bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Tolerability of IC83/LY2603618 Administered After Pemetrexed 500 mg/m2 Every 21 Days in Patients With Cancer
Condition: Cancer
Intervention: IC83/LY2603618; IC83/LY2603618; IC83/LY2603618; IC83/LY2603618; IC83/LY2603618; pemetrexed; pemetrexed
Intervention description: 40 mg/m^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles. Dose finding study: dose is escalated after a minimum of 6 participants receive 40 mg/m^2.; 70 mg/m^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles.; 105 mg/m^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles.; 150 mg/m^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles.; 195 mg/m^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles.; pemetrexed 500 mg/m^2, intravenous (IV), Day 8 of Cycle 1, Day 1 of subsequent cycles, unlimited 21-day cycles; pemetrexed 500 mg/m^2 IV, Day 8 of Cycle 1, Day 1 of subsequent cycles, unlimited 21-day cycles
Intervention MeSH terms: Pemetrexed
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and tolerability of IC83/LY2603618 for
      the treatment of cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has at least one lesion that can be evaluated by Response Evaluation Criteria In Solid
             Tumors (RECIST)

          -  Has fully recovered from all toxicities due to the following:

               1. Local radiation therapy that ended at least 14 days prior to Cycle 1, Day 1.

               2. Surgery.

          -  Has a life expectancy of at least 3 months.

          -  Negative serum pregnancy test.

        Exclusion Criteria:

          -  Is pregnant or breastfeeding.

          -  Is a woman of childbearing potential unwilling to use an approved, effective means of
             contraception according to the institution's standards.

          -  Is a man of childbearing potential unwilling to use an approved, effective means of
             contraception according to the institution's standards.

          -  Has a history of brain metastases, unless adequately treated and without radiologic
             evidence of progressive disease for at least 3 months after completion of therapy.

          -  Has a known active infection.
Effect Of Single-Dose PF-05175157 On Metabolic And Cardiopulmonary Parameters
Condition: Healthy
Intervention: PF-05175157; Placebo
Intervention description: 600 mg as powder in capsule, one dose within 5 minutes prior to AM meal; Placebo powder in capsule, one dose within 5 minutes prior to AM meal
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cardiopulmonary exercise testing; metabolic parameters; Diabetes Mellitus Type 2

Summary:

      This study is designed to assess the effect of one single dose of PF-05175157 on metabolic
      and cardiopulmonary parameters before, during and after treadmill exercise in healthy
      volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and/or female subjects of non child bearing potential only, between the
             ages of 18 and 40 years, inclusive (Healthy is defined as no clinically relevant
             abnormalities identified by a detailed medical history, full physical examination,
             including blood pressure and pulse rate measurement, 12 lead ECG and clinical
             laboratory tests).

          -  Body Mass Index (BMI) of 18 to 28 kg/m2; and a total body weight >50 kg (110 lbs).

          -  Subjects with maximum effort studies (peak RER >1.05) and normal exercise capacity as
             defined by peak VO2 ≥80% and ≤120% of predicted and no evidence of inducible ischemia
             or significant arrhythmia at the time of peak aerobic capacity testing 3 (±1) days
             prior to initiation of the study.

        Exclusion Criteria:

          -  Evidence or history of clinically significant hematological, renal, endocrine,
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
             allergic disease (including drug allergies, but excluding untreated, asymptomatic,
             seasonal allergies at time of dosing).

          -  History of smoking in the past 5 years or history or evidence of habitual use of other
             (non smoked) tobacco or nicotine-containing products within 3 months of Screening or
             positive cotinine test at Screening or Day -3 (±1).

          -  Dry eye symptoms
A Study of LY3007113 in Participants With Advanced Cancer
Condition: Metastatic Cancer
MeSH terms: Neoplasm Metastasis
Intervention: LY3007113
Intervention description: Administered orally
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study evaluates the safety and tolerability of different doses of an experimental
      treatment in participants with advanced cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have histological or cytological evidence of a diagnosis of cancer that is advanced
             and/or metastatic for which available standard therapies have failed to provide
             clinical benefit for their disease

          -  For Dose Escalation (Part A): cancer, either a solid tumor or a lymphoma

          -  For Dose Confirmation (Part B): cancer, either a solid tumor or a lymphoma

          -  Have the presence of measureable or non-measureable disease (Part A) or measureable
             disease (Part B) as defined by the Response Evaluation Criteria in Solid Tumors or the
             Revised Response Criteria for Malignant Lymphoma

          -  Have adequate hematologic, hepatic and renal function

          -  Have a performance status less than or equal to 2 on the Eastern Cooperative Oncology
             Group scale

          -  Have discontinued all previous therapies for cancer (including chemotherapy,
             radiotherapy, and immunotherapy) for at least 21 days for myelosuppressive agents or
             14 days for nonmyelosuppressive agents

          -  Have an estimated life expectancy of greater than or equal to 12 weeks

          -  Are able to swallow capsules

        Exclusion Criteria:

          -  Have an echocardiogram with clinically significant abnormalities

          -  For Dose Escalation (Part A): Have central nervous system malignancy or metastasis

          -  For Dose Confirmation (Part B): Have symptomatic central nervous system malignancy or
             metastasis

          -  Have an acute leukemia

          -  Have a history of any other cancer (except non-melanoma skin cancer or carcinoma
             in-situ of the cervix), unless in complete remission and stopped all therapy for that
             disease for a minimum of 3 years

          -  Have received an autologous or allogeneic stem-cell transplant within 75 days of the
             initial dose of study drug
A Phase 1 Study to Evaluate the Safety of MEDI7814 in Adult Volunteers
Condition: Healthy Subjects
Intervention: Placebo; MEDI7814, 1 MG/KG; MEDI7814, 3 MG/KG; MEDI7814, 10 MG/KG; MEDI7814, 20 MG/KG
Intervention description: A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.; A single dose of MEDI7814, 1 mg/kg intravenous infusion over at least 60 minutes on Day 1.; A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.; A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.; A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 125.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy subjects; MEDI7814; FTiH

Summary:

      This is a Phase 1 study to evaluate the safety and tolerability of single ascending
      intravenous doses of MEDI7814 in healthy adult subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 18 years up to and including 49 years at the time of first dose of
             investigational product

          -  Healthy by medical history, physical examination, and laboratory studies

          -  Body weight 50-125 kilogram (kg); body mass index 19.0-32.0 kilogram per square meter
             (kg/m^2) (inclusive)

          -  Females must be of non-childbearing potential.

        Exclusion criteria:

          -  Any acute illness within 30 days of screening

          -  Concurrent enrollment in another clinical trial

          -  The subject has a positive drug/alcohol screen at screening or Day -1

          -  Pregnancy

          -  Current cigarette smokers

          -  History of cancer other than non-melanoma skin cancer or in situ carcinoma of the
             cervix treated with apparent success

          -  Use of immunosuppressive medications

          -  Subjects who have an unresolved infection with any Neisseria species

          -  Subjects who have had their spleen removed for any reason.
Transfusion of Biotinylated Red Blood Cells
Condition: Anemia
Intervention: Biotin-Labeled Red Blood Cells (RBCs)
Intervention description: 500 mL of blood will be drawn from each participant. The blood will be processed into a packed RBC unit.
For participants 1 and 2, the RBCs will be labeled with biotin at three pre-defined concentrations of biotin labeling reagent (2, 6, 18 µg/mL of RBCs) and the labeled RBCs will be re-infused into the participant on the same day of collection.
For participants 3 through 8, the RBCs will be stored at 2-6 C for 40-42 days before being labeled with three pre-defined concentrations of biotin labeling reagent (2, 6, 18 µg/mL of RBCs) and re-infused into the participant.
Participants will have a 5 mL blood sample drawn within a few minutes of the re-infusion, the day after the re-infusion and then weekly for 70 days (10 weeks) to track the survival of the infused biotin labeled RBCs.
Intervention MeSH terms: Biotin
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Red Blood Cell (RBC) transfusion; Biotin labeled red blood cells

Summary:

      The purpose of this research is to study how red blood cells (RBCs) survive in a person's
      circulation, and how that survival may be different in red blood cells that are donated and
      stored prior to being transfused. Investigators will study this by collecting blood samples
      from participants, "labeling" RBCs with a naturally occurring vitamin, biotin. The RBCs will
      then be re-infused back into the participant and blood samples will be taken weekly for 10
      weeks to assess the number of labeled cells in the samples.
    

Eligibility criteria:

        Inclusion Criteria:

          -  in good health

        Exclusion Criteria:

          -  anemia (defined as hemoglobin < 8 g/dL)

          -  chronic disease, including diabetes, heart or lung disease, poorly managed
             hypertension, and peripheral vascular disease

          -  ongoing consumption of biotin or raw egg supplements

          -  history of a bleeding disorder

          -  evidence of anemia at initial screening

          -  women who are pregnant or plan to become pregnant
Bioequivalence of a FDC Tablet of Linagliptin/Metformin (2.5mg/1000mg) Extended Release in Healthy Subjects.
Condition: Healthy
Intervention: Linagliptin; Metformin; Linagliptin/Metformin FDC
Intervention description: Linagliptin; Metformin; Linagliptin/Metformin FDC
Intervention MeSH terms: Metformin; Linagliptin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose
      combination (FDC) tablet containing linagliptin and metformin extended release compared to
      the free combination of linagliptin and metformin extended release.
    

Eligibility criteria:

        Inclusion criteria:

        - Healthy male or female subjects

        Exclusion criteria:

        - Any relevant deviation from healthy condition
Study Of AG-013736 (Axitinib) In Patients With Advanced Solid Tumors
Condition: Carcinoma
Intervention: Axitinib (AG-013736)
Intervention description: AG-013736 5mg twice daily [BID]
Intervention MeSH terms: Axitinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Safety; PK; Biomarker

Summary:

      To evaluate the clinically recommended dose of AG-013736 (Axitinib) in Japanese patients by
      reviewing the safety of AG-013736 (Axitinib) following single and multiple dosing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients histologically or cytologically diagnosed with advanced malignant solid
             tumors

          -  Patients for whom standard therapies have not been effective, or for whom there are no
             suitable therapies

        Exclusion Criteria:

          -  Central lung lesions involving major blood vessels

          -  Patients who have been treated with bevacizumab or other VEGFR inhibitor(s)
Pilot Study of Head Cooling in Preterm Infants With Hypoxic Ischemic Encephalopathy
Condition: Hypoxic Ischemic Encephalopathy
MeSH terms: Brain Diseases; Brain Ischemia; Hypoxia-Ischemia, Brain; Ischemia; Hypoxia
Intervention: Olympic Cool Cap
Intervention description: Olympic Cool Cap will be applied to infants 32-35 weeks gestation who meet criteria for HIE.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 30 Minutes
Maximum age: 6 Hours
Healthy volunteers: No
Keywords: Hypoxic ischemic encephalopathy; HIE; Neonatal encephalopathy; Cooling; hypothermia

Summary:

      The hypothesis is that premature infants' can have enough cooling applied to cool their brain
      to decrease CNS injury without cooling their body.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Babies < 36 weeks gestation but > 32 0/7 weeks. These babies should be small enough to
             allow brain cooling with water circulating in a cooling cap applied to the surface of
             their head

          -  At least one of the following four criteria which are standard definitions for HIE:

               -  Apgar 0-3 at 1,5,10 minutes due to hypoxia

               -  pH less than 7.0

               -  Base deficit greater than 15

               -  Need for continued resuscitation due to hypoxia at 10 minutes

          -  AND a physical exam with evidence of hypotonia or lethargy or seizures indicative of
             evolving HIE.

          -  Intubated

          -  Age less than 6 hours

          -  Signed informed consent by parent / legal guardian

          -  Previous participant has been followed through 7 day head ultrasound.

        Exclusion Criteria:

          -  Mild HIE will not be cooled, therefore babies without hypotonia or lethargy and babies
             who are not intubated will be excluded.

          -  Gestational age ≥ 36 weeks or < 32 weeks or less than 1200 grams.

          -  Older than 6 hours of age

          -  Infant deemed in extremis on clinical exam.

          -  Survival not expected, i.e. received 3 intravenous doses of epinephrine or more during
             resuscitation; on infusion of dopamine, dobutamine and/or epinephrine at time of
             evaluation; and/or has fixed/dilated pupils.

          -  Evidence of head trauma or skull fracture causing major intracranial hemorrhage

          -  Intraventricular hemorrhage

          -  Weight less than the 5th percentile for gestational age

          -  Refusal of consent

          -  Imperforate anus
Rel. BA of Empagliflozin (BI 10773)/Linagliptin FDC Tbl, Comparison With Mono-components, With a Second FDC Tablet and Influence of Food
Condition: Healthy
Intervention: BI 10773/linagliptin; BI 10773/linagliptin; BI 10773/linagliptin SID; BI 10773/linagliptin FDC
Intervention description: medium single dose of BI 10773/linagliptin FDC (Formulation A1); medium single dose of BI 10773/linagliptin FDC (Formulation A3); medium single dose of mono components BI 10773/linagliptin; medium single dose of BI 10773/linagliptin FDC (Formulation A1) after high fat, high caloric meal
Intervention MeSH terms: Linagliptin; Empagliflozin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of the current study is to investigate the relative bioavailability of
      BI 10773 / linagliptin fixed dose combination tablet (formulation A1, Treatment A, Test)
      compared to BI 10773 given in free combination with linagliptin (Treatment B, Reference),
      both in the fasting state. All 42 subjects entered are planned to be included in this
      comparison.

      The secondary objective is to investigate the relative bioavailability of BI 10773 /
      linagliptin fixed dose combination tablet after administration of a standardised high fat,
      high caloric meal (formulation A1, Treatment C, Test) compared to BI 10773 / linagliptin
      fixed dose combination in the fasting state (formulation A1,Treatment A, Reference). Of the
      42 subjects entered 18 subjects are planned to be included in this comparison.

      An additional objective is to investigate the relative bioavailability of a second
      formulation of the fixed dose combination tablet of BI 10773 / linagliptin (formulation
      A3,Treatment D, Test) compared to BI 10773 / linagliptin fixed dose combination tablet
      (formulation A1,Treatment A, Reference). Of the 42 subjects entered 24 subjects are planned
      to be included in this comparison.
    

Eligibility criteria:

        Inclusion criteria:

        healthy male and female subjects
A Study to Evaluate the Bioequivalence of Single Oral Dose of Esomeprazole Capsule and Tablet Formulation in Healthy Participants
Condition: Healthy Participants
Intervention: Esomeprazole Capsule; Esomeprazole Tablet
Intervention description: Esomeprazole Capsule; Esomeprazole Tablet
Intervention MeSH terms: Esomeprazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug Therapy

Summary:

      The purpose of this study is to determine the bioequivalence of esomeprazole 40 milligram
      (mg) tablets and capsules.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Is a healthy adult male or female participant.

          2. Is aged 18 to 55 years, inclusive, at the time of informed consent and first study
             medication dose.

          3. Weighs at least 50 kilogram (kg) and has a body mass index (BMI) from 18.5 to 30
             kilogram per square meter (kg/m^2), inclusive at Screening and Day -1.

        Exclusion Criteria:

          1. Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary,
             hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other
             abnormality, which may impact the ability of the participant to participate or
             potentially confound the study results. It is the responsibility of the investigator
             to assess the clinical significance; however, consultation with the Takeda Medical
             Monitor may be warranted.

          2. Has a history of significant gastro intestinal (GI) disorders manifested with
             persistent, chronic or intermittent nausea, vomiting, diarrhea, or has a current or
             recent (within 6 months) GI disease that would influence the absorption of drugs
             (example, a history of malabsorption, severe esophageal reflux, peptic ulcer disease
             or erosive esophagitis), or any gastrointestinal-related surgical intervention..

          3. Has a known hypersensitivity to any component of the formulation of esomeprazole
             capsules or tablets or compounds with the same mechanism of action (dexlansoprazole,
             lansoprazole, omeprazole, rabeprazole, pantoprazole), or related compounds.
Safety and Tolerability of AGN-199201 in Patients With Erythema Associated With Rosacea
Condition: Rosacea; Erythema
MeSH terms: Rosacea; Erythema
Intervention: AGN-199201 Formulation A; AGN-199201 Formulation B; AGN-199201 Formulation C; AGN-199201 Vehicle
Intervention description: AGN-199201 Formulation A applied to the face as per protocol twice daily.; AGN-199201 Formulation B applied to the face as per protocol twice daily.; AGN-199201 Formulation C applied to the face as per protocol twice daily.; AGN-199201 vehicle (placebo) applied to the face as per protocol twice daily.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and tolerability of AGN-199201 for the treatment of
      erythema associated with rosacea.
    

Eligibility criteria:

        Inclusion Criteria:

          -  facial erythema associated with rosacea on both sides of the face

        Exclusion Criteria:

          -  Laser light-source or other energy based therapy in the last 6 months

          -  Excessive hair around the treatment area