: CP-690,550 or Placebo; Placebo
Intervention description: CP-690,550 10 mg twice a day (BID) orally or placebo BID orally, approximately 72 days; Placebo BID orally, approximately 72 days
Intervention MeSH terms: Tofacitinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 148.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Phase 1

Summary:

      The purpose of study is to explore the effect of CP-690,550 (Tofacitinib) on measures of
      kidney function in patients with active rheumatoid arthritis (RA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient must meet the American College of Rheumatology (ACR) classification
             criteria for the diagnosis of rheumatoid arthritis by satisfying at least four of the
             seven criteria.

          -  The patient must have active disease at both Screening and predose on Day 1 of Period
             1.

          -  Patient must have had an inadequate response to at least one disease-modifying
             antirheumatic drug (DMARD), non-biologic or biologic, due to ineffectiveness or
             intolerance.

        Exclusion Criteria:

          -  Pregnant or lactating women

          -  Serious medical conditions that would make treatment with CP-690,550 potentially
             unsafe.

          -  A patient who has a history of asthma, multiple allergies or severe allergy (eg,
             anaphylaxis) to any substance. In particular, a history of allergy to iodine,
             povidone-iodine, iohexol or other iodinated contrast media.
A Study to Evaluate the Safety of MEDI2338 in Subjects With Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: MEDI2338; MEDI2338; MEDI2338; MEDI2338; MEDI2338; Placebo
Intervention description: MEDI2338 single intravenous (IV) dose (lowest dose); MEDI2338 single IV dose (next highest dose); MEDI2338 single IV dose (next highest dose); MEDI2338 single IV dose (next highest dose); MEDI2338 single IV dose (highest dose); Placebo single IV dose
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Enrollment: 31.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Chronic Obstructive Pulmonary Disease; COPD

Summary:

      Phase I study to evaluate the safety and tolerability of single ascending intravenous doses
      of MEDI2338 in subjects with stable, mild to moderate chronic obstructive pulmonary disease
      (COPD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged ≥ 40 years at time of screening.

          -  Females of non-childbearing potential defined as surgically sterile or at least 2
             years postmenopausal.

          -  Males, unless surgically sterile, must use 2 highly effective methods of birth control
             from screening through end of trial.

          -  A diagnosis of mild to moderate COPD.

          -  Cigarette smoking history of ≥10 pack years.

          -  Ability to understand and comply with protocol requirements, instructions and
             restrictions.

          -  COPD symptoms adequately controlled on a therapeutic regimen that has not changed in
             the 4 weeks prior to screening.

        Exclusion Criteria:

          -  Current diagnosis of any respiratory condition other than COPD.

          -  Active or history of any disease or condition that would, in the opinion of the
             investigator and/or medical monitor, place the subject at an unacceptable risk to
             participate in this study.

          -  History of or suspected history of alcohol misuse or recreational substance abuse.

          -  Treatment with oral or IV corticosteroids within 8 weeks prior to screening.

          -  Concurrent enrolment in another clinical study.

          -  Receipt of any investigational drug therapy of use of any biologicals within 6 months
             prior to screening.

          -  Known history of allergy or reaction to any component of the investigational product.
Lorlatinib Renal Impairment Study
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Intervention: Lorlatinib
Intervention description: Lorlatinib single oral dose
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a Phase 1, open-label, multi-center, single treatment study in subjects with normal
      renal function and varying degrees of renal impairment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female subjects of non-childbearing potential

          -  Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb)

          -  Evidence of a personally signed and dated informed consent document indicating that
             the subject has been informed of all pertinent aspects of the study

          -  Subjects who are willing and able to comply with all scheduled visits, treatment plan,
             laboratory tests, and other study procedures.

          -  Demonstrate stable renal function

        Exclusion Criteria:

          -  Renal allograft recipients

          -  Any condition possibly affecting drug absorption (eg, gastrectomy)

          -  A positive urine drug test

          -  History of regular alcohol consumption exceeding 7 drinks/week for female subjects or
             14 drinks/week for male subjects (1 drink = 5 ounces [150 mL] of wine or 12 ounces
             [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months before
             screening.

          -  Treatment with an investigational drug within 30 days (or as determined by the local
             requirement) or 5 half lives preceding the first dose of investigational product
             (whichever is longer).

          -  Screening supine triplicate 12 lead ECG demonstrating a corrected QT (QTc) interval
             >450 msec or a QRS interval >120 msec

          -  Second-degree or third-degree AV block (unless paced) or baseline PR interval >180
             msec at any time prior to dosing of study treatment.

          -  Abnormalities in clinical laboratory tests at screening

          -  Pregnant or breastfeeding female subjects

          -  History of HIV, Hepatitis B, Hepatitis C, HIT, sensitivity to heparin

          -  Other acute or chronic medical or psychiatric condition including recent (within the
             past year) or active suicidal ideation or behavior or laboratory abnormality that may
             increase the risk associated with study participation
A Study to Investigate the Effect of CYP3A Inhibition on the Pharmacokinetics of RO7017773 in Healthy Participants
Condition: Healthy Volunteers
Intervention: RO7017773; Itraconazole
Intervention description: Single doses of RO7017773; Multiple doses of Itraconazole
Intervention MeSH terms: Itraconazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to investigate the effect of multiple oral doses of itraconazole
      on the pharmacokinetics of RO7017773 in healthy volunteers.
    

Eligibility criteria:

        Inclusion Criteria

          -  Healthy (absence of evidence of any active or chronic disease following a detailed
             medical and surgical history, a complete physical examination including vital signs,
             12-lead ECG, hematology, blood chemistry, serology and urinalysis) as judged by the
             Investigator.

          -  Male and women of non-childbearing potential (WONCBP)

        Exclusion Criteria

          -  History of convulsions (other than benign febrile convulsions of childhood) including
             epilepsy, or personal history of significant cerebral trauma or central nervous system
             (CNS) infections (e.g., meningitis)

          -  History of clinically significant hypersensitivity or allergic reactions

          -  Abnormal blood pressure

          -  Abnormal pulse rate

          -  History or presence of clinically significant ECG abnormalities before study drug
             administration or cardiovascular disease

          -  Current or chronic history of liver disease, or known hepatic or biliary abnormalities

          -  Positive test for drugs of abuse or alcohol

          -  Evidence of human immunodeficiency virus (HIV) infection

          -  Presence of hepatitis B surface antigen (HBsAg) or positive HCV antibody test result
             at screening or within 3 months prior to starting study treatment

          -  Participants who regularly smoke more than 5 cigarettes daily or the equivalent and
             are unable or unwilling not to smoke during the in-house period
Tailored Intervention to Promote Positive Airway Pressure Adherence
Condition: Sleep Apnea, Obstructive; Patient Compliance
MeSH terms: Sleep Apnea, Obstructive
Intervention: Tailored; Usual care
Intervention description: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy; Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 118.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Social support; Cognition; Adaptation, psychological; Health behavior; Patient education

Summary:

      The purpose of this study is to examine the feasibility of a tailored (i.e., individualized)
      intervention to promote adherence to continuous positive airway pressure therapy (CPAP) in
      adults with newly-diagnosed, CPAP treated, obstructive sleep apnea.
    

Eligibility criteria:

        Inclusion Criteria:

          -  males and females >/= 18 years of age

          -  newly diagnosed with apnea/hypopnea index >/= 10 events/hr

          -  CPAP naive

          -  able to read and speak English

        Exclusion Criteria:

          -  previous diagnosis and/or treatment of OSA

          -  major new psychiatric diagnosis within 6 months of study enrollment

          -  require supplemental oxygen or bilevel positive airway pressure on CPAP titration
             polysomnogram

          -  diagnosis of co-existent sleep disorder on polysomnogram, including periodic limb
             movements >/= 10 events/hr with arousal, central sleep apnea with >/= 5 central
             events/hr, insomnia, sleep hypoventilation syndrome, or narcolepsy
A Study of LY3050258 in Healthy Participants
Condition: Healthy Participants
Intervention: LY3050258; Placebo
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 38.0
Sex: All
Minimum age: 30 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purpose of this study is to evaluate the safety and how well the body will handle a
      single dose of increasing strength of study drug LY3050258. Each participant will receive
      LY3050258 or placebo once, in each of 2 dosing periods. At least 7 days will pass between
      doses. This study will last approximately 45 days for each participant. Screening is required
      within 28 days before the start of the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy males or healthy postmenopausal females, including Japanese participants

          -  Have a body mass index (BMI) of 18 to 35 kilograms per square meter (kg/m^2)

        Exclusion Criteria:

          -  An abnormal sitting blood pressure as determined by the investigator

          -  Any abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the
             investigator, places the participant at an unacceptable risk for study participation

          -  Current use of statins within the last 3 months prior to dosing

          -  Current or previous use of anabolic steroids in the preceding 6 months prior to dosing

          -  Use of dehydroepiandrosterone, other potential over-the-counter (OTC) steroidal
             supplements, or other nutritional products intended to have weight-reduction and/or
             performance-enhancing effects within 21 days prior to dosing
To Demonstrate Similarity of Pharmacokinetics and Evaluate Safety of CT-P16, EU-Approved Avastin and US-licensed Avastin
Condition: Healthy
Intervention: CT-P16; EU-approved Avastin; US-licensed Avastin
Intervention description: CT-P16 is a biosimilar product for Avastin; EU-approved Avastin; US-licensed Avastin
Intervention MeSH terms: Bevacizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 141.0
Sex: Male
Minimum age: 19 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: safety; Pharmacokinetics; Immunogenicity

Summary:

      This study is a Phase 1 Randomized, Double-blind, Three-arm, Parallel Group, Single-dose
      Study to compare the PK, safety and immunogenicity of the proposed biosimilar test product
      CT-P16 with EU-approved Avastin and US-licensed Avastin after a single IV infusion of 5mg/kg
      of each product to healthy male subjects
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male subjects between the ages of 19 and 55 years, both inclusive

          -  Body Mass Index (BMI) between 18.0 and 29.9 kg/m2 (both inclusive) and a body weight ≥
             50 kg

        Exclusion Criteria:

          -  Subject is a female.

          -  Clinically significant allergic reactions, hypersensitivity

          -  A disease classed as significant by the Investigator

          -  Non-healing wound, ulcer, bone fracture, a major surgical procedure, significant
             traumatic injury

          -  Any malignancy

          -  Undergone treatment with an investigational drug or participated in another clinical
             trial

          -  Plans to father a child or donates sperms
Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB5 in Healthy Subjects
Condition: Healthy
Intervention: SB5; EU sourced Humira®; US sourced Humira®
Intervention MeSH terms: Adalimumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 189.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to compare the pharmacokinetics, safety, tolerability, and
      immunogenicity of SB5 and Humira (EU sourced Humira® and US sourced Humira®) in healthy
      subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy subjects

          -  Have a body mass index between 20.0 and 29.9 kg/m², inclusive.

        Exclusion Criteria:

          -  History and/or current presence of clinical significant atopic allergy,
             hypersensitivity or allergic reactions, also including known or suspected clinically
             relevant drug hypersensitivity to any components of the test and reference
             investigational product formulation or comparable drugs

          -  Active or latent Tuberculosis or who have a history of Tuberculosis

          -  History of invasive systemic fungal infections or other opportunistic infections

          -  Systemic or local infection, a known risk for developing sepsis and/or known active
             inflammatory process

          -  Serious infection associated with hospitalisation and/or which required intravenous
             antibiotics

          -  History of and/or current cardiac disease

          -  Have received live vaccine(s) within 4 weeks prior to Screening or who will require
             live vaccine(s) between Screening and the final study visit

          -  Intake medication with a half-life > 24 h within 4 weeks or 10 half-lives of the
             medication prior to investigational product administration