bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Erlotinib in Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: Erlotinib; Gemcitabine
Intervention description: Participants will receive erlotinib tablets as 100 milligrams (mg) orally (PO) once daily.; Participants will receive gemcitabine as 1000 milligrams per meter-squared (mg/m^2) via intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
Intervention MeSH terms: Gemcitabine; Erlotinib Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label, single-arm, multicenter trial is designed to evaluate the safety of
      erlotinib in combination with standard of care chemotherapy (gemcitabine) in participants
      with locally advanced, unresectable, or metastatic pancreatic cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed adenocarcinoma with locally advanced,
             unresectable, or metastatic disease

          -  No prior systemic treatment for metastatic disease

          -  Adjuvant therapy ≥6 months prior to study entry with no residual toxic effects

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3

          -  Life expectancy ≥12 weeks

          -  Adequate hematologic, hepatic, and renal function

          -  Negative pregnancy test within 72 hours of study drug and use of effective
             contraception among women of childbearing potential

        Exclusion Criteria:

          -  Unstable systemic disease

          -  Prior systemic human epidermal growth factor receptor 1 (HER1) or epidermal growth
             factor receptor (EGFR) inhibitors

          -  Other malignancy within 5 years prior to study entry

          -  Significant opthalmologic abnormality

          -  Inability to take oral medication

          -  Need for IV alimentation

          -  Prior surgery affecting absorption

          -  Active peptic ulcer disease

          -  Nursing mothers
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Healthy Children Aged 15 Months to 17 Years
Condition: Healthy Subjects
Intervention: 13 valent pneumococcal conjugate vaccine
Intervention description: Intramuscular injection of 0.5mL at visit 1 and visit 2 for group 1 and and visit 1 for groups 2, 3, and 4.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1200.0
Sex: All
Minimum age: 15 Months
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This open-label, multicenter study is designed to evaluate the safety, tolerability and
      immunogenicity of 13-valent pneumococcal conjugate vaccine in healthy children aged more than
      15 months up to less than 18 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects >15months to <18years in good health, available for entire
             study period and reachable by phone, parents/legal guardian able and willing to
             complete all study procedures, written documentation from health professional showing
             prior vaccination with Prevnar (except for group 4).

        Group 4 only:

          -  Negative urine pregnancy test for female subjects who are menstruating.

        Exclusion Criteria:

          -  Previous reaction or contra-indication to pneumococcal vaccine or vaccine related
             component , bleeding diathesis, received blood transfusion or blood related products,
             immune deficiency,congenital malformation.

        Group 4 only:

          -  Previous vaccination with Prevnar or any other pneumococcal vaccine.

          -  Pregnant or breastfeeding adolescent females.
SANTE - Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Medtronic DBS Therapy for epilepsy; Medtronic DBS Therapy for epilepsy
Intervention description: Stimulation On; Stimulation Off
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 157.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Deep brain stimulation, DBS, SANTE

Summary:

      The purpose of this research is to study the safety and effectiveness of bilateral
      stimulation of the anterior nucleus of the thalamus as adjunctive therapy for reducing the
      frequency of seizures in adults diagnosed with epilepsy characterized by partial-onset
      seizures, with or without secondary generalization, that are refractory to antiepileptic
      medications.
    

Eligibility criteria:

        Relevant Inclusion and Exclusion Criteria are listed below.

        Inclusion Criteria

          -  Partial-onset seizures with or without secondary generalization. The final
             determination shall be made by the Investigator based on a clinical description of the
             seizures and previous diagnostic testing that includes, at a minimum, video/clinical
             EEG that captured at least one ictal event.

          -  Anticipated average of 6 or more partial-onset seizures (with or without secondary
             generalized seizures) per month during the Baseline Phase, with no more than 30 days
             between seizures during the Baseline Phase.

          -  Refractory to antiepileptic drugs (AEDs). Patients will be considered refractory if
             they have failed at least three AEDs due to lack of efficacy.

          -  Receiving one to four currently marketed AEDs

          -  Be between 18 and 65 years of age at the time of lead implant

        Exclusion Criteria:

          -  Multilobar (>3 different lobes) anatomic areas of seizure onset

          -  Symptomatic generalized epilepsy

          -  Previous diagnosis of psychogenic/non-epileptic seizures

          -  Presence of implanted electrical stimulation medical device anywhere in the body
             (e.g., cardiac pacemakers, spinal cord stimulator) or any metallic implants in the
             head (e.g., aneurysm clip, cochlear implant). Vagal nerve stimulators are allowed if
             the device has been turned off for at least 30 days prior to the Baseline Week -12
             visit and the patient agrees to have the generator explanted prior to or at the time
             of the Kinetra Neurostimulator implant.
Comparative Pharmacokinetics and Food-Effect Bioavailability of Lubiprostone Sprinkle in Healthy Volunteers
Condition: Healthy Volunteers
Intervention: Cohort 1: Lubiprostone Capsule, Fasted; Cohort 1: Lubiprostone Sprinkle Formulation, Fasted; Cohort 2: Lubiprostone Sprinkle Formulation, Fed; Cohort 2: Lubiprostone Sprinkle Formulation, Fasted
Intervention description: Lubiprostone soft gelatin capsule administered under fasted conditions; Lubiprostone sprinkle formulation administered under fasted conditions; Lubiprostone sprinkle formulation administered under fed conditions; Lubiprostone sprinkle formulation administered under fasted conditions
Intervention MeSH terms: Lubiprostone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A study to compare the pharmacokinetics and food-effect bioavailability of sprinkle
      formulation of lubiprostone, as compared to lubiprostone capsules in healthy volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is male or female, between 18 and 55 years of age, inclusive.

          -  Has a 12-lead electrocardiogram (ECG) within normal limits and is in good health based
             upon review of medical history, physical examination results, vital signs (within
             normal range), and normal laboratory profile for both blood and urine.

        Exclusion Criteria:

          -  Has an active or recent history of alcoholism or drug addiction (within 1 year prior)

          -  Is a smoker or has a recent history of smoking (within 6 months)

          -  Routinely consumes food known to alter drug metabolism (i.e., grapefruit juice,
             coffee, tea, cola, chocolate, cocoa, or other caffeine or methyl-xanthine containing
             foods or beverages) and/or cannot refrain from these items

          -  Has donated blood within 3 months

          -  Has a medical/surgical condition that might interfere with the absorption,
             distribution, metabolism, or excretion of the study medication.
PGL4001 Versus Placebo in Uterine Myomas
Condition: Uterine Myomas
MeSH terms: Myoma; Leiomyoma; Myofibroma
Intervention: PGL4001 (ulipristal) and iron; PGL4001 matching placebo and iron; PGL4001 (ulipristal) and iron
Intervention description: tablets; tablets; Tablets
Intervention MeSH terms: Iron; Ulipristal acetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 241.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      This trial will assess the efficacy and safety of PGL4001 with concomitant iron
      administration versus placebo with concomitant iron administration, over a 3-month period for
      the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding
      due to uterine myoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be a pre-menopausal woman between 18 and 50 years inclusive.

          -  Have excessive uterine bleeding due to myoma.

          -  Have a myoma-related anaemia.

          -  Have a myomatous uterus with at least one myoma of ≥ 3 cm diameter in size.

          -  Be eligible for one surgical procedure: e.g. hysterectomy, myomectomy or others.

          -  If of childbearing potential the subject must be practicing a non-hormonal method of
             contraception.

          -  Have a Body Mass Index (BMI) ≥ 18 and ≤ 40.

        Exclusion Criteria:

          -  Has a history of or current uterine, cervical, ovarian or breast cancer.

          -  Has a history of or current endometrium atypical hyperplasia.

          -  Has a known severe coagulation disorder.

          -  Has a history of or current treatment for myoma with a Selective Progesterone Receptor
             Modulator (SPRM) or a GnRH-agonist.

          -  Has abnormal hepatic function at study entry.

          -  Has a positive pregnancy test at baseline or is nursing or planning a pregnancy during
             the course of the study.

          -  Has a current (within twelve months) problem with alcohol or drug abuse.

          -  Is currently enrolled in an investigational drug or device study or has participated
             in such a study within the last 30 days.
Rifaximin for Prevention of Travellers' Diarrhea
Condition: Diarrhea
MeSH terms: Diarrhea
Intervention: Rifaximin; Placebo
Intervention MeSH terms: Rifaximin
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 210.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: TD; traveller's diarrhea; campylobacter; shigella; salmonella; E. coli; diarrhea

Summary:

      The purpose of this study is to determine if 600 mg of rifaximin, taken once a day for 14
      days by healthy subjects, is safe and effective for the prevention of travellers' diarrhea
      compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          1. travelling to Mexico within 72 hours of enrollment

          2. read and understand English

          3. in good health

        Exclusion Criteria:

          1. acute diarrhea within previous 7 days

          2. taken FQs (any drug in this class), macrolide, azalide, or
             trimethoprim-sulfamethoxazole within 7 days or enrollment or anytime during study.

          3. taken antidiarrheal medication within 24 hours of enrollment or anytime during study.
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-4
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Evolocumab; Ezetimibe; Placebo to Evolocumab; Placebo Ezetimibe
Intervention description: Administered by subcutaneous injection; Tablet for oral administration; Administered by subcutaneous injection; Tablet for oral administration
Intervention MeSH terms: Ezetimibe; Evolocumab; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 61.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Japanese; High cholesterol; Treatment of high cholesterol; Lowering cholesterol; Lowering high cholesterol; Hypercholesterolemia; Statin intolerant

Summary:

      The primary objective of the study was to evaluate the effect of 12 weeks of subcutaneous
      (SC) evolocumab compared with ezetimibe, on percent change from baseline in low-density
      lipoprotein cholesterol (LDL-C) in hypercholesterolemic adults unable to tolerate an
      effective dose of a statin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥ 20 to ≤ 80 years of age

          -  Japanese by self-identification

          -  Not on a statin or on a low dose statin with stable dose for at least 4 weeks.

          -  Subject not at LDL-C goal

          -  History of statin intolerance to at least 2 statins

          -  Lipid lowering therapy has been stable prior to screening for at least 4 weeks

          -  Fasting triglycerides ≤ 400 mg/dL

        Exclusion Criteria:

          -  New York Heart Association (NYHA) III or IV heart failure

          -  Uncontrolled cardiac arrhythmia

          -  Uncontrolled hypertension

          -  Type 1 diabetes

          -  Poorly controlled type 2 diabetes

          -  Uncontrolled hypothyroidism or hyperthyroidism
A Study to Look at the Efficacy and Safety of Keppra® Extended Release Formulation - XR
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Keppra® extended release formulation - XR; Placebo
Intervention description: 500mg extended release oral tablet, 2 tablets once daily; oral tablets, 2 tablets once daily
Intervention MeSH terms: Levetiracetam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 158.0
Sex: All
Minimum age: 12 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Epilepsy; Keppra® XR; Levetiracetam XR; Extended release

Summary:

      This is a safety and efficacy study of Keppra® extended release formulation - XR in patients
      with epilepsy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a confirmed diagnosis of refractory epilepsy

          -  Patients must be receiving a stable dose of 1 - 3 concomitant Anti-Epileptic Drugs
             (AED)

          -  Female patients without childbearing potential. Female patients with childbearing
             potential are eligible if they use a medically accepted non-hormonal contraceptive
             method

        Exclusion Criteria:

          -  Seizures occurring in clusters

          -  Status epilepticus within 3 months of Visit 1

          -  History of non-epileptic seizures

          -  Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients

          -  Pregnant or lactating women. Any woman with childbearing potential who is not using a
             medically accepted, non-hormonal method of birth control
An Extension to Study MALARIA-055 PRI (NCT00866619) to Evaluate the Long-term Efficacy, Safety and Immunogenicity of GSK Biologicals' Candidate Malaria Vaccine in Infants and Children in Africa
Condition: Malaria
MeSH terms: Malaria
Intervention: Blood sampling; Malaria Vaccine 257049 (MALARIA-055 PRI); Meningococcal C Conjugate Vaccine (MALARIA-055 PRI); Cell-culture rabies vaccine (MALARIA-055 PRI); TritanrixHepB/Hib (MALARIA-055 PRI); Polio Sabin Oral Polio Vaccine (GSK) (MALARIA-055 PRI)
Intervention description: Annual blood sampling (Year 1, Year 2 and Year 3) during the present study.; Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).; Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).; Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).; Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).; Administered orally, during the MALARIA-055 study (NCT00866619).
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3084.0
Sex: All
Minimum age: 42 Months
Maximum age: 9 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Infants; Efficacy; Children; Malaria; Plasmodium falciparum; Safety; Surveillance; Immunogenicity; RTS,S/AS01E; Africa

Summary:

      The purpose of this study is to conduct long-term surveillance for efficacy, safety and
      immunogenicity of the GSK Biologicals RTS,S/AS01E candidate Plasmodium falciparum malaria
      vaccine in infants and children in Africa following a primary vaccination series
      (NCT00866619). No new subjects will be enrolled in this extension study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects' parent(s)/ Legally Acceptable Representative (LARs) who, in the opinion of
             the investigator, can and will comply with the requirements of the protocol.

          -  Subjects who were enrolled and who received at least one vaccine dose in the primary
             study MALARIA-055 PRI NCT00866619 and who did not withdraw consent (except those who
             moved away from the area) during the primary study MALARIA-055 PRI NCT00866619.

          -  Written informed consent obtained from the parent(s)/LAR(s) of the subject.

        Exclusion Criteria:

          -  Child in care.

          -  Use of any investigational or non-registered product or planned use during the study
             period.
Safety and Efficacy Study of Insulin Lispro Versus Insulin Aspart in Participants With Type 2 Diabetes on Insulin Pump Therapy
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Insulin Lispro; Insulin Aspart
Intervention description: Insulin lispro (100 U/mL) administered by CSII pump; Insulin aspart (100 U/mL) administered by CSII pump
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin Lispro
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: diabetes; type 2 diabetes; insulin pump; continuous subcutaneous insulin infusion; CSII; A1C

Summary:

      This study will provide information on the use of insulin lispro and insulin aspart in
      insulin pumps in participants with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have type 2 diabetes (per World Health Organization [WHO] Classification of Diabetes)

          -  Have been treated with CSII therapy using a rapid-acting analog for the previous 6
             months

          -  Have a screening A1C less than or equal to 9.0% (no lower limit for A1C)

          -  Have a body mass index (BMI) less than 45 kilograms/square meter (kg/m²) at screening

          -  Have a history of stable body weight (not varying by greater than 10% for at least 3
             months prior to screening)

          -  For participants on oral anti-diabetes medications (OAMs): must have been on a stable
             dose of OAMs, labeled for use with insulin, for at least 3 months prior to study entry

        Exclusion Criteria:

          -  Have severe insulin resistance [require greater than 2 units/kilogram/day (U/kg/day)
             of insulin]

          -  Are taking or have taken within the last 3 months, antihyperglycemic medication not
             approved for use with insulin, injectable non-insulin antihyperglycemic medications,
             or have a contraindication to current antihyperglycemic medication

          -  Have a serum creatinine greater than or equal to 2 milligrams/deciliter (mg/dL) if not
             on metformin; known metabolic or lactic acidosis; any condition associated with
             hypoperfusion, hypoxemia, dehydration, or sepsis; and/or a radiologic contrast study
             within 48 hours prior to study entry

          -  Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy
             (excluding topical, intraocular, intraarticular, and inhaled preparations) or have
             received such therapy within 2 weeks immediately before screening

          -  Have had more than 1 episode of hypoglycemia (defined as requiring assistance of a
             third party due to disabling hypoglycemia) within 6 months prior to entry into the
             study