bioihbjkbjnl/mcl2 huggingface dataset:
A Study Of 4-1BB Agonist PF-05082566 Plus PD-1 Inhibitor MK-3475 In Patients With Solid Tumors (B1641003/KEYNOTE-0036)
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Intervention: PF-05082566; MK-3475
Intervention description: Starting dose of 0.45 mg/kg q3wks IV, dose escalation; 2 mg/kg q3wks, IV
Intervention MeSH terms: Pembrolizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced Solid Tumors

Summary:

      This is a safety, pharmacokinetic and pharmacodynamic study designed to estimate the maximum
      tolerated dose (MTD), and determine the Recommended Phase 2 Dose (RP2D) of PF-05082566, a
      4-1BB agonist monoclonal antibody (mAb), in combination with MK-3475, a PD-1 inhibitor in
      patients with solid tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological or cytological diagnosis of advanced/metastatic solid tumor malignancy
             which has progressed on standard therapy or for which no standard therapy is
             available.

          -  Measurable disease per RECIST v1.1.

          -  Adequate bone marrow, renal and liver functioning

        Exclusion Criteria:

          -  CNS primary malignancies, active seizure disorder or spinal cord compression, or
             carcinomatous meningitis.

          -  History of any of the following toxicities associated with a prior immunotherapy:

               -  Grade 3 immune mediated adverse event that was considered related to previous
                  immunotherapy and required immune suppressive therapy;

               -  Grade 2 hepatic function related adverse event that persisted more than 1 week,
                  was considered related to immunotherapy, or required treatment discontinuation or
                  immunosuppressive therapy

          -  Any of the following within the 12 months prior to registration: myocardial
             infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic
             congestive heart failure, cerebrovascular accident or transient ischemic attack and 6
             months for deep vein thrombosis or pulmonary embolism.

          -  History of or known presence of extensive, disseminated/bilateral or Grade 3 or 4
             interstitial fibrosis or interstitial lung disease, including a history of
             pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung
             disease, obliterative bronchiolitis, or pulmonary fibrosis, but not including a
             history of prior radiation pneumonitis. Patients with clinically significant lung
             disease requiring oxygen therapy (eg, COPD).
BI 836826 Dose Escalation in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma (NHL)
Condition: Lymphoma, Non-Hodgkin
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: BI 836826
Intervention description: Monotherapy with BI 836826 at escalating dose levels administered as an intravenous infusion
Intervention MeSH terms: BI 836826
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose is to investigate the maximum tolerated dose (MTD), safety and tolerability,
      pharmacokinetics and efficacy of BI 836826 monotherapy in patients with relapsed or
      refractory non-Hodgkin lymphoma with at least prior treatments.
    

Eligibility criteria:

        Inclusion criteria:

          1. Patients with relapsed or refractory non-Hodgkin lymphoma of B cell origin (mature B
             cell lymphoma according to WHO) not considered candidates for intensive anti-lymphoma
             therapy

          2. Patients must have either aggressive NHL and received at least one prior anti-CD20
             containing immunochemotherapy or indolent NHL and received anti-CD20 therapy and at
             least two prior therapies

          3. Measurable disease on computed tomography (CT) scan with involvement of one clearly
             demarcated lesion =2 cm or two or more clearly demarcated lesions of >1.5 cm at
             longest diameter (this criterion applies only for the expansion cohort)

          4. Relapse or progression of disease with an indication for therapy as per investigator's
             judgement

          5. Life expectancy of =3 months

          6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1

        Exclusion criteria:

          1. Primary central nervous system (CNS) lymphoma or known CNS involvement

          2. Prior history of malignancy other than a mature B cell neoplasm according to WHO
             classification (except basal cell or squamous cell carcinoma of the skin, or carcinoma
             in situ of the uterine cervix or breast treated with curative therapy) unless the
             subject has been free of disease and without treatment for at least 5 years

          3. Last chemotherapy <4 weeks prior to visit 1

          4. Last anti-CD20 therapy (non-radiolabelled) <4 weeks prior to visit 1

          5. Last corticosteroid <2 weeks prior to visit 1 unless the dose is less or equal of 10
             mg/day prednisolone or equivalent

          6. High-dose therapy with stem cell support <6 months prior to visit 1

          7. Radio-immunotherapy <3 months prior to visit 1
Breathing Techniques and Meditation for Health Care Workers During COVID-19 Pandemic
Condition: COVID-19 Infection
MeSH terms: COVID-19
Intervention: Media Intervention; Meditation Therapy; Quality-of-Life Assessment; Questionnaire Administration; Yoga
Intervention description: View instructional video; Perform meditation; Ancillary studies; Ancillary studies; Perform breathing techniques
Phase: Phase 1
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This phase I trial investigates breathing techniques and meditation for health care workers
      during COVID-19 pandemic. Breathing techniques and medication may help manage stress and
      improve lung health. The goal of this trial is to learn if breathing techniques and
      meditation may help to reduce stress and improve lung health in health care workers during
      the COVID-19 pandemic.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must be able to read and understand English

          -  Must be employed at MD Anderson Cancer Center

        Exclusion Criteria:

          -  Epilepsy

          -  Brain tumor

          -  Brain aneurysm

          -  Pregnant or trying to get pregnant

          -  Brain bleeding in the past 1 year

          -  Recent abdominal surgery and not cleared to exercise
First-in-Human Trial of Single Ascending Dose, Multiple Ascending Dose and Malaria Challenge Model in Healthy Participants
Condition: Healthy
Intervention: M5717; Placebo; M5717
Intervention description: Participants received single ascending oral dose of M5717 after at least 8 hours of fasting together with water on Day 1, followed by a 4-hour post-dose fast; Participants received placebo matched to M5717; Participants received single ascending oral dose of M5717 from Part A after at least 8 hours of fasting together with water on Day 1, followed by a 4-hour post-dose fast
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 88.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy Participants; M5717; Malaria; Plasmodium falciparum

Summary:

      The primary purpose of this study was to investigate the safety and tolerability of M5717 and
      to characterize the Pharmacokinetics (PK) /Pharmacodynamic relationship between M5717 PK and
      parasite clearance in healthy participants following infection with Plasmodium falciparum.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult men and women of non-childbearing potential, with total body weight greater than
             or equal to 50.0 kilogram and body mass index (BMI) between 19.0 kilogram per meter
             square(kg/m^2) and 29.9 kg/m^2.

          -  Healthy as assessed by the Investigator with no clinically significant abnormality
             identified on physical examination or laboratory evaluation and no active clinically
             significant disorder, condition, infection or disease that would pose a risk to
             participant safety or interfere with the trial evaluation, procedures, or completion.

          -  Other protocol defined inclusion criteria could apply.

        Exclusion Criteria:

          -  Participants with history or presence of clinically relevant respiratory,
             gastrointestinal, renal, hepatic, hematological, lymphatic, neurological,
             cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological
             dermatological, connective tissue diseases or disorders.

          -  Participants with history of relevant drug hypersensitivity, ascertained or
             presumptive allergy/hypersensitivity to the active drug substance and/or formulation
             ingredients; history of serious allergic reactions leading to hospitalization or any
             other allergic reaction in general, which the Investigator considers may affect the
             safety of the participant and/or outcome of the trial.

          -  Participants who have any history of malaria.

          -  Participants who have participated in a previous malaria vaccine trial.

          -  Participants who have participated in a previous human malaria challenge trial.
Study to Evaluate the PK of PO Omadacycline in Adults With Community-Acquired Bacterial Pneumonia
Condition: Community-acquired Pneumonia
MeSH terms: Pneumonia; Pneumonia, Bacterial
Intervention: Omadacycline
Intervention description: Omadacycline: PO Tablets
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the pharmacokinetics of an oral omadacycline dosing
      regimen in the treatment of adults with CABP.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participants, age 18 or older who have signed the informed consent form

          -  Must have a qualifying community-acquired bacterial pneumonia

          -  Has disease severity such that oral antibiotics therapy is appropriate

          -  Participants must not be pregnant at the time of enrollment

          -  Must agree to a reliable method of birth control during the study and for 30 days
             following the last dose of study drug

          -  Must be able to swallow tablets and comply with all of the requirements of the study

        Exclusion Criteria:

          -  Has received more than 24 hours of a potentially effective systemic antibacterial
             therapy within the 72 hours prior to the first dose of test article

          -  Known or suspected infection caused by a pathogen that may be resistant to test
             article

          -  Participants who reside in a long-term care or nursing home

          -  Evidence of empyema

          -  Evidence of significant immunological disease

          -  Evidence of liver impairment or disease

          -  Evidence of unstable cardiac disease

          -  Severe renal disease or requirement for dialysis

          -  Evidence of septic shock

          -  Has a history of hypersensitivity or allergic reaction to any tetracycline

          -  Has received an investigational drug within the past 30 days

          -  Participants who are pregnant or nursing

          -  Unable or unwilling to comply with the protocol requirements
A Phase 1b Open Label, Dose Escalation Study of PLX3397 in Combination With Vemurafenib in V600-mutated BRAF Melanoma
Condition: V600-mutated BRAF Unresectable Melanoma; V600-mutated BRAF Metastatic Melanoma; Stage III or Stage IV Metastatic Melanoma That Has Not Been Previously Treated With a Selective BRAF Inhibitor
MeSH terms: Melanoma
Intervention: PLX3397; vemurafenib
Intervention MeSH terms: Vemurafenib
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
Healthy volunteers: No

Summary:

      The purpose of this research study is to test the safety of an investigational new drug
      called PLX3397 when used in combination with Vemurafenib (Zelboraf™) at different dose
      levels. Vemurafenib has been approved by the United States Food and Drug Administration
      (FDA)/European Medicines Agency (EMA) for the treatment of a specific category of
      unresectable or metastatic melanoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥18 years old.

          -  Patients with histologically confirmed unresectable Stage III or Stage IV metastatic
             melanoma who have not been previously treated with a selective BRAF inhibitor.

          -  Presence of a BRAF V600 mutation in the tumor tissue using the cobas BRAF mutation
             assay or comparable standard of care methodology.

          -  Measurable disease per RECIST v. 1.1 criteria.

          -  ECOG performance status 0 or 1.

        Exclusion Criteria:

          -  Radiation therapy within 14 days of C1D1.

          -  Investigational drug use within 28 days of C1D1.

          -  Patients with active CNS lesions are excluded (i.e., those with radiographically
             unstable, symptomatic lesions). However, patients treated with stereotactic therapy or
             surgery are eligible if they remain without evidence of disease progression in the
             brain for ≥3 weeks.
A Study of Two Different Formulations of LY3074828 in Healthy Participants
Condition: Healthy
Intervention: LY3074828
Intervention description: Administered SC
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: 54.0
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 total duration of the clinical trial will be approximately 13 weeks, not including
      screening.
    

Eligibility criteria:

        Inclusion Criteria:

        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 1 month 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 sever 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
A Study Investigating the Absolute Oral Bioavailability of Balovaptan After Single and Multiple Daily Oral Doses of Balovaptan in Healthy Volunteers
Condition: Healthy Volunteers
Intervention: Oral Balovaptan; IV Balovaptan
Intervention description: In Period 1, balovaptan was administered as a single oral dose.
In Period 2, balovaptan was administered as an oral dose once daily on Day 1 to Day 14.; In Period 1, IV infusion of balovaptan was administered after the balovaptan oral dose.
In Period 2, IV infusion of balovaptan was administered after the final oral dose of balovaptan.
Intervention MeSH terms: Balovaptan
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study was a non-randomized, open-label, parallel group, two-treatment study in healthy
      volunteers to investigate the absolute oral bioavailability of balovaptan. The study was
      conducted at 1 site in the Netherlands.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and female subjects. Healthy status is defined by absence of evidence of
             any active or chronic disease following a detailed medical and surgical history, a
             complete physical examination including vital signs, 12-lead ECG, hematology, blood
             chemistry, urinalysis, and serology.

          -  Body Mass Index of 18 to 30 kg/m2, inclusive.

          -  For women of childbearing potential: agreement to use at least 2 acceptable
             contraceptive methods during the treatment period and for 90 days after the last dose
             of study drug.

          -  For men: agreement to use contraceptive measures, and agreement to refrain from
             donating sperm until 90 days after the last dose of study drug.

        Exclusion Criteria:

          -  Female subjects who are pregnant or lactating.

          -  Any condition or disease detected during the medical interview/physical examination
             that would render the subject unsuitable for the study, place the subject at undue
             risk or interfere with the ability of the subject to complete the study in the opinion
             of the Investigator.
A Phase I Study of OCV-501 in Acute Myeloid Leukemia Patients
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: OCV-501; OCV-501; OCV-501
Intervention description: subcutaneously administered once a week, 4 times at the dose of 0.3 mg; subcutaneously administered once a week, 4 times at the dose of 1 mg; subcutaneously administered once a week, 4 times at the dose of 3 mg
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Acute myeloid leukemia; WT1

Summary:

      The purpose of this study is to assess the safety, tolerability of OCV-501 in patients with
      acute myeloid leukemia (AML) who achieved complete remission after induction regimen and who
      completed a standard consolidation therapy.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Patients with acute myeloid leukemia including patients with secondary leukemia.
             However, the patients with MDS apparently evolved itno AML and patients with AML
             accompanied by t(15;17)(q22;q12),(PML/RARalpha) , should be excluded.

          -  Patients who achieved the first complete remission after the induction regimen and
             finished a standard consolidation therapy.

          -  Age: ≥ 60years of age(at the time of signature of the informed consent form)

          -  Sex: Male and Female

          -  Patients who are capable of giving informed consent

          -  Patient's blasts cells show expression of WT1mRNA, detected by quantitative RT-PCR.

          -  Patients must be one of the following HLA DRB1 types: HLA-DRB1*01:01, *04:05, *15:01,
             *15:02, *08:03 and *09:01.

        Key Exclusion Criteria:

          -  Patients who are scheduled for a bone marrow transplantation

          -  Patients who were administered exceeded acceptable therapeutic dose of
             immunosuppressants and adrenal cortical steroids.

          -  Patients with uncontrollable active infectious diseases

          -  Patients with autoimmune diseases (including Hashimoto's disease, idiopathic
             thrombocytopenic purpura, and autoimmune hepatitis) or with a medical history of
             active autoimmune diseases

          -  Immunocompetent patients

          -  Patients with a complication of interstitial pneumonia or with a medical history of
             interstitial pneumonia