bioihbjkbjnl/mcl2 huggingface dataset:
A Study of LY3303560 in Healthy Participants and Participants With Alzheimer's Disease (AD)
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: LY3303560 - IV; Saline Solution - IV; LY3303560 - SC
Intervention description: Administered IV; Administered IV; Administered SC
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 72.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the safety and tolerability of the study drug,
      LY3303560. Side effects and laboratory results will be monitored. This study will involve
      single doses of LY3303560 administered intravenously (IV), meaning into a vein or
      subcutaneously (SC), meaning under the skin.

      Screening is required within 28 days before the start of the study for healthy participants
      and within 70 days before the start of the study for AD participants. The study requires
      about 16 weeks of each participant's time including a 4 day clinical research unit (CRU)
      admission and 10 follow-up appointments.

      This is the first time that this study drug is being given to participants. This study is for
      research purposes only, and is not intended to treat any medical condition.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy males or females of non-childbearing potential and who have given
             consent and are reliable and willing to make themselves available for the duration of
             the study and are willing to follow study procedures

          -  AD participants must be at least 50 years of age and have diagnostic criteria
             consistent with either mild cognitive impairment due to AD or mild-to moderate AD and
             have a positive florbetapir positron emission tomography (PET) scan

        Exclusion Criteria:

          -  Have known allergies to LY3303560, related compounds or any components of the
             formulation, or history of significant atopy

          -  Have an increased risk of seizures

          -  For AD participants, evidence of macrohemorrhage or greater than 4 microhemorrhage by
             magnetic resonance imaging (MRI)
Safety and Efficacy of Squaric Acid Dibutyl Ester for the Treatment of Herpes Labialis
Condition: Herpes Labialis
MeSH terms: Herpes Simplex; Herpes Labialis
Intervention: Squaric Acid solution; Placebo solution
Intervention MeSH terms: Pharmaceutical Solutions; Squaric acid dibutyl ester
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Subjects with a history of recurrent herpes labialis will be sensitized with either 2% SADBE
      or placebo. Following this, subjects sensitized with 2% SADBE will received.2% sqauric acid
      or.5% squaric acid on their cold sore within 72 hours of a recurrence. Subjects sensitized
      with placebo solution will receive placebo solution on their cold sore within 72 hours of a
      recurrence. Subjects will be followed for up to 6 mos after application of study medication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age >18

          -  With clinical diagnosis of herpes labialis.

          -  who self report having six or more episodes of herpes labialis in the previous 12
             months.

        Exclusion Criteria:

          -  Pregnant or lactating females.

          -  Current or recurrent infection or any underlying condition that may predispose to
             infection or anyone who has been admitted to the hospital due to bacteremia, pneumonia
             or any other serious infection.

          -  Therapy with glucocorticoid or immunosuppressant at time of recruitment or within past
             4 weeks, except for inhaled corticosteroids for asthma.

          -  History of malignancy (except patients with surgically cured basal cell or squamous
             cell skin cancers who will be eligible)

          -  History of organ transplantation

          -  Negative HIV-positive status determined by history at screening or known history of
             any other immuno-suppressing disease.

          -  Severe comorbidities (diabetes mellitus requiring insulin, CHF (EF<50% at baseline
             will be exclusionary) of any severity, MI, CVA or TIA within 3 months of screening
             visit, unstable angina pectoris, oxygen-dependent severe pulmonary disease

          -  Subject is currently enrolled in another investigational device or drug trial(s), or
             subject has received other investigational agent(s) within 28 days of baseline visit.

          -  Subjects who have known hypersensitivity to Squaric acid or any of its components.

          -  History of recent alcohol or substance abuse (< 1 year)

          -  Any condition judged by the investigator to cause this clinical trial to be
             detrimental to the patient.

          -  History of psychiatric disease that would interfere with the patient's ability to
             comply with the study protocol

          -  History of non-compliance with other therapies.
A Study To Investigate The Pharmacokinetics, Safety And Tolerability Of An Intravenous And Oral Form Of A Compound In Subjects With Varying Degrees Of Renal Impairment And Normal Renal Function
Condition: Pneumonia
MeSH terms: Pneumonia; Renal Insufficiency
Intervention: CP-70,429 and PF-03709270
Intervention description: Study Periods 1 and 2 will be separated by a minimum of 14 days. In Period 1, subjects will receive a single dose of CP-70429 (800 mg given as a 1.5 hour intravenous infusion), while in Period 2, subjects will receive a single oral dose of PF-03709270 (1000 mg).
Intervention MeSH terms: Lactams
Phase: Phase 1
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate what effect renal dysfunction has on a drug that has an intravenous
      (CP-70,429) and an oral form (PF-03709270).
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects must meet one of the following renal function categories:

          -  Normal renal function (CLcr >80 mL/min).

          -  Mild renal impairment (CLcr >50 and <80 mL/min).

          -  Moderate renal impairment (CLcr >30 and <50 mL/min).

          -  Severe renal impairment (CLcr <30 mL/min).

        Exclusion Criteria:

        Women who are pregnant or nursing or women who are of childbearing potential. History of
        clinically significant allergies, including seasonal allergies, and especially drug
        hypersensitivity including known allergies to components of the study drug formulation,
        penicillin, carbapenems and/or cephalosporin antibiotics (eg, amoxicillin,
        amoxicillin/clavulanate, ampicillin, cefadroxil, cephalexin, cefaclor and cefixime).

        Subjects should not have evidence of a history of the following:

          -  normal renal function: clinically significant hematological, renal, endocrine,
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological or
             allergic disease.

          -  renal impairment: any clinically significant (hepatic, cardiac or pulmonary or
             subjects with acute nephritic syndrome) diseases (except diabetes). Stable co-morbid
             disease where it is unlikely that the disease and medication will alter the outcome of
             the study will be allowed.
Assessment of Single Doses of Oral Dexanabinol in Healthy Subjects
Condition: Safety; Tolerability; Pharmacokinetics; Cancer
Intervention: Dexanabinol Dose Level 1; Dexanabinol Dose Level 2; Dexanabinol Dose Level 3; Dexanabinol Dose Level 4; Dexanabinol Dose Level 5; Placebo
Intervention description: Oral formulation of dexanabinol; Oral formulation of dexanabinol; Oral formulation of dexanabinol; Oral formulation of dexanabinol; Oral formulation of dexanabinol
Intervention MeSH terms: HU 211; Dronabinol
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dexanabinol; Oral; Safety; Tolerability; Pharmacokinetics

Summary:

      The purpose of this study is to test the safety and observe the pharmacokinetics
      (distribution and elimination of the drug) of the compound dexanabinol (ETS2101) in healthy
      male subjects following a single oral dose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy males aged 18 to 45 years

          -  Body mass index 18.0 to 32.0 kg/m2, or if outside the range, considered not clinically
             significant by the investigator

        Exclusion Criteria:

          -  Participation in a clinical research study within the previous 3 months

          -  Current smokers and those who have smoked within the last 12 months

          -  History of any drug or alcohol abuse in the past 2 years
A Study Of PF-06647263 In Patients With Advanced Solid Tumors
Condition: Neoplasms; Triple-Negative Breast Cancer
MeSH terms: Triple Negative Breast Neoplasms
Intervention: PF-06647263; PF-06647263
Intervention description: Part 1- PF-06647263 will be administered intravenously in either a 21 day cycle or weekly in cohorts of 2 or more patients starting at a dose of 0.015 mg/kg. Increases in dose will continue until MTD is determined.; Part 2- Patients with triple negative breast cancer will be treated at the MTD or Recommended Phase 2 dose selected in Part 1.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ADC; PF-06647263; solid tumors; tumors; neoplasm metastasis; TNBC; Triple negative breast cancer

Summary:

      To assess the safety and tolerability at increasing dose levels of PF-06647263 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 solid tumor that is advanced/metastatic and resistant to standard therapy
             or for whom no standard therapy is available

          -  Performance Status of 0 or 1

          -  Adequate bone marrow, kidney, and liver function

          -  Part 2 includes advanced triple negative breast cancer patients.

        Exclusion Criteria:

          -  Brain metastases requiring steroids

          -  Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of
             study treatment start

          -  Active and clinically significant bacterial, fungal or viral infection
A Prospective Study of a New Device for Monitoring Cerebral Oxygenation on Healthy Volunteers
Condition: Cerebral Ischemia
MeSH terms: Brain Ischemia; Cerebral Infarction; Ischemia
Intervention: CDI 1000 COM
Intervention description: CDI 1000 COM sensors were attached to subject's forehead for a 12 hour period.
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cerebral Oxygenation; Oxygen Monitoring

Summary:

      The purpose of this study is to determine whether a new cerebral oxygen monitoring device is
      effective and comparatively similar to the current approved devices.
    

Eligibility criteria:

        INCLUSION CRITERIA:

          -  Healthy male or Female Volunteers

          -  18 years old or older

          -  Capable and willing to operate a bicycle

          -  Understand enough about the risks and benefits of the study to be able to make an
             informed decision before agreeing to be in the study

        EXLUSION CRITERIA:

          -  History of Cerebrovascular Disease

          -  History of Skin Problems on Forehead (Skin Rashes, Acne, Allergies, etc.)

          -  Pregnancy
Study of Food on Evacetrapib (LY2484595) in Healthy Participants
Condition: Healthy Volunteers
Intervention: Evacetrapib; High-fat Meal
Intervention description: Administered orally; Administered orally, at breakfast.
Intervention MeSH terms: Evacetrapib
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
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 measure how much of the drug gets into the blood stream and
      how long it takes the body to get rid of it when given to healthy participants. Information
      about any side effects that may occur will also be collected.

      The study has 2 periods. In each period, participants will take the study drug for 10 days,
      either with or without a meal. There is a minimum 14-day washout between each period.

      This study is approximately 50 days, not including screening. Screening is required within 28
      days prior to the start of the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy participants as determined by medical history and physical examination

          -  Have a body mass index of 18 to 32 kilograms per square meter (kg/m²)

          -  Are able to eat a high fat breakfast and abide by the food restrictions throughout the
             study

        Exclusion Criteria:

          -  Have known allergies to evacetrapib, 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

          -  Regularly use known drugs of abuse and/or show positive findings on urinary drug
             screening

          -  Are participants who currently smoke cigarettes or use tobacco or nicotine substitutes
A Single-center, Open-label, Single-dose Study Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Nalmefene 10 mg Tablets in Healthy Japanese Male Subjects
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Intervention: nalmefene hydrochloride 10 mg
Intervention MeSH terms: Nalmefene
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: Male
Minimum age: 20 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The safety, tolerability, and pharmacokinetics of nalmefene at a single oral dose of 10 mg in
      healthy Japanese male subjects will be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The subject is a Japanese male.

          -  The subject is able to read and understand the informed consent form (ICF).

          -  The subject has a body mass index (BMI) ≥ 19 kg/m2 and ≤ 25 kg/m2 at the screening
             visit.

          -  The subject has a resting pulse and heart rate (as read on the ECG) ≥ 45 bpm and ≤ 100
             bpm at the screening visit.

        Exclusion Criteria:

          -  The subject has taken any prescription drugs, over-the counter medications, vitamin
             supplements, or supplements containing St. John's Wort (Hypericum perforatum) within 2
             weeks prior to Day 1.

          -  The subject has a significant history of alcohol abuse, defined as an alcohol intake
             greater than 21 units per week. (A unit of alcohol is defined as 250 mL of lager/beer,
             100 mL of wine, or 25 mL of spirits.)

          -  The subject has taken any investigational products within 4 months prior to Day 1.
Samarium-153 With Neoadjuvant Hormonal and Radiation Therapy for Locally Advanced Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Samarium-153; Total Androgen Suppression (TAS) with Bicalutamide; Total androgen suppression (TAS) with Goserelin Acetate; Radiation Therapy
Intervention description: Samarium-153 will be administered as a single dose after one month of hormonal therapy. The dose level of Samarium-153 may change to determine maximum tolerated dose (MTD).; Patients will receive 5 months of total androgen suppression (TAS) consisting of Zoladex and Casodex. Total androgen suppression will begin 3 months prior to initiation of irradiation.; Patients will receive 5 months of total androgen suppression (TAS) consisting of Zoladex and Casodex. Total androgen suppression will begin 3 months prior to initiation of irradiation.; Radiation therapy will begin 3 months following the initiation of hormone administration. Daily tumor doses will be given 5 days per week for 7-8 weeks.
Intervention MeSH terms: Ascorbic Acid; Goserelin; Methyltestosterone; Bicalutamide; Samarium Sm-153 lexidronam; Androgens; Estrogens, Conjugated (USP); Ethylene
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Locally advanced prostate cancer; positive lymph nodes

Summary:

      The purpose of this study is to determine the safety and effectiveness of Samarium-153 when
      given in combination with hormonal and external beam radiation therapy in men with high risk
      prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  PSA 20-150 and Gleason score greater than or equal to 7 or clinical stage greater than
             or equal to T2, Gleason greater than or equal to 8, PSA less than or equal to 150

          -  Pathologically positive lymph nodes

          -  Pretreatment must be prior to study entry and prior to any hormonal therapy

          -  Zubrod 0-1

          -  Adequate hematologic function

        Exclusion Criteria:

          -  Patients with PSA equal to or greater than 150

          -  Neuroendocrine features on histologic examination

          -  Radiologic evidence of metastatic disease

          -  Previous malignancy within last 5 years

          -  Prior pelvic radiation therapy or orchiectomy
Acute Exercise Cardioprotection From Doxorubicin
Condition: Breast Cancer
Intervention: exercise
Intervention description: An acute bout of exercise performed 24 hours prior to every anthracycline infusion.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 27.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cardiotoxicity; Chemotherapy, Adjuvant; Breast Neoplasms; Exercise; Cardiotoxins; Echocardiography; Speckle tracking; Biological Markers; Electrocardiography

Summary:

      In rodents, a single bout of exercise prior to injection of a chemotherapy agent used to
      treat breast cancer prevents or attenuates a number of markers of cardiac injury. This study
      will investigate whether this finding translates to human breast cancer patients.
      Participants scheduled to receive chemotherapy for breast cancer will be randomized to
      exercise or no exercise 24 hours prior to every chemotherapy treatment. The effect on cardiac
      function will be compared between groups noninvasively by echocardiography and
      electrocardiography and a venous blood draw at baseline before chemotherapy, after the first
      treatment and at the end of chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  newly diagnosed with stage I-IIIA breast cancer

          -  scheduled to receive neoadjuvant or adjuvant doxorubicin chemotherapy in cycles of 2-3
             weeks long

          -  receive their oncologist's approval to exercise

          -  be able to complete first time point of data collection prior to first chemotherapy
             cycle

          -  be able to understand and provide written informed consent in English

        Exclusion Criteria:

          -  concurrent participation in a structured exercise program or study

          -  have orthopedic limitations to exercise

          -  pre-existing cardiovascular disease

          -  uncontrolled hypertension (blood pressure ≥ 140/90 mmHg)

          -  uncontrolled diabetes

          -  respiratory disease

          -  current smoking status