bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 1 Study in Subjects With Relapsed or Refractory Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: AMG 224
Intervention description: Administered as an IV infusion.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multiple Myeloma; Relapsed Multiple Myeloma; Refractory Multiple Myeloma

Summary:

      This is a first in human phase 1 multicenter open label study in subjects with relapsed or
      refractory multiple myeloma.
    

Eligibility criteria:

        Inclusion Criteria:

        - Pathologically documented,multiple myeloma relapsed or refractory progressive disease
        after at least 3 lines of therapy for multiple myeloma.

        Prior therapeutic treatment or regimens must include proteasome inhibitors (e.g.
        bortezomib) and immunomodulatory drugs (e.g. lenalidomide).

          -  Willing and able to undergo bone marrow aspirate per protocol (with or without bone
             marrow biopsy per institutional guidelines).

          -  Measurable disease per the International Myeloma Working Group (IMWG) response
             criteria

          -  Hematological function, as follows, without transfusion support:

          -  Absolute neutrophil count ≥ 1.0 X 10^9/L,

          -  Platelet count ≥ 75 X 10^9/L (in patients with < 50% of bone marrow nucleated cells
             were plasma cells) or ≥ 50 X 10^9/L (in patients with ≥ 50% of bone marrow nucleated
             cells were plasma cells) without transfusion or growth factor support

          -  Hemoglobin > 8 g/dL (> 80 g/L)

          -  Adequate renal and hepatic function

          -  Left ventricular ejection fraction (LVEF) > 50%

        Exclusion Criteria:

          -  Currently receiving treatment in another investigational device or drug study, or less
             than 28 days since ending treatment on another investigational device or drug study

          -  Autologous stem cell transplant less than 90 days prior to study day 1

          -  Multiple myeloma with IgM subtype

          -  POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin
             changes) syndrome, Plasma cell leukemia, Waldenstrom's macroglobulinemia or
             Amyloidosis

          -  Glucocorticoid therapy (prednisone > 30 mg/day or equivalent) within 7 days prior to
             study day

          -  Myocardial infarction within 6 months of study day 1, symptomatic congestive heart
             failure (New York Heart Association > class II)

          -  A baseline ECG QTcF > 470 msec

          -  Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, or
             investigational agent) within 28 days prior to study day 1
A Comparative Study of LY900014 to Insulin Lispro (Humalog) in Healthy Participants
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
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: Double (Participant, Investigator)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study compares LY900014, a drug that lowers blood sugar, with insulin lispro (Humalog).
      Both drugs are given 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 in comparison with insulin lispro. The
      study will last about 7 to 12 weeks for each participant, including screening and follow up.
      Screening is required within 28 days prior to entering the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male or a female (not pregnant and agreeable to take birth control measures
             until one month after study completion)

          -  Have a body mass index (BMI) of 18 to 30 kilogram per square meter (kg/m²)

          -  Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine
             laboratory test results

          -  Are nonsmokers, have not smoked for at least 6 months prior to entering the study

        Exclusion Criteria:

          -  Are currently participating in or completed a clinical trial within the last 30 days

          -  Have previously participated or withdrawn from this study

          -  Have donated blood or have blood loss of more than 500 mL within the past 3 months
Phase 1b Study Investigating Safety & Immunogenicity of TDV Given Intradermally by Needle or Needle-Free PharmaJet Injector
Condition: Healthy Volunteers
Intervention: TDV; Placebo
Intervention description: TDV suspension for intradermal administration; Phosphate buffered saline (PBS)
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 67.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Prophylactic vaccination

Summary:

      The purpose of this study is to compare the safety, tolerability and immunogenicity of
      Takeda's Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] when administered
      intradermally in varied dosing schedules and via different methods of administration
      (conventional needle/syringe versus needle-free PharmaJet® injector).
    

Eligibility criteria:

        Inclusion Criteria:

          -  In good health as determined by medical history and physical examination (including
             blood pressure and heart rate).

          -  Negative for human immunodeficiency virus-1 (HIV-1) antibodies, Hepatitis C antibodies
             & Hepatitis B surface antigen.

          -  Females negative by urine pregnancy test at screening and immediately prior to
             injection, and were willing to use reliable means of contraception.

          -  Body Mass Index (BMI) ≤ 35 kg/m^2.

        Exclusion Criteria:

          -  Any Grade 2 or above abnormality in the screening laboratory tests.

          -  History of Dengue Fever, Japanese Encephalitis, West Nile or Yellow Fever disease.

          -  Seropositivity to dengue or West Nile virus.

          -  Extensive scarring or tattoo (> 50%) on arms, shoulders, neck face and head.

          -  History of significant dermatologic disease in the last 6 months.

          -  Receipt or planned receipt of any vaccine in the 4 weeks preceding or following the
             Day 0 or 90 vaccinations.

          -  Any planned travel to dengue endemic areas including the Caribbean, Mexico, Central
             America, South America or Southeast Asia, during the study period and during the month
             prior to screening.

          -  Use of systemic corticosteroids therapy within the previous 6 months (at a dose of 0.5
             mg/kg/day). Topical prednisone is not permitted if currently in use or used within the
             last month prior to the first vaccination.

          -  Use of any prescribed medication 7 days before the first injection.

          -  Previous vaccination in a clinical study or with an approved product against Dengue
             Fever, Yellow Fever and or Japanese Encephalitis.

          -  Known or suspected congenital or acquired immunodeficiency or receipt of
             immunosuppressive therapy in the last 6 months.

          -  Planned donation of blood during the period of the study.
Phase I Study in China - Tolerability of a Single Dose of Abatacept 30 mg/kg
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Intervention: Placebo; Abatacept; Abatacept
Intervention description: Infusion, Intravenous, single dose, Day 1; Infusion, Intravenous, 30mg/kg, single dose, Day 1; Infusion, intravenous, 10 mg/kg, administered on Days 15 and 29 followed by doses every 4 weeks until the end of the study
Intervention MeSH terms: Abatacept
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether abatacept at a dose 30 mg/kg via
      intravenous infusion is safe and well tolerated in the treatment of lupus nephritis in
      mainland Chinese subjects with systemic lupus erythematosus (SLE)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women, at least 18 years of age, with a diagnosis of systemic lupus
             erythematosus (SLE) and with lupus nephritis currently stable for the last 3 months
             without change in treatment for lupus nephritis

          -  Stable renal disease

          -  No flaring of other organ systems in a minimum of the last 3 months

        Exclusion Criteria:

          -  Unstable lupus nephritis and serum creatinine >3 mg/dL

          -  Progressive renal failure, end stage renal disease, or renal transplant requiring
             continuous dialysis

          -  Severe unstable, refractory, or progressive SLE

          -  History of cancer

          -  Participants at risk for tuberculosis

          -  Autoimmune disease other than SLE as main diagnosis

          -  Human immunodeficiency virus or herpes zoster infection

          -  Hepatitis-B surface antigen-positive or hepatitis C antibody-positive participants
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Ascending Oral Single Dose of TAK-418 in Healthy Participants
Condition: Healthy Participants
Intervention: TAK-418; TAK-418 Placebo
Intervention description: TAK-418 Capsule.; TAK-418 placebo-matching capsules.
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
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 evaluate the safety and tolerability of TAK-418 following
      single oral doses in healthy participants.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Is a male or female participants with a body mass index (BMI) within the range of 18.5
             -30.0 kilogram per square meter (kg/m^2) at the Screening Visit.

          2. Is a nonsmoker who has not used tobacco or nicotine-containing products (example,
             nicotine patch) for at least 6 months before trial drug administration of the initial
             dose of trial drug or invasive procedure.

          3. Must be judged to be in good health by the investigator, based on clinical evaluations
             including laboratory safety tests, medical history, physical examination, 12-lead ECG,
             and vital sign measurements performed at the Screening Visit and before administration
             of the initial dose of trial drug or invasive procedure as per principal
             investigator's judgment.

          4. Female subjects with no childbearing potential, defined by at least 1 of the following
             criteria:

               -  Postmenopausal (defined as 12 months of spontaneous amenorrhea in women aged
                  greater than [>]45 years, 6 months of spontaneous amenorrhea in women aged >45
                  years with serum follicle-stimulating hormone [FSH] levels >40
                  milli-international units per milliliter [mIU/mL]). Appropriate documentation of
                  FSH levels is required.

               -  Surgically sterile by hysterectomy and/or bilateral oophorectomy with appropriate
                  documentation of surgical procedure.

               -  Had a tubal ligation with appropriate documentation of surgical procedure.

               -  Has a congenital condition resulting in no uterus.

        Exclusion Criteria:

          1. Has had major surgery, donated or lost 1 unit of blood (approximately 500 milliliter
             [mL]) within 4 weeks before the Screening Visit.

          2. Has a risk of suicide according to the investigator's clinical judgment per the
             Columbia-Suicide Severity Rating Scale at Screening or has made a suicide attempt in
             the 6 months before Screening.
Effect of Calcium Glycerophosphate (CaGP) - Fluoride Dentifrice on Dental Biofilm pH
Condition: Dental Caries
MeSH terms: Dental Caries
Intervention: calcium glycerophosphate; no active ingredient; fluoride; CAGP + fluoride
Intervention description: use of a dentifrice containing CaGP (0.13%) and no fluoride; dentifrice without calcium glycerophosphate and no fluoride; use of a dentifrice containing fluoride (1500ppm) only; calcium glycerophosphate and fluoride dentifrice
Intervention MeSH terms: Calcium; Fluorides; Sodium Fluoride
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 12.0
Sex: All
Minimum age: 19 Years
Maximum age: 30 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Calcium glycerophosphate; Fluoride; Dentifrice; Biofilm; Dental caries

Summary:

      The aim of this study was to investigate the buffering effect of a calcium
      glycerophosphate-fluoride (CaGP-F) dentifrice on in vivo dental biofilm after a cariogenic
      challenge and evaluate its probable 12-hour protective effect. Twelve young adults took part
      in this randomized, double blind, 14-day 4-phase crossover study. Between each phase, the
      volunteers had a 1-week wash-out period. Coded dentifrices were randomly assigned to the
      volunteers: A) no F and no CaGP; B) CaGP-only (0.13%); C) F-only (1500 ppm (ppm= parts per
      million of fluoride which is equivalent to mg/kg)); D) CaGP-F (0.13%, 1500 ppm,
      respectively). The pH measurements were taken from a single-site using a microelectrode, with
      salt bridge established by a 1M KCl (one molar potassium chloride) solution with a reference
      electrode. pH measurements were taken at 0 (baseline), 1, 7, 14 and 21 min (minutes) after a
      cariogenic challenge (10% w/v sucrose solution, %w/v = percent weight per volume). Four sets
      of measurements were carried out: (D0BS) before test dentifrice usage; (D01min) 1-min after
      test dentifrice usage; and (D712h) 7 days and (D1412h) 14 days using the test dentifrice, 12
      hours (h)after brushing. Stephen curves and mean AUC (area under the curve) were obtained.
    

Eligibility criteria:

        Inclusion Criteria:

          -  to live in a non-fluoridated area

          -  to have at least 20 natural teeth

          -  signed a consent form agreeing to carefully follow the research instructions

        Exclusion Criteria:

          -  presence of active caries lesions

          -  periodontal disease

          -  use of antibiotics/medication.
Bioequivalence Study of Sitagliptin/Metformin Combination Tablet (MK0431A-122)
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Co-administration of 50 mg sitagliptin and 500 mg metformin; sitagliptin/metformin 50 mg/500 mg tablet; Co-administration of 50 mg sitagliptin and 850 mg metformin; sitagliptin/metformin 50 mg/850 mg tablet
Intervention description: Co-administration of 50 mg sitagliptin and 500 mg China-sourced metformin as individual tablets with 240 ml water on Day 1 of the relevant treatment period (Sit + Met500) after fasting for at least 10 hours.; Single dose administration of the final marketing image (FMI) sitagliptin/metformin 50 mg/500 mg fixed-dose combination (FDC) tablet with 240 ml water on Day 1 of the relevant treatment period (SitMet850 FDC) after fasting for at least 10 hours.; Co-administration of 50 mg sitagliptin and 850 mg China sourced metformin as individual tablets with 240 ml water on Day 1 of the relevant treatment period (Sit + Met850) after fasting for at least 10 hours.; Single dose administration of the FMI sitagliptin/metformin 50 mg/850 mg FDC tablet with 240 ml water on Day 1 of the relevant treatment period (SitMet850 FDC) after fasting for at least 10 hours.
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: Male
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Type 2 Diabetes

Summary:

      This study will test the hypothesis that the Final Market Image (FMI) sitagliptin/metformin
      50 mg/500 mg and 50 mg/850 mg (Fixed Dose Combination) FDC tablet and co-administration of
      corresponding doses of sitagliptin and China-sourced metformin as individual tablets will be
      bioequivalent based on assessment of the AUC(0-t) and Cmax, for both sitagliptin and
      metformin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is of Chinese descent

          -  Subject is in good health

          -  Subject is a non-smoker

        Exclusion Criteria:

          -  Subject has a history of stroke or chronic seizures

          -  Subject has a history of cancer

          -  Subject has had major surgery, donated blood or participated in another
             investigational study within the past 4 weeks
Single and Multiple Dose Pharmacokinetics of Sufentanil NanoTab
Condition: Plasma Concentrations
Intervention: Single dose of SUF NT 15 mcg; 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Determine the plasma concentration profile after single and multiple dosing of Sufentanil
      NanoTabs
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non smoking

          -  Ages 18 to 45 year, inclusive

          -  BMI between 18 and 30

        Exclusion Criteria:

          -  Subjects taking any prescription or OTC medications or vitamins or supplements

          -  Pregnant females

          -  Subjects with pulmonary disease or sleep apnea
A Phase 1 Study of Continuous Intravenous L-citrulline During Sickle Cell Pain Crisis or Acute Chest Syndrome
Condition: Sickle Cell Disease
MeSH terms: Acute Chest Syndrome; Anemia, Sickle Cell
Intervention: Intravenous citrulline
Intervention description: Intravenous citrulline at a bolus dose of 20 mg/kg over 5 minutes and then continuous at a rate of 7 mg/kg/hour for the next 23 hours for the first 7 participants, and depending on safety and pharmacokinetic profile, increase or decrease the continuous rate to 9 or 5 mg/kg/hour for the next 7 participants.
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: 6 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: sickle cell disease; citrulline

Summary:

      Sickle cell disease is a genetic red blood cell disorder characterized by vaso-occlusion from
      sickling of red blood cells, that can lead to pain or organ complications such as acute chest
      syndrome. Sickle cell disease is associated with low amounts of nitric oxide, a compound
      important for dilating the blood vessel wall. Citrulline is a substance that is known to
      increase nitric oxide. The goal of this Phase I study are to find the highest safe dose of
      continuous IV citrulline that can be given to individuals with sickle cell disease
      experiencing a sickle cell pain crisis or acute chest syndrome without causing severe side
      effects.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Sickle cell disease genotypes (HbSS, HbS/β0-thalassemia, HbS/β+-thalassemia, HbSC)

          2. Ages 6 to 50 years old

          3. Patients with sickle cell disease aged 6 to 50 years old Presence of sickle cell pain
             crisis defined by the presence of pain requiring hospitalization and parental opioid
             therapy

          4. Presence of acute chest syndrome defined by the presence of a new CXR infiltrate and
             any one of the following respiratory symptoms of fever, shortness of breath, wheezing,
             chest pain, cough or new onset hypoxia.

        Exclusion Criteria:

          1. Presence of any other complication related to sickle cell disease requiring
             hospitalization such as splenic sequestration, hepatic sequestration, stroke,
             avascular necrosis of the hip/shoulder, acute priapism, etc.

          2. Severe anemia (hemoglobin < 5g/dL)

          3. History of red blood cell transfusion within the last 30 days

          4. Systemic steroid therapy within the last 48 hours

          5. Pregnant (as confirmed by a negative urine pregnancy test) or lactating female

          6. Alanine/aspartate transferase >2x upper limit of normal laboratory range for age.

          7. Subject has the following serum creatinine:

               -  Age 6 to 13 years > 0.9 mg/dL

               -  Age 14-17 years 1.0 mg/dL

               -  Age 18 years >1.5mg/dL

          8. Patients with an inability to give consent will be excluded