bioihbjkbjnl/mcl2 huggingface dataset:
A Study To Assess The Effect Of Linezolid On QTc Interval
Condition: Bacterial Infections
MeSH terms: Bacterial Infections
Intervention: Placebo; Linezolid 900 mg; Linezolid 1200 mg; Placebo; Linezolid 600 mg; Linezolid 1200 mg; Moxifloxacin 400 mg
Intervention description: Intravenous, Placebo control for blinding, Normal Saline, Single dose; Intravenous, 900 mg linezolid, single dose; Intravenous, 1200 mg linezolid, single dose; Intravenous, Placebo control for blinding, Normal Saline, Single dose; Intravenous, 600 mg linezolid, single dose; Intravenous, 1200 mg linezolid, single dose; Oral, 400 mg moxifloxacin, single dose
Intervention MeSH terms: Moxifloxacin; Linezolid
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 49.0
Sex: All
Minimum age: 21 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Linezolid, QTc interval, pharmacokinetics, therapeutic dose, supra-therapeutic dose

Summary:

      The FDA has asked Pfizer to assess the risk of linezolid on QT interval (obtained from ECG
      readings) which could predispose patients to ventricular arrhythmias. This study is conducted
      to satisfy this requirement.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and female subjects between the ages of 21 and 55 years.

          -  Body mass Index (BMI) of 18 to 30 kg/m2; and a total body weight > 45 kg (99 lbs).

          -  An informed consent document signed and dated.

        Exclusion Criteria:

          -  Evidence or history of clinically significant abnormality.

          -  12-lead ECG demonstrating QTc >450 msec at Screening.

          -  Receiving selective serotonin reuptake inhibitors (SSRIs) and/or sympathomimetic
             agents.

          -  Abnormal liver function tests.

          -  A positive urine drug screen, history of excessive alcohol and tobacco use.
A Safety and Efficacy Study of a Dexamethasone Drug Delivery System for Postoperative Inflammation and Pain After Cataract Surgery
Condition: Cataract
MeSH terms: Cataract
Intervention: Dexamethasone Drug Delivery System; Placebo Drug Delivery System
Intervention description: Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.; Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
Intervention MeSH terms: Dexamethasone
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a safety and efficacy study of a Dexamethasone Drug Delivery System for anterior
      segment inflammation and pain following cataract extraction with lens implantation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Planned single cataract extraction with lens implant

          -  Best-corrected visual acuity of 20/200 or better in the opposite eye

        Exclusion Criteria:

          -  Glaucoma or history of intraocular hypertension in the study eye

          -  History of chronic ocular allergy in the last year requiring treatment

          -  Scheduled for cataract surgery in the non-study eye during study participation
A Study of Abemaciclib (LY2835219) in Healthy Participants With and Without Food
Condition: Healthy
Intervention: Abemaciclib
Intervention description: Administered orally
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the amount of abemaciclib that reaches the blood
      stream and how long the body takes to get rid of it when given with and without food. In
      addition, the safety and tolerability of the study drug will be evaluated. Information about
      any side effects that may occur will also be collected. The study will last about 43 days for
      each participant, not including screening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy sterile males or surgically sterile or postmenopausal females

          -  Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m^2), inclusive

        Exclusion Criteria:

          -  Participated in a clinical trial involving investigational product within 30 days

          -  Have known allergies to abemaciclib, related compounds or any components of the
             formulation, or history of significant atopy

          -  Have an 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

          -  Show evidence of human immunodeficiency virus (HIV), hepatitis B or hepatitis C

          -  Have donated blood of more than 500 milliliter (mL) within the last month

          -  Have an average weekly alcohol intake that exceeds 21 units per week (males up to age
             65) and 14 units per week (males over 65 and females), or are unwilling to stop
             alcohol consumption 48 hours prior to each admission until collection of the last PK
             sample in each period

          -  Are unwilling to refrain from consuming xanthine-containing food and drink from 48
             hours prior to admission until collection of the last pharmacokinetic (PK) sample in
             each period

          -  Are currently or have been smokers or users of tobacco or nicotine replacement
             products within the 6 months prior to admission or have a positive urine cotinine test

          -  Are unwilling to comply with the dietary requirements/restrictions during the study:
             Consume only the meals provided during the inpatient stays and refrain from eating any
             food or drinking any beverages containing grapefruit, grapefruit juice,
             grapefruit-containing products, Seville oranges, star fruit or star fruit juice,
             pomelo, or commercial apple juice or orange juice for at least 2 weeks prior to the
             first dose until the final PK sample is collected
Safety, Tolerability, and Pharmacokinetic Study of EVP-6124 in Patients With Alzheimer's Disease
Condition: Alzheimer's Disease; Central Nervous System Diseases
MeSH terms: Alzheimer Disease; Nervous System Diseases; Central Nervous System Diseases
Intervention: EVP-6124 (0.1 mg/day); EVP-6124 (0.3 mg/day); EVP-6124 (1.0 mg/day); Comparator: Placebo; Donepezil; Rivastigmine
Intervention description: EVP-6124 was administered as one 0.1 mg capsule per day for 28 days.; EVP-6124 was administered as one 0.3 mg capsule every day for 28 days.; EVP-6124 was administered as one 1.0 mg capsule every day for 28 days.; Matching placebo was administered as one capsule per day for 28 days.; Concomitant therapy with donepezil at a stable dose, taken daily at the same time or immediately after the assigned EVP-6124 dose. Patients must have been taking concomitant therapy for at least 3 months prior to enrollment to be eligible for the study.; Concomitant therapy with rivastigmine at a stable dose, taken daily at the same time or immediately after the assigned EVP-6124 dose. Patients must have been taking concomitant therapy for at least 3 months prior to enrollment to be eligible for the study.
Intervention MeSH terms: Rivastigmine; Donepezil
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 49.0
Sex: All
Minimum age: 50 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Alzheimer's Disease; Central Nervous System Diseases; Pharmacokinetics; Cognition

Summary:

      This study is being conducted to determine the safety, tolerability, and pharmacokinetics
      (PK) of three different doses of an investigational medication, EVP-6124, in individuals with
      mild to moderate Alzheimer's disease who are also taking an Alzheimer's medication (AChEI
      [acetylcholinesterase inhibitor]: either donepezil or rivastigmine). In addition, PK of AChEI
      medications will be assessed. Cognitive function will be evaluated on an exploratory basis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male and post-menopausal or surgically sterile female pts

          -  50-90 yrs old, who meet clinical criteria for probable Alzheimer's disease
             (Mini-Mental State Examination of 18-26; Hachinski Ischemic Score ≤4)

          -  must be taking donepezil or rivastigmine for at least 3 mos.

        Exclusion Criteria:

          -  Unstable medical condition that is clinically significant in the judgment of the
             investigator; major organ system dysfunction

          -  Untreated hypothyroidism

          -  Insufficiently controlled diabetes mellitus

          -  Diagnosis of major depression requiring antidepressant medications within the last 5
             years

          -  Stroke within 6 months before screening, or concomitant with onset of dementia

          -  Certain concomitant medications
Bioequivalence of a Fixed Dose Combination Tablet of Empagliflozin/Metformin Extended Release Compared With Mono Compound Tablets in Healthy Male and Female
Condition: Healthy
Intervention: metformin; empagliflozin/metformin; empagliflozin
Intervention description: single dose of metformin given as tablets; Single dose empagliflozin/metformin given as fixed-dose combination tablet; single dose of empagliflozin given as tablet
Intervention MeSH terms: Metformin; Empagliflozin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this trial is to investigate bioequivalence of a newly developed fixed dose
      combination (FDC) tablet containing empagliflozin and metformin extended release compared to
      the free combination of empagliflozin and metformin extended release under fed conditions.
    

Eligibility criteria:

        Inclusion criteria:

          -  Healthy male and female subjects

          -  age of 18 to 55 years

          -  body mass index (BMI) of 18.5 to 29.9 kg/m2

          -  additional inclusion criteria may apply

        Exclusion criteria:

          -  Any finding in the medical examination (including BP, PR or ECG) deviating from normal
             and judged as clinically relevant by the investigator

          -  Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg or
             diastolic blood pressure outside the range of 50 to 90 mmHg or pulse rate outside the
             range of 45 to 90 bpm

          -  Any laboratory value outside the reference range that the investigator considers to be
             of clinical relevance

          -  Any evidence of a concomitant disease judged as clinically relevant by the
             investigator

          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
             immunological or hormonal disorders

          -  Surgery of the gastrointestinal tract that could interfere with kinetics of the trial
             medication

          -  Diseases of the central nervous system (including but not limited to any kind of
             seizures and stroke), and other relevant neurological disorders or psychiatric
             disorders

          -  additional exclusion criteria may apply
Estimation Study to Assess the Effect of Severe Renal Impairment and End-stage Renal Disease Hemodialysis on the Pharmacokinetics of Evolocumab
Condition: Hyperlipidemia; Mixed Dyslipidemia
MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Renal Insufficiency; Dyslipidemias; Hyperlipidemias
Intervention: Evolocumab
Intervention description: Administered by subcutaneous injection
Intervention MeSH terms: Evolocumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Subjects with normal renal function or severe renal impairment (RI) or end stage renal disease (ESRD) receiving hemodialysis

Summary:

      The primary objective of this study was to evaluate the pharmacokinetics of evolocumab after
      a single 140 mg subcutaneous (SC) dose in aduts with normal renal function or severe renal
      impairment or end-stage renal disease (ESRD) receiving hemodialysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body mass index (BMI) of ≥ 18 and ≤ 35 kg/m² at screening.

          -  Subjects will have low-density lipoprotein cholesterol (LDL-C) of 70-190 mg/dL
             (inclusive) and on statin therapy.

          -  Other inclusion criteria may apply.

        Exclusion Criteria:

          -  Subject with current or prior history of statin intolerance

          -  Subject has previously received Evolocumab (AMG 145) or any other investigational
             therapy directed against PCSK9

          -  Known substance abuse (eg, alcohol, licit or illicit drugs) within 12 months of day -1

          -  Testing positive for alcohol and/or drugs-of-abuse at screening, day -1, or day 1
             (alcohol only)

          -  History of hypersensitivity or allergic reaction to mammalian-derived drug
             preparations

          -  Known sensitivity to any of the active substances or their excipients to be
             administered during dosing, eg, carboxymethylcellulose

          -  Other exclusion criteria may apply.
Pharmacokinetics and Safety Study of BI 695501 in Healthy Subjects
Condition: Healthy
Intervention: adalimumab; BI695501; adalimumab
Intervention description: 40mg adalimumab single s.c. injection; BI 695501 single s.c injection; 40mg adalimumab single s.c. injection
Intervention MeSH terms: Adalimumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 193.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This trial will investigate the pharmacokinetics, safety and tolerability of BI 695501 and to
      establish pharmacokinetic equivalence of BI 695501 to adalimumab.
    

Eligibility criteria:

        Inclusion criteria:

          1. Healthy males

          2. Body mass index (BMI) =18.5 to =29.9 kg/m2

        Exclusion criteria:

          1. Any clinically relevant abnormal finding of the medical examination (including blood
             pressure, pulse rate and electrocardiogram) deviating from normal and of clinical
             relevance

          2. Any evidence of a clinically relevant previous or concomitant disease as judged by the
             investigator.

          3. Chronic or relevant acute infections. A negative result for Human Immunodeficiency
             Virus, Hepatitis B and Hepatitis C testing is required for participation.

          4. History of relevant allergy/hypersensitivity (including allergy to drug or its
             excipients)

          5. Intake of prescribed or over-the-counter drugs with a long half-life (>24 hours)
             within at least one month or less than 5 half-lives of the respective drug prior to
             administration or during the trial

          6. Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)

          7. Inability to refrain from smoking during days of confinement at the study center

          8. Alcohol abuse (average more than 30 g/day)

          9. Current drug abuse
To Evaluate the Food Effect on Relative Bioavailability of RP6530 in Healthy Volunteers
Condition: Healthy
Intervention: RP6530
Intervention description: Single oral dose
Intervention MeSH terms: Tenalisib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Fasting; Fed condition; Pharmacokinetics

Summary:

      This is a single centre, open label, randomized, two-treatment, two-period, two-sequence,
      single dose crossover food effect study in 18 subjects. The subjects will receive the study
      medication under either fed or fast during each treatment period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male volunteers; aged 18 to 45 years;

          -  Body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive, weight ≥ 50 kg;

          -  Non- smokers or ex-smokers;

          -  Able to give informed consent.

        Exclusion Criteria:

          -  Subjects with evidence or history of clinically significant disease;

          -  Positive results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG (B) (hepatitis
             B)) or Hepatitis C Virus (HCV (C)) tests;

          -  Subjects who have received any investigational drug in the previous 28 days;

          -  Subjects participated in a study with PI3k inhibitors at least once in past year;

          -  Subjects who have received drugs metabolised by CYP3A4 enzyme in the previous 28 days.
A Study of LY900014 Formulations in Healthy Participants
Condition: Healthy Volunteers
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: 29.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study evaluated four test formulations of a glucose lowering drug (LY900014)
      administered by injection under the skin of the abdomen. The study was conducted in healthy
      people to investigate how the human body handles LY900014 and the effect of LY900014 on blood
      sugar levels. Side effects and tolerability were documented. The study was to be conducted in
      two parts (Part A and Part B) to achieve its objectives. Each part of the study was to last
      for about 11 to 12 weeks, including screening and follow up. Screening was required within 28
      days prior to entering into either study Part A or Part B. Part B was not executed because no
      suitable formulation was identified.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly 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 18.5 to 30 kilogram per square meter (kg/m^2),
             inclusive, at screening

          -  Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine
             laboratory test results that are acceptable for the study

          -  Are nonsmokers, have not smoked for at least 2 months prior to entering the study, and
             agree not to smoke (cigars, cigarettes, or pipes) or use smokeless tobacco for the
             duration of the study

        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 or laboratory test results or ECG readings that,
             in the opinion of the doctor, could make it unsafe to participate, or could interfere
             with understanding the results of the study
Florbetaben (BAY94-9172) PET (Positron Emission Tomography) Imaging in MCI (Mild Cognitive Impairment) Patients
Condition: Alzheimer Disease; Amyloid Beta-Protein
MeSH terms: Alzheimer Disease; Amyloidosis; Cognitive Dysfunction
Intervention: Florbetaben (BAY94-9172)
Intervention description: single 300 megabecquerel (MBq) intravenous injection 2 mL to 10 mL, at baseline, at 12 and 24 months
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Florbetaben; Amyloid beta-protein; MCI; Alzheimer's disease

Summary:

      The aim of the study is to investigate whether Florbetaben (BAY94-9172)positron emission
      tomography (PET) is able to distinguish between subjects with mild cognitive impairment (MCI)
      progressing to Alzheimer's disease (AD) from those with MCI not progressing to AD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Presence of MCI defined as abnormal cognition on objective testing in the absence of
             dementia or significant functional loss.

          -  Absence of systemic or other neurological disease that may contribute to cognitive
             impairment or prevent follow-up over two years.

          -  Able to give written informed consent.

          -  Age >/= 60 years of age

          -  >/= 7 years of education

        Exclusion Criteria:

          -  Mini mental state examination (MMSE) score < 24 at baseline

          -  Clinical dementia rating (CDR) score > 0.5 at baseline

          -  Patients who receive regular medication of drugs which may adversely impact cognition
             (e.g. tricyclic antidepressants, antipsychotics and/or large doses of hypnotics or
             anxiolytics)

          -  Existing or history of cancer

          -  History of severe head trauma, brain surgery or intracranial hematoma with permanent
             brain lesion

          -  Lifetime history of major affective disorder, schizophrenia, or schizo-affective
             disorder

          -  Contraindications to MRI (Magnetic resonance imaging)

          -  Relevant history, physical or imaging findings of neurological disease other than MCI
             and mild depression

          -  History of severe anaphylactic reaction or high risk of allergic reaction to drugs

          -  Patient has received another investigational drug in the preceding 14 days