bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Effect of Famotidine and Omeprazole on MK0518 (Raltegravir) Pharmacokinetics in Human Immunodeficiency Virus (HIV)-Infected Patients (0518-054)
Condition: HIV-1 Infection; HIV Infections
MeSH terms: Infections; Communicable Diseases
Intervention: MK0518 (Raltegravir); famotidine; omeprazole
Intervention description: 400 mg oral tablet of MK0518 once every 12 hours. Period 1 duration is one day, Period 2 duration is one day, Period 3 duration is five days.; Single 20 mg famotidine oral tablet taken 2 hours prior to administration of AM dose of MK0518; 20 mg oral tablet of omeprazole, once daily for 5 days
Intervention MeSH terms: Raltegravir Potassium; Omeprazole; Famotidine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Treatment experienced

Summary:

      An open-label, 3-period, fixed-sequence study in a panel of 18 HIV-infected patients on
      MK0518 as part of a stable treatment regimen for HIV.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is Human immunodeficiency virus (HIV) positive

          -  Patient is taking an MK0518 (Raltegravir) containing regimen

          -  Patient has not had any changes to his/her antiviral regimen in the last 2 weeks

          -  Patient who is of reproductive potential agrees to use an acceptable method of birth
             control

          -  Patients baseline health is stable

        Exclusion Criteria:

          -  Patient has a history of stroke or chronic seizures.

          -  Patient has a history of gastric bypass surgery

          -  Patient is pregnant of breastfeeding

          -  Patient consumes excessive amounts of caffeinated beverages daily

          -  Patient has had major surgery, donated blood, or participated in another
             investigational study in the past 4 weeks
A Study of Abemaciclib in Healthy Participants
Condition: Healthy
Intervention: Abemaciclib Capsules (Reference Formulation); Abemaciclib Tablet (Test Formulation)
Intervention description: Administered orally; Administered orally
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 127.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to measure how much abemaciclib gets into the blood stream and
      how long it takes the body to get rid of it when given as capsules versus a tablet(s). The
      effect of a high fat meal on the tablet formulation will also be evaluated. In addition, the
      tolerability of abemaciclib tablet and capsule formulations will be evaluated. Information
      about any side effects that may occur will also be collected.

      This study has 3 parts. Parts A and C will last about 44 days including follow-up. Part B
      will last about 60 days including follow-up. Screening may occur up to 28 days before the
      first dose of study drug. Participants are only allowed to enroll in one part.

      This study is for research purposes only and is not intended to treat any medical condition.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy surgically sterile or postmenopausal females and sterile males

          -  Have a body mass index (BMI) 18 to 32 kilograms per square meter (kg/m²)

        Exclusion Criteria:

          -  Have known allergies to abemaciclib, related compounds, or any components of the
             formulation

          -  Regularly use known drugs of abuse and/or show positive findings on urinary drug
             screening

          -  Show evidence of human immunodeficiency virus (HIV) infection and/or positive human
             HIV antibodies

          -  Show evidence of hepatitis C and/or positive hepatitis C antibody

          -  Show evidence of hepatitis B and/or positive hepatitis B surface antigen
Encouraging Cognitive Screenings at African American Churches
Condition: Dementia; Healthy
MeSH terms: Dementia
Intervention: Project Grace
Intervention description: A multilevel church-based intervention to encourage cognitive screens and brain health.
Phase: Phase 1
Study type: Interventional
Primary purpose: Screening
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 99.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This pilot study plans to examine feasibility and outcomes of a
      culturally/religiously-tailored church-based dementia screening intervention among older
      adult African American church members and community members who use church outreach services
      in 4 African American churches.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age ≥55

          2. Regular church member (attending church > monthly) or community member receiving
             church outreach services (>3 times annually)

          3. Willing to participate in two surveys (baseline and 4 months)

          4. Willing to provide contact information for at least 2 other persons

          5. Residing in the Kansas City metropolitan area

          6. Provide a working contact email address or number

        Exclusion Criteria:

          -  None
A Trial to Evaluate the Effect of the Proton Pump Inhibitor Esomeprazole on the Single-dose Pharmacokinetics (PK) of Oral TAK-906 in Healthy Adult Participants
Condition: Healthy Volunteers
Intervention: TAK-906; Esomeprazole
Intervention description: TAK-906 capsules.; Esomeprazole capsules.
Intervention MeSH terms: Esomeprazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug Therapy

Summary:

      The purpose of this study is to evaluate the effect of the proton pump inhibitor (PPI)
      esomeprazole on the single-dose PK of orally administered TAK-906.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Continuous non-smoker who has not used nicotine containing products for at least 3
             months prior to the first dosing and throughout the study, based on screening urine
             cotinine test.

          2. Has a body mass index (BMI) greater than or equal to (>=) 18 and less than or equal to
             (<=) 30 kilogram per square meter (kg/m^2) at Screening.

        Exclusion Criteria:

          1. History or presence of alcoholism or drug abuse within the past 2 years prior to the
             first dosing.

          2. QT interval corrected using Fridericia's formula (QTcF) interval is greater than (>)
             450 millisecond (msec) or ECG findings are deemed abnormal with clinical significance
             by the Investigator or designee at screening.

          3. Donation of blood or significant blood loss (example, approximately 500 milliliter
             [mL]) within 56 days prior to the first dosing.

          4. Plasma donation within 7 days prior to the first dosing.

          5. Participation in another clinical study within 30 days or 5 half-lives prior to the
             first dosing. The 30 day window or 5 half-lives will be derived from the date of the
             last blood collection or dosing, whichever is later, in the previous study to Day 1 of
             Study Period 1 of the current study.
Absorption, Metabolism and Excretion Study of [14C]PBT2 and Absolute Bioavailability of PBT2
Condition: Healthy Volunteers
Intervention: IV PBT2 microtracer and oral PBT2 single dose; oral 14C-PBT2
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: Male
Minimum age: 30 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the study is to investigate how the test drug, PBT2, is taken up, broken down
      and removed from the body when given as an oral capsule, a radiolabelled oral suspension and
      a radiolabelled intravenous injection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy males

          -  Body mass index of 18.0 to 35.0 kg/m2

        Exclusion Criteria:

          -  History of any drug or alcohol abuse in the past 2 years

          -  Regular alcohol consumption >21 units per week (1 unit = ½ pint beer, 25 mL of 40%
             spirit or a 125 mL glass of wine)

          -  Current smokers and those who have smoked within the last 12 months

          -  Radiation exposure, including that from the present study, excluding background
             radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv
             in the last 12 months or 10 mSv in the last 5 years.

          -  Clinically significant abnormal biochemistry, haematology or urinalysis as judged by
             the investigator

          -  Positive drugs of abuse test result

          -  Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or
             human immunodeficiency virus (HIV) results

          -  History of cardiovascular, renal, hepatic, chronic respiratory or GI disease as judged
             by the investigator
Monoclonal Antibody Therapy in Treating Patients Scheduled for Surgery to Remove Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: Monoclonal antibody hu3S193
Intervention description: Hu3S193 was to be administered intraperitoneally or intravenously at a dose of 5mg. Doses of hu3S193 were radiolabeled with 5 mCi of 111In.
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ovarian epithelial cancer

Summary:

      RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver
      tumor-killing substances to them without harming normal cells. Giving monoclonal antibodies
      in different ways may kill more tumor cells.

      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating
      patients who have ovarian cancer.
    

Eligibility criteria:

        Inclusion Criteria

        Cytologic or pathologic diagnosis consistent with ovarian carcinoma. Scheduled to undergo
        surgical evaluation. Karnofsky performance status of > 60%.

        Adequate organ function as defined by:

          -  Absolute neutrophil count (ANC) > 1.5 x 10^9/L

          -  Platelet count > 100 x 10^9/L

          -  Bilirubin < 2.0 mg/dL

          -  Aspartate aminotransferase (AST) and Alanine transaminase (ALT) < 2.5 X upper limit of
             normal

          -  Serum creatinine < 2.0 mg/dL

          -  Forced expiratory volume at one second (FEV1) and forced vital capacity (FVC)> 70% of
             predicted

          -  Left Ventricular Ejection Fraction >50%

        Recovered from the toxicity of any prior therapy. No evidence of active infection which
        requires antibiotic therapy. > 18 years of age. Able to sign written informed consent.

        Exclusion Criteria

        Any significant intercurrent medical problems which may limit the amount of antibody they
        can tolerate, or render them ineligible for surgery.

        Clinically significant cardiac disease (New York Heart Association Class III/IV, or
        abnormalities on ECG that are considered by the investigator to place the patient at
        increased risk), severe debilitating pulmonary disease, active infections or coagulation
        disorders.

        Survival expectancy less than 12 weeks. History of autoimmune hepatitis or history of
        autoimmune disease. Chemotherapy, radiotherapy, or immunotherapy within four weeks prior to
        receiving hu3S193.

        Psychiatric, addictive or other disorders that compromise the ability to give informed
        consent.
This is a Phase 1 Study to Evaluate the Safety,Tolerability and Virology of CT P59 in Patients With Mild Symptoms of Symptoms of Coronavirus Disease (COVID-19)
Condition: SARS-CoV-2 Infection
MeSH terms: Infections; COVID-19
Intervention: CT-P59
Intervention description: administered
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      This is a Phase I study that randomized, double-blind, Placebo-controlled, Parallel Group,
      Single Ascending Dose Study to evaluate Safety, Tolerability and Virology of CT-P59 in
      Patient with Mild Symptoms of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2)
      Infection.
    

Eligibility criteria:

        Inclusion Criteria:

        Each patient must meet all of the following criteria to be randomized in this study:

          1. Adult male or female patient, aged between 18 to 60 years (both inclusive).

          2. Patient with laboratory confirmed SARS-CoV-2 infection by Reverse Transcription
             Polymerase Chain Reaction (RT-PCR) at Screening.

          3. Patient has mild conditions meeting all of the following criteria:

               1. Oxygen saturation ≥ 94% on room air.

               2. Not requiring supplemental oxygen.

          4. Onset of symptom is no more than 7 days prior to the study drug administration.

        Exclusion Criteria:

        1. Patient with severe condition meeting one of the following:

          1. Respiratory distress with respiratory rate ≥ 30 breaths/min.

          2. Requires supplemental oxygen.

          3. Experience shock.

          4. Complicated with other organs failure, and intensive care unit monitoring treatment is
             needed by investigator's discretion.

          5. Any other conditions suspected of being severe symptoms of SARS-CoV-2 infection, in
             the opinion of the investigator, including but not limited to radiographic findings in
             lung.
A Study of Two Formulations of LY3074828 in Healthy Participants
Condition: Healthy
Intervention: LY3074828; LY3074828; Auto-injector (AI); Prefilled syringe (PFS)
Intervention description: Administered SC; Administered SC; AI to administer LY3074828; PFS to administer LY3074828
Intervention MeSH terms: Mirikizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to look at the amount of the study drug, LY3074828, that gets
      into the blood stream and how long it takes the body to get rid of LY3074828 when given as
      different formulations. The tolerability of LY3074828 will also be evaluated and information
      about any side effects experienced will be collected.

      Screening is required within 28 days prior to the start of the study. For each participant,
      the study will last about 12 weeks, not including screening.
    

Eligibility criteria:

        Inclusion Criteria: Healthy participants.

        Exclusion Criteria:

          -  Must not have an average weekly alcohol intake that exceeds 21 units/week (males) and
             14 units/week (females)

          -  Must not show evidence of active or latent tuberculosis (TB)

          -  Must not have received live vaccine(s) (including attenuated live vaccines and those
             administered intranasally) within 8 weeks of screening, or intend to during the study

          -  Must not have been treated with steroids within 1 month of screening, or intend to
             during the study

          -  Must not be immunocompromised

          -  Must not have received treatment with biologic agents (e.g. monoclonal antibodies,
             including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior
             to Day 1

          -  Must not have significant allergies to humanised monoclonal antibodies

          -  Must not have clinically significant multiple or severe drug allergies, or intolerance
             to topical corticosteroids, or severe post treatment hypersensitivity reactions

          -  Must not have had lymphoma, leukemia, or any malignancy within the past 5 years except
             for basal cell or squamous epithelial carcinomas of the skin that have been resected
             with no evidence of metastatic disease for 3 years

          -  Must not have had breast cancer within the past 10 years
Chronic Resveratrol Supplementation in Healthy Humans
Condition: Healthy
Intervention: Resveratrol; Placebo
Intervention description: Transmax (Biotivia). 500mg (1 capsule) per day for 28 days.; Methyl Cellulose. 1 capsule taken once daily for 28 days.
Intervention MeSH terms: Resveratrol
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cognitive performance; Cerebral blood flow; Subjective sleep; Subjective mood; Subjective health

Summary:

      The effects of chronic resveratrol supplementation have yet to be investigated in healthy
      humans. It is hypothesised that the effects will be different to those seen in acute
      supplementation. This study will look specifically at cognitive performance, cerebral blood
      flow, subjective sleep, mood and health, blood pressure and plasma levels of resveratrol. It
      is hypothesized that these measures will be affected differently by acute and chronic
      supplementation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy

          -  Between 18-35

          -  At least enrolled on undergraduate degree programme

          -  Native English speaker

        Exclusion Criteria:

          -  Smoking

          -  Taking other medication/ supplements

          -  Pregnant/ breast feeding

          -  High caffeine consumers

          -  Migraine sufferers
Radial Artery Dilation Study: The Effect of Topical Administration of Nitroglycerin and Lidocaine Versus Lidocaine Alone of the Radial Artery Diameter
Condition: Healthy
Intervention: Nitroglycerin 15mg; Nitroglycerin 30mg; Lidocaine 20mg; Lidocaine 40mg; Placebo
Intervention description: 15mg Nitroglycerin applied topically to one wrist; 30mg Nitroglycerin applied topically to one wrist; 20mg Lidocaine applied topically to one wrist in combination with nitroglycerin or placebo; 40mg Lidocaine applied topically to one wrist in combination with nitroglycerin or placebo; Topical skin moisturizing cream with same appearance as active agent
Intervention MeSH terms: Lidocaine; Nitroglycerin
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: To determine if topical nitroglycerin acts to vasodilate the radial artery by a direct local action, or by systemic vasodilation; To determine if topical nitroglycerin dilates the radial artery in the presence of local anesthetic agents used in cardiac catheterization

Summary:

      The radial artery, which is located on the outer side of the forearm, can be used in
      interventional procedures, such as cardiac catheterization, to provide access to the arterial
      blood supply. In order to facilitate successful catheterization of the artery, a dilated
      artery and one free of arterial spasm is desirable. The proposed study will randomize twenty
      three healthy subjects in 2 visits to determine the effect of topical nitroglycerin on radial
      artery vasodilation. Radial artery diameter will be measured with ultrasound at regular
      intervals up to two hours.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing and able to give written informed consent and comply with study requirements

          -  Patient who speak English

        Exclusion Criteria:

          -  Presence or history of liver, cardiovascular, rheumatologic, cancer or renal disease.

          -  Current treatment with any vasodilator therapy

          -  Systolic blood pressure of less than 90 mmHg

          -  History of radial artery catheterization within the previous year

          -  Absence of radial artery blood flow in one or both arms

          -  Pregnancy.

          -  Active infection

          -  Staff members of the Cardiac Catheterization Laboratory.
V710 Clinical Study in Healthy Male Japanese Subjects (V710-006) (COMPLETED)
Condition: Staphylococcal Infection
MeSH terms: Staphylococcal Infections
Intervention: V710; Placebo
Intervention description: V710 vaccination (60 mcg, 0.5 ml) single injection on Day 1; Saline placebo (0.5 ml) single injection on Day 1
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: Male
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is to evaluate the safety and immunogenicity of V710 in Japanese male subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Generally Good Physical Health

        Exclusion Criteria:

          -  Received V710 Vaccine, Any Other Investigational S. Aureus Vaccine, Or Investigational
             S. Aureus Antibodies Before

          -  Temperature Of Equal/Greater Than 100.4 Degrees F(38 Degrees C) Within The Past 48
             Hours