bioihbjkbjnl/mcl2 huggingface dataset:
A Target Occupancy Study With Ritlecitinib.
Condition: Healthy
Intervention: Ritlecitinib 50 mg; Ritlecitinib 200 mg
Intervention description: 50 mg single dose; 200 mg single dose
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a phase 1, open label, two-arm study to assess target occupancy and functional
      inhibition of JAK3 and TEC kinases by Ritlecitinib in healthy adult participants
    

Eligibility criteria:

        Inclusion Criteria:

        Participants are eligible to be included in the study only if all the following criteria
        apply:

          -  Participants who are willing and able to comply with all scheduled visits, treatment
             plan, laboratory tests, lifestyle considerations, and other study procedures.

          -  Male and female participants who are overtly healthy as determined by medical
             evaluation including medical history, physical examination including BP and pulse rate
             measurement, 12-lead ECG, or clinical and laboratory tests.

          -  BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

        Exclusion Criteria:

        Participants are excluded from the study if any of the following criteria apply:

          -  Evidence or history of clinically significant hematological, renal, endocrine,
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or
             allergic disease (including drug allergies, but excluding untreated, asymptomatic,
             seasonal allergies at the time of dosing).

          -  Infection with HIV, hepatitis B or hepatitis C viruses

          -  Have evidence of untreated or inadequately treated active or latent Mycobacterium TB
             infection

          -  Known active or history of recurrent bacterial, viral, fungal, mycobacterial or other
             infections.

          -  Have received only one of the 2 required doses of COVID-19 vaccine.

          -  Participants have a known present or a history of malignancy other than a successfully
             treated or excised non metastatic basal cell or squamous cell cancer of the skin or
             cervical carcinoma in situ.
A Study of LY3164530 in Participants With Cancer
Condition: Neoplasms; Neoplasm Metastasis
MeSH terms: Neoplasms; Neoplasm Metastasis
Intervention: LY3164530
Intervention description: Administered IV.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to evaluate the safety of a study drug known as LY3164530
      in participants with cancer that is advanced and/or has spread to another part(s) of the
      body.
    

Eligibility criteria:

        Inclusion Criteria

          -  Have advanced or metastatic cancer and be an appropriate candidate for experimental
             therapy.

          -  Have adequate organ function.

          -  Prior Treatments:

               -  Systemic treatments: Must have discontinued previous systemic treatments for
                  cancer and recovered from the acute effects of therapy. Participants must have
                  discontinued:

                    -  Cytotoxic therapies or targeted agents that are small molecule inhibitors
                       for 5 half-lives or at least 28 days.

                    -  Mitomycin-C or nitrosourea therapy for at least 42 days and biologic agents
                       for at least 28 days.

               -  Radiation therapy and surgery must be completed 4 weeks prior to therapy, except
                  for limited field radiation therapy, which must be completed 2 weeks before
                  therapy.

          -  If participant is of reproductive potential, must agree to use medically approved
             contraceptive precautions during the study and for three months following the last
             dose of study drug.

          -  If the participant is a female of childbearing potential, must have had a negative
             serum or urine pregnancy test within 14 days of the first dose of study drug and must
             not be breast feeding.

        Exclusion Criteria:

          -  Must not have taken an unapproved drug as treatment for any indication within the last
             28 days prior to starting study treatment.

          -  Must not have an active symptomatic fungal, bacterial or viral infection, including
             human immunodeficiency virus (HIV) or Hepatitis A, B, or C.

          -  Must not have a serious preexisting medical conditions or concomitant disorders.

          -  Must not have leukemia.

          -  Must not have QT interval of >470 millisecond.

          -  Must not have a serious cardiac condition, such as congestive heart failure, unstable
             angina pectoris, or heart attack within the last 3 months.
Comparison Bioavailability Study of Quinine Sulfate in Chocolate Pudding
Condition: Healthy
Intervention: quinine sulfate; quinine sulfate
Intervention description: 2 x 324 mg capsules (648 mg); 2 x 324 mg capsules (648 mg)
Intervention MeSH terms: Quinine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy; Bioequivalence; Pharmacokinetics

Summary:

      This is an open label randomized single dose two-way crossover study to compare the
      bioavailability of a single oral dose of quinine sulfate 648 mg(2 x 324 mg) when mixed with
      120 ml of chocolate pudding relative to the same dose given as two intact capsules.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy nonsmoking adults with hemoglobin at least 12 g/dl. Males at least 52 kg,
             females at least 45kg with body mass index in the normal range, females must be
             chemically or surgically sterile or postmenopausal (amenorrhea at least 2years)

        Exclusion Criteria:

          -  Pregnant or lactating

          -  Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface
             antigen (HbsAg), or hepatitis C virus (HCV) Recent (1-year) history or evidence of
             alcoholism or drug abuse History or presence of significant cardiovascular, pulmonary,
             hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic,
             neurological, or psychiatric disease, myasthenia gravis, optic neuritis or
             Glucose-6-phosphate dehydrogenase (G6PD) deficiency

          -  Prolonged corrected QT interval(QTc) on Electrocardiogram(EKG) at screening -males
             >430 msec, females >450 msec.

        PR interval on EKG >200 msec at screening or prior to dose in either dosing period

          -  Subjects who have used any drugs or substances known to inhibit or induce cytochrome
             (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 30 days prior to the first dose
             and throughout the study
The Effect of Palatal Brushing on Denture Stomatitis
Condition: Denture Stomatitis
MeSH terms: Stomatitis; Stomatitis, Denture
Intervention: Palatal brushing
Intervention description: Participants will be instructed to brush their palate with a manual soft-bristle brush after each meal and before sleeping for a period of 3 months. They will be asked to keep to their usual oral and denture hygiene routine during the trial to allow the isolation of the effect of palatal brushing.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Denture stomatitis; Denture Plaque; Oral Candidiasis; Oral Hygiene

Summary:

      Palatal brushing has several advantages including removal of debris and stimulation of blood
      flow and saliva, which may help to prevent or treat oral diseases, such as denture-related
      stomatitis in complete denture wearers.

      However, there is no previous clinical trial testing this effect. Therefore, the
      investigators goal is to evaluate whether palatal brushing may change the severity of denture
      stomatitis and counts of microbes on denture and palatal mucosa.

      After an initial exam and data collection, participants will receive instructions about
      palatal brushing and they will be assessed after 1 and 3 months. Collection of data will
      include patient-reported information, intraoral photographs and swabbing (for counting
      microbes).

      Tested Hypotheses:

        -  There is no difference in the extent of palatal inflammation in edentulous patients with
           denture stomatitis before and after 3 months of palatal brushing.

        -  There is no difference in the number of colony forming unit (CFU) of Candida isolated
           from palate and denture of patients affected by denture stomatitis before and after 3
           months of palatal brushing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Good general health.

          -  Completely edentulous maxilla.

          -  Currently wearing complete upper dentures.

          -  A clinical diagnosis of denture stomatitis.

        Exclusion Criteria:

          -  Conditions known to promote Candida carriage such as diabetes, anemia, xerostomia,
             immunosuppression, chemotherapy and radiotherapy.

          -  Use of antibiotics, antifungal agents or corticosteroids at least 4 weeks before the
             study.

          -  Previous palatal brushing habit.

          -  Changing of the existing prosthesis during the trial.
A Study Of CP-690,550 In Stable Kidney Transplant Patients
Condition: Kidney Transplant
Intervention: Placebo; CP-690,550 5 mg BID; CP-690,550 15 mg BID; CP-690,550 30 mg BID
Intervention description: Placebo tables twice daily (BID) for 28 days; CP-690,550 5 mg BID for 28 days; CP-690,550 15 mg BID for 28 days; CP-690,550 30 mg BID for 28 days
Intervention MeSH terms: Tofacitinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: CP-690,550; kidney transplant

Summary:

      This was a Phase 1 dose escalation study to evaluate the safety, tolerability and
      pharmacokinetics of 28-day treatment of CP-690,550 in stable renal allograft recipients. In
      Stage 1, ascending doses of CP-690,550 were to be administered sequentially to 3-4 cohorts of
      subjects. After Stage 1, one dose level was to be selected for dosing in an expanded cohort
      in Stage 2.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Medically stable kidney transplant patients 6 or more months after transplantation.

          -  Subjects must be on mycophenolate mofetil 1-2 gm daily

          -  In Cohort 3 (and 4, if conducted) in Stage 1 and the expanded cohort in Stage 2,
             subjects must be on a calcineurin inhibitor-free regimen.

        Exclusion Criteria:

          -  Any rejection episodes in the preceding 3 months.

          -  Treated with Thymoglobulin or OKT3 for acute rejection in the past 6 months.
MK0524B Bioequivalence Study (0524B-070)
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Intervention: MK0524B (ER niacin (+) laropiprant (+) simvastatin); MK0524A (ER niacin + laropiprant); Simvastatin
Intervention description: Single dose of MK0524B (ER niacin 900 mg/ laropiprant 20 mg/ simvastatin 20 mg) in one of two treatment periods.; Single dose of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) in one of two treatment periods.; Single dose simvastatin (Zocor™) 20 mg in one of two treatment periods.
Intervention MeSH terms: Niacin; Niacinamide; Nicotinic Acids; Simvastatin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 220.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate:

        1. the bioequivalence of simvastatin and simvastatin acid following dose of simvastatin
           (ZOCOR™) given together with one tablet of MK0524A or as a component of the triple
           combination tablet MK0524B.

        2. the bioequivalence of laropiprant and ER niacin when administered as the triple
           combination tablet MK0524B or as the double combination tablet MK0524A given together
           with simvastatin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is in good health

          -  Subject is a nonsmoker

          -  Subject is willing to follow the study guidelines

        Exclusion Criteria:

          -  Subject has or has a history of any illness that might confound the results of the
             study or make participation in the study unsafe for the subject
Drug-Drug Interaction Study Between Fenofibric Acid and Efavirenz
Condition: Healthy
Intervention: Efavirenz 600 mg; Efavirenz 600 mg; Fenofibric Acid
Intervention description: Efavirenz 600 mg administered as a single oral dose on the morning of Day 1.; Co-administered single oral doses of Efavirenz 600 mg and Fenofibric Acid 105 mg on Day 31.; Co-administered single oral doses of Efavirenz 600 mg and Fenofibric Acid 105 mg on Day 31.
Intervention MeSH terms: Efavirenz; Fenofibric acid
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: healthy; adult; efavirenz; fenofibric acid; blood levels

Summary:

      Efavirenz is predominantly metabolized by cytochrome P450 (CYP) 2B6. Fenofibric Acid is an
      inhibitor of CYP 2B6. This study will evaluate the effect of multiple doses of fenofibric
      acid at steady-state on the pharmacokinetics of single-dose efavirenz in healthy adult
      subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adults 18-45 years of age

          -  Non-smoking

          -  Non-pregnant (post-menopausal, surgically sterile or using effective contraceptive
             measures)

          -  Body mass index (BMI) less than 30

          -  Medically healthy on the basis of medical history and physical examination

          -  Hemoglobin > or = to 12g/dL

          -  Completion of the screening process within 28 days prior to dosing

          -  Provision of voluntary written informed consent

        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 fenofibric acid or efavirenz
CP-751,871 In Combination With Docetaxel In Advance Non-hematologic Malignancies
Condition: Advanced Non-Hematologic Malignancies
MeSH terms: Neoplasms
Intervention: CP-751,871; Docetaxel
Intervention description: CP-751,871 was given intravenously [IV] every 3 weeks in escalating doses ranging from 0.1 mg/kg up to 20 mg/kg.
Standard doses of Docetaxel were given every 3 weeks with CP-751,871. Study therapy was continued until disease progression, lack of tolerability for up to 17 cycles (approximately 1 year).; Docetaxel up to 75 mg/m^2 was administered intravenously [IV] on Day 1 of each 3-week dosing cycle.
Intervention MeSH terms: Docetaxel
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: non-hematologic cancer; advanced solid tumors; prostrate cancer

Summary:

      This clinical trial is designed to determine the safety, tolerability, pharmacokinetics and
      pharmacodynamic effects of escalating doses of CP 751,871 given in combination with docetaxel
      in patients with non-hematologic malignancies for whom docetaxel is a reasonable treatment
      option.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age greater than 18 years

          -  Documented advanced-stage non-hematologic malignancy for whom docetaxel monotherapy is
             a reasonable treatment option

          -  Eastern Cooperative Oncology Group [ECOG] performance status 0-1

        Exclusion Criteria:

          -  Significant active cardiac disease

          -  Chemotherapy, biological or investigational agents within 4 weeks prior to dosing

          -  Inadequate bone marrow, renal, cardiac or liver function
Phase I Study to Investigate the Effect on the Blood Pressure After Oral Administration of SK3530 and Amlodipine
Condition: Hypertension
MeSH terms: Hypertension
Intervention: SK3530 100mg, Placebo, Amlodipine
Intervention MeSH terms: Amlodipine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 13.0
Sex: Male
Minimum age: 19 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      To assess the pharmacodynamic effects of co-administrated SK3530 (PDE5 inhibitor) and
      Amlodipine, phase I study in Hypertensive patient was designed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male subjects 19-65 years of age inclusive

          -  Subjects with hypertension as defined 100 mmHg ≤ SBP<140 mmHg and 65 mmHg ≤ DBP < 90
             mmHg after more than 5 minutes in the supine position

          -  Written informed consent

          -  Willing and able to comply with the requirements of the protocol

        Exclusion Criteria:

          -  Subjects with acute or chronic disease within 4 weeks of study initiation.

          -  Subejcts with any gastrointestinal disorders known to alter drug absorption(except
             appendectomy, herniotomy, etc.)

          -  Subjects with any clinically significant allergic disease or with a known allergy to
             the PDE5 inhibitors

          -  Subjects with clinically significant abnormalities on laboratory tests

          -  Subjects with orthostatic hypotension defined as a fall in systolic blood pressure of
             at least 20 mmHg or diastolic blood pressure of at least 10 mmHg when a person assumes
             a standing position

          -  Subjects with abnormal QTc interval(≥440ms)

          -  Subjects with color-blindness or weakness

          -  Subejcts with alcohol, drug or caffeine abuse

          -  Diet known to alter drug absorption, distribution, metabolism or elimination processes

          -  Subjects who participated in other clinical studies within 2 months before an
             administration

          -  Other subjects who are ineligible for the study at the discretion of the principle
             investigator or sub-investigators
A Study of LY900014 Formulation at Different Injection Sites in Healthy Participants
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: LY900014 (SC); LY900014 (IV)
Intervention description: Administered SC; Administered IV
Intervention MeSH terms: Insulin Lispro
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study evaluates a new formulation of insulin lispro, LY900014, a drug that lowers blood
      sugar. It is administered by injection into the vein and under the skin of the abdomen, thigh
      and arm.

      The study will be conducted in healthy people to investigate the effect of different
      injection sites on the amount of insulin lispro in the bloodstream.

      Side effects and tolerability will be documented. The study will last for about 10 weeks for
      each participant, including screening and follow up. Screening is required within 28 days
      prior to entering the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy male or a female (not pregnant and agreeable to take birth control
             measures until study completion)

          -  Have a body mass index (BMI) of 18 to 30 kilogram per square meter (kg/m²)

          -  Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine
             laboratory test results that are acceptable for the study

          -  Are nonsmokers, have not smoked for at least 6 months prior to entering the study

        Exclusion Criteria:

          -  Are currently participating in or completed a clinical trial within the last 30 days
             or any other type of medical research judged to be incompatible with this study

          -  Have previously participated or withdrawn from this study

          -  Had blood loss of more than 450 milliliters (mL) within the last 3 months