bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Lasmiditan in Healthy Participants
Condition: Healthy
Intervention: Lasmiditan; Placebo
Intervention description: Oral administration; Oral administration
Intervention MeSH terms: Lasmiditan
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 2 Groups: Group 1 - Double-blind Randomized 2-Period Crossover, Group 2 - Open-label single dose
Masking: Double (Participant, Investigator)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to look at the amount of study drug that gets into the blood
      stream and how long it takes the body to get rid of it by comparing the results of healthy
      elderly participants to those of healthy young participants. The tolerability of the study
      drug will be evaluated. Information about any side effects that may occur will also be
      collected.

      This study will last up to approximately 19 days, not including screening. This study
      requires either one (Group 2) or two (Group 1) stays at the clinic each of at least four
      days/three nights. Participants will return for a follow-up seven days after last dose of
      study drug. Screening is required within 28 days prior to Day 1.

      This study is for research purposes only and is not intended to treat any medical condition.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy males or females, as determined by medical history and physical
             examination.

          -  Have a body mass index (BMI) of 19 to 35 kilograms per meter squared (kg/m²)
             inclusive, at the time of screening.

        Exclusion Criteria:

          -  Have known allergies to lasmiditan, related compounds or any components of the
             formulation.

          -  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.

          -  Show evidence of active renal disease or estimated glomerular filtration rate (eGFR)
             less than 60 milliliter per minute (mL/min) per 1.73 m².

          -  Show evidence of or positive serology for human immunodeficiency virus (HIV)
             infection, hepatitis B or C.

          -  Are women with a positive pregnancy test or women who are lactating.

          -  Have a clinically significant abnormality in the neurological examination.

          -  Have a history of syncope, presyncopy, uncontrolled vertigo, postural dizziness, or at
             risk for falls, as judged to be clinically significant by the investigator.

          -  Have orthostatic hypotension with or without dizziness and/or syncope at screening or
             Day -1 upon repeat testing, or a history of it.
Phase 1 Trial of Bevacizumab Treatment for Severe Retinopathy of Prematurity
Condition: Retinopathy of Prematurity
MeSH terms: Retinal Diseases; Retinopathy of Prematurity; Premature Birth
Intervention: Bevacizumab
Intervention description: Varying dosages in 10µl
Intervention MeSH terms: Bevacizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: 8 bevacizumab doses were evaluated in this dose de-escalation study in the following dosage amounts: 0.250mg, 0.125mg, 0.063mg, 0.031mg, 0.016mg, 0.008mg, 0.004mg, 0.002mg. Each dose was planned to be used in up to 14 infants to ensure at least 10 infants with 4-week outcomes
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 120.0
Sex: All
Maximum age: 6 Months
Healthy volunteers: No
Keywords: Retinopathy of Prematurity; Bevacizumab; ROP

Summary:

      The purpose of this study is to find a dose of intravitreal bevacizumab that is lower than
      currently used for severe retinopathy of prematurity (ROP), is effective in this study, and
      can be tested in future larger studies.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Type 1 ROP; defined as:

               -  Zone I, any stage ROP with plus disease, or

               -  Zone I, stage 3 ROP without plus disease, or

               -  Zone II, stage 2 or 3 ROP with plus disease

          2. No previous treatment for ROP in the study eye; no previous bevacizumab treatment in
             the non-study eye

        Exclusion Criteria:

        The following exclusions apply to the study eye:

          1. Nasolacrimal duct obstruction

          2. Major ocular anomalies (e.g., cataract, coloboma)

          3. Any opacity that precludes an adequate view of the retina

        If purulent ocular discharge is present in either eye, then the infant is ineligible.
Phase 1 Pediatric Pharmacokinetics/Pharmacodynamics (PK/PD) Study
Condition: Deep Vein Thrombosis; Venous Thromboembolism
MeSH terms: Thrombosis; Thromboembolism; Venous Thromboembolism; Venous Thrombosis
Intervention: Edoxaban low dose; Edoxaban high dose
Intervention description: Edoxaban low dose; Edoxaban high dose
Intervention MeSH terms: Edoxaban
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: All
Minimum age: 0 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Pediatric; Pharmacokinetics (PK); Pharmacodynamics (PDy); Anticoagulant; Safety

Summary:

      This is the first evaluation of edoxaban in pediatric subjects. In this Phase 1 study, a
      single dose of edoxaban will be given to pediatric subjects who require anticoagulant therapy
      to see what the body does to the drug (pharmacokinetics) and what the drug does to the body
      (pharmacodynamics), and to compare if these effects are similar to those observed in adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is a pediatric subject requiring anticoagulant therapy

          -  Will abstain from the use of nonsteroidal anti-inflammatory drugs (such as ibuprofen),
             and other antiplatelet and anticoagulant agents (except for aspirin) from 24 hours
             prior to edoxaban dose until after the last PK sample is collected

          -  Will follow food and concomitant medication restrictions

        Exclusion Criteria:

          -  Any major or clinically relevant unexplained bleeding during prior anticoagulant
             therapy

          -  History of abnormal bleeding or coagulation within last 6 months prior to study drug
             administration

          -  Renal function with glomerular filtration rate (GFR) less than 50% of normal for age
             and size

          -  Malabsorption disorders (e.g., cystic fibrosis or short bowel syndrome)

          -  Hepatic disease associated with coagulopathy leading to a clinically relevant bleeding
             risk, alanine transaminase (ALT) > 5 times the upper limit of normal (ULN) or total
             bilirubin > 2 times the ULN with direct bilirubin > 20% of the total
Phase 1 Study of SGI-110 in Patients With Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: SGI-110
Intervention MeSH terms: Guadecitabine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      To evaluate the tolerability and pharmacokinetics of SGI-110 when administered subcutaneously
      to Japanese patients with acute myeloid leukemia (AML).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients with a diagnosis of AML (WHO classification 2008).

               -  Patients, 20 years of age or older, who are unresponsive to standard chemotherapy
                  or have relapsed following standard chemotherapy

               -  Patients, 65 years of age or older, who are not eligible for standard intensive
                  chemotherapy

          -  Patients with ECOG performance status (PS) of 0 to 2

          -  Patients with adequate organ function

          -  Women of child-bearing potential must not be pregnant or breast feeding (pregnancy
             test will be performed at Screening). Women of child bearing potential and all men
             with female partners of child bearing potential must practice two medically acceptable
             methods of birth control and must not become pregnant or father a child while
             receiving treatment with SGI-110 and for 3 months following last dosing.

          -  Patients who have undergone prior allogeneic hematopoietic stem cell transplantation
             must have no evidence of active graft-versus host disease (GVHD) and must be off
             immunosuppressive therapy by ≥2 weeks prior to IMP administration.

        Exclusion Criteria:

          -  Patients with acute promyelocytic leukemia accompanied by t(15;17)(q22;q12) or
             (PML/RARA) karyotype abnormalities (include other variant types of APL)

          -  Patients with multiple cancers (except for adequately treated basal cell or squamous
             cell skin cancer, in situ cervical cancer, or other cancer from which the subject has
             been disease free for at least 3 years)

          -  Subjects with life-threatening illnesses other than AML or MDS, uncontrolled medical
             conditions or organ system dysfunction which, in the investigator's opinion, could
             compromise the subject's safety, or put the study outcomes at risk.

          -  Patients with poorly controlled arrhythmias, or any Class 3 or 4 cardiac disease as
             defined by the New York Heart Association Functional Classification

          -  Patients with symptomatic central nervous system involvement.
A Study of Lasmiditan When Given With Sumatriptan in Healthy Participants
Condition: Healthy
Intervention: Lasmiditan; Sumatriptan; Placebo for Lasmiditan; Placebo for Sumatriptan
Intervention description: Administered orally; Administered orally; Administered orally; Administered orally
Intervention MeSH terms: Sumatriptan; Lasmiditan
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to assess whether taking lasmiditan and sumatriptan together
      will have any additional effects on heart rate and blood pressure compared to taking
      lasmiditan and sumatriptan individually. This study will also look at the amount of study
      drug that gets into the blood stream and how long it takes the body to get rid of it when
      these two drugs are taken together.

      This study will last about 21 days, not including the screening. Participants will spend 16
      days/15 nights in the clinical research unit (CRU) followed by follow-up. Screening is
      required within 28 days prior to the start of the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy males or females, as determined by medical history and physical
             examination

          -  Have a body mass index of 19.0 to 35.0 kilograms per meter squared (kg/m²) inclusive

        Exclusion Criteria:

          -  Have known allergies to Lasmiditan, Sumatriptan, related compounds, or any components
             of the formulations of Lasmiditan and Sumatriptan

          -  Have a history of, or electrocardiogram (ECG) findings of, clinically significant
             bradycardia, heart block, tachy or brady arrhythmias

          -  Have a history, signs, or symptoms of arrhythmia or Wolff Parkinson White syndrome
             that could affect the participant's safety

          -  Have an estimated glomerular filtration rate (eGFR) of less than (<) 60 milliliter per
             minute (mL/min) per 1.73 m²

          -  Have a resting systolic blood pressure (SBP) greater than (>) 135 millimeters of
             mercury (mmHg) and diastolic blood pressure (DBP) >85 mmHg at screening

          -  Have a supine pulse rate (PR) of <50 or >90 beats per minute (bpm) at screening

          -  Have a history, signs, or symptoms of vasospastic coronary artery disease

          -  Have known or ongoing neuropsychiatric disorders (for example, manic depressive
             illness, schizophrenia, depression) considered as clinically significant by the
             investigator

          -  Use of monoamine oxidase-A inhibitors and other drugs associated with serotonin within
             the 3 months prior to the first dosing occasion
An Open-Label, Phase 1b Study of Acalabrutinib With and Without Dexamethasone in Subjects With Multiple Myeloma
Condition: Multiple Myeloma (MM)
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: acalabrutinib
Intervention MeSH terms: Acalabrutinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bruton tyrosine kinase inhibitor; Btk; Multiple Myeloma; MM; ACP-196; acalabrutinib; Calquence

Summary:

      To characterize the safety profile of acalabrutinib with and without dexamethasone in
      subjects with relapsed or refractory Multiple Myeloma (MM)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women ≥ 18 years of age.

          -  A confirmed diagnosis of MM, which has relapsed after, or been refractory to ≥ 1 prior
             therapy for MM, and is progressing at the time of study entry.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.

          -  Agreement to use contraception during the study and for 30 days after the last dose of
             study drugs if sexually active and able to bear or beget children.

        Exclusion Criteria:

          -  A life-threatening illness, medical condition or organ system dysfunction which, in
             the investigator's opinion, could compromise the subject's safety, interfere with the
             absorption or metabolism of acalabrutinib, or put the study outcomes at undue risk

          -  Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias,
             congestive heart failure, or myocardial infarction within 6 months of screening, or
             any Class 3 or 4 cardiac disease as defined by the New York Heart Association
             Functional Classification

          -  Malabsorption syndrome, disease significantly affecting gastrointestinal function,
             gastric bypass, resection of the stomach or small bowel, symptomatic inflammatory
             bowel disease, or partial or complete bowel obstruction.

          -  Breast feeding or pregnant
A Study to Evaluate Sigma-1 and Dopamine-2 Receptor Occupancy by Pridopidine in the Human Brain of Healthy Volunteers and in Patients With Huntington's Disease
Condition: Health Volunteers, Huntington Disease
MeSH terms: Huntington Disease
Intervention: pridopidine (90 mg)
Intervention description: single dose will be administered in Cohort 1. Other optional cohorts 2 and 3 may include single dose 0.5 mg, 1 mg, 2.5 mg, 5 mg, 10 mg, 22.5 mg, 45 mg, or 90 mg. The dose will be selected based on the results obtained from Cohorts 1 and 2.
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: Male
Minimum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to demonstrate engagement of pridopidine with S1R and D2R
      (optional) in the living human brain. No formal statistical analysis will be conducted
    

Eligibility criteria:

        Inclusion Criteria:

          -  In general, good physical health as determined by medical history and psychiatric
             history, suicidality assessment & physical examination

          -  Men who are potentially fertile (not surgically [eg, vasectomy] or congenitally
             sterile

          -  Patients with Huntington's disease (HD): diagnosis of HD and with an onset of HD after
             18 years of age

               -  Additional criteria apply, please contact the investigator for more information

        Exclusion Criteria:

          -  The subject has been previously exposed to ionizing radiation or radioactive
             substances as a result of clinical research or medical treatment in the past 10 years.

          -  The subject has a counterindication to having an MRI

          -  History of alcohol, narcotic, or any other substance dependence in the past 2 years

          -  Additional Exclusion criteria to patients with Huntington's disease:

          -  The patient has a severe motor impairment that might cause artifacts.

          -  Patients with a known history of Long QT Syndrome or a first degree relative with this
             condition.

          -  Treatment with any investigational product within 6 weeks of screening or patients
             planning to participate in another clinical study assessing any investigational
             product during the study.

               -  Additional criteria apply, please contact the investigator for more information
Flortaucipir PET Imaging in Subjects With FTD
Condition: Frontotemporal Dementia
MeSH terms: Dementia; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain
Intervention: Flortaucipir F18; Brain PET scan
Intervention description: 370 megabecquerel (MBq)(10 millicurie [mCi]) injection, single dose; positron emission tomography (PET) scan of the brain
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is designed to assess the usefulness of flortaucipir in Positron Emission
      Tomography (PET) imaging for subjects diagnosed with Frontotemporal Dementia (FTD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects diagnosed by a dementia specialist with symptomatic clinical syndromes with
             expected Frontotemporal Dementia (FTD) pathology will be enrolled. Clinical syndromes
             associated with FTD pathology include: behavioral-variant FTD, FTD with motor-neuron
             disease, non-fluent/agrammatic and semantic variants of primary progressive aphasia,
             progressive supranuclear palsy syndrome and corticobasal syndrome.

          -  Have provided informed consent or have a legally authorized (LAR) provide consent for
             study procedures

          -  Have had volumetric brain MRI obtained in site's companion protocol within one year of
             enrollment

          -  Can tolerate PET scan procedures

        Exclusion Criteria:

          -  Have clinically significant cardiac, hepatic, renal, pulmonary, metabolic, or
             endocrine disturbances that pose potential safety risk

          -  Have history of risk factors for Torsades de Pointes (TdP) or taking medication known
             to cause QT prolongation

          -  Have history of drug or alcohol dependence within the last year

          -  Are females of childbearing potential who are not surgically sterile, not refraining
             from sexual activity, or not using reliable contraception

          -  Have history of relevant severe drug allergy or hypersensitivity

          -  Have received an investigational medication under FDA IND protocol within 30 days of
             planned imaging session

          -  Have received a radiopharmaceutical for imaging/therapy within 24 hours of imaging
             session

          -  Possess PET scan evidence of amyloid deposition

          -  Determined by the investigator to be unsuitable for this type of study
Study of Ixekizumab in Healthy Participants
Condition: Healthy
Intervention: Ixekizumab
Intervention description: Administered SC
Intervention MeSH terms: Ixekizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to compare the tolerability of injections of each of 3
      formulations of ixekizumab using a prefilled syringe. Information about any side effects
      (including injection site reactions [ISRs]) will be collected.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male participants or female participants who agree not to get pregnant

          -  Are male participants or female participants with chronic, stable medical problems
             that, in the investigator's opinion, will not place the participant at increased risk
             by participating in the study

        Exclusion Criteria:

          -  Have a significant history of, or current, cardiovascular, respiratory, hepatic,
             renal, gastrointestinal, endocrine, or hematologic disorders that in the opinion of
             the investigator poses an unacceptable risk to the participant if participating in the
             study

          -  Are allergic or hypersensitive to the study medicine

          -  Have dullness or loss of sensitivity on either side of your abdomen

          -  Have any condition that could affect pain perception from an injection

          -  Had a vaccination with a live vaccine within 12 months prior to the first check-in or
             intend to get a vaccine for tuberculosis within 12 months of completing treatment on
             this study

          -  Have any type of hepatitis, human immunodeficiency virus (HIV) infection, or other
             serious infection

          -  Show evidence of active or latent tuberculosis (TB)

          -  Presence of significant neuropsychiatric disorder or a recent history of depression

          -  Have excessive tattoos or scars over the abdomen or other factors such as rash or
             excessive folds of skin that would interfere with injection site assessments

          -  Have had any active or recent infection within 4 weeks of Day 1 that, in the opinion
             of the investigator would pose an unacceptable risk to the participant if
             participating in the study