bioihbjkbjnl/mcl2 huggingface dataset:
A Study of the Biodistribution and Safety of [18F]GTP1 in Healthy Japanese Participants
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Intervention: [18F]GTP1
Intervention description: [18F]GTP1 IV bolus injection of up to 370 megabecquerel (MBq) (10 millicurie [mCi]), with a maximum drug mass dose of 10 microgram (μg).
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the biodistribution, safety and tolerability of a
      single dose of [18F]GTP1 as a tau targeted radiopharmaceutical in healthy Japanese
      participants.
    

Eligibility criteria:

        Key inclusion criteria:

          -  Healthy with no clinically relevant finding on physical examination at screening and
             prior to radiopharmaceutical administration

          -  Female participants must be willing to avoid pregnancy and refrain from donating eggs
             during the treatment period and for 30 days after the final dose

          -  Male participants with partners of childbearing potential must commit to the use of
             two methods of contraception for the study duration and 90 days after the last dose

          -  Male participants must not donate sperm for the duration of the study and 90 days
             after the last dose

          -  Participants must have both Japanese parents and all Japanese grandparents

        Key exclusion criteria:

          -  Participants with any significant medical disorder or disease expected to interfere
             with the study

          -  Current or prior history (within a six-month period) of exposure to nicotine products

          -  History of drug or alcohol abuse within 12 months prior to screening

          -  Prior participation in other research protocols or clinical care in the last year,
             such that radiation exposure combined with that from the present study exceeds an
             effective dose of 50 millisievert (mSv), the allowable annual limit for research
             participants as established by the US Federal Guidelines

          -  Use of any prescription drugs, herbal supplements, within 4 weeks prior to initial
             dosing

          -  Use of over the counter (OTC) medication, dietary supplements, or vitamins, within 2
             weeks prior to initial dosing

          -  Known hypersensitivity to any component of the formulation of [18F]GTP1 or related
             compounds

          -  Major surgery, or donation or loss of 400 mL or more of blood within 4 weeks prior to
             initial dosing

          -  History of immunodeficiency diseases, including positive human immunodeficiency virus
             (HIV) test

          -  Positive for Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody

          -  Women who are pregnant, lactating or breastfeeding

          -  Unsuitable veins for repeated venipuncture
A Drug-drug Interaction Study of Lanabecestat (LY3314814) in Healthy Participants
Condition: Healthy
Intervention: Lanabecestat; Dabigatran etexilate
Intervention description: Administered orally; Administered orally
Intervention MeSH terms: Dabigatran
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to learn about the effect of lanabecestat on how the body
      absorbs and processes dabigatran etexilate and how dabigatran etexilate affects lanabecestat
      when they are taken together. This study will last about 28 days and participants will be
      asked to take an lanabecestat tablet daily for 19 days and a dabigatran etexilate tablet on 3
      occasions. Screening is required within 30 days prior to the start of the study.
    

Eligibility criteria:

        Inclusion Criteria:

        - Overtly healthy males and females

        Exclusion Criteria:

          -  Eye abnormalities or disease

          -  History of vitiligo or any skin color disorder

          -  Have a history psychiatric or brain disease including seizures

          -  Have smoked within the last 3 months

          -  Are unwilling to avoid food and drinks containing grapefruit or Seville oranges for
             the duration of the study

          -  Have known allergies to dabigatran etexilate and related compounds
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
Study Of Sunitinib In Combination With Folfox In Patients With Colorectal Cancer
Condition: Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms
Intervention: sunitinib + mFOLFOX6; sunitinib + mFOLFOX6
Intervention description: 37.5 mg/day, oral, administered on an outpatient basis for 4 weeks on, 2 weeks off (Schedule 4/2); 50 mg/day, oral, administered on an outpatient basis for 2 weeks on, 2 weeks off (Schedule 2/2)
Intervention MeSH terms: Sunitinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Phase 1; CRC; SU011248; Sunitinib; FOLFOX; Colorectal cancer; metastatic carcinoma of the colon or rectum

Summary:

      To assess the safety and tolerability of sunitinib when administered in combination with
      modified FOLFOX6 in Japanese patients with metastatic colorectal cancer in the first-line
      treatment setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed adenocarcinoma of the colon or rectum with
             documented locally advanced or metastatic disease.

          -  Evidence of unidimensionally measurable disease as defined by the Response Evaluation
             Criteria in Solid Tumors (RECIST).

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

        Exclusion Criteria:

          -  Prior treatment with systemic therapy for locally advanced or metastatic colorectal
             cancer.

          -  Prior surgery or investigational agent within 4 weeks prior to study entry.

          -  Pregnancy or breastfeeding. All female patients of reproductive potential must have a
             negative pregnancy test (serum or urine) prior to the start of the study.
A Study to Evaluate the Single Dose Safety, Tolerability and Pharmacokinetics of IV BCX4430
Condition: Marburg Virus Disease
MeSH terms: Virus Diseases; Marburg Virus Disease
Intervention: galidesivir; placebo
Intervention description: galidesivir IV infusion; placebo IV infusion
Intervention MeSH terms: Galidesivir
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: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a placebo-controlled, randomized, double-blind study to evaluate the pharmacokinetics
      of galidesivir following administration of single doses by IV infusion
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  written informed consent

          -  males and non-pregnant, non-lactating females

          -  BMI 19.0-32.0

          -  willing to abide by contraceptive requirements

          -  normal vitals

          -  willing to abide by study procedures and restrictions

        Exclusion Criteria:

          -  clinically significant medical condition or medical history or psychiatric condition
             or history of psychiatric condition

          -  abnormal cardiac finding, or laboratory/urinalysis abnormality at screening

          -  known family history of sudden death or long QT syndrome, family or personal history
             of QT prolongation, or arrhythmia that required medical intervention

          -  current participation in any other investigational drug study or participation in an
             investigational drug study within 3 months of screening visit

          -  use of prescription, OTC, or herbal medications during study or use of any specified
             medications within 30 days prior to study

          -  Recent or current history of alcohol or drug abuse

          -  Regular use of tobacco or nicotine products

          -  Positive serology for HBV, HCV, or HIV

          -  history of severe adverse reaction to or known sensitivity to any drug

          -  pregnant, lactating, or planning to become pregnant within 30 days of the study. Male
             subjects with pregnant female partners are excluded
A Study of LY3053102 in Healthy Participants
Condition: Healthy Volunteers
Intervention: LY3053102; Placebo
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 41.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purpose of this study was to evaluate the safety and tolerability of the study drug
      known as LY3053102 in healthy participants. The study also investigated how much of the study
      drug entered the blood stream and how long it took the body to dispose of the study drug.
      Information about any side effects that occurred was also collected. The study was expected
      to last approximately 8 weeks for each participant (up to 4 weeks from screening to the
      administration of study drug and an additional 4 weeks of follow up).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Normal blood pressure

          -  Female participants were not of child-bearing potential due to surgical sterilization
             (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause

          -  Had a body mass index (BMI) of 18.5 to 40.0 kilograms per square meter (kg/m^2),
             inclusive, at screening

        Exclusion Criteria:

          -  Had known allergies to LY3053102 or related compounds

          -  Had a history of significant disease that may have affected the actions of drugs or
             may pose a risk when taking the study medication

          -  Had a history of developing allergies, asthma, severe drug allergies (symptoms
             including, but not limited to, itching, red rashes, sores on the skin, scaling and
             shedding of skin), allergies or reactions to more than one drug, or have had bad
             reactions to skin creams containing corticosteroids

          -  Heavy smokers (more than 10 cigarettes a day)
A Dose Escalation Study of PF-06650808 in Patients With Advanced Solid Tumors
Condition: Neoplasms; Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: PF-06650808; PF-06650808
Intervention description: Dose Escalation Phase [Part 1] - PF-06650808 will be administered at doses starting at 0.2 mg/kg. Increases in dose will continue until MTD is determined.; Dose Expansion Phase [Part 2] - Patients will be treated at the MTD or Recommended Phase 2 dose selected in Part 1.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: solid tumors; triple negative breast cancer; PF-06650808; Phase 1

Summary:

      To assess the safety and tolerability at increasing dose levels of PF-06650808 in patients
      with advanced solid tumors in order to determine the maximum tolerated dose and select the
      recommended Phase 2 dose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of advanced/metastatic solid tumor that is resistant to standard therapy or
             for which no standard therapy is available

          -  Previously treated metastatic triple negative breast cancer that expresses Notch3 with
             at least one measurable lesion

          -  Adequate bone marrow, renal and liver function

        Exclusion Criteria:

          -  Major surgery, radiation therapy or systemic anti-cancer therapy within 4 weeks of
             starting study treatment

          -  Patients with known symptomatic brain metastases requiring steroids

          -  Prior treatment with a compound of the same mechanism
Auditory Training and Hearing Aid Satisfaction
Condition: Hearing Impairment, Sensorineural
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Sensorineural
Intervention: Auditory Brian Training Games/Activities
Intervention description: Game-based activities that encourage listening to words and sentences in noisy situations. Participants will receive subscriptions to the clEAR online auditory training activities and recommended protocol for those who recently received new hearing aids.
Phase: Phase 1
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: All participants experience the same interventions and assessments. Subjects are divided into either early or late intervention groups.
Masking: Single (Participant)
Masking description: Participants are unaware if they are in the late or early intervention group.
Enrollment: 30.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Auditory Training

Summary:

      Although hearing aids are the most common treatment for hearing loss, and have the potential
      to help seniors stay active and productive, almost 50% of them who receive hearing aids
      rarely if ever use them, a state of affairs sometimes referred to as "the hearing aid in the
      drawer" syndrome. clEAR's customized auditory brain training has been shown to be effective
      in improving adults' abilities to recognize speech, in reducing their perceptual effort
      associated with listening with a hearing loss, and in increasing their confidence to engage
      in everyday conversations. In the proposed research, we will determine whether older adults
      who receive hearing aids for the first time report higher satisfaction with their new hearing
      aids and have longer daily use time as a result of having completed clEAR's auditory brain
      training program for new hearing aid users.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be a native English speaker

          -  Must have a mild to severe bilateral sensorineural hearing loss

          -  Must be a candidate for new hearing aid(s) (have never used hearing aids)

        Exclusion Criteria:

          -  Cognitive impairment or any factors that would prohibit a participant from completing
             questionnaires

          -  Cognitive or speech production factors that would prohibit a participant from
             repeating words during a speech perception test.
Breathing Techniques and Meditation for Health Care Workers During COVID-19 Pandemic
Condition: COVID-19 Infection
MeSH terms: COVID-19
Intervention: Media Intervention; Meditation Therapy; Quality-of-Life Assessment; Questionnaire Administration; Yoga
Intervention description: View instructional video; Perform meditation; Ancillary studies; Ancillary studies; Perform breathing techniques
Phase: Phase 1
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This phase I trial investigates breathing techniques and meditation for health care workers
      during COVID-19 pandemic. Breathing techniques and medication may help manage stress and
      improve lung health. The goal of this trial is to learn if breathing techniques and
      meditation may help to reduce stress and improve lung health in health care workers during
      the COVID-19 pandemic.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must be able to read and understand English

          -  Must be employed at MD Anderson Cancer Center

        Exclusion Criteria:

          -  Epilepsy

          -  Brain tumor

          -  Brain aneurysm

          -  Pregnant or trying to get pregnant

          -  Brain bleeding in the past 1 year

          -  Recent abdominal surgery and not cleared to exercise
A Study of Lasmiditan on Simulated Driving Performance in Healthy Participants
Condition: Healthy
Intervention: Lasmiditan; Placebo; Diphenhydramine
Intervention description: Administered orally; Administered orally; Administered orally
Intervention MeSH terms: Diphenhydramine; Promethazine; Lasmiditan
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 68.0
Sex: All
Minimum age: 21 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the effect of lasmiditan on simulated driving
      performance in healthy participants. Participants are expected to complete each of four study
      periods, which will last a total of about 10 days. During this time, participants will remain
      in the clinical research unit. Screening must be completed within 28 days before the start of
      the study. Follow-up will be completed about one week after discharge.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy males or females, as determined through medical history and
             physical examination.

          -  Possess a valid driver's license and is an active driver at screening. Driven a
             minimum of 8,000 miles (about 13,000 kilometers) per year for the preceding 3 years.

          -  Have a score of <10 on the Epworth Sleepiness Scale.

        Exclusion Criteria:

          -  Have a history within 3 months of admission, or current treatment for, a sleeping
             disorder (including excessive snoring, obstructive sleep apnea), or a chronic painful
             condition that interferes with the subject's sleep.

          -  Have a history of difficulty either falling asleep or staying asleep in the previous 3
             months of admission that is considered clinically significant by the investigator.

          -  Are expected to use any other medication or dietary supplement to promote sleep
             including over the-counter sleep medications, during their participation in the study.

          -  Have traveled across 2 or more time zones (transmeridian travel) in the past 2 weeks
             prior to randomization.

          -  Have worked in a night shift in the past 2 weeks prior to randomization.

          -  Show a history of central nervous system (CNS) conditions such as strokes, transient
             ischemic attacks, significant head trauma, seizures, CNS infections, migraine, brain
             surgery, or any other neurological conditions that, in the opinion of the
             investigator, increase the risk of participating in the study.

          -  Show evidence of significant active neuropsychiatric disease (e.g., manic depressive
             illness, schizophrenia, depression) considered as clinically significant by the
             investigator.