bioihbjkbjnl/mcl2 huggingface dataset:
A Study of LY3435151 in Participants With Solid Tumors
Condition: Solid Tumor; Triple-negative Breast Cancer; Gastric Adenocarcinoma; Head and Neck Squamous Cell Carcinoma; Cervical Carcinoma; High Grade Serous Ovarian Carcinoma; Hepatocellular Carcinoma; Undifferentiated Pleomorphic Sarcoma; Leiomyosarcoma
MeSH terms: Carcinoma; Triple Negative Breast Neoplasms; Squamous Cell Carcinoma of Head and Neck; Leiomyosarcoma; Histiocytoma, Malignant Fibrous
Intervention: LY3435151; Pembrolizumab
Intervention description: Administered IV; Administered IV
Intervention MeSH terms: Pembrolizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: immunotherapy; CD226 agonist

Summary:

      The reason for this study is to see if the study drug LY3435151 is safe in participants with
      advanced solid tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant must have certain types of cancer, which your study doctor will discuss
             with you

          -  Participant must have stopped other forms of treatment for cancer, which your study
             doctor will discuss with you

          -  Participant must be able and willing to provide a sample of your tumor before
             beginning treatment and once while on treatment. For certain tumor types, the outcome
             of the biopsy may exclude you from the study treatment (for Phase 1b)

          -  Participant must agree to use birth control

          -  Participant must have progressed through or are intolerant to therapies with known
             clinical benefit, which your study doctor will discuss with you

        Exclusion Criteria:

          -  Participant must not have a history of tuberculosis, uncontrolled HIV or uncontrolled
             hepatitis B or C virus infection

          -  Participant must not have an autoimmune disease, which your study doctor will discuss
             with you

          -  Participant must not use corticosteroids, which your study doctor will discuss with
             you

          -  Participant must not have heart disease, Crohn's disease or brain cancer

          -  Participant must not be pregnant or breastfeeding
Bexagliflozin Drug/Drug Interaction Study With Digoxin
Condition: Type2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Bexagliflozin; Digoxin
Intervention description: Bexagliflozin tablets, 20 mg; 2 0.25 mg Digoxin tablets (total dose 0.5 mg digoxin)
Intervention MeSH terms: Bexagliflozin; Digoxin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to examine the drug-drug interaction in your body when given the
      study drug, bexagliflozin, with the heart failure medication digoxin. The study will evaluate
      whether bexagliflozin effects the amount of digoxin in your blood and how safe the study drug
      is and how well the study drug is tolerated when taken with digoxin.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects with body-mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2

          2. Subjects who are non-smokers for at least 6 months prior to first dose

          3. Subjects who are willing to use an adequate form of birth control during the study and
             for 30 days after discharge from clinic

        Exclusion Criteria:

          1. Subjects with a clinically significant history of allergy to drugs or latex

          2. Subjects with a history of alcohol or drug dependence in the past 12 months

          3. Subjects who have donated a significant amount of blood in the past 2 months

          4. Subjects who have taken an investigational drug in the past 30 days or 7 half-lives of
             the investigational drug, whichever is longer

          5. Subjects who had previously received digoxin or drugs of the same class, or SGLT2
             inhibitors, in the past 3 months
A Dose Escalation Study of PF-06650808 in Patients With Advanced Solid Tumors
Condition: Neoplasms; Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: PF-06650808; PF-06650808
Intervention description: Dose Escalation Phase [Part 1] - PF-06650808 will be administered at doses starting at 0.2 mg/kg. Increases in dose will continue until MTD is determined.; Dose Expansion Phase [Part 2] - Patients will be treated at the MTD or Recommended Phase 2 dose selected in Part 1.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: solid tumors; triple negative breast cancer; PF-06650808; Phase 1

Summary:

      To assess the safety and tolerability at increasing dose levels of PF-06650808 in patients
      with advanced solid tumors in order to determine the maximum tolerated dose and select the
      recommended Phase 2 dose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of advanced/metastatic solid tumor that is resistant to standard therapy or
             for which no standard therapy is available

          -  Previously treated metastatic triple negative breast cancer that expresses Notch3 with
             at least one measurable lesion

          -  Adequate bone marrow, renal and liver function

        Exclusion Criteria:

          -  Major surgery, radiation therapy or systemic anti-cancer therapy within 4 weeks of
             starting study treatment

          -  Patients with known symptomatic brain metastases requiring steroids

          -  Prior treatment with a compound of the same mechanism
Single Rising Dose Study of BI 655088 Administered Intravenously in Healthy Male Volunteers
Condition: Healthy
Intervention: BI 655088; Placebo
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 47.0
Sex: Male
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Investigation of safety and tolerability of BI 655088 following intravenous infusion of
      single rising doses and exploration of the pharmacokinetics and pharmacodynamics of BI 655088
      after single dosing
    

Eligibility criteria:

        Inclusion criteria:

          -  Healthy male subjects

          -  Age of 18 to 50 years

          -  Body mass index (BMI) of 18.5 to 29.9 kg/m2

          -  Additional inclusion criteria may apply

        Exclusion criteria:

          -  Any finding in the medical examination (including BP, PR or ECG) deviating from normal
             and judged as clinically relevant by the investigator

          -  Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg or
             diastolic blood pressure outside the range of 50 to 90 mmHg or pulse rate outside the
             range of 45 to 90 bpm

          -  Any laboratory value outside the reference range that the investigator considers to be
             of clinical relevance

          -  Any evidence of a concomitant disease judged as clinically relevant by the
             investigator

          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
             immunological or hormonal disorders

          -  Diseases of the central nervous system (including but not limited to any kind of
             seizures and stroke), and other relevant neurological disorders or psychiatric
             disorders

          -  Additional 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
Withdrawal of Immunosuppression in Pediatric Liver Transplant Recipients
Condition: Liver Transplant; Liver Transplantation
Intervention: Immunosuppression Withdrawal
Intervention description: Gradual withdrawal of immunosuppressive medication. With high dose, daily dose reduction by 25% for 8 weeks. With low dose, daily dose reduction by 25% for 4 weeks.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Recipients of parental living-donor liver allografts will undergo gradual withdrawal as tolerated of immunosuppression with the goal of complete withdrawal.
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 4 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: immunosuppression withdrawal (IS); anti-rejection drugs; tolerance; allograft function

Summary:

      Antirejection medicines, also known as immunosuppressive drugs, are prescribed to organ
      transplant recipients to prevent their bodies from rejecting the new organ. Long-term use of
      these drugs places transplant recipients at higher risk of serious infections and certain
      types of cancer. The purpose of this study is to determine whether immunosuppressive drugs
      can be safely withdrawn over a minimum of 9 months from children who received liver
      transplants at least 4 years ago.
    

Eligibility criteria:

        Inclusion Criteria for Liver Recipients:

          -  Received liver from living parent donor

          -  Received transplant at least 4 years prior to study entry

          -  Less than 18 years of age at time of transplant

          -  Parent or guardian willing to provide informed consent

        Inclusion Criteria for Liver Donors:

          -  Willing to participate in this study

        Exclusion Criteria for Liver Recipients:

          -  Underwent transplant because of liver failure related to autoimmune disease

          -  Underwent transplant of a second organ simultaneously with or after liver transplant
             OR liver retransplantation

          -  Receiving immunosuppression with more than one drug

          -  50% increase in dose of current immunosuppressive drug

          -  HIV infection

          -  Hepatitis B or C virus infection

          -  Pregnancy or breastfeeding
Effects of Once and Twice Daily Dosing Regimen of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-040)
Condition: Diabetes Mellitus, Type 2; Adult
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Ertugliflozin 2 mg single dose; Ertugliflozin 2 mg split into twice daily; Ertugliflozin 4 mg single dose; Ertugliflozin 4 mg split into twice daily; Placebo
Intervention description: Ertugliflozin 2 mg dose (two 1 mg strength tablets), administered as a single dose; Ertugliflozin 1 mg dose (1 mg strength tablet) administered twice daily x 1 day; Ertugliflozin 4 mg dose (four 1 mg strength tablets), administered as a single dose; Ertugliflozin 2 mg dose (two 1 mg strength tablets) administered twice daily x 1 day; Placebo to ertugliflozin administered as a single dose
Intervention MeSH terms: Ertugliflozin
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a Phase 1 randomized, double-blind, sponsor open, 4 arm, 2 way cross-over study using
      2 cohorts. The objective of the study is to evaluate the pharmacodynamics (PD) effects and
      the pharmacokinetic (PK) of single day dosing of 2 mg and 4 mg doses of ertugliflozin (Ertu,
      PF-04971729/MK-8835) each administered once vs twice daily (morning [AM] and evening [PM]) in
      adults with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with type 2 diabetes mellitus, either treatment-naïve or on up to 2
             acceptable oral anti-diabetes drugs for at least 8-weeks prior to study.

        Exclusion Criteria:

          -  Participants with type 1 diabetes mellitus, participants with stroke, unstable angina,
             heart attack in last 6-months, uncontrolled blood pressure.
COVID-19 Convalescent Plasma for the Treatment of Hospitalized Patients With Pneumonia Caused by SARS-CoV-2.
Condition: COVID-19
MeSH terms: COVID-19; Pneumonia
Intervention: COVID-19 Convalescent Plasma
Intervention description: 2 units of COVID-19 convalescent plasma compatible with their blood type
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized 1:1 to receive either convalescent plasma on Study Day 1 in addition to standard care or standard care alone.
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Convalescent plasma

Summary:

      The purpose of this study is to see if this plasma can be safely used in humans with COVID-19
      and to see if it improves patients' health as compared to not using it in patients with
      pneumonia caused by SARS-CoV-2.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult ≥18 years of age

          2. Laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other authorized or
             approved assay in any specimen collected within 72 hours prior to enrollment.

             Note - An exception must be requested to the Sponsor if ≥72 hours since positive test.

          3. Hospitalized in participating facility.

          4. Documentation of pneumonia with radiographic evidence of infiltrates by imaging (e.g.,
             chest x-ray or CT scan).

          5. Abnormal respiratory status that is judged worse than baseline by the investigator and
             as documented at any point within 24 hours prior to randomization, consistent with
             ordinal scale levels 5, 6 or 7, specifically defined as:

               -  Room air saturation of oxygen (SaO2) < 93%, OR

               -  Requiring supplemental oxygen, OR

               -  Tachypnea with respiratory rate ≥30

          6. Patient or proxy is willing and able to provide written informed consent and comply
             with all protocol requirements

        Exclusion Criteria:

          1. Contraindication to transfusion (e.g., severe volume overload, history of severe
             allergic reaction to blood products), as judged by the investigator.

          2. Clinical suspicion that the etiology of acute illness (acute decompensation) is
             primarily due to a condition other than COVID-19

          3. Receipt of other investigational therapy as a part of another clinical trial. Note:
             investigational therapies used as part of clinical care, (eg, remdesivir,
             hydroxychloroquine) are permissible.
Bioequivalence of 5 Tablets of 100 mg Versus 2 Tablets of 250 mg TF3 of Tepotinib
Condition: Healthy
Intervention: Tepotinib 100 mg; Tepotinib 250 mg
Intervention description: Participants received a single oral dose of test treatment of tepotinib TF3 (5 * 100 mg) in either treatment period 1 or 2.; Participants received a single oral dose of reference treatment of tepotinib TF3 (2 * 250 mg) in either treatment period 1 or 2.
Intervention MeSH terms: Tepotinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
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
Keywords: Tepotinib; Bioequivalence; Pharmacokinetics

Summary:

      This study investigated the bioequivalence of the 100 milligrams (mg) and 250 mg dose
      strengths of tepotinib tablet formulation 3 (TF3) when administered at the same dose under
      fasted condition.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy participants of non-child bearing potential

          -  Body weight between 50 to 100 kilogram (kg)

          -  Body mass index (BMI) between 18.5 and 29.9 kilogram per meter square (kg/m^2)

          -  Other protocol defined inclusion criteria could apply

        Exclusion Criteria:

          -  Participation in a clinical study within 60 days prior to first drug administration

          -  Whole blood donation or loss of greater than 450 milliliter (mL) within 60 days prior
             to first drug administration

          -  Any surgical or medical condition, or any other significant disease that could
             interfere with the study objectives, conduct, or evaluation

          -  Other protocol defined exclusion criteria could apply
Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB3 in Healthy Male Subjects
Condition: Healthy
Intervention: SB3; EU sourced Herceptin®; US sourced Herceptin®
Intervention MeSH terms: Trastuzumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 109.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pharmacokinetics

Summary:

      The purpose of this study is to compare the pharmacokinetics, safety, tolerability and
      immunogenicity of SB3 and Herceptin® (EU sourced Herceptin® and US sourced Herceptin®) in
      healthy male subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male subjects

          -  Have a body weight between 60.0 and 94.9 kg and a body mass index between 18.0 and
             29.9 kg/m², inclusive.

        Exclusion Criteria:

          -  history of and/or current clinically significant gastrointestinal, renal, hepatic,
             cardiovascular, haematological (including pancytopenia, aplastic anaemia or blood
             dyscrasia), pulmonary, neurologic, metabolic (including known diabetes mellitus),
             psychiatric or significant allergic disease excluding mild asymptomatic allergies.

          -  history of and/or current cardiac disease

          -  previously received any monoclonal antibody or fusion protein.

          -  history of cancer including lymphoma, leukaemia and skin cancer.

          -  Have received live vaccine(s) within 30 days prior to Screening or who will require a
             vaccine(s) between Screening and the End of Study visit.

          -  intake medication with a half-life > 24 h within 1 month or 10 half-lives of the
             medication prior to the administration of investigational product.