bioihbjkbjnl/mcl2 huggingface dataset:
First in Human Study of RVP-001, a New Manganese Based MRI Contrast Agent
Condition: Healthy
Intervention: RVP-001; Placebo
Intervention description: Intravenous administration of RVP-001; Intravenous administration of saline placebo
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objectives of this trial are:

        1. To evaluate the safety and tolerability of single ascending doses of RVP-001 in healthy
           adult volunteers

        2. To determine the pharmacokinetics and elimination of RVP-001 in healthy adult
           volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subjects

          2. Healthy subjects aged 18 to 55 years inclusive

          3. Suitable veins for phlebotomy, cannulation, or repeated venipuncture

          4. Have a body mass index between 18 and 32 kg/m^2 (inclusive); weigh at least 55 kg.

          5. Appropriately completed written informed consent prior to any study specific
             procedures.

        Exclusion Criteria:

          1. Any clinically significant abnormality or abnormal laboratory test results found
             during medical screening

          2. Vital sign abnormalities at screening or admission

          3. History of clinically significant cardiovascular, renal, hepatic, chronic respiratory
             or gastrointestinal disease; neurological or psychiatric disorder, as judged by the
             investigator

          4. Positive pregnancy test at screening or admission

          5. History of alcohol abuse

          6. History of drug abuse

          7. Use of nicotine-containing products within 12 months of study start

          8. Use of medication except topical products without significant systemic absorption

          9. Known allergies to any component of RVP-001

         10. Subjects who have received any investigational product (IP) in a clinical research
             study within 5 IP half-lives or 30 days prior to first dose.

         11. Donation of plasma within 7 days prior to dosing; significant donation or loss of
             blood within 30 days prior to the first dosing.

         12. Any reason which, in the opinion of the Principal Investigator, would prevent the
             subject from participating in the study.
Behavioral Effects of Drugs (Inpatient): 40 [Methamphetamine, Methylphenidate, Duloxetine]
Condition: Methamphetamine Use Disorder
Intervention: Methamphetamine; Methylphenidate; Placebo oral capsule; Duloxetine
Intervention description: In each arm, subjects will receive doses of methamphetamine.; In each arm, subjects will receive methylphenidate capsules.; In each arm, subjects will receive placebo capsules.; Subjects will receive duloxetine capsules in the duloxetine arm.
Intervention MeSH terms: Duloxetine Hydrochloride; Methylphenidate; Methamphetamine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Methamphetamine; Methylphenidate; Duloxetine Hydrochloride; Central Nervous System Stimulants; Physiological Effects of Drugs; Dopamine Uptake Inhibitors; Serotonin and Noradrenaline Reuptake Inhibitors; Membrane Transport Modulators; Neurotransmitter Agents; Dopamine Agents; Molecular Mechanisms of Pharmacological Action; Sensory System Agents; Peripheral Nervous System Agents; Vasoconstrictor Agents; Antidepressive Agents; Psychotropic Drugs

Summary:

      This study will evaluate the behavioral effects of methamphetamine during maintenance on
      placebo, duloxetine, methylphenidate and duloxetine combined with methylphenidate using
      sophisticated human laboratory methods.
    

Eligibility criteria:

        Inclusion Criteria:

          -  recent use of inhaled (i.e., snorted), smoked or injected methamphetamine

        Exclusion Criteria:

          -  Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians
             deem clinically significant.

          -  Current or past histories of substance use that are deemed by the study physicians to
             interfere with study completion.

          -  History of serious physical disease, current physical disease, impaired cardiovascular
             functioning, chronic obstructive pulmonary disease, history of seizure or current or
             past histories of serious psychiatric disorder that in the opinion of the study
             physician would interfere with study participation will be excluded from
             participation.

          -  Females not currently using effective birth control.

          -  Contraindications to methamphetamine, methylphenidate, or duloxetine.
Spironolactone Versus Prednisolone in DMD
Condition: Muscular Dystrophy, Duchenne
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Intervention: Spironolactone; Prednisolone
Intervention description: Spironolactone will be prescribed for 6 months, after which the family and primary care physician will determine to either remain on spironolactone or transfer to prednisolone.; Prednisolone will be prescribed for 6 months as the clinical standard of care.
Intervention MeSH terms: Prednisolone; Spironolactone
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomly assigned to either to the spironolactone treatment group or to the standard clinical dose of corticosteroids.
Masking: None (Open Label)
Enrollment: 2.0
Sex: Male
Minimum age: 4 Years
Maximum age: 7 Years
Healthy volunteers: No

Summary:

      This is a randomized, open-label, pilot clinical trial of spironolactone suspension versus
      oral prednisolone for use in Duchenne muscular dystrophy. The goals are to determine the
      safety of 6 months of treatment with spironolactone treatment int he steroid-naive DMD
      population as well as to determine if either spironolactone or a standard clinical dose of
      corticosteroids results in equivalent improvement in time to complete the 100 meter timed
      test (100M).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Duchenne muscular dystrophy (DMD) patients ≥4 to ≤7 years of age

          -  Clinical features of DMD that include proximal predominant weakness and/or gait
             disturbance

          -  Presence of a truncating mutation of the DMD gene in the patient or an affected male
             relative OR a muscle biopsy that demonstrates <5% dystrophin in the patient or an
             affected male relative

          -  Normal left ventricular ejection fraction by screening echocardiogram

          -  Ability to cooperate for testing

          -  No prior treatment with glucocorticoids or vamorolone

          -  No concomitant experimental therapies

        Exclusion Criteria:

          -  Subject amenable to or currently being treated with eteplirsen, casimersen, or
             viltolarsen

          -  Hyperkalemia at screening

          -  History of or ongoing renal failure (elevated creatinine, oliguria, anuria)

          -  Hypersensitivity to spironolactone (rash, respiratory distress, arrhythmia, numbness
             or tingling of extremities)

          -  Current treatment with an ACEi

          -  Severe peptic ulcer disease or recent gastrointestinal perforations
Paxil CR Bioequivalence Study Brazil
Condition: Depressive Disorder
MeSH terms: Depressive Disorder
Intervention: Test formulation; Reference formulation
Intervention description: Paroxetine Hydrochloride 25 miligrams (mg) tablet with controlled release (Paxil CR) manufactured by GlaxoSmithKline Inc. - Mississauga - Canada (test formulation); Paroxetine Hydrochloride 25 mg tablets with controlled release (Paxil CR) manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico (reference formulation)
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: fast condition; Paroxetine reference/test; healthy volunteers; Bioequivalence

Summary:

      The study is prospective, open, randomized, crossover in steady state and the volunteers
      received multiple doses of the drug test and reference (two periods of drug administration).
    

Eligibility criteria:

        EXCLUSION CRITERIA:

          -  hypersensitivity to the study drug or to compounds chemically related;

          -  history of serious adverse events;

          -  concurrent or recent use of other antidepressives, schizophrenia, anticonvulsant;

          -  History of liver, heart, gastrointestinal or renal illness;

          -  ECG findings not recommended according to the investigator judgement;

          -  The volunteer ingests more than 5 cups of coffee or tea a day.

        INCLUSION CRITERIA:

          -  Man and woman (since they are not pregnant or breastfeeding);

          -  age between 18 and 40 years;

          -  non-smoker and not addict;

          -  mass index between 18,5 and 27;

          -  good health conditions or without significant illness, by judgement of a legally
             qualified professional;

          -  sign the informed consent.
Study to Learn When Platelets Return to Normal After One Loading Dose of Anti-platelet Drugs in Patients With Symptoms of Acute Coronary Syndromes
Condition: Acute Coronary Syndromes
MeSH terms: Acute Coronary Syndrome; Syndrome
Intervention: clopidogrel; prasugrel
Intervention description: taken orally, day one, single dose; taken orally, day one, single dose
Intervention MeSH terms: Clopidogrel; Prasugrel Hydrochloride
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: Acute Coronary Syndromes; Angina; Platelet Function; Coronary Angiography; Clinical Symptoms of Angina; Positive Stress Test

Summary:

      To investigate how platelets recover to normal function in subjects who have symptoms of a
      heart attack or unstable angina and who get a loading dose of prasugrel or clopidogrel for
      planned coronary angiography.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women ≥18 to <80 years of age who present with any one of the following:

          -  symptoms of Acute Coronary Syndromes (ACS)

          -  clinical symptoms of angina, or a positive stress test or who return for routine
             follow up angiography post stent placement in whom co-administration of aspirin and a
             thienopyridine (that is, clopidogrel, ticlopidine, or prasugrel) is not
             contraindicated

        Exclusion Criteria:

          -  Those presenting with ST-elevation MI (STEMI)

          -  histories of refractory ventricular arrhythmias

          -  an implanted defibrillator device

          -  congestive heart failure (NYHA Class III or above) within 6 months prior to screening

          -  significant hypertension

          -  subjects with a history or clinical suspicion of cerebral vascular malformations,
             transient ischaemic attack, or stroke

          -  bleeding disorders

          -  women known to be pregnant, who have given birth within the past 90 days, or who are
             breastfeeding
Reperfusion With Cooling in Cerebral Acute Ischemia
Condition: Stroke, Acute
MeSH terms: Stroke
Intervention: Zoll- Coolgaurd 3000
Intervention description: Goal temperature of 33 degrees Centigrade for a duration of 12 hours and then actively rewarmed by 0.2 degrees Centigrade per hour.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Ischemic Stoke; Endovascular Reperfusion; Reperfusion Injury; Mild hypothermia

Summary:

      The purpose of this study is to determine whether reducing a patients body temperature (mild
      hypothermia of 33 degrees Centigrade) will significantly reduce the risk of brain injury
      (notably reperfusion injury and hemorrhagic conversion) in patients that have suffered a
      significant interruption of blood flow to an area of brain (occlusion of large proximal
      cerebral artery) and have undergone successful removal of that interruption
      (revascularization).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-85 years old

          -  Symptoms consistent with an ischemic stroke with a large vessel occlusion (MCA,
             ICA-terminus) as determined by vascular imaging

          -  ASPECTS score of 5-7 on non-contrast CT of the brain

          -  Ability to undergo endovascular reperfusion therapy

          -  Must have no contraindications to general anesthesia

          -  A pre-treatment modified Rankin Score of 0 or 1

          -  Arterial puncture performed under 8 hours from symptom onset or last seen normal

          -  Immediate post reperfusion CT scan shows no hemorrhage

        Exclusion Criteria:

          -  Bleeding diathesis with a platelet count < 50,000 or INR > 1.5

          -  Involved in another clinical trial

          -  History of dementia

          -  End stage renal disease on hemodialysis

          -  History of ventricular dysrhythmias

          -  Life threatening medical condition precluding survival under 6 months

          -  Presence of an IVC filter

          -  Contrast dye allergy with history of anaphylaxis
Kappa-PET Imaging and Naltrexone in Alcohol Drinking Behaviors
Condition: Alcohol Drinking
MeSH terms: Alcohol Drinking; Drinking Behavior
Intervention: Naltrexone
Intervention description: Naltrexone 100 mg titrated over one week
Intervention MeSH terms: Naltrexone
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 21 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Alcohol; Drinking; Drinkers; Alcohol Drinking; Naltrexone; Alcohol Dependence; Alcohol Abuse; Alcohol-Related Disorders; Ethanol; Alcoholism

Summary:

      The primary purpose of the study is to increase our knowledge of receptor function in the
      brains of people who are heavy drinkers and taking naltrexone (NTX), a medication that has
      been approved for the treatment of alcohol dependence. Receptors are special molecules in the
      brain to which other molecules (neurotransmitters) attach during the normal every-day
      workings of the brain. Drugs can bind to those receptor molecules as well. Recent evidence
      suggests that kappa opioid receptors (KOR's) may play an important role in alcohol drinking
      behavior. This study will try to determine if naltrexone's ability to attach to these
      receptors is related to its effectiveness. We will use PET (positron emission tomography) for
      this study. PET is a type of imaging device found in nuclear medicine. It is used for
      tracking the presence of injected radioactive materials in the body.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages 21-50

          -  Able to read English at 6th grade level or higher and to complete study evaluations

          -  Regular alcohol drinker

        Exclusion Criteria:

          -  Individuals who are seeking alcohol treatment

          -  Medical conditions that would contraindicate the use of study medication

          -  Regular use of other substances
The Effects of Antihypertensive Agents on Central Blood Pressure in Healthy Participants and Participants With Hypertension (MK-0000-166) (COMPLETED)
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Placebo; Comparator: Amlodipine; Comparator: ISMN ER
Intervention description: Placebo, capsule taken orally once daily during 4 weeks of treatment; Amlodipine 10 mg, taken orally as two 5 mg capsules, single daily dose for 4 weeks; ISMN ER 30 mg capsule, taken orally as single daily dose for 4 weeks
Intervention MeSH terms: Amlodipine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 38.0
Sex: All
Minimum age: 30 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will test the relationship between CBP (central blood pressure) and PBP
      (peripheral blood pressure) effects after single and multiple doses of Isosorbide mononitrate
      extended release (ISMN ER) or Amlodipine besylate in participants with hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant is a male or female between 30 and 65 years of age (inclusive) at the
             pre-study (screening)

          -  Female participant of childbearing potential must have a negative pregnancy test

          -  Participant has a brachial systolic blood pressure >130 mm Hg

        and <180 mm Hg

          -  Participant has a Body Mass Index (BMI) that is >20 kg/m^2 and <35 kg/m^2

          -  Participant has been a nonsmoker and/or has not used nicotine or nicotine-containing
             products for at least approximately 6 months

        Exclusion Criteria:

          -  Female Participant is pregnant or lactating

          -  Participant anticipates the use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
             other than acetaminophen

          -  Participant is currently a user (including "recreational use") of any illicit drugs,
             has a history of drug or alcohol abuse within approximately 2 years, or has a positive
             prestudy urine drug screen

          -  Participant has a condition for which there is a warning, contraindication, or
             precaution against the use of ISMN ER including: acute myocardial infarction or
             congestive heart failure, hypotension, volume depletion, and pregnancy

          -  Participant has a history of significant drug allergy or any clinically significant
             adverse experience of a serious nature related to the administration of either a
             marketed or an investigational drug, including nitrates, nitrites, Amlodipine, and
             ISMN ER
The Effect of Moderate CYP3A Inducer Rifabutin on the Pharmacokinetics of Zanubrutinib in Healthy Males
Condition: Healthy; Male
Intervention: Zanubrutinib; Rifabutin
Intervention description: Single oral dose of 320 mg; Oral dose of 300 mg once daily
Intervention MeSH terms: Rifabutin; Zanubrutinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Phase 1; Healthy volunteers; Pharmacokinetics

Summary:

      The primary objective of this study was to determine the effect of the moderate cytochrome
      P450 3A (CYP3A) inducer rifabutin on the pharmacokinetics (PK) of zanubrutinib in healthy
      males.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Males of any race, between 18 and 65 years of age, inclusive.

          2. Male participants in good health as determined by past medical history, physical
             examination, vital signs, ECG and laboratory tests at screening

          3. Must have a body mass index (BMI) between 18 and 32 kg/m^2

        Key Exclusion Criteria:

          1. Participants with a clinically relevant history or presence of any clinically
             significant disease

          2. History of stomach or intestinal surgery or resection that would potentially alter
             absorption and/or excretion of orally administered drugs (uncomplicated appendectomy,
             cholecystectomy, and hernia repair will be allowed)

          3. History of drug or alcohol abuse within 1 year prior to check-in

          4. Use or intended use of any nonprescription medications/products including vitamins,
             minerals, herbal/plant-derived preparations within 7 days prior to check-in

          5. A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result and/or a
             positive human immunodeficiency virus (HIV) at screening

          6. Use of tobacco- or nicotine-containing products within 3 months prior to check-in

          7. Use or intended use of any prescription medications/products within 14 days prior to
             check-in

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.