bioihbjkbjnl/mcl2 huggingface dataset:
Nicotinic Agonist Effects on BMI and Neuronal Response
Condition: Obesity
Intervention: DMXB-A; Placebo
Intervention description: 150 mg DMXB-A (3-(2,4-dimethoxybenzylidene anabaseine) b.i.d. for 12 weeks.; Placebo capsules b.i.d. for 12 weeks
Intervention MeSH terms: 3-(2,4-dimethoxybenzylidene)anabaseine
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 61.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Obesity is a serious and growing health problem in the United States. Obesity is associated
      with health problems such as type-2 diabetes and cardiovascular disease, leading to decreased
      quality of life and increased mortality. Given the health and quality-of-life effects of
      obesity, developing effective treatments clearly is an important goal.

      This study plans to learn more about the effects of an investigational new drug (DMXB-A
      (3-(2,4-dimethoxybenzylidene anabaseine)) and its effects on obesity. The study drug has
      similar effects to nicotine. Since nicotine has been found to affect appetite, the
      investigators are interested in studying effects of the study drug, which has some
      similarities to nicotine, on how your brain responds to such things as pictures of food. The
      study drug has not been approved by the Food and Drug Administration (FDA), and is considered
      experimental.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overweight/obese (BMI > 27)

          -  Between 21-65 years old

        Exclusion Criteria:

          -  Known cardiovascular disease (e.g., coronary artery disease, uncontrolled hypertension

          -  Women capable of conception (must be post-menopausal, surgically sterilized, or have
             adhered to an anti-contraception birth control regimen for at least 1 year)

          -  Nicotine use

          -  Significant endocrine/metabolic disease

          -  Kidney disease

          -  Neurological illness

          -  Liver disease

          -  Medication use affecting appetite and/or metabolism

          -  MRI-specific exclusion criteria (e.g., claustrophobia, metal in the body)
A Phase Ib, Open-label, Multicenter Study of the Safety and PK of the Combination of rhuMAb2c4 (Omnitarg), a Recombinant Humanized Antibody to HER2, and Capecitabine (Xeloda) in Patients With Advanced Solid Tumors
Condition: Solid Tumor
MeSH terms: Neoplasms
Intervention: Capecitabine; RhuMab 2C4
Intervention description: Participants will receive capecitabine on Days 1 to 14 of each 3-week cycle as 825, 1000, or 1250 mg/m^2 PO twice daily. Treatment may continue until disease progression, unacceptable toxicity, or consent withdrawal.; Participants will receive rhuMab 2C4 on Day 1 of each 3-week cycle as 1050 mg via IV infusion. Treatment may continue until disease progression, unacceptable toxicity, or consent withdrawal.
Intervention MeSH terms: Capecitabine; Pertuzumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety, tolerability, and pharmacokinetics of the combination of
      rhuMab 2C4(Perjeta) and capecitabine (Xeloda) in participants with advanced solid tumors that
      have progressed during or after standard therapy, or for which no standard therapy is
      available. Participants will be enrolled and evaluated for dose-limiting toxicities (DLTs) in
      escalating-dose cohorts in order to determine the maximum tolerated dose (MTD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults at least 18 years of age

          -  Easter Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  Life expectancy at least 12 weeks

          -  Locally advanced or metastatic solid tumor with at least 1 measurable lesion, which
             has progressed during/after standard therapy

          -  Human epidermal growth factor receptor 2 (HER2)-negative among participants with
             breast cancer

          -  Negative pregnancy test or use of an adequate contraceptive method among women of
             childbearing potential

          -  Adequate hematologic, hepatic, and renal function

        Exclusion Criteria:

          -  Clinical evidence of central nervous system (CNS) metastases

          -  Prior chemotherapy, radiotherapy, or immunotherapy within 4 weeks, or hormone therapy
             within 2 weeks of study Day 1

          -  History of palmar plantar syndrome Grade 2 or worse, or any unresolved residual
             chemotherapy effects

          -  Prior HER2-active agents, continuous intravenous (IV) 5-fluorouracil, capecitabine, or
             other fluoropyrimidine

          -  Any investigational agent within 28 days of study start

          -  Prior cumulative doxorubicin dose greater than (>) 360 mg/m^2 or equivalent

          -  Significant cardiovascular disease

          -  Active/uncontrolled concurrent illness or infection-

          -  Major surgery or trauma within 4 weeks of study Day 1
Mesalamine 4 gm/60 mL Rectal Enema
Condition: Healthy
Intervention: Rowasa® 4 gm/60 mL Rectal Enema; Mesalamine 4 gm/60 mL Rectal Enema
Intervention description: 1 x 4 gm/60 mL, single-dose; 1 x 4 gm/60 mL, single-dose
Intervention MeSH terms: Mesalamine
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence; Healthy Subjects

Summary:

      The objective of this study is to evaluate the relative bioavailability of the test
      formulation of mesalamine suspension rectal enema with the already marketed reference
      formulation Rowasa® in healthy, adult subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females, 18 years or older, with a body mass index (BMI) of 30 or less.

          -  Good health as determined by lack of clinically significant abnormalities in health
             assessments performed at screening.

          -  Signed informed consent form, which meets all criteria of current FDA regulations.

          -  If female and of child bearing potential prepared to abstain from sexual intercourse
             or use a reliable method of contraception during the study (e.g. condom, IUD, hormonal
             contraceptives).

        Exclusion Criteria:

          -  If female pregnant, lactating, or likely to become pregnant during the study.

          -  History of allergy or sensitivity to mesalamine or other salicylic drugs (e.g.
             aspirin, sulfasalazine) or history of any drug hypersensitivity or intolerance which,
             in the opinion of the Investigator, would compromise the safety of the subject or the
             study.

          -  Colitis, hemorrhoids, anal fissures, or other disease of the anus, rectum or colon.

          -  Significant history or current evidence of chronic infections disease, system disorder
             or organ disorder.

          -  History of psychiatric disorders occuring within the last two years that required
             hospitalization or medication.

          -  Presence of a medical condition requiring regular treatment with prescription drugs
             (other than contraceptives).

          -  Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing
             enzymes within 30 days prior to dosing.

          -  Receipt of any drug as part of a research study within 30 days prior to dosing.

          -  Drug or alcohol addiction requiring treatment in the past 12 months.

          -  Donation or significant loss of whole blood (480 mL or more) within 30 days or plasma
             within 14 days prior to dosing.

          -  Positive test for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.

          -  Positive test results for drugs of abuse at screening.

          -  Positive serum pregnancy test at screening.

          -  Unable or unwilling to tolerate multiple venipunctures.
Safety, Tolerability and Pharmacokinetics of Escalating Single Doses of TAK-828 in Healthy Participants
Condition: Dose Finding Study
Intervention: TAK-828; Placebo
Intervention description: TAK-828 oral solution; TAK-828 placebo-matching oral solution
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 36.0
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 safety and tolerability of single oral doses of
      TAK-828 in healthy non-Japanese and Japanese participants.
    

Eligibility criteria:

        Inclusion Criteria: -

          1. Is a healthy male and female (non-child bearing potential) participants.

          2. Cohorts 1 and 2: non-Japanese participants aged 18 to 55 years, inclusive, with body
             mass index (BMI) of 18 to 30 kilogram per square meter (kg/m^ 2), inclusive, and body
             weight greater than or equal (>=) 50 kilograms (kg).

          3. Cohort 3: Japanese participants (born to Japanese parents and grandparents) aged 20 to
             55 years, inclusive, with BMI of 18.5 to 25 kg/m^ 2, inclusive, and body weight >= 45
             kg.

        Exclusion Criteria: -

        1. Has used prescription or nonprescription drugs and dietary supplements within 7 days or
        5 half-lives (whichever is longer) prior to Check-in (Day -1). Herbal supplements and
        hormone replacement therapy (HRT) must be discontinued 28 days prior to Check-in (Day -1).
        As an exception, acetaminophen may be used at doses of less than equal to (<=) 1 gram per
        day (g/day). Limited use of nonprescription medications that are not believed to affect
        participant safety or the overall results of the study may be permitted on a case-by-case
        basis following approval by the sponsor.
A Study of Mirikizumab (LY3074828) in Healthy Participants
Condition: Healthy
Intervention: Mirikizumab - IV; Mirikizumab - SC; Placebo - IV; Placebo - SC
Intervention description: Administered IV; Administered SC; Administered IV; Administered SC
Intervention MeSH terms: Mirikizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 51.0
Sex: All
Minimum age: 20 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purpose of this study is to explore the safety and tolerability of mirikizumab in
      healthy Japanese and Caucasian participants. The study will also estimate how much
      mirikizumab gets into the blood stream and how long it takes the body to remove it. The study
      is expected to last about 16 weeks for each participant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy males or females, as determined by medical history and physical
             examination.

          -  Are first generation Japanese or are Caucasian.

          -  Have a body mass index (BMI) of 18.0 kilograms per square meter (kg/m2) to 32.0 kg/m2,
             inclusive, at screening.

          -  Have a body weight of 40.0 kg or higher for Cohorts 1, 2, 3 and 4, and 48.0 kg or
             higher for Cohort 5 and 6.

        Exclusion Criteria:

          -  Have had symptomatic herpes zoster within 3 months of screening.

          -  Show evidence of active or latent tuberculosis (TB), as documented by medical history
             and examination, chest x-rays (posterior anterior and lateral), and TB testing.

          -  Have received live vaccine(s) within 1 month of screening or intend to during the
             study.

          -  Are immunocompromised.

          -  Have received treatment with biologic agents (such as monoclonal antibodies, including
             marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing.
A Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of PF-04958242 in Healthy Subjects
Condition: Healthy
Intervention: PF-04958242; Itraconazole
Intervention description: Administered as specified in the treatment arm; Administered as specified in the treatment arm
Intervention MeSH terms: Itraconazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Itraconazole; Healthy Volunteers; Drug-drug interaction; PF-04958242

Summary:

      The purpose of the current study is to characterize the pharmacokinetic (PK) profile of PF
      04958242 when co administered with a strong cytochrome P450 3A4 (CYP3A4) inhibitor.
    

Eligibility criteria:

        Key Inclusion Criteria:

        -Healthy male subjects and female subjects of non childbearing with a Body Mass Index (BMI)
        of 17.5 to 30.5 kg/m2; and a total body weight >55 kg (121 lbs).

        Key Exclusion Criteria:

          -  Subjects with ANY of the following abnormalities in clinical laboratory tests at
             screening, as assessed by the study specific laboratory and confirmed by a single
             repeat, if deemed necessary:

               -  Aspartate transaminase (AST)/serum glutamic oxaloacetic transminase (SGOT) or
                  alanine transaminase (ALT)/serum glutamic pyruvic transminase (SGPT) >=1 x upper
                  limit of normal (ULN);

               -  Total bilirubin >=1.5 x ULN; subjects with a history of Gilbert's syndrome may
                  have a direct bilirubin measured and would be eligible for this study provided
                  the direct bilirubin is <= ULN.

          -  Subjects with epilepsy, or history of epilepsy, or conditions that lower seizure
             threshold, seizures of any etiology (including substance or drug withdrawal), or who
             have increased risk of seizures as evidenced by self reported history of
             electroencephalogram (EEG) with epileptiform activity. Subjects with a history of
             childhood seizures and history of head trauma with loss of consciousness requiring
             hospitalization overnight will be excluded as well.

          -  Subjects who had a history of allergy or intolerance to azole antifungal drugs.

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
A Dose Finding Study To Evaluate Safety, Drug Interaction, Tumor Markers Of Axitinib In Combination With MK-3475 In Adult Patients With Previously Untreated Advanced Renal Cell Cancer
Condition: Renal Cell Carcinoma
MeSH terms: Carcinoma, Renal Cell
Intervention: Axitinib; MK-3475
Intervention description: Axitinib at starting dose of 5 mg and 3 mg BID.; MK-3475 with two dose levels: 2 mg/kg every three weeks to find the maximum tolerated dose and continue treatment in a dose expansion phase.
Intervention MeSH terms: Pembrolizumab; Axitinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Axitinib and MK-3475; patients with advanced Renal Cell Cancer.

Summary:

      Despite substantial improvements of patients outcome in advanced RCC, durable and complete
      response is uncommon. The majority of patients eventually develop resistance and exhibit
      disease progression. Combining a PD-1 inhibitor, which has shown single-agent efficacy with
      axitinib may provide additional clinical benefit compared to axitinib alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed advanced RCC with predominantly clear-cell
             subtype with primary tumor resected

          -  At least one measureable lesion as defined by Response Evaluation Criteria In Solid
             Tumors (RECIST) version 1.1.

          -  Eastern Cooperative Oncology Group performance status 0 or 1

          -  Controlled hypertension

        Exclusion Criteria:

          -  Prior treatment with systemic therapy for advanced RCC

          -  Prior adjuvant or neoadjuvant therapy if disease progression or relapse has occurred
             during or within 12 months after the last dose of treatment

          -  Prior treatment with any agent specifically targeting T-cell co-stimulation or
             checkpoint pathways

          -  Active seizure disorder or evidence of brain metastases, spinal cord compression, or
             carcinomatous meningitis

          -  Diagnosis of any non-RCC malignancy occurring within 2 years prior to the date of
             randomization except for adequately treated basal cell or squamous cell skin cancer,
             or carcinoma in situ of the breast or of the cervix or low grade prostate cancer with
             no plans for treatment intervention

          -  In past 12 months: myocardial infarction, uncontrolled angina, coronary/peripheral
             artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident,
             or transient ischemic attack

          -  In past 6 months: deep vein thrombosis or pulmonary embolism
PK Study With Pantoprazole in Obese Children and Adolescents
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux
Intervention: Pantoprazole
Intervention MeSH terms: Pantoprazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: obese; children; adolescents; GERD; pharmacokinetic

Summary:

      Multicenter, comparative single-dose pharmacokinetic (PK) study
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participant is between 6 and 17 (inclusive) years of age at the time of consent

          2. BMI ≥95th percentile

          3. Diagnosis of GERD established prior to 7 days before receipt of study drug dose
             defined as 1 or more of the following:

               1. clinical symptoms consistent with GERD as determined by the investigator

               2. a diagnosis of erosive esophagitis by endoscopy

               3. esophageal biopsy with histopathology consistent with reflux esophagitis

               4. abnormal pH-metry consistent with reflux esophagitis

               5. other test result consistent with GERD

          4. Written informed consent from the parent or legally authorized representative/guardian
             and participant assent per local IRB recommendation of age-appropriate consent and
             assent requirements

        Exclusion Criteria:

          1. Use of pantoprazole, lansoprazole, omeprazole, esomeprazole or rabeprazole within 48
             hours prior to dose of study drug

          2. Use of fluoxetine, fluvoxamine, ketoconazole, ticlopidine, felbamate, topiramate,
             valproic acid, phenobarbital, carbamazepine, erythromycin, clarithromycin, grapefruit
             juice, verapamil, diltiazem, cimetidine, St. John's Wort, rifampin, rifapentine within
             seven days prior to dose of study drug

          3. Consumption of food after midnight on the day of the baseline visit

          4. Symptomatic asthma

          5. Type I diabetes

          6. History of adverse reaction to PPI

          7. Impaired hepatic activity as defined as any of the following: AST ≥150 IU/L, ALT ≥150
             IU/L, total bilirubin ≥2.0 mg/dl, or alkaline phosphatase ≥600 IU/L

          8. Serum creatinine ≥2.0 mg/dL

          9. For females of childbearing potential, a positive pregnancy test result

         10. Known infection with hepatitis B, C, or HIV

         11. Any other condition that, in the opinion of the principal investigator, makes
             participation unadvised or unsafe.
A Study to Evaluate the Effect of Single-Dose Intravenous Rifampin as a Prototypic Inhibitor of Organic Anion Transporting Polypeptide (OATP) 1B1 and OATP1B3 on the Single-Dose Pharmacokinetics (PK) of Oral TAK-906 in Healthy Adult Participants
Condition: Healthy Volunteers
Intervention: TAK-906; Rifampin
Intervention description: TAK-906 capsule.; Rifampin infusion.
Intervention MeSH terms: Rifampin
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 19 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 single dose intravenous rifampin 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. Body Mass Index (BMI) greater than or equal to (>=) 18.0 and less than or equal to
             (<=) 30.0 kilogram per square meter (kg/ m^2) at screening.

          3. Medically healthy with no clinically significant medical history, physical
             examination, laboratory profiles, vital signs, or ECGs, as deemed by the investigator
             or designee.

        Exclusion Criteria:

          1. Positive urine drug or alcohol results at screening and each check in.

          2. Positive urine cotinine at screening.

          3. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B
             surface antigen (HBsAg), or hepatitis C virus (HCV).

          4. QT interval with Fridericia's correction (QTcF) interval is >450 millisecond (msec) or
             ECG findings are deemed abnormal with clinical significance by the investigator or
             designee at screening.

          5. Estimated creatinine clearance <90 milliliter per minute (mL/min) at screening.

          6. Has been on a diet incompatible with the on-study diet, in the opinion of the
             investigator or designee, within the 30 days prior to the first dosing and throughout
             the study.

          7. Donation of blood or significant blood loss (example, approximately 500 milliliter
             [mL]) within 56 days prior to the first dosing.

          8. Plasma donation within 7 days prior to the first dosing.