bioihbjkbjnl/mcl2 huggingface dataset:
A Study of LY3478006 in Healthy Participants
Condition: Healthy
Intervention: LY3478006 - IV; LY3478006 - SC; Placebo - IV; Placebo - SC
Intervention description: Administered IV; Administered SC; 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: 4.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to learn more about how safe and how well tolerated LY3478006 is
      when given by injection into a vein or just under the skin to healthy participants. Blood
      tests will be done to check how much LY3478006 is in the bloodstream and how long the body
      takes to get rid of it. For each participant, the study will last up to about 16 weeks,
      including screening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy male or female Japanese or non-Japanese participants, as
             determined by medical history and physical examination

          -  Women not of childbearing potential

          -  Are aged 18 to 55 years (20 to 55 years for Japanese participants), inclusive, at
             screening

        Exclusion Criteria:

          -  Have clinically significant abnormal electrocardiogram (ECG) results

          -  Have persistent abnormal blood pressure or pulse rate, as determined by the
             investigator

          -  Have evidence of orthostatic hypotension, defined as a decrease in systolic or
             diastolic blood pressure greater than or equal to (≥)20 millimeters of mercury (mmHg)
             or ≥10 mmHg, respectively

          -  Have significant history or presence of cardiovascular, respiratory, hepatic,
             ophthalmological, renal, gastrointestinal, endocrine, hematological, neurological, or
             psychiatric disorders

          -  Have a history or presence of mononeuropathy, polyneuropathy, or autonomic neuropathy

          -  Have significant allergies to humanized monoclonal antibodies
A Study of Galcanezumab in Healthy Participants.
Condition: Healthy
Intervention: Galcanezumab
Intervention description: Administered SC
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 160.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purpose of this study is to evaluate how much galcanezumab gets into the body after
      it is given as an injection just under the skin by two different devices. This study will
      measure how much galcanezumab reaches the blood stream and will test how it affects
      calcitonin-gene related peptide (CGRP) in blood. Information about any side effects that may
      occur will be collected. The study will last about 20 weeks for each participant. Screening
      is required within 45 days prior to the start of the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy as determined by medical history and physical examination

          -  Have a body mass index (BMI) between 19.0 and 35.0 kilogram per meter square (kg/m²)

          -  Have clinical laboratory test results within normal reference range for the
             investigative site, or results with acceptable deviations that are judged to be not
             clinically significant by the investigator

        Exclusion Criteria:

          -  Have previously completed or withdrawn from this study or any other study
             investigating galcanezumab, and have previously received galcanezumab

          -  Have allergies to either humanized monoclonal antibodies, diphenhydramine,
             epinephrine, or methylprednisolone

          -  Intend to use over-the-counter or prescription medication within 7 days prior to
             dosing and during the study (especially systemic glucocorticoids, immunomodulatory
             drugs, drugs with propensity for dermal reactions, drugs with known hepatic toxicity,
             etc). Stable doses of hormone replacement therapy (HRT) are allowed for inclusion at
             the discretion of the investigator

          -  Have had lymphoma, leukemia, or any malignancy within the past 5 years except for
             basal cell or squamous epithelial carcinomas of the skin that have been resected with
             no evidence of metastatic disease for 3 years
Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of Recombinant Human C1 Esterase Inhibitor in Healthy Adult Subjects
Condition: Hereditary Angioedema (HAE)
MeSH terms: Angioedema; Angioedemas, Hereditary
Intervention: Recombinant human C1 esterase inhibitor; Placebo; SHP623; Placebo
Intervention description: Subjects will receive escalating doses I-IV as both IV and SC injections; Subjects will receive matching placebo; SHP623; Placebo
Intervention MeSH terms: Complement C1s; Complement C1 Inhibitor Protein; Complement C1 Inactivator Proteins
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This trial is looking to gain information about the safety and tolerability of an
      investigational treatment (SHP623) in healthy adult volunteers. This study will also collect
      pharmacokinetic data (how the body absorbs and breaks down the study drug).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Must be considered healthy. Healthy status is defined by absence of evidence of any
             active or chronic disease

          2. Male, or non-pregnant, non-lactating female, who agrees to comply with any applicable
             contraceptive requirements of the protocol, or females of non-child-bearing potential.

          3. Body mass index between 18.0 and 30.0 kg/m2 inclusive with a body weight >50 kg (110
             lbs.). This inclusion criterion will be assessed only at the first screening visit.

          4. Hemoglobin ≥12.0g/ld.

        Exclusion Criteria:

          1. Have a history of allergic reaction to C1 INH products (e.g. C1 Inhibitor [Human],
             Berinert [C1 Estrace Inhibitor (Human)] and C1 estrace [recombinant]

          2. Known history of alcohol or other substance abuse within the last year.

          3. Donation of blood or blood products within 60 days prior to receiving investigational
             product.

          4. Current use of any medication except hormonal replacement therapy, hormonal
             contraceptives and occasional use of any over-the-counter non-steroidal
             anti-inflammatory drug (NSAID) or acetaminophen.

          5. Have a history of hypercoagulability or other predisposition to thrombotic events.
PK Study With Pantoprazole in Obese Children and Adolescents
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux
Intervention: Pantoprazole
Intervention MeSH terms: Pantoprazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: obese; children; adolescents; GERD; pharmacokinetic

Summary:

      Multicenter, comparative single-dose pharmacokinetic (PK) study
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participant is between 6 and 17 (inclusive) years of age at the time of consent

          2. BMI ≥95th percentile

          3. Diagnosis of GERD established prior to 7 days before receipt of study drug dose
             defined as 1 or more of the following:

               1. clinical symptoms consistent with GERD as determined by the investigator

               2. a diagnosis of erosive esophagitis by endoscopy

               3. esophageal biopsy with histopathology consistent with reflux esophagitis

               4. abnormal pH-metry consistent with reflux esophagitis

               5. other test result consistent with GERD

          4. Written informed consent from the parent or legally authorized representative/guardian
             and participant assent per local IRB recommendation of age-appropriate consent and
             assent requirements

        Exclusion Criteria:

          1. Use of pantoprazole, lansoprazole, omeprazole, esomeprazole or rabeprazole within 48
             hours prior to dose of study drug

          2. Use of fluoxetine, fluvoxamine, ketoconazole, ticlopidine, felbamate, topiramate,
             valproic acid, phenobarbital, carbamazepine, erythromycin, clarithromycin, grapefruit
             juice, verapamil, diltiazem, cimetidine, St. John's Wort, rifampin, rifapentine within
             seven days prior to dose of study drug

          3. Consumption of food after midnight on the day of the baseline visit

          4. Symptomatic asthma

          5. Type I diabetes

          6. History of adverse reaction to PPI

          7. Impaired hepatic activity as defined as any of the following: AST ≥150 IU/L, ALT ≥150
             IU/L, total bilirubin ≥2.0 mg/dl, or alkaline phosphatase ≥600 IU/L

          8. Serum creatinine ≥2.0 mg/dL

          9. For females of childbearing potential, a positive pregnancy test result

         10. Known infection with hepatitis B, C, or HIV

         11. Any other condition that, in the opinion of the principal investigator, makes
             participation unadvised or unsafe.
Harnessing the Power of Technology: MOMBA for Postpartum Smoking
Condition: Smoking Cessation
Intervention: MoMba Live Long app & Sensordrone™ carbon-monoxide sensor; Office contingency management; Sensordrone™ carbon-monoxide sensor; MoMba Live Long Smartphone application
Intervention description: MoMba Live Long application & Sensordrone™ carbon-monoxide sensor to deliver contingency management remotely; A control group which will receive financial incentives at an in-person office/clinic visit based on expired CO levels obtained through the piCO sensor.; A custom breath CO meter built by Sensorcon Inc. (Sensordrone, part No. SDRONEG1) that uses an electrochemical CO gas sensor to measure environmental CO. The Sensordrone is accurate to within 10% with a resolution of 1 parts per million (ppm). The Sensordrone pairs via Bluetooth with the MoMba Live Long application.; The MoMba Live Long app provides an interface for the Sensordrone which allows participants to complete a breath test and see results of smoking status. The app verifies the user is correctly taking the tests by recording pictures using the front facing camera as well as recording audio to verify that the participants where exhaling while taking the test. The app also provided a platform for social interaction based on a previous system where app users can interact with each other and provide support during the quitting process.
Intervention MeSH terms: Carbon Monoxide
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Tobacco cessation

Summary:

      Through a smartphone platform, financial incentives for smoking abstinence in postpartum
      women can be delivered remotely, thus minimizing the need for participants to come to the
      office to receive traditional contingency management.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women who are over the age of 18

          -  Speak English

          -  Second or third trimester of pregnancy

          -  Smoking in the third trimester of pregnancy

          -  No complicating general medical or psychiatric conditions (including marijuana use).

        Exclusion Criteria:

          -  Receiving other smoking cessation medication

          -  Planning to move out of New Haven in the next 15 months

          -  Actively suicidal, psychotic or unable to provide informed consent
TL011 in Severe, Active Rheumatoid Arthritis Patients
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: TL011, anti CD20, for the treatment of rheumatoid arthritis; MabThera infusions
Intervention description: TL011 administered by 2 infusions, 2 weeks apart; MabThera, administered by 2 infusions, 2 weeks apart
Intervention MeSH terms: Rituximab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the safety and pharmacology of TL011 in patients
      with severe rheumatoid arthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult subjects

          -  Rheumatoid arthritis as defined by the 1987 ACR Classification

          -  Severe active seropositive disease

          -  Inadequate response or intolerance to other DMARDs

          -  Treatment with MTX

        Exclusion Criteria:

          -  Rheumatic autoimmune disease other than RA

          -  Active infection

          -  Known immunodeficiency syndrome

          -  Positive Hepatitis B surface antigen or antibodies to Hepatitis C

          -  History of cancer
A Study to Evaluate the Safety and Immunogenicity of Inactivated Varicella-Zoster Virus (VZV) Vaccine in Adults With Hematologic Malignancies (HM) Receiving Treatment With Anti-Cluster of Differentiation (CD) 20 Monoclonal Antibodies (V212-013)
Condition: Herpes Zoster
MeSH terms: Herpes Zoster; Chickenpox; Hematologic Neoplasms
Intervention: V212
Intervention description: V212 viral antigen for HZ
Intervention MeSH terms: Vaccines
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      An open-label, multicenter study to evaluate the safety and immunogenicity of inactivated VZV
      vaccine (V212) in participants with hematologic malignancies (HM) who are currently receiving
      anti-CD20 monoclonal antibodies. The primary hypothesis is that vaccination with V212 vaccine
      will elicit significant VZV-specific immune responses at ~28 days after vaccination 4. The
      statistical criterion for significance requires that the lower bound of the 2-sided 90%
      confidence interval of the geometric mean fold rise in immune response in V212 recipients is
      >1.0.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with a HM and is receiving treatment with anti-CD20 monoclonal antibodies
             and is not likely to undergo hematopoietic cell transplant (HCT).

          -  Has a predicted life expectancy of ≥ 12 months.

          -  Has prior history of varicella or antibodies to VZV due to exposure to the disease in
             a country where the disease is common.

          -  All female participants of childbearing potential must have a negative serum or urine
             pregnancy test.

        Exclusion Criteria:

          -  A history of allergic reaction to any vaccine component (including gelatin) or an
             anaphylactic/anaphylactoid reaction to neomycin.

          -  Prior history of HZ within 1 year of enrollment.

          -  Prior receipt of any varicella or zoster vaccine.

          -  Participant is pregnant or breastfeeding or expecting to conceive within the period of
             2 weeks prior to enrollment throughout 6 months after last vaccination dose.

          -  Any live virus vaccine administered or scheduled in the period from 4 weeks prior to
             Dose 1 through 28 days postvaccination dose 4.

          -  Any inactivated vaccine administered or scheduled within the period from 7 days prior
             to, through 7 days following, any dose of study vaccine.

          -  Participant is currently participating or has participated in a study with an
             investigational anti-CD20 monoclonal antibody within 3 months of signing informed
             consent.
A Single-dose Study in Paediatric Patients Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving Haemodialysis
Condition: Chronic Kidney Disease, Secondary Hyperparathyroidism
MeSH terms: Neoplasm Metastasis; Kidney Diseases; Renal Insufficiency, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary
Intervention: Etelcalcetide
Intervention description: A single IV-bolus dose of 0.035 mg/kg etelcalcetide into the venous line of the dialysis circuit at the end of a hemodialysis session.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Secondary Hyperparathyroidism, chronic kidney disease, hemodialysis

Summary:

      This is a study to evaluate the safety and pharmacokinetics in pediatric patients with
      secondary hyperparathyroidism receiving a single dose of etelcalcetide at the end of
      hemodialysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject's parent has provided informed consent and subject has provided assent

          -  Children Age 2 to less than 18 years

          -  Diagnosed with chronic kidney disease

          -  Diagnosed with secondary hyperparathyroidism receiving hemodialysis,

          -  Weighing at least 7 kg

          -  Laboratory results within specified range.

        Exclusion Criteria:

          -  Currently receiving treatment in another investigation device or drug study

          -  Subject has received cinacalcet therapy within 30 days

          -  History of prolongation QT interval

          -  Subject is taking any medications that are on the QT prolongation medication list

          -  Electrocardiograph (ECG) measurements within specified range.
Japanese Study of BMS-901608 (Elotuzumab) in Combination With Lenalidomide and Low Dose Dexamethasone
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: BMS-901608 (Elotuzumab) 10 mg; BMS-901608 (Elotuzumab) 20 mg
Intervention description: Injection, Intravenous, 10 mg/kg, Weekly at cycle 1 and 2, bi-weekly at cycle 3 and thereafter, Until disease progression or unacceptable toxicity became apparent; Injection, Intravenous, 20 mg/kg, Weekly at cycle 1 and 2, bi-weekly at cycle 3 and thereafter, Until disease progression or unacceptable toxicity became apparent
Intervention MeSH terms: Elotuzumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the safety and tolerability of Elotuzumab when given
      in combination with Lenalidomide and low-dose Dexamethasone in subjects with relapsed or
      refractory multiple myeloma (MM) in Japan.
    

Eligibility criteria:

        For additional information, please contact the BMS oncology clinical trial information
        service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit
        www.BMSStudyConnect.com for more information on clinical trial participation.

        Inclusion Criteria:

          -  Received between 1 to 4 prior lines of therapy

          -  Measureable disease

          -  Men and women of childbearing potential (WOCBP) must be using two acceptable methods
             of contraception

          -  Men must agree to use a latex condom and a second form of birth control during sexual
             contact with WOCBP and must agree to not donate semen during study drug therapy

          -  Subjects must be willing to refrain from blood donations during study drug therapy

        Exclusion Criteria:

          -  Subjects with non-secretory or oligo-secretory or light-chain only myeloma or
             active/prior plasma cell leukemia or known /suspect POEMS syndrome

          -  Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma
             cell dyscrasia

          -  Unable to take aspirin daily as prophylactic anticoagulation therapy. Prior history of
             inability to tolerate weekly 40 mg dexamethasone

          -  History of renal failure

          -  History of clinical significant thrombosis, such as treatment for thrombosis was
             required
A Study to Evaluate the Relative Bioavailability (BA) and Effect of Food on TAK-831 Tablet Formulations in Healthy Participants
Condition: Healthy Volunteers
Intervention: TAK-831 T2; TAK-831 T3
Intervention description: TAK-831 T2 Tablets.; TAK-831 T3 Tablets.
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 19 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug Therapy

Summary:

      The purpose of this study is to assess the oral BA of TAK-831 T3 tablet formulation relative
      to TAK-831 T2 tablet formulation under fasting conditions and to assess the effect of food on
      the pharmacokinetics (PK) of TAK-831 T3 tablet formulation.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Body mass index (BMI) greater than or equal to (>=) 18.0 and less than (<) 30.0 kilogram
        per square meter (kg/m^2), at Screening.

        Exclusion Criteria:

          1. History or presence of alcoholism or drug abuse within the past 2 years prior to the
             first dosing.

          2. Smokes more than 20 cigarettes or equivalent per day within 3 months prior to the
             first dose and is unwilling to discontinue use of any tobacco- or nicotine-containing
             products during the confinement period(s) of the study.

          3. Has been on a diet incompatible with the on-study diet, in the opinion of the
             Investigator or designee, within the 30 days prior to the first dosing and throughout
             the study.

          4. Is lactose intolerant or unable/unwilling to eat the high-fat breakfast.

          5. Donation of blood or significant blood loss within 56 days prior to the first dosing.