bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Lanabecestat (LY3314814) in Healthy Participants When Taken With Rosuvastatin
Condition: Healthy
Intervention: Lanabecestat; Rosuvastatin
Intervention description: Administered orally; Administered orally
Intervention MeSH terms: Rosuvastatin Calcium
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the effect of lanabecestat on rosuvastatin. The
      amount of rosuvastatin in the blood will be compared, when taken alone, and then when taken
      with lanabecestat. The amount of lanabecestat that gets into the bloodstream will be
      measured. Information about any side effects that may occur will also be collected.

      Participants will be on study for 21 days with a follow-up at least 7 days afterwards.

      Screening will be undertaken within 45 days prior to enrollment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women not of childbearing potential may participate and include those who are:

               -  Infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or
                  tubal ligation), congenital anomaly such as mullerian agenesis; or

               -  Postmenopausal - defined as women over 50 years of age with an intact uterus who
                  have not taken hormones or oral contraceptives within 1 year, who have had either
                  Spontaneous cessation of menses for at least 12 consecutive months, or 6 to 12
                  months of spontaneous amenorrhea with follicle-stimulating hormone level greater
                  than (>)40 milli-international units per millilitre (mIU/mL) consistent with
                  menopause

          -  Caucasian and may be of Hispanic ethnicity

          -  Body mass index (BMI) of 19 to 32 kilogram per meter square (kg/m²), inclusive, at the
             time of screening

        Exclusion Criteria:

        - Have a clinically significant abnormal blood pressure or heart rate (supine) as
        determined by the investigator
Study of Combination Treatment With IMO-2125 and Ribavirin in Naïve Hepatitis C-infected, Genotype 1 Patients
Condition: Hepatitis C, Treatment Naïve, Genotype 1 Patients
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: IMO-2125; Saline
Intervention description: IMO 2125 is a synthetic DNA-based agonist of Toll-like receptor 9, which is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system.; Subcutaneous injection once per week for four weeks
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Phase 1, randomized, double-blind, placebo-controlled, dose-escalation study with 3 dose
      levels of IMO-2125 in combination with standard weight based ribavirin (investigational
      treatment arm) or placebo in combination with ribavirin (RBV). Each cohort of 15 patients
      will be randomized 4:1 to receive the investigational treatment arm (12 patients) or placebo
      and RBV arm (3 patients).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented genotype 1

          -  HCV-positive with documented detectable plasma viral concentration > 10,000 IU/mL

        Exclusion Criteria:

          -  Positive test for HIV or HbsAg

          -  Inadequate bone marrow, liver, and renal function

          -  Treatment with any IFN-based or other experimental or antiviral therapies - prior or
             current

          -  Other significant medical disease

          -  Concurrent or planned treatment during the study
Study to Evaluate Effect of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination on the Pharmacokinetics of a Representative Hormonal Contraceptive Medication, Norgestimate/Ethinyl Estradiol
Condition: HCV Infection
MeSH terms: Hepatitis C
Intervention: SOF/VEL/VOX; VOX; Norgestimate/ethinyl estradiol
Intervention description: 400/100/100 mg FDC tablet administered orally once daily; 100 mg tablet administered orally once daily; Norgestimate 0.180 mg/0.215 mg/0.25 mg/ethinyl estradiol 0.025 mg tablet administered orally once daily according to the package insert
Intervention MeSH terms: Ethinyl Estradiol; Norgestimate; Norgestimate, ethinyl estradiol drug combination; Estradiol
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate the effect of sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX)
      fixed-dose combination (FDC) + voxilaprevir on the pharmacokinetics (PK) of a representative
      hormonal contraceptive medication, norgestimate/ethinyl estradiol (Ortho Tri-Cyclen® Lo (OC))
      and will assess the effect of norgestimate/ethinyl estradiol on the PK of SOF/VEL/VOX+VOX.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Premenopausal female

          -  Must have a calculated body mass index (BMI) ≥ 19.0 and ≤ 30.0 kg/m^2 at screening

          -  Must have a negative serum pregnancy test at screening and urine pregnancy test at Day
             -1

          -  Be willing and able to comply with all study requirements.

        Exclusion Criteria:

          -  Lactating female

          -  Have a history of any of the following:

               -  Significant drug sensitivity or drug allergy (such as anaphylaxis or
                  hepatoxicity)

               -  Known hypersensitivity to the study drugs, the metabolites or formulation
                  excipients

          -  Believed, by the study investigator, to be inappropriate for study participation for
             any reason
The Effect of Topiramate on Etonogestrel Concentrations in Contraceptive Implant Users
Condition: Migraine; Migraine;Menstrual; Contraception
MeSH terms: Migraine Disorders
Intervention: Topiramate
Intervention description: Topiramate - Participants will undergo a 6 week titrated regimen of oral topiramate to reach a maximum dose of 400mg per day:
Week 1 - topiramate PO 25mg daily Week 2 - topiramate PO 25mg twice daily Week 3 - topiramate PO 50mg twice daily Week 4 - topiramate PO 100mg twice daily Week 5 - topiramate PO 150mg twice daily Week 6 - topiramate PO 200mg twice daily
Intervention MeSH terms: Topiramate
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Prospective, non-inferiority study to evaluate the pharmacokinetic effect of topiramate on serum ENG levels in contraceptive implant users
Masking: None (Open Label)
Enrollment: 48.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A prospective, non-inferiority study to evaluate the pharmacokinetic effect of topiramate on
      serum Etonogestrel (ENG) levels in contraceptive implant users.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy women, who have had an ENG implant for 12-36 months at the time of enrollment;

          -  Will maintain their implant during the study without modifications.

        Exclusion Criteria:

          -  Women who are taking any medications or supplements known to be

               1. Cytochrome P-450 enzyme inducers, inhibitors, or substrates, and

               2. are not willing to abstain from any of these medications or supplements during
                  the entire course of the study.

          -  Women with liver disease (i.e. hepatitis, fatty liver disease), and

          -  Women with abnormal liver or renal function, or

          -  Women with abnormal electrolytes on their screening blood work.
Memory Modulation by Pain During Anesthesia
Condition: Amnesia; Pain; Anesthesia
MeSH terms: Amnesia
Intervention: Dexmedetomidine; Midazolam; Peripheral nerve stimulation; Ketamine
Intervention description: Selected subjects received this drug during a portion of the study; Selected subjects received this drug during a portion of the study; Experimental acute pain stimulus was delivered using a nerve stimulator. These painful shocks were paired randomly with some of the auditory experimental cues.; Selected subjects received this drug during a portion of the study
Intervention MeSH terms: Midazolam; Dexmedetomidine; Ketamine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: There are 3 single drug arms completed by a few participants. The majority of participants participated in a crossover design with two drugs, midazolam & ketamine.
Masking: Single (Participant)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 39 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: midazolam; dexmedetomidine; memory; ketamine

Summary:

      The purpose of this study is to determine the effects of pain on facilitating long-term
      auditory memory in the presence and absence of distinct intravenous anesthetics. The ability
      to identify previously presented words from a list assessed the degree of memory formation.
      In a subset of subjects, functional magnetic resonance imaging was used to identify the
      neural correlates of memory inhibition or facilitation by the combination of pain and
      anesthetic used.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adult volunteers, with normal memory and hearing, whose native language is
             English

        Exclusion Criteria:

          -  pregnancy

          -  significant memory or hearing loss

          -  sleep apnea

          -  chronic pain

          -  metal or electronic implants

          -  claustrophobia

          -  Currently taking: antidepressants, anti-psychotics, antihistamines, anti-anxiety
             medication, stimulants, sleep-aids, or pain medication
Placebo-controlled, Dose-escalation Study of the Safety of IMO-2125 (Immunomodulatory Oligonucleotide) in Hepatitis C-infected Patients
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: IMO-2125; Saline placebo
Intervention description: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system; saline placebo given subcutaneously
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Hepatitis C; unresponsive to pegylated interferon and ribavirin therapy; hepatitis C virus

Summary:

      First-in-humans, phase 1, dose-escalation study with 4 dose levels of single-agent IMO-2125.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HCV-positive

          -  Nonresponder to standard-dose pegylated interferon-α-2a or -α-2b in combination with
             standard-dose ribavirin

        Exclusion Criteria:

          -  Human immunodeficiency virus (HIV)or hepatitis B surface antigen (HbsAg)

          -  Inadequate bone marrow, liver, and renal function

          -  Treatment with any IFN (interferon)-based or other experimental or antiviral therapies
             within 30 days

          -  Other significant medical diseases

          -  Known alcohol or drug abuse within the past 12 months
Safety Study of PLX108-01 in Patients With Solid Tumors
Condition: Solid Tumor
MeSH terms: Neoplasms
Intervention: PLX3397
Intervention description: Capsules administered once or twice daily, continuous dosing
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 132.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PVNS

Summary:

      PLX3397 is a selective inhibitor of Fms, Kit, and oncogenic Flt3 activity. The primary
      objective of this study is to evaluate the safety and pharmacokinetics of orally administered
      PLX3397 in patients with advanced, incurable, solid tumors in which these target kinases are
      linked to disease pathophysiology. The secondary objective is to measure the pharmacodynamic
      activity of PLX3397 via blood, plasma and urine biomarkers of Fms activity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 and older

          -  Solid tumors refractory to standard therapy

          -  For the Extension cohorts, patients must have measurable disease by RECIST criteria
             and meet the following disease-specific criteria:

               -  For advanced or recurrent mucoepidermal carcinoma (MEC) of the salivary gland,
                  patients must not be candidates for curative surgery or radiotherapy.

               -  For pigmented villo-nodular synovitis (PVNS), patients must have a histologically
                  confirmed diagnosis of inoperable progressive or relapsing PVNS, or resectable
                  tumor requesting mutilating surgery, as well as demonstrated progressive disease
                  in the last 12 months.

               -  For gastrointestinal stromal tumors (GIST), patients must have failed previous
                  therapy with imatinib and sunitinib. Patients with known PDGFR mutations are
                  excluded, but mutation testing is not required for study entry.

               -  For anaplastic thyroid cancer (ATC), patients must have histologically or
                  cytologically diagnosed advanced ATC.

               -  For metastatic solid tumors with documented malignant pleural and/or peritoneal
                  effusions, patients must not be receiving specific therapy for the effusion or
                  have an indwelling drain.

          -  Eastern Cooperative Oncology Group performance status 0 or 1

          -  Life expectancy >= 3 months

          -  Adequate hepatic, renal, and bone marrow function

        Exclusion Criteria:

          -  Specific anti-cancer therapy within 3 weeks of study start

          -  Uncontrolled intercurrent illness

          -  Refractory nausea or vomiting, or malabsorption

          -  Mean corrected QT interval (QTc) >= 450 msec (for males) or QTc >= 470 msec (for
             females)
Safety Study of OPC-12759 Ophthalmic Solution
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes
Intervention: OPC-12759 Ophthalmic solution; OPC-12759 Ophthalmic suspension
Intervention description: 2％ OPC-12759 Ophthalmic solution; 2％ OPC-12759 Ophthalmic suspension
Intervention MeSH terms: Rebamipide; Ophthalmic Solutions
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to assess the safety of OPC-12759 ophthalmic solution in healthy
      subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  BMI : {body weight (kg) / [height (m)] 2 } must be 17.6 or greater, and less than 26.4
             kg/m2

        Exclusion Criteria:

          1. Presence of ocular disorder

          2. Intraocular pressure of 21mmHg or higher

          3. Corrected visual acuity of less than 1.0

          4. Dysfunction of nasolacrimal duct or history of surgery related to nasolacrimal duct or
             eye lid which affects the nasolacrimal outflow

          5. History of refractive surgery

          6. History of other ocular surgeries within 12 months

          7. Those who cannot discontinue the use of contact lenses from the 1st dose to
             5-hour-post-dose
Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Hepatic Impairment
Condition: Hepatic Impairment; Healthy
MeSH terms: Liver Diseases
Intervention: MCI-186
Intervention description: 30 mg of edaravone will be administered intravenously over 60 minutes
Intervention MeSH terms: Edaravone
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To assess the pharmacokinetics of MCI-186 after a single intravenous infusion of 30mg/hour in
      subjects with mild or moderate Hepatic impairment compared to subjects with normal hepatic
      function
    

Eligibility criteria:

        Inclusion Criteria:

        All subjects

          -  Able to provide written informed consent to participate in this study after reading
             the ICF

          -  Subjects is able to understand and willing to cooperate and comply with the Protocol
             restrictions and requirements.

          -  A body weight of ≥45 kg in males or ≥40 kg in females and a body mass index ranging
             from 18 to 30 kg/m2

        Hepatic impaired subjects (in addition)

          -  A Child-Pugh score of 5 or 6 for subjects with mild hepatic impairment, and between 7
             and 9, inclusive, for subjects with moderate hepatic impairment

          -  Chronic and stable hepatic impairment

        Healthy subjects (in addition)

          -  Subject with normal hepatic function

          -  Good health and free from clinically significant illness or disease

        Exclusion Criteria:

        All subjects

          -  Presence or history of severe allergy to food, or any medicinal product or relevant
             excipient that is of clinical significance

          -  Subjects were previously administered MCI-186.

          -  Positive urine drug screen (if not due to concomitant medication) or alcohol test

          -  History of drug abuse

          -  Presence of alcohol abuse

          -  Presence of active infection requiring antibiotics

          -  Positive test for human immunodeficiency virus (HIV) antigen/antibody

          -  Uncontrolled, or untreated hypertension defined as systolic blood pressure (SBP)>160
             mmHg and/or diastolic blood pressure (DBP)>100 mmHg

          -  eGFR <60 mL/min/1.73m2

        Hepatic impairment subject (in addition)

          -  Subjects with severe ascites

        Healthy subject (in addition)

          -  History or presence of any parenchymal hepatic disease

          -  Positive test for hepatitis B surface antigen (HBsAg) and hepatitis C virus antibody
             (HCVAb)
Study Evaluating Single and Repeated Intravitreal Doses of ICON-1 in Patients With Uveal Melanoma
Condition: Uveal Melanoma; Choroid Neoplasm
MeSH terms: Melanoma; Uveal Neoplasms; Choroid Neoplasms
Intervention: ICON-1
Intervention description: Intravitreal injection of ICON-1
Intervention MeSH terms: Immunoconjugates
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety, tolerability, biological activity,
      pharmacokinetics and pharmacodynamic activity of single and repeated escalating intravitreal
      doses of ICON-1 in patients with primary uveal melanoma who are planned to undergo
      enucleation or brachytherapy of the affected eye.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females of any race at least 18 years of age

          -  Clinical diagnosis of primary uveal melanoma involving the posterior uveal tract in
             the study eye

          -  Planned enucleation or brachytherapy of the study eye due to uveal melanoma

        Exclusion Criteria:

          -  Uveal melanoma in the study eye originating in the anterior uveal tract (iris)

          -  Hereditary or chronic hemorrhagic or coagulopathy conditions (i.e., hemophilia)

          -  Woman who is pregnant or lactating
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of MT-6345 in Healthy Subjects
Condition: Healthy
Intervention: MT-6345; MT-6345 Placebo
Intervention description: MT-6345; MT-6345 Placebo
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 52.0
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 Safety, Tolerability and Pharmacokinetics of
      MT-6345 in Healthy Subjects.
    

Eligibility criteria:

        Inclusion Criteria:

        Additional screening criteria check may apply for qualification:

          -  Able to provide written informed consent to participate in this study after reading
             the participant information sheet and Informed Consent Form (ICF), and after having
             the opportunity to discuss the study with the Investigator or designee.

          -  Healthy and free from clinically significant illness or disease as determined by
             medical history, physical examination, laboratory and other tests at Screening and Day
             -1.

          -  A body weight of ≥60 kg for males and ≥50 kg for females and a body mass index (BMI)
             (Quetelet index) ranging from 18 to 30.0 kg/m2 inclusive at Screening and Day -1.

          -  In the Investigator's opinion, subject is able to understand the nature of the study
             and any risks involved in participation, and willing to cooperate and comply with the
             Protocol restrictions and requirements.

        Exclusion Criteria:

        Additional screening criteria check may apply for qualification:

          -  Subjects with clinically significant (in the opinion of the Investigator) endocrine,
             thyroid, hepatic, respiratory, gastrointestinal, neurological, renal, cardiovascular
             disease, or history (within the last 5 years) of any significant psychiatric/psychotic
             illness disorder (including anxiety, depression and reactive depression).

          -  Female subjects who are pregnant (positive pregnancy test at Screening or Day -1) or
             lactating.

          -  Having previously received MT-6345 as part of this study.

          -  Clinically relevant abnormal medical history, physical findings or laboratory values
             at Screening or Day -1 that could interfere with the objectives of the study or the
             safety of the subject, as judged by the Investigator.

          -  Subjects who test positive for hepatitis B surface antigen, hepatitis B core antibody,
             hepatitis C antibody, human immunodeficiency virus (HIV)-1 or HIV-2 antibodies at
             Screening.