bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess the Effects of 2 Prothrombin Complex Concentrates on the Pharmacodynamics of Apixaban in Healthy Adult Subjects
Condition: Anticoagulation
Intervention: Apixaban; Cofact (4-Factor PCC); Beriplex P/N (4-Factor PCC); Placebo (Saline solution)
Intervention MeSH terms: Apixaban
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to assess the effect of two 4-Factor PCC formulations on
      Apixaban pharmacodynamics in healthy adult subjects.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Healthy subjects

          -  Body Mass Index (BMI) of 18 to 30 kg/m2

          -  Ages 18 to 45 years, including

          -  Women of childbearing potential (WOCBP) on acceptable contraception and with negative
             pregnancy test and not breastfeeding

        Exclusion Criteria:

          -  History or evidence of coagulopathy

          -  History or evidence of thrombosis such as deep vein thrombosis or other thromboembolic
             disease or having a first degree relative under 50 years of age with a history of
             thromboembolic disease

          -  Any significant acute or chronic medical illness or relevant trauma

          -  Any major surgery within 4 weeks of dosing (prior to dosing) or planned within 2 weeks
             after completion of the study

          -  History of heavy menstrual bleeding that has produced anemia within the past 1 year

          -  Current symptomatic or recent gastrointestinal disease or surgery that could impact
             the absorption of study drug

          -  History of smoking within 1 month prior to dosing

          -  Recent history (within 6 months of dosing) of pregnancy

          -  Use of hormonal contraceptives

          -  Exposure to any investigational drug or placebo within 4 weeks of study drug
             administration

          -  Use of any agent, including but not limited to Aspirin, Nonsteroidal anti-inflammatory
             drugs (NSAIDs), Anticoagulants, Fish oil capsules, Gingko, etc, that are known to
             increase the potential for bleeding, within 2 weeks prior to dosing

          -  History of any severe drug allergy including allergy to Heparin or history of
             Heparin-induced thrombocytopenia, hypersensitivity to PCCs or Factor Xa inhibitors, or
             history of allergy to human blood plasma derived products; history of any adverse drug
             reaction to Anticoagulants or Antiplatelet agents that resulted in excessive bleeding
             requiring medical intervention
Drug-Food Interaction Study of Seville Orange Juice and Colchicine
Condition: Healthy
Intervention: Colchicine; Seville Orange Juice
Intervention description: A single dose of 0.6 mg colchicine administered alone in the morning on Day 1 and a single dose of 0.6 mg colchicine administered with Seville orange juice in the morning on Day 18 after an overnight fast of at least 10 hours.; 240 mL of Seville orange juice administered in the morning and evening on Days 15 to 18.
Intervention MeSH terms: Colchicine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: blood levels over time; colchicine; seville orange juice; pharmacokinetics

Summary:

      Seville orange juice is an inhibitor of the intestinal cytochrome P450 (CYP) 3A4 enzyme, one
      of the enzymes responsible for the metabolism of colchicine. This study will evaluate the
      effect of multiple daily consumptions of Seville orange juice on the pharmacokinetic profile
      of a single 0.6 mg dose of colchicine. A secondary objective is to evaluate the safety and
      tolerability of this regimen in healthy volunteers. All study subjects will be monitored for
      adverse events throughout the study period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adults 18-45 years of age

          -  Non-smoking and non-pregnant (post-menopausal, surgically sterile or using effective
             contraceptive measures)

          -  Body mass index (BMI) greater than or equal to 18 and less than or equal to 32,
             inclusive

          -  Hemoglobin greater than or equal to 11.5g/dL

        Exclusion Criteria:

          -  Recent participation (within 28 days) in other research studies

          -  Recent significant blood donation or plasma donation

          -  Pregnant or lactating

          -  Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface
             antigen (HbsAg), or hepatitis C virus (HCV)

          -  Recent (2-year) history or evidence of alcoholism or drug abuse

          -  History or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or
             biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic,
             dermatologic, neurologic, or psychiatric disease

          -  Subjects who have used any drugs or substances known to inhibit or induce cytochrome
             (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 28 days prior to the first dose
             and throughout the study

          -  Drug allergies to colchicine

          -  Intolerance or food allergy to Seville orange juice
Differential Responses to Drugs and Sweet Tastes
Condition: Bipolar II Disorder
Intervention: Placebo oral capsule; d-amphetamine 10 mg oral capsule; d-amphetamine 20 mg oral capsule
Intervention description: Placebo oral capsule; d-amphetamine 10 mg oral capsule; d-amphetamine 20 mg oral capsule
Intervention MeSH terms: Amphetamine; Dextroamphetamine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study will track participants in two assigned groups (participants that exhibit either High or Low Bipolar II/Hypomanic phenotypes)
Masking: Double (Participant, Investigator)
Enrollment: 93.0
Sex: All
Minimum age: 18 Years
Maximum age: 19 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Young adults who exhibit "bipolar phenotype" (BPP), defined as occasional episodes of mood
      elevation and heightened activity, are at risk for several psychiatric disorders, including
      problem use of drugs and alcohol. Mood elevation has been linked to higher alcohol
      consumption and alcohol use disorders. Individuals with BPP show elevated lifetime prevalence
      of alcohol use disorders (between 39%-61%), figures that exceed those reported in both major
      depression and schizophrenia. Recently, the investigators demonstrated in a controlled
      laboratory study that individuals with BPP (but not meeting criteria for full Bipolar I
      Disorder), report dampened responses to a single dose of alcohol, compared to placebo. In the
      current study, the investigators seek to extend these findings to determine if young adults
      reporting BPP, based on a questionnaire, will exhibit reduced responses to other rewarding
      stimuli, such as d-amphetamine and sweet tastes. The investigators hypothesize that the BPP
      individuals will exhibit dampened subjective responses to stimulant and sweet taste rewards
      compared to healthy controls.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 18-19 years old

          -  BMI of 19-26

          -  Physical/EKG/Medical History/Medications Approved by Physician for d-amphetamine

          -  at least High School education

          -  Fluent in English

        Exclusion Criteria:

          -  No Current Mood, Anxiety, Eating or Psychotic Disorder

          -  No current psychotropic medication

          -  No Recent Drug Dependence

          -  < 4 alcoholic drinks/day for males; < 3 alcoholic drinks/day for females (monthly
             average)

          -  No weekly (or more frequent) illicit drug use

          -  No women who are pregnant, nursing, or planning pregnancy within 3 months (birth
             control is okay)
A Study of LY900014 in Participants With Type 1 Diabetes on Insulin Injection Therapy
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: LY900014; Insulin Lispro
Intervention description: Administered subcutaneously (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: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The study will be conducted in participants with type1 diabetes on insulin injection therapy
      to investigate how the body processes LY900014 and the effect of LY900014 on blood sugar
      levels. Side effects and tolerability will be documented. The study will be conducted in two
      parts (Part A and Part B) to achieve its objectives. Participants are expected to enroll in
      both parts.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are male or female participants with Type 1 Diabetes Mellitus (T1DM) on a stable
             multiple daily injection regimen with a short-acting as well as a long-acting insulin

          -  Have a body mass index (BMI) ranging from 18.5 to 33.0 kilogram per square meter
             (kg/m²), inclusive, at screening

          -  Have blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory
             test results acceptable for the study

          -  Have had no episodes of severe hypoglycemia in the past 6 months (requiring assistance
             in treatment by a second party)

          -  Have venous access sufficient to allow for blood sampling

          -  Have provided written consent and are willing to follow study procedures and commit to
             the study duration

        Exclusion Criteria:

          -  Are currently enrolled, or have participated within the last 30 days, in a clinical
             trial or any other type of medical research judged to be incompatible with this study

          -  Have previously completed or withdrawn from this study

          -  Have or used to have health problems that, in the opinion of the doctor, could make it
             unsafe to participate in the study

          -  Had blood loss of more than 500 milliliters (mL) within the last month

          -  Are treated with a continuous subcutaneous insulin infusion (insulin pump)
ZD1839 With Hypofractionated Radiation Therapy With an Immobilization Device for Advanced Non-Small Cell Lung Cancer
Condition: Non-Small Cell Lung Carcinoma (NSCLC)
MeSH terms: Carcinoma, Non-Small-Cell Lung; Lung Neoplasms
Intervention: ZD1839 (Iressa); Thoracic Radiotherapy
Intervention MeSH terms: Gefitinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced NSCLC; Non-Small Cell Lung Carcinoma; Stage IV NSCLC

Summary:

      The purpose of this study is to determine the safety and effectiveness of Iressa when used
      with a short course of high dose radiation therapy in patients with lung cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed non small cell lung cancer

          -  Stage IV needing radiation therapy to control symptoms

          -  Patients with brain metastases

          -  Unresectable or medically inoperable

        Exclusion Criteria:

          -  Small cell lung cancer

          -  Previous thoracic radiation therapy

          -  Oxygen-dependent patients

          -  Forced expiratory volume in 1 second (FEV1) less than 1.5

          -  Patients with active interstitial lung disease

          -  Patients with underlying lung disease
Study of the Mechanisms of Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Pulmicort
Intervention description: inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks
Intervention MeSH terms: Budesonide
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 127.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to identify the causes of asthma that were not previously
      suspected, to better understand the effects of inhaled steroids on asthma and to identify new
      way to treat asthma. In order to take advantage of the most current scientific expertise, we
      (scientists at UCSF) plan to work together with Genentech Inc. We believe that working with
      Genentech will provide the best chance of developing new treatments for asthma.
    

Eligibility criteria:

        Inclusion Criteria:

        Group C:

          -  Male and female subjects between the ages of 18 and 70 years

          -  History of asthma

          -  Continuous treatment with inhaled corticosteroids for at least the 6-week

          -  Hyperreactivity to methacholine (provocative concentration of methacholine causing a
             20% drop in forced expiratory volume in 1 second (PC20 FEV1) Methacholine ≤ 16.0
             mg/mL).

        Exclusion Criteria:

          -  History of asthma

          -  No use of oral or inhaled corticosteroids for the treatment of asthma in the past 6
             weeks

          -  Hyperreactivity to methacholine (PC20 FEV1 Methacholine ≤ 8.0 mg/mL).

          -  At least one of the following symptoms, beta agonist use, or FEV1 criteria:

               -  Asthma symptoms on at least two days per week; OR

               -  Beta agonist use on at least two days per week; OR

               -  Forced expiratory volume in 1 second (FEV1) < 85% predicted

          -  Subjects must be non-smokers (patients who have never smoked or patients who have not
             smoked for 1 year and have a total pack-year smoking history < 15 packs).
A Study To Evaluate The Safety And Tolerability Of PF-06342674 (RN168) In Subjects With Multiple Sclerosis (MS)
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: PF-06342674 0.25 mg/kg; Placebo; PF-06342674 1.5 mg/kg; PF-06342674 6.0 mg/kg
Intervention description: Bi-Weekly Subcutaneous Injections X 6; Bi-Weekly Subcutaneous Injections X 6; Bi-Weekly Subcutaneous Injections X 6; Bi-Weekly Subcutaneous Injections X 6
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Multiple Sclerosis; MRI

Summary:

      PF-06342674 (RN168), being developed for the treatment of multiple sclerosis (MS), is an
      antibody that binds to and inhibits the human interleukin-7 receptor, a component potentially
      involved in MS. PF-06342674 (RN168) is expected to play a role in slowing down the
      progression of the disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women and men aged 18-55 yrs.

          -  Confirmed diagnosis of Multiple Sclerosis (MS) according to the 2010 revision of the
             McDonald Criteria.

          -  Expanded Disability Status Scale (EDSS) between 0-5, inclusive.

        Exclusion Criteria:

          -  Relapse episode of MS within 2 weeks of enrollment.

          -  Primary progressive MS without a relapsing component.

          -  Intolerant or unwilling to undergo MRI scanning. Treatment with disease modifying
             agents up to 6 weeks prior to enrollment.
A Phase 1 Study In Japanese Subjects With Type 2 Diabetes Mellitus As Monotherapy
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: PF-04937319 high dose; PF-04937319 low dose; Placebo
Intervention description: tablets, 150 mg with breakfast plus 100 mg with lunch, 7 days; tablets, 50 mg with breakfast plus 50 mg with lunch, 7 days; tablets, breakfast plus lunch, 7 days
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 12.0
Sex: All
Minimum age: 20 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Phase 1; type 2 diabetes; monotherapy; PF-04937319

Summary:

      Study B1621018 will assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics
      of Two Dose Levels of Pf-04937319 in Japanese Subjects with Type 2 Diabetes Mellitus As
      Monotherapy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with type 2 diabetes, on diet/exercise therapy only or background therapy
             with 1 oral anti-diabetic agent (excluding Actos)

        Exclusion Criteria:

          -  Patients with cardiovascular event

          -  Patients with diabetic complications

          -  Female subjects who are pregnant or planning to become pregnant

          -  Subjects with unstable medical conditions (eg, hypertension)
A Study of LY900014 Formulation in Participants With Type 1 Diabetes Mellitus Using Insulin Pumps
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: LY900014; Insulin Lispro
Intervention description: Administered subcutaneously (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: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study evaluated a blood sugar lowering insulin, LY900014, delivered by an insulin pump
      continuously under the skin. The study was conducted in participants with type 1 diabetes
      mellitus to investigate how the human body processed LY900014 and its effect on blood sugar
      levels when it was delivered via an insulin pump. Side effects and tolerability were be
      documented.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participants with Type 1 Diabetes Mellitus (T1DM) who are receiving
             insulin therapy via an approved insulin pump

          -  Have a body mass index (BMI) of 18.5 to 33 kilogram per square meter (kg/m²),
             inclusive, at screening

          -  Have blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory
             test results that are acceptable for the study

          -  Have had no episodes of severe hypoglycemia in the past 6 months (requiring assistance
             in treatment by a second party)

          -  Have venous access sufficient to allow for blood sampling

          -  Have provided written consent and are willing to follow study procedures and commit to
             the study duration

        Exclusion Criteria:

          -  Are currently participating in or completed a clinical trial within the last 30 days
             from a clinical trial or any other type of medical research judged to be incompatible
             with this study

          -  Have previously participated or withdrawn from this study

          -  Have or used to have health problems, laboratory test results, blood pressure or ECG
             readings that, in the opinion of the doctor, could make it unsafe to participate in
             the study

          -  Had blood loss of more than 500 milliliters (mL) within the last month
A Study of LY3006072 in Healthy Participants
Condition: Healthy Volunteers
Intervention: Placebo; LY3006072
Intervention description: Capsules administered orally; Capsules administered orally
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate how safe LY3006072 (study drug) is and whether it
      causes any side effects. The study will also measure how much of the study drug gets into the
      blood stream and how long it takes the body to get rid of the study drug. The study drug will
      be given in the morning or evening with or without a meal.

      This is the first time that this study drug is being given to humans. This study is for
      research purposes only and is not intended to treat any medical condition.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy males or females, as determined by medical history and physical
             examination

          -  Male participants with a partner of childbearing potential must agree to use barrier
             protection during sexual intercourse while in the study and for 3 months after the
             last dose of study drug

          -  Women must not be pregnant or nursing and must be of non-childbearing potential, due
             to either surgical sterilization or menopause

          -  Body mass index between 19.0 and 30.0 kilograms per square meter (kg/m^2), inclusive
Investigation of Pharmacodynamic Effects of Dabigatran and Ticagrelor and Assessment of Ticagrelor Interaction Potential With Dabigatran
Condition: Healthy
Intervention: dabigatran etexilate; Ticagrelor; Ticagrelor; dabigatran etexilate; dabigatran etexilate
Intervention description: medium dose dabigatran; high dose ticagrelor; high dose ticagrelor; low dose dabigatran; medium dose dabigatran
Intervention MeSH terms: Dabigatran; Ticagrelor
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Evaluation of potential ticagrelor effects on dabigatran exposure and evaluation of two new
      pharmacodynamic methods
    

Eligibility criteria:

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