bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Ramucirumab (LY3009806) in Children With Refractory Solid Tumors
Condition: Pediatric Solid Tumor; Refractory Tumor; Recurrent Tumor; CNS Malignancies
MeSH terms: Neoplasms; Recurrence
Intervention: Ramucirumab
Intervention description: Administered IV
Intervention MeSH terms: Ramucirumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 12 Months
Maximum age: 21 Years
Healthy volunteers: No
Keywords: relapsed pediatric solid tumors; unspecified childhood solid tumor; brain and central nervous system tumors

Summary:

      The main purpose of this study is to evaluate the safety of the study drug known as
      ramucirumab in children with recurrent or refractory solid tumors including central nervous
      system (CNS) tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Part A: participants with recurrent or refractory non-CNS solid tumors

          -  Part B: participants with recurrent or refractory CNS tumors

          -  Measurable or evaluable disease

          -  No other therapeutic options

          -  Performance Status: Karnofsky ≥50% for participants >16 years and Lansky ≥50 for
             participants ≤16 years

        Exclusion Criteria:

          -  Active or recent history of serious bleeding events

          -  Active or recent history of gastrointestinal perforations, ulcers, fistulas or
             abscesses

          -  Active or recent history of hypertensive crisis or hypertensive encephalopathy

          -  Active non-healing wound or bone fracture

          -  History of solid organ transplant
Pharmacokinetics, Safety, and Tolerability Study of the Pen and PFS of SB5 in Healthy Subjects
Condition: Healthy
Intervention: Pen of SB5; PFS of SB5
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 190.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of the
      pre-filled pen and pre-filled syringe of SB5 in healthy subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy subjects

          -  Have a body mass index between 20.0 to 29.9 kg/m², inclusive.

        Exclusion Criteria:

          -  History and/or current presence of clinical significant atopic allergy,
             hypersensitivity or allergic reactions, also including known or suspected clinically
             relevant drug hypersensitivity to any components of the test and reference
             investigational product formulation or comparable drugs

          -  Active or latent Tuberculosis or who have a history of Tuberculosis

          -  History of invasive systemic fungal infections or other opportunistic infections

          -  Systemic or local infection, a known risk for developing sepsis and/or known active
             inflammatory process

          -  Serious infection associated with hospitalisation and/or which required intravenous
             antibiotics

          -  History of and/or current cardiac disease

          -  Have received live vaccine(s) within 4 weeks prior to Screening or who will require
             live vaccine(s) between Screening and the subject's last visit

          -  Intake medication with a half-life > 24 h within 4 weeks or 10 half-lives of the
             medication prior to investigational product administration
Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis
Condition: Systemic Lupus Erythematosus; Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid; Lupus Erythematosus, Systemic
Intervention: PF-06835375; Placebo
Intervention description: Intravenous (IV) or subcutaneous (SC) administration. Subjects will receive one or two doses. Doses will be ascending and determined by emerging data.; Matching placebo for PF-06835375 IV or SC. Subjects will receive one or two doses.
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This is a Phase 1 single and multiple dose escalation study to evaluate the safety,
      tolerability, pharmacokinetics, and pharmacodynamics of PF-06835375 in subjects with
      seropositive SLE or RA. The design is double-blind, sponsor open and placebo controlled. This
      study will include two parts: Part A and Part B. Part A will consist of single ascending dose
      cohorts, Part B of multiple ascending dose cohorts. This study will enroll up to a total of
      approximately 112 subjects at approximately 10 sites.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with Rheumatoid Arthritis: confirmed diagnosis according to 2010 ACR/EULAR
             criteria with symptom duration at least 6 months and positive with Rheumatoid Factor
             and/or anti citrullinated peptide antibody

          -  Patients with Systemic Lupus Erythematosus: Confirmed diagnosis according to the SLICC
             Classification Criteria with symptom duration at least 6 months and at least one of
             the following: positive antinuclear antibody titer, positive anti-dsDNA, anti-Smith
             antibodies

        Exclusion Criteria:

          -  Active central nervous system manifestations, systemic vasculitis or
             pleuro/pericarditis

          -  Active lupus nephritis

          -  Treatment with B cell depleting agents within 52 weeks prior to screening
A Study of LY2951742 in Healthy Japanese and Caucasian Participants
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Intervention: LY2951742; Placebo
Intervention description: Administered subcutaneously.; Administered subcutaneously.
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 45.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purpose of this study is to evaluate the safety of the study drug known as LY2951742
      in healthy Japanese and Caucasians. The study will also investigate how the body processes
      the drug and how the drug affects the body. The study is expected to last about 5 to 7
      months, depending on the arm.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants are either Caucasian or first generation Japanese.

          -  Participants' body mass index (BMI) is between 18.0 and 35.0 kilogram per meter square
             (kg/ m^2).

        Exclusion Criteria:

          -  Participants are heavy caffeine drinkers defined by regular intake of more than 5 cups
             of coffee (or equivalent in xanthine containing beverages) per day, and/or are unable
             or unwilling to abide by caffeine restrictions as specified in the protocol.

          -  Participants are smoking within the previous 6 months.

          -  Participants have received treatment with biologic agents (such as monoclonal
             antibodies) within 3 months or 5 half-lives (whichever is longer) prior to dosing or
             have received a vaccination within 1 month.

          -  Participants have known allergies to LY2951742, related compounds or any components of
             the formulation, or history of significant atopy.

          -  Participants are allergies to either humanized monoclonal antibodies, diphenhydramine,
             epinephrine, or methylprednisolone.
Voluma Filler Agent For The Treatment of HIV-associated Facial Lipoatrophy
Condition: HIV Facial Lipoatrophy
MeSH terms: Lipodystrophy; Facies
Intervention: Voluma
Intervention MeSH terms: Hyaluronic Acid
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: human immunodeficiency virus; facial lipoatrophy; facial lipodystrophy; hyaluronic acid; dermal filler; filler agent

Summary:

      The purpose of this study is to test the safety of Voluma and see what effects it has on HIV
      facial lipoatrophy. The hypothesis is that Voluma will be safe, efficacious and positively
      impact the quality-of-life in the treatment of facial lipoatrophy in patients with HIV.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 18 years or more with laboratory evidence of HIV-1 infection and have been on
             HAART therapy for at least 1 (one) year.

          -  Not to have AIDS (CD4 count < 250) or AIDS-defining illness.

          -  Bilateral lipoatrophy corresponding to a visual grade 2 or above in the attached
             Carruthers Lipoatrophy Severity Scale (CLSS).

          -  Available and willing to attend study follow-up visits.

          -  Able and willing to give informed consent.

        Exclusion Criteria:

          -  Any active skin inflammation or infection in or near the treatment area.

          -  Hypersensitivity to the components of Voluma.

          -  Previous treatment with Voluma or any other product for facial lipoatrophy within the
             past year.

          -  Has known bleeding disorder

          -  History of keloid formation

          -  Currently receiving systemic corticosteroids or anabolic steroids

          -  Currently on known anticoagulants (i.e. aspirin, non-steroidal anti-inflammatory
             drugs)

          -  Pregnancy or breastfeeding or anticipating becoming pregnant during the study period.

          -  Any other excluding factors that, according to the investigator's judgment, would
             preclude enrollment in the study.

          -  Any condition that may interfere with ability to comply with study requirements.
A Study to Evaluate the Pharmacokinetics and Safety of Cobimetinib in Volunteers With and Without Liver Damage
Condition: Healthy Volunteer
Intervention: cobimetinib
Intervention description: single oral 10-mg dose of cobimetinib
Phase: Phase 1
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is an open-label, multi-center, single-dose, parallel group study to determine the
      pharmacokinetics, safety, and tolerability of cobimetinib administered at 10 mg to fasted
      male and female adult subjects with varying degrees of hepatic function. The study will be
      conducted based on the Child-Pugh classification of hepatic impairment. The anticipated
      duration of the study is 7.5 weeks. The target sample sizes are: 18 volunteers with varying
      degrees of hepatic function and up to 12 healthy control volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects between 18 and 74 years of age, inclusive

          -  Body weight >/=45 kg and body mass index between 17 and 41 kg/m2, inclusive

          -  Subjects with hepatic impairment must have a Child-Pugh score of 5 to 6 (mild), 7 to 9
             (moderate), or 10 to 15 (severe) and have stable hepatic insufficiency within 1 month
             prior to Screening and a stable medication regimen for at least 1 month prior to
             Check-in

          -  Agreement to use highly effective contraceptive methods as defined in the protocol

        Exclusion Criteria:

          -  Significant illness, including infections, or hospitalization within the 2 weeks prior
             to dosing, except for subjects with hepatic impairment who due to their liver disease
             may be affected by significant medical problems which require frequent
             hospitalizations. Invasive systemic fungal infections need to be fully treated prior
             to study entry

          -  Significant history or clinical manifestations of any cardiac event that would put the
             subject at risk in the opinion of the Investigator

          -  Use of drugs of abuse within 1 month of Screening or during the entire study

          -  Any acute or chronic condition that, in the opinion of the Investigator, would limit
             the subject's ability to complete and/or participate in this clinical study
A Study on the Effects of a Single Dose of Prednisone on Biomarkers of Allergen Responses in Asthmatics (MK-0000-175)
Condition: Asthma
MeSH terms: Asthma
Intervention: Prednisone; Placebo
Intervention description: Prednisone (25 mg) tablets as a single oral dose on Day 1 of each study period; Matching placebo tablets as a single oral dose on Day 1 of each study period
Intervention MeSH terms: Prednisone
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Nasal Allergen Challenge, Inhaled Allergen Challenge, Asthma

Summary:

      The purpose of this study is to evaluate the relationship between upper and lower airway
      allergen-induced cytokine responses in mild asthmatics by attempting to demonstrate the
      following: 1) a positive correlation between allergen-induced Type 2 T-helper cell (Th2)
      cytokines (interleukins 5 and 13) in sputum and nasal exudates; and 2) a positive correlation
      between effects of prednisone versus placebo on Th2 cytokines in sputum and nasal exudates.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a clinical history of mild to moderate asthma for at least 6 months, but otherwise
             is in good health

          -  Participant with allergic rhinitis and asthma has a history of nonseasonal airway
             symptoms in response to aeroallergens OR has seasonal symptoms but can be evaluated
             out-of-season

          -  Is clinically stable and free of respiratory infection or change in allergen exposure
             for at least 4 weeks prior to start of study

        Exclusion Criteria:

          -  Has intolerance to the study drug, inhaled salbutamol, antihistamines, or any other
             potential asthma/anaphylaxis rescue medication

          -  Has intolerance to lidocaine/lignocaine, sedatives, atropine or glycopyrrolate, or any
             other medication associated with bronchoscopy

          -  Has taken oral parenteral corticosteroids within 8 weeks or inhaled
             corticosteroids/nasal corticosteroids within 5 weeks of screening and/or during the
             study

          -  Has recent (4 weeks) or ongoing upper or lower respiratory tract infection

          -  Has active allergic rhinitis at screening

          -  Has received a vaccination within 3 weeks of screening
A Study of the Metabolic Profile of Dalcetrapib in Healthy Volunteers
Condition: Healthy Volunteer
Intervention: dalcetrapib
Intervention description: Single oral radiolabeled dose
Intervention MeSH terms: Dalcetrapib
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: Male
Minimum age: 45 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This single center, open-label, non-randomized, one-treatment, one-period study will evaluate
      the metabolic profile and the safety of a single oral radiolabeled dose of dalcetrapib in
      male healthy volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male subjects, 45 to 65 years of age inclusive

          -  Body mass index (BMI) between 18 and 32 kg/m2 inclusive

        Exclusion Criteria:

          -  Any concomitant disease or ongoing condition that in the investigator's opinion could
             interfere with the study or could pose an unacceptable risk to the subject

          -  Clinically significant abnormal laboratory values

          -  Infrequent bowel movements (e.g. less than one movement per 24 h on average)

          -  An intent to father children within 3 months of dosing

          -  Any external or internal radiotherapy with open (nuclear medicine) or sealed sources
             (brachy therapy)

          -  External irradiation (radiological examination) or internal radiation (diagnostic
             nuclear medicine procedure) within one year before study drug dosing; dental
             radiography and plain X-rays of the extremities are allowed before dosing
Heat Retention Head Wrap Use for Re-warming of Infants Requiring Cardio-Pulmonary Bypass
Condition: Impaired Thermoregulation
Intervention: Heat Retention Head Wrap
Intervention description: Applied to infant's heads during the rewarming phase of CBP surgery
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 1 Day
Maximum age: 1 Year
Healthy volunteers: No

Summary:

      This is a phase I descriptive pilot study to determine the feasibility of using the Heat
      Retention Head Wrap on infants during the re-warming period following cardio-pulmonary
      bypass.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Undergoing CPB surgery.

          -  Weigh ≥ 3 and ≤ 10 kg.

          -  Cooled to 24-30 degrees Celsius.

          -  Head circumferences between 33-48 cm.

          -  Scalp free of skin lesions such as reddened areas, ulcerations, abrasions, burns, and
             hemangiomas.

        Exclusion Criteria:

          -  Require cooling below 24 degrees Celsius at any point during CPB surgery.

          -  Weigh less than 3 kg or more than that 10kg.

          -  Are premature or < 37 weeks corrected gestational age.

          -  Have a head circumference smaller than 33 cm or larger than 48 cm.

          -  Have a known or previously diagnosed neurological trauma, malignant hyperthermia,
             stroke, seizure, VP shunt, evidence of scalp lesions, or other known comorbidity.

          -  Have hair braided close to the scalp.

          -  Infants with known allergy or sensitivity to polyethylene terephthalate (known as
             Mylar)
A Study to Compare the Pharmacokinetics of Belatacept Using Active Pharmaceutical Ingredient Manufactured by Process E Relative to Process C
Condition: Renal Transplantation
Intervention: Process E Belatacept; Process C Belatacept
Intervention MeSH terms: Abatacept
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 491.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the study is to compare the Pharmacokinetics (PK) of Process E belatacept
      relative to Process C belatacept in Healthy subjects
    

Eligibility criteria:

        Inclusion Criteria:

          1. Signed Informed Consent

          2. Target population: Healthy males and females.

          3. Males and females, ages 18 to 55 years, inclusive.

          4. Women of child bearing potential (WOCBP) with negative serum or urine pregnancy test

          5. Women must not be breastfeeding

          6. Men and WOCBP must agree to follow instructions for contraception

        Exclusion Criteria:

          1. History of TB, malignancy, any other chronic or acute infecton or disease.

          2. History of acute or chronic medical illness

          3. Evidence of organ dysfunction or any clinically significant deviation from normal in
             physical examination, vital signs, ECG or clinical laboratory determinations beyond
             what is consistent with the target population.

          4. History of allergy to belatacept or related compounds -
Safety and Tolerability of Ascending Intravenous Doses of PF-05231023 In Adult Subjects With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: PF-05231023; PF-05231023; PF-05231023; PF-05231023; Placebo
Intervention description: 5 mg IV twice a week for 4 weeks; 25 mg IV twice a week for 4 weeks; 100 mg IV twice a week for 4 weeks; 200 mg IV twice a week for 4 weeks; 0.9% w/v sodium chloride injection, United States Pharmacopeia (USP), twice a week IV for 4 weeks
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 30 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Type 2 diabetes; safety; multiple dose; intravenous

Summary:

      This is a trial in subjects with Type 2 diabetes mellitus to study the safety, tolerability
      and pharmacokinetics of multiple ascending doses of PF-05231023.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male subjects and female subjects of non-childbearing potential between the ages of 30
             and 70 years, inclusive, with a historical diagnosis of type 2 diabetes mellitus,
             diagnosed according to the American Diabetes Association guidelines. Subjects who have
             other conditions but are well controlled by either diet or medications may be included
             as well (for example, a subject with high cholesterol level on appropriate treatment
             is eligible).

          -  Body Mass Index (BMI) of 25 to 35.5 kg/m2, and a total body weight >50 kg (110 lbs).

        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).

          -  Diagnosis of Type 1 diabetes mellitus.

          -  Evidence of diabetic complications with significant end organ damage