bioihbjkbjnl/mcl2 huggingface dataset:
Diagnosing Natriuretic Peptide Deficiency
Condition: Healthy; Lean
Intervention: Dexamethasone
Intervention description: A single dose of dexamethasone IV 4 mg will be administered.
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; BB 1101
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      In this pilot study, the investigators will determine the response of the natriuretic peptide
      (NP) hormone system after a dose of intravenous dexamethasone (a steroid medication). The
      goal of the proposed project is to generate preliminary data that will be used to develop
      power calculations, inform cutoff ranges, and inform the timing of the NP response for larger
      subsequent studies.

      Aim: To determine the range of distribution and time course of natriuretic peptide (NP)
      responses to a single dose of dexamethasone IV 4 mg in healthy lean individuals.

      Hypothesis: Determination of the NP responses (the range and time course of changes in NP
      levels) to dexamethasone in 10 healthy individuals will inform the time course and frequency
      of blood sampling in a definitive prospective study, as well as enable investigators to
      perform a sample size calculation for a definitive prospective study.
    

Eligibility criteria:

        Inclusion criteria:

          -  Men and women ages 18-50 years

          -  BMI 18.5 to <25 kg/m^2

        Exclusion Criteria:

          -  Significant use of systemically-absorbed glucocorticoids currently or for an extended
             period of time during the prior 6 months

          -  Current use of antihypertensive medications

          -  Current use of metformin, or any antidiabetic medications (which could affect glucose
             and insulin levels)

          -  Current use of medications known to affect dexamethasone metabolism, including
             phenytoin, rifampin, carbamazepine, troglitazone, and barbiturates

          -  Active, clinically significant infection at time of visit

          -  History of adrenal insufficiency or Cushing's syndrome

          -  Prior or current cardiovascular disease, renal disease, or liver disease

          -  Diabetes mellitus, pre-diabetes, impaired fasting glucose, or impaired glucose
             tolerance

          -  Atrial fibrillation

          -  Bleeding disorder or anemia

          -  Elevated Liver Functions Tests > 2 times upper limit of normal

          -  Estimated glomerular filtration rate < 60 ml/min

          -  HbA1c > 5.7

          -  Abnormal sodium or potassium level

          -  Positive pregnancy test, women of child-bearing age not practicing birth control,
             women who are breastfeeding
Transcoronary Infusion of Cardiac Progenitor Cells in Pediatric Dilated Cardiomyopathy
Condition: Dilated Cardiomyopathy
MeSH terms: Cardiomyopathies; Cardiomyopathy, Dilated
Intervention: CDC infusion
Intervention description: Injection of CDCs (0.3 million per kg of body weight).
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Transcoronary infusion
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      A phase 1 prospective study to determine the procedural feasibility and safety and
      preliminary efficacy of intracoronary infusion of cardiosphere-derived cells (CDCs) in
      patients with dilated cardiomyopathy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients diagnosed as dilated cardiomyopathy.

          -  Patients aged under 18 years old.

          -  Cardiac ejection fraction < 40%.

        Exclusion Criteria:

          -  Contradiction to cardiac magnetic resonance imaging.

          -  Cardiogenic shock.

          -  A patient with unstoppable extracorporeal circulation.

          -  A patient with lethal, uncontrollable arrhythmia.

          -  A patient with a complication of coronary artery disease.

          -  A patient with a complication of brain dysfunction due to circulatory failure.

          -  A patient with malignant neoplasm.

          -  A patient with a complication of a serious neurologic disorder.

          -  A patient with high-grade pulmonary embolism or pulmonary hypertension.

          -  A patient with high-grade renal failure.

          -  A patient with multiple organ failure.

          -  Active infection (including endocarditis).

          -  Sepsis.

          -  Active hemorrhagic disease (e.g. gastrointestinal bleeding, injury).
Taste Assessment Study of 2 Atazanavir Powder Formulations in Healthy Subjects
Condition: HIV
Intervention: Atazanavir (current formulation); Atazanavir, powder for oral use 1 (POU1); Atazanavir (POU2)
Intervention description: Solution, oral, atazanavir 15 mg/5 mL with 10% aspartame, single dose; Solution, oral, atazanavir 15 mg/5 mL with 4.2% aspartame, single dose; Solution, oral, atazanavir 15 mg/5 mL with 4.2% aspartame and sucralose, single dose
Intervention MeSH terms: Atazanavir Sulfate
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to compare the sweetness of 2 new atazanavir powder for oral use
      (POU) formulations to the current atazanavir POU in healthy participants and to select 1
      atazanavir POU that has the sweetness most similar to the current atazanavir POU.
    

Eligibility criteria:

        Key inclusion criteria:

          -  Healthy men and women, ages 18 to 49, inclusive

          -  Nonsmokers

          -  Women not pregnant or breastfeeding

          -  Participants who could match solutions of the same sweetness and provide consistent
             sweetness scores during the taste screening

        Key exclusion criteria:

          -  Any significant acute or chronic medical illness

          -  Any acute or chronic condition that may have altered taste sensory perception

          -  Any major surgery or trauma within 4 weeks of Day 1

          -  Blood transfusion within 4 weeks of study participation

          -  Recent (within 6 months of Day 1) drug or alcohol abuse as defined in the Diagnostic
             and Statistical Manual, 4th edition, Diagnostic Criteria for Drug and Alcohol Abuse

          -  Positive urine drug screen

          -  Positive urine screen for cotinine

          -  Positive hepatitis C antibody, hepatitis B surface antigen, or human immunodeficiency
             virus antibodies

          -  Clinically significant elevations in results of liver function tests above normal
             range
Bioequivalence of a FDC Tablet of Linagliptin/Metformin (2.5mg/750mg) Extended Release in Healthy Subjects
Condition: Healthy
Intervention: Linagliptin; Linagliptin/Metformin ER FDC; Metformin ER
Intervention description: 1 x Linagliptin tablet; 2 x Linagliptin/Metformin ER FDC tablet; 3 x Metformin ER tablets
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
A Study to Compare and Measure the Effects of Insulin Peglispro (LY2605541) and Glargine on Meal Time Insulin Requirements
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Insulin Peglispro; Insulin Lispro; Insulin Glargine
Intervention description: Administered SC; Administered SC; Administered SC
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Lispro
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will look into how a base dose of insulin peglispro and insulin glargine will
      affect the meal time dose and efficacy of insulin lispro in type 1 diabetics.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a stable (within 0.5 percent (%) from last measure) glycated hemoglobin (HbA1c)
             <9.0%

          -  Have a stable (within 30%) basal insulin dose of 0.2 to 1.0 units per kilogram per day
             (U/kg/day) and a total daily insulin dose (basal + prandial/bolus) <1.5 units per
             kilogram (U/kg)

          -  Have C-peptide <0.3 nanomoles per liter (nmol/L)

          -  Are able and willing to eat the protocol specified standard breakfast and other meals
             as required

        Exclusion Criteria:

          -  Have corrected QT interval (QTc) prolongation >500 milliseconds (ms) or have any other
             abnormality in the 12 lead electrocardiogram (ECG) that, in the opinion of the
             investigator, increases the risks associated with participating in the study

          -  Have an abnormal blood pressure as determined by the investigator

          -  Have a history or presence of cardiovascular, respiratory, hepatic, renal,
             gastrointestinal, endocrine (apart from Type 1 Diabetes Mellitus [T1DM]),
             hematological, or neurological disorders

          -  Have fasting triglycerides (TGs) >400 milligrams per deciliter (mg/dL) (4.52
             micromoles per liter [mmol/L])

          -  Have used systemic corticosteroids within 4 weeks prior to randomization

          -  Currently receive insulin pump or insulin degludec

          -  Have poorly controlled diabetes or are known to have poor awareness of hypoglycemia

          -  Have history of gastroparesis or gastrointestinal malabsorption

          -  Require treatment with any drug other than insulin to treat diabetes

          -  Have a previous history of proliferative retinopathy
A Study of Infusion Site Pain After Infusion of Excipients in Participants With Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Sodium Citrate; Treprostinil; Humalog diluent; Magnesium Chloride
Intervention description: Administered SC infusion.; Administered SC infusion.; Administered SC infusion.; Administered SC infusion.
Intervention MeSH terms: Insulin Lispro; Treprostinil; Citric Acid; Sodium Citrate
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 69 Years
Healthy volunteers: No
Keywords: Humalog - Insulin lispro; Citrate; Infusion Site Pain; Excipients

Summary:

      The main purpose of this study is to evaluate the effect of excipients sodium citrate and
      treprostinil without insulin on local infusion site pain in participants with type 1 diabetes
      mellitus (T1DM) on continuous subcutaneous insulin infusion (CSII). The study may last up to
      36 days including a screening period and 3 visits.
    

Eligibility criteria:

        Inclusion Criteria:

          -  T1D for at least 1 year and continuously using insulin for at least 1 year

          -  Using an insulin pump for at least the last 6 months

          -  Have hemoglobin A1c (HbA1c) value of ≤ 9.0%

          -  Have a body mass index (BMI) within the range of 18.5 to 35.0 kilograms per square
             meter (kg/m²)

          -  Have medical and laboratory test results that are acceptable for the study

          -  Have venous access sufficient to allow for blood sampling

        Exclusion Criteria:

          -  Hemophilia or any other bleeding disorder

          -  Have a pathologic tuning fork test as assessed with a Rydel-Seiffer tuning fork

          -  Are taking anesthetics or pain medication regularly or intermittently which could
             interfere with interpretation of pain scale

          -  Have had more than 1 episode of severe hypoglycemia (defined as requiring assistance
             due to neurologically disabling hypoglycemia) within the last 90 days prior to
             screening

          -  Have had more than 1 emergency room visit or hospitalization due to poor glucose
             control (hyperglycemia or diabetic ketoacidosis) within the last 6 months prior to
             screening

          -  Have any hypersensitivity or allergy to any of the diluents or excipients used in this
             trial

          -  Have or used to have health problems or medical test results that, in the opinion of
             the doctor, could make it unsafe to participate, or could interfere with understanding
             the results of the study

          -  Have participated, within the last 30 days, in a clinical trial involving an
             investigational product

          -  Have used or are currently using Lyumjev® as part of their standard insulin therapy
Dose Finding Study Of CP-870,893, An Immune System Stimulating Antibody, In Combination With Paclitaxel And Carboplatin For Patients With Metastatic Solid Tumors
Condition: Neoplasms
Intervention: Paclitaxel + Carboplatin + CP-870,893; Paclitaxel + Carboplatin + CP-870,893
Intervention description: Paclitaxel is administered intravenously on day 1 of a 21-day cycle at a dose of 175 mg/m^2. Carboplatin is administered intravenously on day 1 of a 21-day cycle at AUC 6. CP-870,893 is administered intravenously on DAY 3 of a 21-day cycle in escalating doses (0.1 mg/kg and 0.2 mg/kg); Paclitaxel is administered intravenously on day 1 of a 21-day cycle at a dose of 175 mg/m^2. Carboplatin is administered intravenously on day 1 of a 21-day cycle at AUC 6. CP-870,893 is administered intravenously on DAY 8 of a 21-day cycle in escalating doses (0.1 mg/kg and 0.2 mg/kg)
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Carboplatin; Antibodies, Monoclonal
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This is a dose-finding study; therefore, there is no hypothesis testing
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with metastatic solid tumors, for whom carboplatin and paclitaxel are
             appropriate;

          -  Patients >18 years of age;

          -  Good performance status;

          -  Adequate bone marrow and organ function

        Exclusion Criteria:

          -  Previous treatment with any other compound that targets CD40

          -  Current or planned concurrent treatment with any anticancer agent;

          -  Patients who have received bone marrow transplant;

          -  History of autoimmune disorder

          -  History (within the previous year) of heart failure or heart attack

          -  Cancer-associated coagulation disorders
Single Ascending Dose Study of AMG 570 in Healthy Subjects
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: AMG 570; AMG 570 Matching Placebo
Intervention description: 7 dose levels of AMG 570 administered as single dose subcutaneous in healthy volunteers.; Placebo administered as single dose subcutaneous in healthy volunteers.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Lupus; Healthy Volunteer; Safety Study; Placebo Control; Phase 1

Summary:

      The purpose of this study is to obtain initial information on the safety and tolerability
      (effects good or bad), pharmacokinetics (what the body does to the drug), and
      pharmacodynamics (what the drug does to the body) of a single dose of AMG 570.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy as determined by the investigator

          -  Normal or clinically acceptable electrocardiogram (ECG)

          -  Female subjects must be of documented non-reproductive potential

          -  Subjects must be current for all vaccinations

          -  Other inclusion criteria may apply

        Exclusion Criteria:

          -  Current or chronic history of liver disease

          -  History of active infections

          -  History of significant respiratory disorder

          -  Evidence of renal disease

          -  Other exclusion criteria may apply
Olmesartan Pediatric Pharmacokinetic (PK) Study
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Olmesartan medoxomil
Intervention description: Children less than 6 years old: oral suspension or tablets equal to 0.3 mg/kg; 20 mg or 40 mg tablets for older children depending on weight.
Intervention MeSH terms: Olmesartan; Olmesartan Medoxomil
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 12 Months
Maximum age: 16 Years
Healthy volunteers: No
Keywords: Olmesartan PK in children

Summary:

      Determine single dose pharmacokinetic parameters of olmesartan in pediatric patients with
      hypertension in ages 12 months - 16 years
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 12 months to 16 years inclusive

          -  Signed parental/guardian informed consent and assent from the subject

          -  Current treatment for hypertension, or, if not currently treated for hypertension,
             systolic blood pressure (SBP) greater than or equal to 95th percentile for gender and
             height-for-age, or, if not currently treated for hypertension, systolic blood pressure
             or diastolic blood pressure greater than or equal to 90th percentile for gender and
             height-for-age and diabetic or having a family history of hypertension

          -  Glomerular filtration rate (GFR) greater than or equal to 30 mL/min/1.73 m2, estimated
             using the Schwartz equation

          -  Sexually active females of child-bearing potential must be practicing an acceptable
             method of birth control

          -  Negative serum beta-human chorionic gonadotropin at screening and at admission (female
             of child-bearing potential only)

        Exclusion Criteria:

          -  Clinically significant cardiac, gastrointestinal, hematologic, hepatic or
             hepatobiliary, neurologic, or pulmonary (except asthma) disorder

          -  History of severe or symptomatic hypertension associated with stroke, seizures,
             encephalopathy, or other significant neurologic findings within 1 year prior to
             screening

          -  Current treatment with more than 2 antihypertensive medications

          -  Secondary hypertension from uncorrected coarctation of the aorta, bilateral renal
             artery stenosis, or unilateral renal artery stenosis in a single kidney

          -  Serum albumin < 2.5 g/dL

          -  Major organ or bone marrow transplantation except for prior kidney transplantation of
             at least 6 months and with stable renal function meeting the inclusion criteria
First in Man Trial of BI 113608
Condition: Healthy
Intervention: BI 113608; BI 113608; BI 113608; BI 113608; Placebo; BI 113608; BI 113608; BI 113608; BI 113608; BI 113608; BI 113608
Intervention description: Low dose powder for oral solution; High dose powder for oral solution; Medium dose powder for oral solution; Low dose powder for oral solution; Powder for oral solution; Low dose powder for oral solution; High dose powder for oral solution; High dose powder for oral solution; Medium dose powder for oral solution; Medium dose powder for oral solution; Low dose powder for oral solution
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 80.0
Sex: Male
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of the current study is to investigate the safety and tolerability of
      BI 113608 in healthy male volunteers following oral administration of single rising doses.

      A secondary objective is the exploration of the pharmacokinetics of BI 113608 after single
      dosing.
    

Eligibility criteria:

        Inclusion criteria:

        1. Healthy male subjects

        Exclusion criteria:

        1. Any relevant deviation from healthy conditions