bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 1 Study To Evaluate Escalating Doses Of A Vaccine-Based Immunotherapy Regimen For Prostate Cancer (PrCa VBIR)
Condition: Prostatic Neoplasms
MeSH terms: Prostatic Neoplasms
Intervention: PF-06755992; PF-06755990; TDS-IM Electroporation Device; Tremelimumab; PF-06801591; PF-06753512
Intervention description: PF-06755992 will be administered on Day 1 of Cycles 1 and 2.; PF-06755990 will be administered using a device on Day 29, 57 and 85 of each cycle.; TDS-IM electroporation device and associated supplies will be used for PF-06755990 administration; PF-06753388 will be administered every 28 days.; PF-06801591 will be administered every 28 days.; Combination of adenovirus (AdC68) + plasmid DNA (pDNA) + tremelimumab
Intervention MeSH terms: Tremelimumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 91.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses
      of a vaccine-based immunotherapy regimen for patients with prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological or cytological diagnosis of prostate cancer

          -  Adequate bone marrow, kidney and liver function

          -  Hormone sensitive relapsing prostate cancer after definitive local therapy
             (biochemical relapse) OR

          -  Failed prior therapy with a novel hormone (e.g. enzalutamide, abiraterone) with
             documented progressive disease (post-novel hormone therapy CRPC)

        Exclusion Criteria:

          -  ECOG performance status greater than or equal to 2

          -  Concurrent immunotherapy for prostate cancer

          -  History of or active autoimmune disorders (including but not limited to: myasthenia
             gravis, thyroiditis, pneumonitis, rheumatoid arthritis, multiple sclerosis, systemic
             lupus erythematosus, scleroderma) and other conditions that disorganize or alter the
             immune system.

          -  History of inflammatory bowel disease.

          -  Current use of any implanted electronic stimulation device

          -  For biochemically relapsed patients, no concurrent use of ADT or orchiectomy and no
             known prior or current evidence of any metastatic involvement of distant organs

          -  For post-novel hormone patients, no concurrent treatment with a secondary hormone
             (e.g. enzalutamide, abiraterone), no metastasis to the liver or brain
A Comparative Study of LY900014 With Insulin Lispro (Humalog) in Participants With Type 1 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: LY900014; Insulin Lispro
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Insulin Lispro
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate a new formulation of insulin lispro, LY900014, which
      is a drug that lowers blood sugar. The study will look at how the body processes LY900014,
      and the effect of LY900014 on blood sugar levels following a standard meal. For each
      participant, the study will consist of 4 periods and there will be approximately 12 weeks
      from screening to final study follow up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are male or female participants with Type 1 Diabetes Mellitus (T1DM) for at least 1
             year

          -  Have a body mass index (BMI) of 18.5 kilogram per meter square (kg/m²) to 35.0 kg/m²

          -  Have a glycated hemoglobin (HbA1c) ≤9.0% at screening

          -  Are on stable prandial insulin and basal insulin (neutral protamine Hagedorn [NPH]
             insulin, insulin glargine or insulin detemir) for at least 3 months before screening
             with a total insulin dose demand of less than or equal to (≤) 1.5 units per kilogram
             per day (U/kg/day)

        Exclusion Criteria:

          -  Are currently enrolled, or have participated within the last 30 days, in a clinical
             trial or any other type of medical research

          -  Have or used to have health problems that, in the opinion of the doctor, could make it
             unsafe to participate in the study

          -  Have donated blood of more than 450 millilitre (mL) or more in the last 3 months or
             provided any blood donation within the last month before screening.

          -  Any significant changes in insulin regimen and/or unstable blood glucose control
             within the past 3 months prior to screening as assessed by the investigator.

          -  Are treated with a CSII (insulin pump)
A Study of Evacetrapib in Healthy Participants
Condition: Healthy Volunteers
Intervention: Evacetrapib; Gemfibrozil
Intervention MeSH terms: Gemfibrozil; Evacetrapib
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine whether concentrations of the study drug
      (evacetrapib) in the blood stream is the same or is different when the person is also taking
      gemfibrozil (a drug used to lower lipid levels). Each participant will receive gemfibrozil
      alone, evacetrapib alone, and both drugs in combination. There is no washout period between
      doses. The safety of both of the study drugs given together will be evaluated. Information
      about any side effects that may have occurred will also be collected. This study will last
      approximately 36 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy participants as determined by medical history and physical examination

          -  Have a body mass index of 18 to 32 kilograms per square meter (kg/m^2)

        Exclusion Criteria:

          -  Have known allergies to evacetrapib and gemfibrozil, related compounds or any
             components of the formulation

          -  Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the
             investigator, increases the risks associated with participating in the study

          -  Regularly use known drugs of abuse and/or show positive findings on urinary drug
             screening

          -  Currently smoke cigarettes or use tobacco or nicotine substitutes
Study to Compare 2 Formulations of LY900014 in Healthy Participants
Condition: Healthy
Intervention: LY900014 U-200; LY900014 U-100
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Insulin Lispro
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 69.0
Sex: All
Minimum age: 21 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The study involves a comparison of 2 formulations of LY900014, which is a type of fast acting
      insulin. Study participants will be administered LY900014 U-100 two times and LY900014 U-200
      two times, over 4 study periods, by injection under the skin. Blood samples will be taken to
      compare how the body handles the study drugs and how they affect the blood sugar levels. Side
      effects and tolerability will be documented. The study will last about 4 weeks, not including
      screening and follow up. Screening is required within 28 days prior to the start of the study
      and follow up is required at least 2 weeks after the last dose of study drug.
    

Eligibility criteria:

        Inclusion Criteria:

        - Healthy male or a female (not pregnant and agreeable to take birth control measures until
        study completion)

          -  Have a body mass index (BMI) of 18 to 30 kilogram per square meter (kg/m²)

          -  Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine
             laboratory test results that are acceptable for the study

          -  Have veins suitable for easy blood collection and glucose solution infusion

        Exclusion Criteria:

        - Are currently participating in or completed a clinical trial within the last 30 days or
        any other type of medical research judged to be incompatible with this study

          -  Had donated blood of more than 450 milliliters (mL) or participated in a clinical
             trial with similar blood loss within the last 3 months

          -  Have a regular alcohol intake greater than 21 units/week (male), or 14 units/week
             (female)

          -  Smoke more than 10 cigarettes per day

          -  Are infected with hepatitis B or human immunodeficiency virus (HIV)

          -  Are taking illegal drugs
Effect of Repeat Administration of Eslicarbazepine Acetate on the Pharmacokinetics of a Combined Oral Contraceptive
Condition: Partial Epilepsy
MeSH terms: Epilepsy; Epilepsies, Partial
Intervention: eslicarbazepine acetate and Microginon®; Microginon®
Intervention description: eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period.
Microginon®: single oral dose on day 14 of treatment period; Single oral dose of Microginon® (30ug ethinyloestradiol and 150ug levonorgestrel)
Intervention MeSH terms: Eslicarbazepine acetate
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Partial; Epilepsy; Eslicarbazepine acetate; Combined oral contraceptive; Pharmacokinetics; Tolerability

Summary:

      The purpose of this study is to investigate whether multiple-dose administration of
      eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics
      and tolerability of the components of a combined oral contraceptive (ethinyloestradiol and
      levonorgestrel).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pre-menopausal female subjects

          -  Age 18-40 years, inclusive

          -  Body mass index (BMI) 19-30 kg/m2, inclusive

          -  Healthy as determined by pre-study medical history, physical examination, vital signs,
             complete neurological examination and 12-lead ECG

          -  Negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening

          -  Negative urine pregnancy test at screening and admission to each treatment period.

          -  Using one of the following methods of contraception: double barrier or intrauterine
             device

        Exclusion Criteria:

          -  Subjects who have any contra-indication to the use of oral contraceptives

          -  History or presence of clinically relevant diseases, disorders or surgical history

          -  History of alcoholism or drug abuse

          -  Have used medicines within two weeks of admission to first period that may affect the
             safety or other study assessments, in the investigator's opinion
A Phase 1 Study Of PF-00868554 In Hepatitis C Virus (HCV) Positive Patients
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: PF-00868554; PF-00868554; PF-00868554; PF-00868554; Placebo
Intervention description: 300 mg BID; 450 mg BID; 100 mg BID; 300 mg TID; Placebo
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Assess the safety, tolerability and pharmacokinetics of multiple oral doses of PF-00868554 in
      HCV positive patient volunteers
    

Eligibility criteria:

        Inclusion Criteria:

          -  HCV RNA ≥ 100,000 IU/mL at screening

          -  Genotype 1a or 1b

        Exclusion Criteria:

          -  Current or prior treatment with IFN and/or RBV

          -  Evidence of decompensated liver disease
A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897 in Healthy Adults
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Intervention: MEDI8897 Intravenous; Placebo; MEDI8897 Intravenous; MEDI8897 Intravenous; MEDI8897 Intramuscular; MEDI8897 Intramuscular
Intervention description: Participants received a single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.; Participants received placebo on Day 1.; Participants received a single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.; Participants received a single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.; Participants received a single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.; Participants received a single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 342.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Respiratory Syncytial Virus, RSV

Summary:

      The purpose of this study was to evaluate the safety, tolerability and pharmacokinetics of an
      extended half-life anti-respiratory syncytial virus (RSV) monoclonal antibody compared to
      placebo when administered to healthy adult participants.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Age 18 through 49 years and in good health by history, physical exam, and labs

          -  Weight greater than or equal to (>=) 45 kilogram (kg) and less than or equal to (<=)
             110 kg at Screening

          -  Written informed consent prior to performing any protocol related procedures,
             including Screening evaluations

          -  Ability to complete the Follow-up period of 360 days

        Key Exclusion Criteria:

          -  Acute illness including fever >= 99.5 Fahrenheit (°F) on day of dosing

          -  Any drug therapy within 7 days prior to Day 1 (except contraceptives)

          -  Receipt of any investigational drug therapy within 120 days prior to investigational
             product dosing through 360 days after investigational product dosing

          -  Previous receipt of a monoclonal antibody (mAb)

          -  Pregnant or nursing mother

          -  Concurrent enrollment in another interventional study
Phase 1 Study to Evaluate the Effect of DS-8201a on the QT/QTc Interval and Pharmacokinetics in HER2-Expressing Breast Cancer
Condition: Malignant Neoplasm of Breast
MeSH terms: Breast Neoplasms; Neoplasms
Intervention: DS-8201a
Intervention description: DS-8201a is supplied as a lyophilized powder which is reconstituted for infusion
Intervention MeSH terms: Trastuzumab deruxtecan
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: HER2; Breast cancer; Oncology; Antibody drug conjugate; ADC

Summary:

      This study will look at the effect on the QTc interval and pharmacokinetics after multiple
      dosing in subjects with HER2-expressing metastatic and/or unresectable breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a pathologically documented unresectable or metastatic breast cancer with HER2
             expression (immunohistochemistry [IHC] 3+, IHC 2+, IHC 1+ and/or in situ hybridization
             [ISH] +) that is refractory to or intolerable with standard treatment, or for which no
             standard treatment is available

          -  Has a left ventricular ejection fraction (LVEF) ≥ 50%

          -  Has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1

        Exclusion Criteria:

          -  Has a medical history of myocardial infarction within 6 months before enrollment

          -  Has a medical history of ventricular arrhythmias, other than rare occasional premature
             ventricular contractions

          -  Has uncontrolled or significant cardiovascular disease
Automatic External Defibrillation Monitoring in Cardiac Arrest
Condition: Death, Sudden, Cardiac; Ventricular Fibrillation; Tachycardia, Ventricular
MeSH terms: Heart Arrest; Tachycardia; Ventricular Fibrillation; Tachycardia, Ventricular; Death, Sudden, Cardiac; Death, Sudden
Intervention: Defibrillation of pulseless VT/VF by AECD
Intervention description: In case of cardiac arrest caused by shockable rhythms the automatic external cardioverter defibrillator (AECD) will automatically deliver defibrillation. Automated External Cardioverter Defibrillator (AECD; The PowerHeart CRM, Cardiac Science Inc., Seattle, WA) is a device attached to the chest wall by pads, monitors the electrocardiogram, and is capable of automatically delivering electric countershock to appropriate rhythms without operator intervention. The device will deliver only one shock of 150 Joules for pulseless ventricular tachycardia and ventricular fibrillation.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 192.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Randomized Controlled Trials; Defibrillators; Medical Devices

Summary:

      We propose to randomize automatic external cardioverter/defibrillators (AECD) in patients who
      are at high risk for life-threatening abnormal heart rhythms (arrhythmias) and are admitted
      to the telemetry ward, all other treatments being constant including cardiopulmonary
      resuscitation.

      We hypothesize that the automatic, rapid, accurate and specific diagnostic and therapeutic
      technology used in AECDs will further increase the rate of survival in patients with cardiac
      arrest through rapid and automatic defibrillation, independent of operator initiation, as
      compared to standard cardiopulmonary resuscitation initiated by healthcare providers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients admitted to telemetry ward and emergency department

          -  Age > 18 years.

        Exclusion Criteria:

          -  Pregnant women

          -  Patients with R wave less than 0.5 millivolts.

          -  Patients with functioning Internal Cardiac Device.

          -  Patients with cardiac pacemakers if oversensing by AECD is demonstrated (double
             counting of pacer spikes).

          -  Patients with visible chest lesions that would prevent AECD pad placement.

          -  Patients who are designated Do Not Resuscitate.

          -  Right bundle branch block.

          -  Patients with Parkinson's disease.

          -  Patients with seizure disorders
Safety Study of Recombinant M2e Influenza-A Vaccine in Healthy Adults
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Influenza A Vaccine: ACAM FLU-A; Influenza A Vaccine: ACAM FLU-A; Influenza A Vaccine: ACAM FLU-A; Saline placebo
Intervention description: 0.5 mL ACAM-FLU-A low dose + Adjuvant 1, Intramuscular; 0.5 mL ACAM-FLU-A low dose + Adjuvant 2, Intramuscular; 0.5 mL ACAM FLU-A low dose, Intramuscular; 0.5 mL, Intramuscular
Intervention MeSH terms: Vaccines
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 87.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This multi-center study will be conducted in the United States with up to 80 healthy adult
      subjects. Subjects will be scheduled to receive a total of two (2) injections with 1
      injection each administered.

      Subjects will be randomized according to a randomization scheme.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult males or females 18 - 40 years of age in good general health

        Exclusion Criteria:

          -  Known allergies or severe reactions to any of the vaccine components including those
             to adjuvants

          -  History of severe allergic reactions, including angioedema;

          -  History of asthma or recurrent wheezing; (current or within past 2 years);

          -  History of neurological symptoms or signs following administration of any vaccine;