bioihbjkbjnl/mcl2 huggingface dataset:
Placebo-Controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of SXC-2023 in Healthy Volunteers
Condition: Healthy
Intervention: SXC-2023; Placebo oral capsule
Intervention description: Oral capsule; Placebo given as oral capsule.
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: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a randomized, double-blind, placebo-controlled, single ascending oral dose and food
      effect study conducted at one study center in the United States. Safety and tolerability will
      be assessed throughout the study and serial blood samples and urine samples will be collected
      for the safety and pharmacokinetic assessment of SXC-2023.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy adult male or females (women of non child bearing potential), 18-55 years of
             age (inclusive).

          2. Medically healthy with no clinically significant screening results.

          3. Non-vasectomized male subjects must agree to use birth control or abstain from sexual
             intercourse during and until 90 days beyond the last dose of study drug/placebo.

          4. Continuous non-smoker, at least 3 months prior to first dose and throughout the study.

          5. Understands the study procedures in the informed consent form, and be willing and able
             to comply with the protocol

        Exclusion Criteria:

          1. Subject is mentally or legally incapacitated.

          2. History of any illness that, in the opinion of the PI, might confound the results of
             the study or poses an additional risk to the subjects by their participation in the
             study.

          3. History or presence of alcoholism or drug abuse within the past 2 years

          4. Female subject of childbearing potential.

          5. Blood donation or significant blood loss within 56 days prior to first dose.

          6. Plasma donation within 7 days prior to first dose.

          7. Participation in another clinical trial within 30 days prior to first dose.
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
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
2-Week Study In People With Nonalcoholic Fatty Liver Disease
Condition: Non-alcoholic Steatohepatitis; Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: Placebo; PF-06865571; PF-06865571
Intervention description: tablet, 0 mg, 14 days, every 12 hours; tablet, 50 mg, 14 days, every 12 hours; tablet, 300 mg, 14 days, every 12 hours
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      2-week study in people with nonalcoholic fatty liver disease. Study drug at 1 of 2 doses, or
      placebo, will be given for 14 days. Blood samples, heart monitoring, vital signs, and imaging
      procedures will be performed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  controlled attenuation parameter greater than or equal to 260 dB/m via FibroScan

          -  liver fat greater than or equal to 6% via MRI

        Exclusion Criteria:

          -  Chronic liver disease

          -  Type 2 diabetes requiring drug treatment

          -  Unable to undergo MRI

          -  History of heart attack or stroke
Effect of 1,25-dihydroxyvitamin D3, Treatment on Insulin Secretion and Muscle Strength in Pre-diabetic Persons
Condition: Pre-Diabetic
MeSH terms: Prediabetic State
Intervention: Calcitriol capsules; Oral Placebo
Intervention description: 0.25micrograms, taken daily for eight weeks, orally; Placebo will be created to mimic the appearance of the study drug
Intervention MeSH terms: Calcitriol
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 17.0
Sex: All
Minimum age: 20 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pre-menopausal women

Summary:

      The purpose of this research is to study the effects of 1,25(OH)2 D3 (a prescription form of
      active Vitamin D) on muscle strength and insulin secretion by the pancreas and glucose
      utilization by skeletal muscle.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body mass index (BMI) of >24kg/m2

          -  Fasting serum glucose <126 mg/dL

        Exclusion Criteria:

          -  BMI</=24 kg/m2

          -  Fasting serum glucose >/=126 mg/dL

          -  Patient is taking Calcium or Vitamin D supplements and is unwilling to stop for 8
             weeks

          -  Serum Calcium >10.2 mg/dL

          -  Serum inorganic phosphorous >4.5mg/dL

          -  Pregnancy or breastfeeding

          -  Diagnosis of Diabetes Mellitus

          -  Diagnosis of Rheumatoid Arthritis

          -  Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)

          -  Renal in sufficiency/failure ( serum creatinine >1.5 mg/dL men, > 1.3 mg/dL women)

          -  Chronic active liver disease (bilirubin >1.2 mg/dL, AST>144IU/L, or ALT >165 IU/L)

          -  History of chronic hepatitis

          -  Active coronary artery disease ( unstable angina, myocardial infarction, stroke and
             revascularization of coronary, peripheral or carotid artery within the last 3 months)

          -  Oral warfarin group medications or history of blood clotting disorders

          -  Platelet count <100,000 per uL within the last 7 days

          -  Alcohol consumption greater than 2 glasses/day or other substance abuse

          -  Untreated or uncontrolled thyroid disorders (outside a TSH range of 0.5 to 10mIU/L)

          -  Debilitating chronic disease (at the discretion of the investigators)

          -  The presence of infections, highly communicable diseases ( AIDS, active tuberculosis,
             venereal disease, hepatitis)

          -  Any malignancy
A Study to Compare 2 Formulations of LY900014 in Healthy Participants
Condition: Healthy
Intervention: LY900014-U200; LY900014-U100
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: 49.0
Sex: All
Minimum age: 21 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The study involves a comparison of a LY900014 U-200 formulation with a LY900014 U-100
      formulation. LY900014 is a type of fast acting insulin. Study participants will be
      administered LY900014 U-100 two times and LY900014 U-200 two times, over 4 study periods, by
      injection under the skin. Blood samples will be taken to compare how the body handles the
      study drugs and how they affect the blood sugar levels. Side effects and tolerability will be
      documented. The study will last about 4 weeks, not including screening and follow up.
      Screening is required within 28 days prior to the start of the study and follow up is
      required at least 2 weeks after the last dose of study drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male or a female (not pregnant and agreeable to take birth control measures
             until 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 that are acceptable for the study

          -  Have veins suitable for easy blood collection and glucose solution infusion

        Exclusion Criteria:

          -  Are currently participating in or completed a clinical trial within the last 30 days
             or any other type of medical research judged to be incompatible with this study

          -  Have previously participated or withdrawn from this study

          -  Had blood loss of more than 450 milliliters (mL) within the last 3 months

          -  Have a regular alcohol intake greater than 21 units/week (male), or 14 units/week
             (female)

          -  Smoke more than 10 cigarettes per day

          -  Are infected with hepatitis B or human immunodeficiency virus (HIV)

          -  Are taking illegal drugs
Nicotinic Agonist Effects on BMI and Neuronal Response
Condition: Obesity
Intervention: DMXB-A; Placebo
Intervention description: 150 mg DMXB-A (3-(2,4-dimethoxybenzylidene anabaseine) b.i.d. for 12 weeks.; Placebo capsules b.i.d. for 12 weeks
Intervention MeSH terms: 3-(2,4-dimethoxybenzylidene)anabaseine
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 61.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Obesity is a serious and growing health problem in the United States. Obesity is associated
      with health problems such as type-2 diabetes and cardiovascular disease, leading to decreased
      quality of life and increased mortality. Given the health and quality-of-life effects of
      obesity, developing effective treatments clearly is an important goal.

      This study plans to learn more about the effects of an investigational new drug (DMXB-A
      (3-(2,4-dimethoxybenzylidene anabaseine)) and its effects on obesity. The study drug has
      similar effects to nicotine. Since nicotine has been found to affect appetite, the
      investigators are interested in studying effects of the study drug, which has some
      similarities to nicotine, on how your brain responds to such things as pictures of food. The
      study drug has not been approved by the Food and Drug Administration (FDA), and is considered
      experimental.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overweight/obese (BMI > 27)

          -  Between 21-65 years old

        Exclusion Criteria:

          -  Known cardiovascular disease (e.g., coronary artery disease, uncontrolled hypertension

          -  Women capable of conception (must be post-menopausal, surgically sterilized, or have
             adhered to an anti-contraception birth control regimen for at least 1 year)

          -  Nicotine use

          -  Significant endocrine/metabolic disease

          -  Kidney disease

          -  Neurological illness

          -  Liver disease

          -  Medication use affecting appetite and/or metabolism

          -  MRI-specific exclusion criteria (e.g., claustrophobia, metal in the body)
A Study of Tralokinumab When Delivered Subcutaneously at Different Flow Rates to Healthy Volunteers
Condition: Asthma; Healthy Subjects or Volunteers
MeSH terms: Asthma
Intervention: Tralokinumab 300 mg
Intervention description: Participants will receive 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at different flow rates.
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 19 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Asthma; Healthy Subjects or Volunteers; Tralokinumab; CAT-354

Summary:

      The primary objective of this study is to evaluate the pharmacokinetics (PK) and tolerability
      of tralokinumab when delivered subcutaneously at different flow rates to healthy volunteers.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Healthy males and females ages 19-65 years

          -  Body mass index of 19.0-30.0 kilogram per meter square (kg/m^2)

          -  No clinically significant abnormality

          -  Vital signs, electrocardiogram (ECG), and laboratory parameters within normal range

          -  Negative alcohol and drug screens

          -  Females of childbearing potential who are sexually active with a nonsterilized male
             partner must use highly effective contraception

          -  Nonsterilized males who are sexually active with a female partner of childbearing
             potential must use highly effective contraception.

        Key Exclusion Criteria:

          -  Concurrent enrollment in another clinical study where the subject is receiving an
             investigational product

          -  Receipt of any marketed or investigational biologic agent within 4 months or 5
             half-lives prior to screening, whichever is longer

          -  Receipt of any investigational nonbiologic agent within 3 months or 5 half-lives prior
             to screening, whichever is longer

          -  Current use of regular pain-modifying, anti-depressant, anxiolytic, or hypnotic
             medication

          -  History of thrombocytopenia or bleeding disorder or use of anticoagulants

          -  History of any immunodeficiency disorder or use of immunosuppressive medication.

          -  History of a clinically significant infection

          -  History of cancer

          -  Positive Hepatitis B or C

          -  Positive HIV