bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetics of Different Formulations of Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ) in Japanese Healthy Male Volunteers
Condition: Healthy
Intervention: Telmisartan/Amlodipine; Telmisartan/Amlodipine/HCTZ; Telmisartan/HCTZ
Intervention description: Telmisartan/Amlodipine fixed-dose combination; Telmisartan/Amlodipine/HCTZ fixed-dose combination; Telmisartan/HCTZ fixed-dose combination
Intervention MeSH terms: Amlodipine; Telmisartan; Hydrochlorothiazide; Telmisartan amlodipine combination
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: Male
Minimum age: 20 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To assess drug drug interaction through pharmacokinetics investigation at steady state of
      Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ) given as three different formulations
      in healthy Japanese male subjects
    

Eligibility criteria:

        Inclusion criteria:

          -  Healthy Japanese male subjects age >=20 and <=35 years; body weight: >=50 kg and <=80
             kg; body mass index: >=18.0 and <=25.0 kg/m2

          -  Without any clinically significant findings and complications on the basis of a
             complete medical history, including the physical examination, vital signs (blood
             pressure (BP), pulse rate (PR), body temperature), 12-lead electrocardiograms (ECGs),
             clinical laboratory tests

          -  Signed and dated written informed consent prior to admission to the trial in
             accordance with the Good Clinical Practice (GCP) and the local legislation.

        Exclusion criteria:

        - Any finding of the medical examination (including BP, PR and ECGs) deviating from normal
        and of clinical relevance.
Vaccination With Autologous Breast Cancer Cells Engineered to Secrete Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Metastatic Breast Cancer Patients
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Autologous, Lethally Irradiated Breast Cancer Cells
Intervention description: Vaccine will be administered on days 1, 8, 15, 29 and then every 2 weeks until the supply of vaccine runs out
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: autologous vaccination; GM-CSF; adenoviral mediated gene transfer; Stage IV breast cancer

Summary:

      The purpose of this trial is to test the safety of a vaccine made from a patient's own breast
      cancer cells, and determine if this vaccine will delay or stop the growth of the cancer. The
      vaccine is made by genetically modifying a patient's own tumor cells to secrete
      granulocyte-macrophage colony-stimulating factor (GM-CSF) to activate the immune response.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed Stage IV breast cancer

          -  Prior banked malignant effusion or significant malignant effusion for tumor harvest or
             surgically-accessible tumor nodule of at least 2cm in greatest diameter by physical
             exam, magnetic resonance imaging (MRI) or computed tomography (CT) scan

          -  Must have received at least one prior regimen of chemotherapy for metastatic disease

          -  Patients with HER2 positive tumors must have received at least one prior
             trastuzumab-based therapy in the metastatic setting, and may not receive trastuzumab
             therapy and vaccine treatment concurrently

          -  Patients may receive concurrent bisphosphonate therapy and/or erythropoetin therapy at
             any point while on study

          -  ECOG performance status 0 or 1

          -  Estimated life expectancy of greater than or equal to 6 months

          -  18 years of age or older

          -  Greater than 4 weeks from immunotherapy, or systemic glucocorticoid therapy

          -  Adequate recovery from drug-related toxicities from prior systemic therapies

          -  Adequate recovery from recent surgery and radiation therapy

          -  Greater than 6 months since bone marrow or peripheral blood stem cell transplant

        Exclusion Criteria:

          -  Urgent need for cytotoxic chemotherapy, radiotherapy, or surgery in the next 60 days

          -  Uncontrolled active infection or illness

          -  Psychiatric illness/social situation that would limit study compliance

          -  Pregnant or nursing mothers

          -  Evidence of HIV infection

          -  Previous participation in an adenovirus-based trial

          -  Concurrent invasive malignancy
The Interaction of Flavor With Nicotine Form in Adult Smokers
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Intervention: Nicotine form; E-cigarette experimental flavor
Intervention description: participants will receive 36mg/ml nicotine salt and freebase nicotine; Participants will receive menthol and tobacco flavored e-cigarettes
Intervention MeSH terms: Nicotine
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 20.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study seeks to elucidate the impact of e-cigarette flavor on subjective effects and
      nicotine exposure from e-cigarettes containing different forms of nicotine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 21 years old, able to read and write, use of combustible

        Exclusion Criteria:

        -
Oral Ketamine for Control of Chronic Pain in Children
Condition: Chronic Pain
MeSH terms: Chronic Pain
Intervention: Ketamine
Intervention description: Drug will be given orally three times a day at doses escalating from 0.25mg/kg/dose to 1.5mg/kg/dose in cohorts of 3. Each subject will be administered study drug for 2 weeks.
Intervention MeSH terms: Ketamine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 8 Years
Maximum age: 22 Years
Healthy volunteers: No
Keywords: Ketamine; Chronic pain; Children; Oral pain medication

Summary:

      The study is a maximum tolerated dose finding study for oral, chronic, daily administration
      of oral ketamine (by mouth) in children with long-term daily pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject, parent, or guardian willing and able to give informed consent

          -  NRS for pain >4

          -  Chronic pain, which has been present for >3 months, or persisting longer than is
             normal for the underlying diagnosis

          -  Chronic pain related to diagnoses including but not limited to: cancer, rheumatologic
             disease, sickle cell anemia, cystic fibrosis, pancreatitis, and neuromuscular disease
             (e.g. Duchenne muscular dystrophy)

          -  Able to tolerate and cooperate with neurocognitive assessment

          -  Age 8-22 years old

        Exclusion Criteria:

          -  If they are known or suspected to have drug dependence or addiction

          -  History of psychiatric disorder such as depression, schizophrenia, or bipolar disorder

          -  History of hypertension

          -  Unable to cooperate with neurocognitive assessment

          -  Chronic pain related to chronic abdominal pain syndrome

          -  Known liver disease or elevation of AST or ALT greater than 3 times the upper limit of
             normal.

          -  Previous intolerance or allergic reaction to ketamine

          -  Pregnancy

          -  Use of CYP3A4 inhibitors or inducers within the 2 week period prior the study drug
             administration or within 5 half-lives of the respective medication, whichever is
             longer, until study conclusion.

          -  Consumption of grapefruit or grapefruit products from at least 2 weeks prior to study
             drug administration until study conclusion.
Pharmacokinetic Study of AG200-15 Transdermal Patch to Three Anatomical Sites in Healthy Females
Condition: Healthy
Intervention: AG200-15
Intervention description: A transdermal contraceptive delivery system for levonorgestrel (LNG) and ethinyl estradiol (EE). . A total of 3 patches will be worn during the study. Each patch will be worn for 1 week followed by a patch free week.
Intervention MeSH terms: Contraceptive Agents
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: PK and safety; Pharmacokinetic profile (PK) and safety

Summary:

      This is a pharmacokinetics and safety study over 3 weekly applications.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy women, ages 18-45 years

          -  Body mass index 18 - 32, and weight ≥ 110 lbs.

          -  Willing to use a non-hormonal method of contraception if of childbearing potential, Or
             have already undergone previous bilateral tubal ligation or hysterectomy

          -  Willing to refrain from use of alcohol and grapefruit juice from 48 hours prior to
             patch application until completion of each treatment period

          -  Willing to give informed consent to participate in study

          -  Hemoglobin within normal range.

        Exclusion Criteria:

          -  Known or suspected pregnancy

          -  A cervical cytology smear of Papanicolaou (Pap) class III or greater or a Bethesda
             System report of low grade squamous intraepithelial lesions (SIL) or greater

          -  Smoking

          -  Hypertension (blood pressure >140 mm Hg systolic and/or >90 mm Hg diastolic)

          -  Diabetes Mellitus

          -  History of headaches with focal neurological symptoms

          -  Current or history of clinically significant depression in the last year

          -  Acute or chronic hepatocellular disease with abnormal liver function

          -  History of or existing venous and arterial thrombotic and thromboembolic disorder,
             vascular disease, cerebral vascular, or coronary artery disease

          -  Chronic use of any medication that might interfere with the efficacy of hormone
             contraceptives (including barbiturates, bosentan, carbamazepine, felbamate,
             griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John's Wort, topiramate, and HIV
             protease inhibitors), OR use of these medications within the past 3 months prior to
             screening visit
Investigation of the Effect of Food on the Bioavailability of a 25 mg Empagliflozin Tablet as Well as Assessment of Dose Proportionality Between 10 mg and 25 mg Empagliflozin Tablets Under Fasting Conditions.
Condition: Healthy
Intervention: Empagliflozin; Empagliflozin; Empagliflozin
Intervention description: high dose of empagliflozin after overnight fasting for at least 10 h; low dose empagliflozin after overnight fasting for at least 10 h; high dose of empagliflozin after a standardised high fat breakfast
Intervention MeSH terms: Empagliflozin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Investigation of food effect on the bioavailability of a 25 mg empagliflozin tablet and
      assessment of dose proportionality between 10 mg and 25 mg empagliflozin tablets under
      fasting conditions.
    

Eligibility criteria:

        Inclusion criteria:

        1. Healthy male and female subjects

        Exclusion criteria:

        1. Any relevant deviation from healthy conditions
Effect of Vitamin D Replacement on Insulin Sensitivity
Condition: Insulin Sensitivity
MeSH terms: Insulin Resistance; Vitamin D Deficiency; Hypersensitivity
Intervention: Ergocalciferols; Placebo
Intervention description: ERgocaclciferol 50,000 units weekly for 8 weeks; matching placebo
Intervention MeSH terms: Ergocalciferols; Vitamin D
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: vitamin D deficiency, insulin sensitivity

Summary:

      Healthy subjects with low Vitamin D levels will be randomly assigned to either Vitamin D
      replacement or placebo for a period of 8 weeks. Insulin sensitivity will be measured before
      and after the intervention, and the changes will be compared between the two groups. This
      will help us understand if Vitamin D replacement improves insulin sensitivity. Serum Retinol
      Binding Protein 4 levels will also be measured to see if changes in insulin sensitivity are
      mediated by RBP4.
    

Eligibility criteria:

        Inclusion Criteria:

          -  1. Age 18-60 years 2. No known medical illnesses requiring pharmacotherapy 3. Not on
             any mineral or vitamin supplements in the last 3 months

        Exclusion Criteria:

          -  1. Subjects requiring prompt initiation of pharmacotherapy, such as those with
             incidentally discovered diabetes mellitus or hypertension.

             2. Previous administration of glucocorticoids, retinoic acid derivatives, or insulin
             sensitizers in the preceding 3 months.

             3. Bariatric surgery or liposuction 4. Unintentional weight loss >5% of the body
             weight in last 3 months 5. Chronic smokers (> 1 pk/d for 10 years) 6. Alcohol use > 2
             drinks/day
A Study of LY2623091 in Healthy Participants
Condition: Healthy Volunteers
Intervention: LY2623091; Itraconazole; Simvastatin; Tadalafil; Diltiazem
Intervention description: Administered orally; Administered orally; Administered orally; Administered orally; Administered orally
Intervention MeSH terms: Itraconazole; Diltiazem; Tadalafil; Simvastatin
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The first purpose of this study is to evaluate the effect of itraconazole (and possibly
      diltiazem) on the amount of LY2623091 in the blood stream and how long the body takes to get
      rid of it.

      The second purpose of the study is to evaluate the effect of LY2623091 on the amount of
      simvastatin (and possibly tadalafil) in the blood stream and how long the body takes to get
      rid of it.

      The safety and tolerability of LY2623091 when given with itraconazole, simvastatin and
      diltiazem or tadalafil will be evaluated.

      There will be three groups of participants in this study. Results from Groups 1 and 2 will be
      analyzed during the study to determine whether to enroll participants in Group 3 or 4. The
      study is expected to last up to 40 days from the first dose to follow-up (inclusive).
      Screening may occur up to 28 days prior to enrollment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy participants as determined by medical history, physical examination, clinical
             laboratory tests, and electrocardiograms (ECGs).

          -  Have a body mass index (BMI) between 18 and 32.0 kilograms per square meter (kg/m^2)
             inclusive, at screening

          -  Female participants must be of non-childbearing potential

        Exclusion Criteria:

          -  In the opinion of the investigator or sponsor, are unsuitable for inclusion in the
             study
PD-1 Knockout Engineered T Cells for Metastatic Non-small Cell Lung Cancer
Condition: Metastatic Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Cyclophosphamide; PD-1 Knockout T Cells
Intervention description: To deplete Tregs before collecting peripheral blood; Autologous lymphocytes are collected and PDCD1 gene is knocked out in the laboratory. Cells are selected and expanded ex vivo. Cells are infused back to the patients for treatment
Intervention MeSH terms: Cyclophosphamide
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: lung cancer; immune checkpoint; PD-1; CRISPR; autologous cell infusion

Summary:

      This study will evaluate the safety of PD-1 knockout engineered T cells in treating
      metastatic non-small cell lung cancer. Blood samples will also be collected for research
      purposes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically verified stage IV non-small cell lung cancer with measurable lesions
             (On CT: longest diameter of tumoral lesion >=10 mm, shorted diameter of lymph node
             >=15 mm; measurable lesions should not have been irradiated)

          -  Progressed after all standard treatment

          -  Performance score: 0-1

          -  Expected life span: >= 6 months

          -  Toxicities from prior treatment has resolved. Washout period is 4 weeks for
             chemotherapy, and 2 weeks for targeted therapy

          -  Major organs function normally

          -  Women at pregnant ages should be under contraception

          -  Willing and able to provide informed consent

        Exclusion Criteria:

          -  Pathology is mixed type

          -  Emergent treatment of tumor emergency is needed

          -  Poor vasculature

          -  Coagulopathy, or ongoing thrombolytics and/or anticoagulation

          -  Blood-borne infectious disease, e.g. hepatitis B

          -  History of mandatory custody because of psychosis or other psychological disease
             inappropriate for treatment deemed by treating physician

          -  With other immune diseases, or chronic use of immunosuppressants or steroids

          -  Compliance cannot be expected

          -  Other conditions requiring exclusion deemed by physician
Study of TRC105 + Paclitaxel/Carboplatin and Bevacizumab in Patients With NSCLC
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: TRC105
Intervention description: Dose-finding study of TRC105 in combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive patients with stage IV non-squamous NSCLC.
Intervention MeSH terms: Paclitaxel; Carboplatin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a single center, open-label, nonrandomized, phase 1b, dose-finding study of TRC105 in
      combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive
      patients with stage IV non-squamous NSCLC.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Stage 4 Non-Squamous Cell Lung Cancer that has not been treated previously with
             systemic chemotherapy or bevacizumab, but may have received prior targeted treatment
             (e.g., alk1 inhibitor)

          -  ECOG performance status ≤ 1

          -  Measurable disease by RECIST

        Key Exclusion Criteria:

          -  Non-small cell lung cancer of squamous histology

          -  Current treatment on another therapeutic clinical trial

          -  Patients who have received wide field radiotherapy ≤ 28 days (defined as > 50% of
             volume of pelvic bones or equivalent) or limited field radiation for palliation < 14
             days prior to study registration or those patients who have not recovered adequately
             from side effects of such therapy

          -  Active bleeding or pathologic condition that carries a high risk of bleeding (e.g.
             hereditary hemorrhagic telangiectasia). Patients who have been uneventfully
             anti-coagulated with low molecular weight heparin are eligible.
Phase 1 Study of SGI-110 in Patients With Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: SGI-110
Intervention MeSH terms: Guadecitabine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      To evaluate the tolerability and pharmacokinetics of SGI-110 when administered subcutaneously
      to Japanese patients with acute myeloid leukemia (AML).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients with a diagnosis of AML (WHO classification 2008).

               -  Patients, 20 years of age or older, who are unresponsive to standard chemotherapy
                  or have relapsed following standard chemotherapy

               -  Patients, 65 years of age or older, who are not eligible for standard intensive
                  chemotherapy

          -  Patients with ECOG performance status (PS) of 0 to 2

          -  Patients with adequate organ function

          -  Women of child-bearing potential must not be pregnant or breast feeding (pregnancy
             test will be performed at Screening). Women of child bearing potential and all men
             with female partners of child bearing potential must practice two medically acceptable
             methods of birth control and must not become pregnant or father a child while
             receiving treatment with SGI-110 and for 3 months following last dosing.

          -  Patients who have undergone prior allogeneic hematopoietic stem cell transplantation
             must have no evidence of active graft-versus host disease (GVHD) and must be off
             immunosuppressive therapy by ≥2 weeks prior to IMP administration.

        Exclusion Criteria:

          -  Patients with acute promyelocytic leukemia accompanied by t(15;17)(q22;q12) or
             (PML/RARA) karyotype abnormalities (include other variant types of APL)

          -  Patients with multiple cancers (except for adequately treated basal cell or squamous
             cell skin cancer, in situ cervical cancer, or other cancer from which the subject has
             been disease free for at least 3 years)

          -  Subjects with life-threatening illnesses other than AML or MDS, uncontrolled medical
             conditions or organ system dysfunction which, in the investigator's opinion, could
             compromise the subject's safety, or put the study outcomes at risk.

          -  Patients with poorly controlled arrhythmias, or any Class 3 or 4 cardiac disease as
             defined by the New York Heart Association Functional Classification

          -  Patients with symptomatic central nervous system involvement.