bioihbjkbjnl/mcl2 huggingface dataset:
Cabozantinib (XL184) in Men With Castrate-Resistant Prostate Cancer
Condition: Prostate Adenocarcinoma
MeSH terms: Prostatic Neoplasms
Intervention: cabozantinib
Intervention description: Cabozantinib PO QD
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostate cancer; Castration Resistant; Bone Metastases

Summary:

      Cabozantinib (XL184) is a new drug that is being developed to treat cancer. Cabozantinib
      works by blocking the "angiogenesis," or the growth of new blood vessels, to the tumor. This
      is similar to how several other cancer drugs work but in addition Cabozantinib also blocks
      other pathways that may be responsible for allowing cancer cells to become resistant to these
      other "anti-angiogenic" treatments. So far cabozantinib has been investigated in treating
      brain cancer and a rare form of thyroid cancer. This study will explore lower doses of
      cabozantinib with the goal to find the most effective, safe, and tolerable dose without
      undesirable side effects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed prostate adenocarcinoma

          -  Bone metastases confirmed by bone scan

          -  Current androgen deprivation therapy

          -  Castration-resistant disease based on progression in bone and/or PSA progression

          -  Recovered from toxicities related to prior treatment, except alopecia, lymphopenia,
             other non-clinically significant adverse events

          -  Life expectancy of greater than 3 months

          -  Normal organ and marrow function

          -  Capable of understanding and complying with the protocol requirements

          -  Agree to use medically accepted methods of contraception

          -  Able to swallow capsules

        Exclusion Criteria:

          -  More than two prior chemotherapy regimens for metastatic prostate cancer

          -  Known untreated, symptomatic or uncontrolled brain metastases

          -  Serious or unhealed wound

          -  Treatment with anticoagulants

          -  Previously identified allergy or hypersensitivity to components of the study treatment
             formulation

          -  History of a different malignancy unless disease-free for at least 5 years, or basal
             or squamous cell carcinoma of the skin

          -  Current antiretroviral therapy

          -  Uncontrolled hypertension

          -  Uncontrolled intercurrent illness
A Study of LY900014 Formulation in Healthy Participants
Condition: Healthy
Intervention: LY900014; Insulin Lispro
Intervention description: Administered subcutaneously (SC); Administered SC
Intervention MeSH terms: Insulin Lispro
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 32.0
Sex: All
Minimum age: 21 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study evaluates a new formulation of LY900014, a drug that lowers blood sugar. It is
      administered by injection under the skin of the abdomen. The study will be conducted in
      healthy people to investigate how quickly and how much LY900014 is absorbed and the effect of
      different doses of LY900014 on blood sugar levels. Side effects and tolerability will be
      documented. The study will last about 6 to 7 weeks for each participant, including screening
      and follow up. Screening is required within 28 days prior to entering the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy male or a female (not pregnant and agreeable to take birth control
             measures until study completion)

          -  Have a body mass index (BMI) of 18 to 30 kilogram per square meter (kg/m²), inclusive,
             at screening

          -  Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine
             laboratory test results that are acceptable for the study

          -  Are nonsmokers, have not smoked for at least 2 months prior to entering the study, and
             agree not to smoke (cigars, cigarettes, or pipes) or use smokeless tobacco for the
             duration of the study

        Exclusion Criteria:

          -  Are currently participating in or completed a clinical trial within the last 30 days
             or any other type of medical research judged to be incompatible with this study

          -  Have previously participated or withdrawn from this study

          -  Have or used to have health problems or laboratory test results or ECG readings that,
             in the opinion of the doctor, could make it unsafe to participate, or could interfere
             with understanding the results of the study

          -  Had blood loss of more than 450 milliliters (mL) within the last month
A Study to Assess the Pharmacokinetics, Safety and Tolerability of Sitagliptin in Adolescents (0431-081)
Condition: Type 2 Diabetes
Intervention: Sitagliptin phosphate; Comparator: matching placebo
Intervention description: Participants will fast 8 hours prior to dosing. All doses will be given with 240 ml of water. Participants received either a single oral dose of sitagliptin 50 mg tablet, sitagliptin 100 mg tablet, or sitagliptin 200 mg.; Participants will fast 8 hours prior to dosing. All doses will be given with 240 ml of water. Participants received either a single oral dose of matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg.
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 35.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This study will assess the safety, tolerability and pharmacokinetics of sitagliptin in 10 to
      17 year old diabetic patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females who are 10 - 17 years of age

          -  History of type 2 diabetes

          -  Nonsmoker

          -  No clinical or laboratory evidence to indicate a diagnosis of type 1 diabetes

        Exclusion Criteria:

          -  History of diabetic ketoacidosis

          -  History of stroke, chronic seizures or major neurological disorder

          -  Consumes alcohol

          -  Consume more than 6 servings (1 serving is approximately equivalent to 120 mg of
             caffeine) of coffee, tea, cola or other beverages containing caffeine per day

          -  Unable to swallow tablets

          -  Has had surgery, donated or lost 1 unit of blood, or participated in another
             investigational study within a minimum of 4 weeks prior to starting the study

          -  History of multiple and/or severe allergies or has had an allergic reaction to or
             significant intolerability to prescription or non-prescription drugs or food

          -  Currently a regular user of any illicit drugs or has a history of drug or alcohol
             abuse

          -  History of clinically significant endocrine, gastrointestinal,

        cardiovascular, hematological, hepatic, immunological, renal, respiratory, or

        genitourinary abnormalities or diseases

          -  Has an estimated creatinine clearance of less than or equal to 80 mL/min
The Capillary Index Score Trial
Condition: Acute Stroke; Brain Ischemia; Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Brain Ischemia; Ischemia
Intervention: Endovascular Treatment (EVT)
Intervention description: EVT is an endovascular procedure in which a catheter is inserted into an artery and directed to the site of the blocked blood vessel in the brain. The clot is removed using a mechanical device with or without an injection of tPA (tissue plasminogen activator) directly at the site of the clot. The protocol calls for use of the Trevo stent retriever (Stryker Neurovascular) for the first pass of clot removal.
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be assigned to one of two groups based on the outcome of diagnostic evaluation. Treatment will be identical for the two groups.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: The participants and investigators evaluating 90 day outcomes will be blinded to the group.
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: capillary index score; acute ischemic stroke; collateral circulation; cerebral ischemia; diagnostic imaging

Summary:

      This study seeks to investigate the capillary index score (CIS) to further improve patient
      selection of endovascular treatment (EVT) in acute ischemic stroke (AIS).

      The hypothesis or idea being tested:

      Patients with favorable CIS who are successfully revascularized with EVT can have successful
      outcomes with an extended time window for treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Anterior circulation acute ischemic stroke due to blockage of the intracranial
             internal carotid artery or middle cerebral artery (M1)

          2. Within 24 hours of onset of symptoms

          3. NIHSS Score is 8 or greater

        Exclusion Criteria:

          1. Contra-indication for IAT found on initial CT

          2. Intracranial hemorrhage

          3. Stroke mimics (tumor, herpetic encephalitis, etc.)

          4. More than 1/3 hypodensity on non-enhanced head CT prior to intervention

          5. ASPECT Score less than 6

          6. Pre-existing disability defined as modified Rankin Scale (mRS) score more than 2

          7. Pregnant women
Bioequivalence Study of 2.5-mg Saxagliptin and 500-mg Glucophage in Tablets and a Fixed-dose Combination Tablet in Healthy Participants
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Saxagliptin, 2.5 mg + Metformin, 500 mg (fasted state); Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fasted state); Saxagliptin, 2.5 mg + Metformin, 500 mg (fed state); Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fed state)
Intervention description: Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin, once daily, 1 week; Tablets, oral, 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC), once daily, 1 week; Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin, once daily, 1 week; Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin FDC, once daily, 1 week
Intervention MeSH terms: Metformin; Saxagliptin
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To demonstrate the bioequivalence of a 2.5-mg saxagliptin/500-mg metformin fixed-dose
      combination (FDC) tablet to that of 2.5-mg saxagliptin (Onglyza) and 500-mg metformin
      (Glucophage, marketed in Canada by Sanofi-Aventis) tablets coadministered to healthy
      participants in the fasted and fed states.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women, aged 18 to 55 years, inclusive

          -  Healthy participants as determined by a lack of clinically significant deviation from
             normal in medical history, physical examination, electrocardiograms, and clinical
             laboratory determinations

          -  Body Mass Index of 18 to 32 kg/m^2, inclusive

        Exclusion Criteria:

          -  Any significant acute or chronic medical illness

          -  Current or recent (within 3 months) gastrointestinal disease

          -  Any major surgery within 4 weeks of study drug administration

          -  History of allergy to DPP-4 inhibitors or related compounds

          -  History of allergy or intolerance to metformin or other similar acting agents

          -  Previous exposure to saxagliptin

          -  Exposure to metformin within 3 months pervious to study drug administration

          -  Estimated creatinine clearance of <80 mL/min using the Cockcroft Gault formula
A Study of LY3832479 (LY-CoV016) in Healthy Participants
Condition: Healthy
Intervention: LY3832479; Placebo
Intervention description: Administered IV.; Administered IV.
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purpose of this study is to learn more about the safety of LY3832479 and any side
      effects that might be associated with it. Blood tests will be done to measure how much
      LY3832479 is in the bloodstream and how long it takes the body to eliminate it. Participation
      could last up to 16 weeks and may include up to 10 visits to the study center.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy as determined by medical evaluation including medical history and
             physical examination

        Exclusion Criteria:

          -  Test positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)

          -  Pregnant women and women of childbearing potential

          -  Have a history or presence of cardiovascular (including hypertension), respiratory,
             hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders
             that, in the opinion of the investigator, are capable of significantly altering the
             absorption, metabolism, or elimination of drugs, or of constituting a risk while
             taking the investigational product, or of interfering with the interpretation of data

          -  Have participated in a clinical study involving an investigational product, with last
             dose within the past 30 days or 5 half-lives (whichever is longer) prior to dosing
A Relative Bioavailability Study of SSP-004184AQ (Magnesium Salt) and SSP-004184SS (Disodium Salt)
Condition: Healthy
Intervention: SSP-004184AQ; SSP-004184SS
Intervention description: Magnesium salt; Disodium salt
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate the relative bioavailability of the new SSP-004184SS capsule
      formulation compared to the original SSP-004184AQ drug plus excipients formulation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-65 years

          -  Must be considered "healthy".

          -  Serum ferritin >20ng/mL, hemoglobin >125g/L and erythrocyte indices within normal
             range

        Exclusion Criteria:

          -  Subject has a clinically significant history or a disorder detected during the medical
             interview/physical examination at the Screening Visit or any other medical condition
             that is capable of altering the absorption, metabolism, or elimination of drugs

          -  Acute illness, as judged by the investigator, within 2 weeks of Day 1 of Treatment
             Period 1.

          -  Known or suspected intolerance or hypersensitivity to the investigational products,
             closely related compounds, or any of the stated ingredients.

          -  Subject has a history of thyroid disorder that has not been stabilized on thyroid
             medication or treatment within 3 months

          -  History of alcohol or other substance abuse within the last year.

          -  A positive screen for alcohol or drugs of abuse at the Screening Visit.

          -  Confirmed systolic blood pressure >139mmHg or <89mmHg, and diastolic blood pressure
             >89mmHg or <49mmHg.

          -  Twelve-lead ECG demonstrating QTc >450msec at screening.

          -  Routine consumption of more than 2 units of caffeine per day or subjects who
             experience caffeine withdrawal headaches.

          -  Male subjects who consume more than 3 units of alcohol per day. Female subjects who
             consume more than 2 units of alcohol per day.

          -  A positive HIV antibody screen, HBsAg, or HCV antibody screen.

          -  Use of tobacco in any form (eg, smoking or chewing) or other nicotine-containing
             products in any form (eg, gum, patch) within 30 days prior to Day 1 of Treatment
             Period 1.
Pharmacokinetic and Exploratory Electrocardiogram (ECG) Study
Condition: Pharmacokinetics
Intervention: Colchicine; Moxifloxacin
Intervention description: two 0.6 mg capsules (1.2 mg dose) followed by an additional 0.6mg capsule every hour for 6 additional doses; 400 mg capsule at the 6 hour point
Intervention MeSH terms: Moxifloxacin; Colchicine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: healthy

Summary:

      This study will characterize the pharmacokinetics of colchicine after an oral dosing regimen
      of 4.8 mg over 6 hours. In addition it will compare the electrocardiogram (ECG) changes, if
      any, from this dosing regimen to that of a single dose of moxifloxacin 400 mg, a positive
      control for the corrected QT interval (QTc) prolongation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adults 18-55 years of age, non smoking and non-pregnant, weighing at least
             55kg and within 15% of ideal body weight, with no significant EKG changes

        Exclusion Criteria:

          -  Pregnant or lactating

          -  Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface
             antigen (HbsAg), or hepatitis C virus (HCV)

          -  Recent (2-year) history or evidence of alcoholism or drug abuse

          -  History or presence of significant cardiovascular, pulmonary, hepatic, renal,
             haematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological,
             or psychiatric disease

          -  History or family history of congenital long QT syndrome (LQTS) or sudden death
             possibly related to LQTS

          -  Subjects who have used any drugs or substances known to inhibit or induce cytochrome
             (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 30 days prior to the first dose
             and throughout the study
A Study of LY900014 in Healthy Chinese Participants
Condition: Healthy
Intervention: LY900014; Insulin Lispro
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Insulin Lispro
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate a new formulation of insulin lispro, LY900014, which
      is a drug that lowers blood sugar. The study will look at how the body processes LY900014 and
      the effect of LY900014 on blood sugar levels. For each participant, the study will consist of
      3 periods and will last about 51 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy native Chinese males or females

          -  Female participants:

               -  Women of child-bearing potential who are abstinent or use effective methods of
                  contraception for the entirety of the study.

               -  Women not of child-bearing potential who are infertile or post-menopausal

          -  Have a body mass index (BMI) of 18 to 28 kilograms per square meter (kg/m²)

          -  Are nonsmokers

          -  Have a fasting plasma glucose value >71 milligrams per deciliter (mg/dL) (3.9
             millimoles per liter [mmol/L]) and <108 mg/dL (6.0 mmol/L)

        Exclusion Criteria:

          -  Are currently enrolled in a clinical study, or have participated, within the last 30
             days, in a clinical study involving an investigational product

          -  Have previously completed or withdrawn from this study or any other study
             investigating LY900014

          -  Have known allergies to LY900014 or any components of the formulation

          -  Have a significant history of cardiovascular, respiratory, hepatic, renal,
             gastrointestinal, endocrine, hematological, or neurological disorders capable of
             significantly altering the absorption, metabolism, or elimination of drugs; of
             constituting a risk when taking the investigational product; or of interfering with
             the interpretation of data

          -  Intend to use over-the-counter or prescription medication within 7 and 14 days,
             respectively, prior to dosing or during the study.

          -  Have donated blood of more than 400 milliliters (mL) within the previous 6 months of
             study screening or donated more than 100 mL within the last 30 days.

          -  Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14
             units per week (females)