bioihbjkbjnl/mcl2 huggingface dataset:
Dose Study of ACAM2000 Smallpox Vaccine in Previously Vaccinated Adults
Condition: Smallpox
MeSH terms: Smallpox
Intervention: ACAM2000 Smallpox Vaccine; Vaccinia virus (calf lymph) smallpox vaccine: Dryvax®
Intervention description: Group 1 dose: 1.0x10-8th PFU/ml, Group 2 dose: 2.0x10-7th PFU/ml, Group 3 dose: 1.0x10-7th PFU/ml, Group 4 dose: 5.0x10-6th PFUL/ml; Group 5 dose: 1.0x10-8th PFU/ml
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 357.0
Sex: All
Minimum age: 28 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Smallpox vaccines; Dryvax®; Orthopoxvirus; Vaccinia virus; ACAM2000

Summary:

      The objective of this study is to determine the minimum dose of ACAM2000 needed to produce a
      cutaneous reaction in at least 90% of a population of healthy adults at least 28 years of age
      and previously vaccinated against smallpox.
    

Eligibility criteria:

        Inclusion criteria:

          -  have a history of previous smallpox vaccination greater than 10 years previous to the
             date of screening and presence of a vaccination scar.

          -  females must not be pregnant, lactating and must agree to use an effective form of
             birth control for the 30 days following vaccination or unable to bear children.

          -  agree to be available for the entire study and agree to comply with all requirements.

        exclusion criteria:

          -  children 1 year of age or younger in the household or be in close contact

          -  smallpox vaccination within ten years

          -  known or suspected Human immunodeficient virus (HIV) infection, primary
             immunodeficiency disorder, leukemia, lymphoma, or current radiation treatment or use
             of immunosuppressive or anti-neoplastic drugs or have a household member or intimate
             contact with the conditions listed above.

          -  renal disease

          -  current or past history of eczema or a household member or direct contact who has
             eczema.

          -  known allergy or past allergic reactions to latex gloves or to antibiotics which
             include neomycin, streptomycin, chlortetracycline, and polymyxin B

          -  known allergy or past allergic reaction to blood products.

          -  known allergy to cidofovir or sulfa-containing drugs.

          -  history of allergic phenomena following smallpox vaccination in the past, including
             urticaria, erythema multiforme, or Stevens-Johnson syndrome.

          -  transfusion of blood or treatment with any blood product.

          -  current or history of drug or alcohol abuse

          -  innoculation with any other live vaccine or participating in another drug or vaccine
             trial within 30 days of enrollment.
Uric Acid Reduction as a Novel Treatment for Pediatric Chronic Kidney Disease
Condition: Hyperuricemia; Chronic Kidney Diseases
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hyperuricemia
Intervention: Allopurinol
Intervention description: Allopurinol dosed to target uric acid levels of 3-5 mg/dL.
Intervention MeSH terms: Allopurinol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 2 Years
Maximum age: 20 Years
Healthy volunteers: No

Summary:

      Aim 1. To determine the effect of Allopurinol treatment on renal function (glomerular
      filtration rate, GFR) in pediatric chronic kidney disease (CKD) patients with high uric acid
      levels (hyperuricemia).

      Aim 2. Establish whether Allopurinol treatment reduces Nlrp3 inflammasome and renal injury
      biomarkers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic Kidney Disease stage 1-5

          -  Hyperuricemic (UA >= 5.5 mg/dL)

        Exclusion Criteria:

          -  Contraindication to Allopurinol

          -  Elevated baseline liver function tests

          -  Receiving acute or chronic dialysis

          -  Primary metabolic disorder

          -  Sickle cell disease

          -  Autosomal Dominant Polycystic Kidney Disease

          -  Cystinosis

          -  Bartter or Gitelman Disease

          -  Pregnant or nursing
Dose-Finding Study Comparing the Safety and Efficacy of Latanoprost to a Novel Treatment for Glaucoma
Condition: Primary Open Angle Glaucoma; Ocular Hypertension; Pigmentary Glaucoma; Pseudoexfoliative Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension
Intervention: PF-03187207 and Latanoprost Vehicle; Latanoprost 0.005% and PF-03187207 Vehicle
Intervention MeSH terms: Latanoprost
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 176.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of PF 03187207.
    

Eligibility criteria:

        Inclusion Criteria:

        -Diagnosis of primary open angle glaucoma (including pigmentary or pseudoexfoliative) or
        ocular hypertension in one or both eyes

        Exclusion Criteria:

        -Closed or barely open anterior chamber angle or a history of acute angle closure in either
        eye
A Study to Compare the Efficacy and Safety of Different Dosings of Olodaterol Administered With the Respimat® Inhaler in Patients With Moderate to Severe Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Placebo twice daily; Olodaterol low daily dose twice daily; Olodaterol medium daily dose twice daily; Placebo twice daily; Olodaterol high daily dose once daily and placebo; Olodaterol medium daily dose once daily and placebo
Intervention description: Inhaled Placebo of Olodaterol twice daily; Inhaled Olodaterol medium daily dose administered as low dose twice daily; Inhaled Olodaterol high daily dose administered as medium dose twice daily; Inhaled Placebo of Olodaterol twice daily; Inhaled Olodaterol high daily dose administered as one full dose once daily and placebo once daily; Inhaled Olodaterol medium daily dose administered as one full dose once daily and placebo once daily
Intervention MeSH terms: Olodaterol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Enrollment: 206.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This study will compare efficacy and safety of different regimens of olodaterol
      administration in asthma (once daily, twice daily) with placebo in a complete cross-over
      design each within one of the two daily dose groups (medium or high daily dose).
    

Eligibility criteria:

        Inclusion criteria:

          1. Patients of either sex.

          2. Aged 18 to 70 years.

          3. A current diagnosis and a documented minimum 3 month history of asthma Global
             Initiative for Asthma (GINA) treatment steps 3 and 4.

          4. Prebronchodilator Forced Expiratory Volume in one second (FEV1) >= 60% predicted and <
             90% predicted according to European Coal and Steel Community (ECSC).

          5. Increase in FEV1 >=12% and >=200 mL 15 min. after 400 µg salbutamol (albuterol);

          6. Stable on medium to high dose inhaled corticosteroids (ICS) or low to high dose ICS in
             combination with a long acting beta-adrenergics (LABA) for at least 6 weeks prior to
             screening. Stable on ICS mono component of the former fixed LABA/ICS treatment for at
             least 48 hours prior to Visit 1b.

        Exclusion criteria:

          1. Patients with a significant disease other than asthma.

          2. History of frequent seasonal exacerbations of asthma (defined as one or more seasonal
             exacerbations every year for the past three years).

          3. Upper respiratory tract infection in the past 3 weeks prior to screening visit 1b.

          4. Oral or other systemic corticosteroids in the past 6 weeks.

          5. Patients with allergen desensitization therapy if started within two years, if they
             are not on an established maintenance regimen characterized by dose adjustments but no
             further increase to the tolerable maximum in the same course of immunotherapy.
Multi-catheter High Dose Rate (HDR) Breast Brachytherapy
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: brachytherapy
Intervention description: breast brachytherapy to 34 Gy
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 127.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Breast conservation therapy (BCT) is now widely accepted as a treatment option for most women
      with Stage I and II invasive breast cancer and most patients with ductal carcinoma in situ
      (DCIS). Despite superior cosmetic outcome, BCT is more complex and requires a protracted
      treatment regimen comprised of 6 weeks of daily external beam radiation therapy to the whole
      breast. The purpose of this study is to determine if an acceptable outcome can be achieved
      with radiation delivered only to the region of the tumor bed. If this is true, partial breast
      irradiation may lend itself to much shorter treatment times (one week) and the toxicities to
      adjacent normal structures (heart, lung, chest wall) will be greatly reduced.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Invasive breast cancer or DCIS, tumor stage of Tis, T1, T2 if lesion is < 3 cm, N0 or
             N1 if 1-3 + nodes with no extracapsular extension
A Study of the Correlation Between Pharmacokinetic and Pharmacodynamic Parameters of CellCept (Mycophenolate Mofetil).
Condition: Kidney Transplantation
Intervention: mycophenolate mofetil; antibody induction; Cyclosporine; corticosteroid
Intervention description: 1 g PO BID for 24 weeks; According to manufacturer recommendation; According to manufacturer recommendation; According to manufacturer recommendation
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Antibodies; Cyclosporins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will evaluate the correlation between the pharmacokinetic and pharmacodynamic
      parameters of CellCept in patients undergoing primary kidney transplantation, in order to
      assess the impact on clinical outcome and the risks of acute rejection. All patients will
      receive oral CellCept, 1g twice daily, and pharmacokinetic and pharmacodynamic parameters
      will be measured at weeks 2, 4, 12 and 24. The anticipated time on study treatment is 24
      weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, 18 to 65 years of age

          -  Patients undergoing primary kidney transplantation

        Exclusion Criteria:

          -  Recipients of multiple organ transplants

          -  Prior therapy with CellCept

          -  Presence or history of malignancies, except for successfully treated basal or squamous
             cell carcinoma of the skin

          -  Active peptic ulcer or active serious digestive system disease that may affect the
             absorption of CellCept
Study to Assess the Efficacy and Safety of a PARP Inhibitor for the Treatment of BRCA-positive Advanced Ovarian Cancer
Condition: Ovarian Neoplasm
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: KU-0059436 (AZD2281)(PARP inhibitor); KU-0059436 (AZD2281)(PARP inhibitor)
Intervention description: oral; oral
Intervention MeSH terms: Olaparib; Poly(ADP-ribose) Polymerase Inhibitors
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: Female
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Advanced ovarian cancer; Poly(ADP ribose) polymerases; KU-0059436; AZD2281; BRCA1 protein; BRCA2 protein

Summary:

      The purpose of the study is to see if the drug KU 0059436 is effective and well tolerated in
      treating patients with measurable BRCA1- or BRCA2-positive advanced ovarian cancer and for
      whom no curative therapeutic option exists.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Advanced ovarian cancer with positive BRCA1 or BRCA2 status

          -  Failed at least one prior chemotherapy

          -  In investigators opinion, no curative standard therapy exists

          -  Measurable disease

        Exclusion Criteria:

          -  Brain metastases

          -  Less than 28 days since last treatment used to treat the disease

          -  Considered a poor medical risk due to a serious uncontrolled disorder
A Study of Emibetuzumab in Non Small Cell Lung Cancer (NSCLC) Participants
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: Emibetuzumab; Erlotinib
Intervention description: Administered IV; Administered Orally
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 111.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to evaluate the efficacy of the study drug known as
      LY2875358, administered alone or in combination with a second drug named Erlotinib, in
      participants affected by a defined type of lung cancer (MET biomarker diagnostic positive
      Non-Small-Cell Lung Cancer) that experienced a disease progression during the most recent
      treatment with Erlotinib.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of metastatic Stage IV NSCLC

          -  At least 1 measurable extra-central nervous system (CNS) lesion

          -  Documented radiographic progression while on continuous treatment with erlotinib
             monotherapy

          -  Objective clinical benefit from erlotinib treatment as defined by either documented
             partial or complete response or stable disease ≥6 months or, if most recent erlotinib
             treatment has been initiated based on documented epidermal growth factor receptor
             mutation (EGFRmt) status, at least 12 weeks stable disease

          -  Determined to be MET diagnostic positive (+)

          -  Availability of a tumor sample post-erlotinib progression

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤2

          -  Have adequate organ function

        Exclusion Criteria:

          -  Are currently enrolled in, or discontinued within the last 30 days from, a clinical
             trial involving an investigational product or non-approved use of a drug or device

          -  Have previously been treated with LY2875358 or any other MET-targeting experimental
             therapeutic

          -  Have a serious concomitant systemic disorder or significant cardiac disease

          -  Have interstitial pneumonia or interstitial fibrosis of the lung or have pleural
             effusion, pericardial fluids or ascites, requiring drainage every other week or more
             frequently

          -  Have a history of another malignancy except for basal or squamous cell skin cancer
             and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and
             without evidence of recurrence for at least 3 years prior to the study

          -  Have major surgery less than 2 weeks prior initiation of study treatment therapy

          -  Pregnant or lactating women

          -  Have symptomatic CNS metastasis
Effect of iNO on Invasively Derived Pulmonary Pressures in Patients With PAH
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: Nitric Oxide
Intervention description: Ambulatory inhaled nitric oxide delivery system and 6 minute walk distance test
Intervention MeSH terms: Nitric Oxide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Inhaled nitric oxide; Exercise; 6 minute walk test; CardioMems

Summary:

      Pulmonary hypertension is characterized by an increase in the pressures in the blood supply
      to the lungs greater than a mean pressure of 25mmHg and a concomitant increase in overall
      pulmonary vascular resistance (PVR). In patients who have remodeling of their pulmonary
      vasculature, PVR will increase with exercise instead of decreasing as it would in normal
      patients. Based on published evidence, the investigators intend to investigate the effects of
      inhaled nitric oxide (iNO) on patients undergoing standard exercise techniques who have
      separately and previously had an implanted pulmonary artery monitoring device (CardioMems by
      St Jude Medical, Inc.) placed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females age 18 to 80 years with a diagnosis of pulmonary arterial
             hypertension (WHO Group I pulmonary hypertension).

          -  Must be able to read and understand English and consent for themselves

          -  Previously implanted CardioMems continuous PA pressure

          -  Ambulatory and able to complete 6MWD test.

        Exclusion Criteria:

          -  Pregnant or lactating females; negative pregnancy test as confirmed by evaluation of
             data from pre-enrolled Risk Evaluation and Mitigation Strategies (REMS) program.
Study to Investigate Pharmacokinetics, Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) Fixed Dose Combination (FDC) in Adolescents and Children With Chronic Hepatitis C Virus (HCV) Infection
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis
Intervention: SOF/VEL/VOX
Intervention description: Administered once daily with food.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the steady-state pharmacokinetics (PK) and
      confirm the age-appropriate dose of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX)
      fixed-dose combination (FDC) in pediatric participants with chronic hepatitis C virus (HCV)
      infection.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Consent of parent or legal guardian required

          -  Chronic HCV infection

          -  Screening laboratory values within defined thresholds

          -  Individuals must have a determination of prior treatment status:

               -  DAA-naive is defined as either:

                    -  Treatment naive with no prior exposure to any interferon (IFN), ribavirin
                       (RBV), or approved or experimental HCV-specific DAA

                    -  Treatment experienced with an IFN-based regimen and no prior exposure to an
                       approved or experimental HCV-specific DAA

               -  DAA-experienced is defined as prior exposure to a regimen including any DAA (eg,
                  non-structural protein (NS)3/4A protease inhibitor, NS5A inhibitor, or NS5B
                  nucleotide/nucleoside inhibitor)

        Key Exclusion Criteria:

          -  History of clinically significant illness or any other medical disorder that may
             interfere with subject treatment, assessment or compliance with the protocol

          -  Co-infection with human immunodeficiency virus (HIV), acute hepatitis A virus (HAV) or
             hepatitis B virus (HBV)

          -  Clinical hepatic decompensation (eg, clinical ascites, encephalopathy, and/or variceal
             hemorrhage)

          -  Pregnant or nursing females

          -  Known hypersensitivity to study medication

          -  Use of any prohibited concomitant medications as within 28 days of the Day 1 visit

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Erlotinib (Tarceva) as a Single Agent or Intercalated With Combination Chemotherapy in Patients With EGFR Positive NSCLC
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: Tarceva; carboplatin; paclitaxel
Intervention description: oral tablet; IV; IV
Intervention MeSH terms: Paclitaxel; Carboplatin; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 143.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: NSCLC; Erlotinib; Tarceva; Lung Cancer

Summary:

      This will be the first prospective study where patients will be selected on the basis of two
      measures of the epidermal growth factor receptor (EGFR) pathway. The study will assess
      prospectively the efficacy of erlotinib as a single agent or intercalated with chemotherapy
      in highly selected patients with EGFR overexpression and/or EGFR amplification.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age >= 18

          -  Histologically or cytologically documented non-small cell lung cancer (NSCLC)

          -  Eastern Cooperative Oncology Group (ECOG)performance status (PS)0, 1, 2

          -  Radiologically measurable or evaluable disease No prior chemotherapy

          -  1 or 2 epithelial growth factor receptor (EGFR) pathway markers positive at screening

          -  Tumor tissue block or fine needle aspirate

        Exclusion Criteria:

          -  Any concurrent anticancer therapy or radiation

          -  Other active malignancy

          -  Uncontrolled brain metastases

          -  GI abnormalities

          -  Severe abnormalities of the cornea

          -  Significant cardiac disease

          -  Active infection