bioihbjkbjnl/mcl2 huggingface dataset:
Paclitaxel in Treating Patients With Ovarian Stromal Cancer
Condition: Adult Type Ovarian Granulosa Cell Tumor; Ovarian Gynandroblastoma; Ovarian Sertoli-Leydig Cell Tumor; Ovarian Sex Cord Tumor With Annular Tubules; Ovarian Steroid Cell Tumor
MeSH terms: Neoplasms; Granulosa Cell Tumor; Leydig Cell Tumor; Sertoli-Leydig Cell Tumor; Sex Cord-Gonadal Stromal Tumors
Intervention: Paclitaxel
Intervention description: Given IV
Intervention MeSH terms: Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: Female
Healthy volunteers: No

Summary:

      This phase II trial studies the effectiveness of paclitaxel in treating patients who have
      ovarian stromal cancer. Drugs used in chemotherapy use different ways to stop tumor cells
      from dividing so they stop growing or die.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients diagnosed with histologically confirmed ovarian stromal tumor (granulosa cell
             tumor, granulosa cell-theca cell tumor, Sertoli-Leydig cell tumor [androblastoma],
             steroid [lipid] cell tumor, gynandroblastoma, unclassified sex cord stromal tumor, sex
             cord tumor with annular tubules)

          -  Patients must have recurrent stromal tumor having received no more than one prior
             chemotherapy regimen

          -  Patients must have measurable disease as defined by Gynecological Oncology Group (GOG)
             Response Evaluation Criteria in Solid Tumors (RECIST) criteria

          -  White blood count equal to or greater than 3000/mcl

          -  Granulocyte count equal to or greater than 1500/mcl

          -  Platelet count equal to or greater than 100,000/mcl

          -  Creatinine equal to or less than 2.0 mg%

          -  Bilirubin less than or equal to 1.5 times normal

          -  Serum glutamic oxaloacetic transaminase (SGOT) less than or equal to 3 times normal

          -  Patients with a GOG performance grade of 0, 1 or 2

          -  Patients of child bearing potential must have a negative pregnancy test and must agree
             to practice an effective means of birth control

          -  Patients who have met the pre-entry requirements as specified

          -  Patients must have signed an approved informed consent and Health Insurance
             Portability and Accountability Act (HIPAA) authorization

        Exclusion Criteria:

          -  Patients with GOG performance grade of 3 or 4

          -  Patients with a prior invasive malignancy (except non-melanoma skin cancer) who have
             had any evidence of disease within the last 5 years or whose prior malignancy
             treatment contraindicates the current protocol therapy

          -  Patients having received more than one prior chemotherapy regimen

          -  Patients amenable to cure by surgery

          -  Patients with prior radiation except for those whose recurrent disease is outside the
             radiation port
BI 671800 ED in Steroid-naive Asthmatic Patients
Condition: Asthma
MeSH terms: Asthma
Intervention: BI 671800; Fluticasone propionate placebo; Fluticasone propionate; BI 671800 Placebo
Intervention description: BI 671800; Placebo matching Fluticasone propionate; Fluticasone propionate; Placebo matching BI 671800
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 389.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a 6 week study to investigate the effectiveness and safety of BI 671800 ED in
      patients with asthma who do not take inhaled corticosteroids.
    

Eligibility criteria:

        Inclusion criteria:

          1. Signed informed consent consistent with ICH-GCP

          2. Three month history of reversible (12% with 200 mL) asthma (according to GINA) with
             following spirometry at randomization: FEV1 60%-85%.

          3. No ICS previous 3 months prior to screening.

          4. Diagnosis of asthma prior to 40 years.

          5. ACQ at least 1.5 at randomization.

          6. Male or female, 18 to 65 years.

          7. Non-smokers or ex-smokers ( less than 10 pack year history) with negative cotinine
             screen.

          8. Able to perform PFT

        Exclusion criteria:

          1. Significant diseases other than asthma or allergic rhinitis.

          2. Hepatic transaminases or total bilirubin greater than 1.5 ULN.

          3. Hospitalizations for asthma or asthma related intubation within 3 months.

          4. Uncontrolled asthma.

          5. Respiratory tract infection or exacerbation within 4 weeks.

          6. FEV1 less than 40%, more than 12 puffs of SABA on more than two consecutive days or
             asthma exacerbation during the run-in period.

          7. Participation in another interventional study.

          8. Pregnant or nursing women.

          9. Women of child bearing potential nor using appropriate methods of birth control as
             defined by protocol
AGN-151586 Dose-Ranging Study for Treatment of Glabellar Lines
Condition: Glabellar Lines
Intervention: AGN-151586; Placebo
Intervention description: AGN-151586 solution for injection.; Placebo solution for injection.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 198.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of AGN-151586 over a range
      of doses for the treatment of moderate to severe glabellar lines (GL).
    

Eligibility criteria:

        Inclusion Criteria:

        -Female participants willing to minimize the risk of inducing pregnancy for the duration of
        the clinical study and follow-up period (at least 10 weeks after study intervention).

        Exclusion Criteria:

          -  Known immunization or hypersensitivity to any botulinum neurotoxin serotype

          -  Any medical condition that may put the participant at increased risk with exposure to
             AGN-151586, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic
             lateral sclerosis, or any other condition that might interfere with neuromuscular
             function

          -  Marked facial asymmetry, dermatochalasis, deep dermal scarring, excessively thick
             sebaceous skin, or the inability to substantially lessen facial lines even by
             physically spreading them apart, as determined by the investigator

          -  Any brow or eyelid ptosis, as determined by the investigator

          -  Infection or skin disorder at the injection sites

          -  History of facial nerve palsy

          -  Any uncontrolled systemic disease

          -  Anticipated need for treatment with botulinum neurotoxin of any serotype for any
             reason during the study (other than study intervention)

          -  Anticipated need for surgery or overnight hospitalization during the study

          -  Prior periorbital surgery, facial lift (full face or mid-face), thread lift, brow
             lift, or related procedures (eg, eyelid [blepharoplasty] and/or eyebrow surgery)

          -  Prior facial treatment with permanent soft tissue fillers, synthetic implantation (eg,
             Gore-Tex®), and/or autologous fat transplantation

          -  Current enrollment in an investigational drug or device study or participation in such
             a study within 30 days of Screening
The Utility of 18F-DOPA-PET in the Treatment of Recurrent High-grade Glioma
Condition: Glioma
MeSH terms: Glioma
Intervention: Fluorine F 18 Fluorodopa; Intensity-Modulated Radiation Therapy; Positron Emission Tomography
Intervention description: Contrast used in PET; Radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor; imaging test
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This proposal is for a pilot study comparing volumes of 18F-DOPA-PET avidity with contrast
      enhancement and T2 FLAIR on MRI. Investigators then plan to compare patterns of failure with
      target volumes, pre-treatment MRI changes and pre-treatment 18F-DOPA-PET.
    

Eligibility criteria:

        Inclusion Criteria

          -  Age > or equal to 18 years

          -  ECOG PS < or equal to 3

          -  Histologically confirmed or radiographic evidence of recurrent/progressive glioma.

          -  History of radiation therapy to the brain for prior diagnosis of glioma

          -  Planned radiation treatments at Mayo Clinic Rochester

          -  Provide informed written consent

          -  Willing to sign consent onto the Mayo Clinic Radiotherapy Patient Outcomes Registry
             and Biobanking study, IRB number 15-000136 (blood draw optional)

          -  Willing to return to enrolling institution for follow-up during Active Monitoring
             Phase of the study.

        Exclusion Criteria

          -  More than one prior course of radiotherapy or prior prescription doses exceeding 60 Gy
             to re-irradiation target volumes

          -  Unable to undergo MRI scans with contrast

          -  Unable to undergo an 18F-DOPA-PET scan (e.g., Parkinson's Disease, taking anti
             dopaminergic, or dopamine agonist medication or less than 6 half-lives from
             discontinuance of dopamine agonists.)

        Note: Other potentially interfering drugs: amoxapine, amphetamine, benztropine, buproprion,
        buspirone, cocaine, mazindol, methamphetamine, methylphenidate, norephedrine, phentermine,
        phenylpropanolamine, selegiline, paroxetine, citalopram, and sertraline). If a patient is
        on any of these drugs, list which ones on the On-Study form.

        -Any of the following:

          -  Pregnant women

          -  Nursing women

          -  Men or women of childbearing potential who are unwilling to employ adequate
             contraception
Post-operative Radiation With Cetuximab for Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck
Condition: Head and Neck Cancer
MeSH terms: Carcinoma, Squamous Cell; Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck
Intervention: Cetuximab; Radiation Therapy
Intervention description: 400 mg/m2 IV over 120 minutes week 1; 250 mg/m2 IV over 60 minutes weekly weeks 2-7; Radiation Therapy 60-66 Gy in 2 Gy fractions starting week 2 of Cetuximab
Intervention MeSH terms: Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: head and neck cancer

Summary:

      The standard treatment of surgery followed by radiation therapy can stop tumors from growing
      in the head and neck region in most patients. However, the cancer can recur or can spread to
      other parts of the body. Cetuximab is a drug that may delay or prevent tumor growth by
      blocking certain cellular chemical pathways that lead to tumor development. It was approved
      by the United States Food and Drug Administration (FDA) in 2006 for the treatment of head and
      neck cancer.

      The purpose of this study is to determine how easily cetuximab can be added to treatment with
      radiation therapy in patients with cutaneous cancer of the head and neck. This study will
      also look at how well cetuximab added to radiation therapy works over time and how well this
      treatment is tolerated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically (histologically) proven diagnosis of cutaneous squamous cell carcinoma
             of the head and neck

          -  Clinical stage >/= T3 or >/= N1, M0 including no distant metastases

          -  Gross total resection of the primary tumor with curative intent must be completed
             within 7 weeks of registration

          -  Performance status of 0-1 within 2 weeks prior to registration

          -  Age >/= 18

          -  Adequate labs within 2 weeks prior to registration

        Exclusion Criteria:

          -  Prior invasive malignancy unless disease free for a minimum of 3 years; noninvasive
             cancers (For example, carcinoma in situ of the breast, oral cavity, or cervix are all
             permissible) are permitted even if diagnosed and treated < 3 years ago. Patients with
             a history of T1-2, N0, M0 resected differentiated thyroid carcinoma are considered
             eligible.

          -  Prior systemic chemotherapy or anti-epidermal growth factor therapy for the study
             cancer or for a different prior cancer

          -  Prior radiotherapy to the region of the study cancer that would result in overlap of
             radiation therapy fields
Study to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine Given With Prevnar 13 in Healthy Infants
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Intervention: Multivalent; Prevnar 13
Intervention description: Pneumococcal conjugate vaccine; Pneumococcal conjugate vaccine
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 565.0
Sex: All
Minimum age: 42 Days
Maximum age: 98 Days
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a Phase 2, randomized, active-controlled, open-label study with a 3-arm parallel
      design. Healthy 2-month old infants (42 to 98 days of age) with no history of pneumococcal
      vaccination will be randomized in a 1:1:1 ratio to receive a 4-dose series of: multivalent
      pneumococcal conjugate vaccine coadministered with Prevnar 13 (Group 1); multivalent
      pneumococcal conjugate vaccine given 1 month after Prevnar 13 (Group 2); or Prevnar 13 with a
      single dose of multivalent pneumococcal conjugate vaccine (Group 3).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female infant born at >36 weeks of gestation and aged 2 months (42 to 98 days)
             at the time of consent (the day of birth is considered day of life 1).

          -  Healthy infant determined by medical history, physical examination, and clinical
             judgment.

        Exclusion Criteria:

          -  Previous vaccination with licensed or investigational pneumococcal vaccine.

          -  Prior receipt of routine pediatric vaccines, with the exception of hepatitis B
             vaccine.

          -  Previous receipt of >1 dose of hepatitis B vaccine.

          -  Prior hepatitis B vaccine must have been administered at age <30 days.

          -  Major known congenital malformation or serious chronic disorder.

          -  Receipt of blood/plasma products or immunoglobulins.
Network-Level Mechanisms for Preclinical Alzheimer's Disease Development
Condition: APOE 4
MeSH terms: Alzheimer Disease
Intervention: AGB101 220 mg; Placebo
Intervention description: AGB101 oral dose of 220 mg/day capsule, given as once-daily dosing.; Placebo, oral capsule given once-daily.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a randomized, double-blind, placebo-controlled crossover study in which a low dose of AGB101 (220mg QD) or placebo will be administered to 50 healthy 55-75-year-old subjects, with the order of treatments counterbalanced in a within-subject crossover design.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 26.0
Sex: All
Minimum age: 55 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy; Adult; Normal Memory; APOE 4; Brain; Magnetic Resonance Imaging; MRI; Alzheimer's disease; Hippocampus; Genetic testing; Dementia; AGB101

Summary:

      The purpose of this project is to test the hypothesis that AGB101 low dose levetiracetam
      extended release formulation can reduce abnormal hyperfunctional activity in the hippocampus
      in normal, healthy adults. The investigators will compare the functional connectivity results
      after taking AGB101 or placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Fluent in English

          -  At least eight (8) years of education

          -  Geriatric Depression Scale (GDS) (62) score < 6

          -  Hachinski Ischemic Score ≤ 4

          -  Normal general cognitive function as well as 1) normal memory function, documented by
             MOCA score of 23 or greater, and a RBANS Delayed Memory Index score of 85 or greater.

        Exclusion Criteria:

          -  Neurological disease, such as Parkinson's disease, multi-infarct dementia,
             Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive
             supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or a
             history of significant head trauma or known structural brain abnormalities

          -  Major psychiatric disease or chronic unstable medical conditions

          -  History of drug abuse

          -  History of alcohol abuse (4 or greater drinks per day on average)

          -  Unable to complete MRI scans (no Pacemaker/Defibrillator)

          -  Known clinically significant abnormalities in B12 or thyroid function tests

          -  End Stage Renal Disease (ESRD)

          -  Hemodialysis (HD)
Phase 2 Safety and Efficacy Study of Zilucoplan (RA101495) to Treat PNH Patients Who Have an Inadequate Response to Eculizumab
Condition: Paroxysmal Nocturnal Hemoglobinuria (PNH)
MeSH terms: Hemoglobinuria; Hemoglobinuria, Paroxysmal
Intervention: Zilucoplan (RA101495)
Intervention description: 0.3 mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PNH

Summary:

      The purpose of the study is to evaluate the safety and efficacy of RA101495 in patients with
      paroxysmal nocturnal hemoglobinuria (PNH) who have an inadequate response to eculizumab.
      Patients will be treated with RA101495 for 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of PNH by flow cytometry

          -  Inadequate response to eculizumab defined as having received eculizumab for at least 6
             months plus a documented LDH level ≥ 1.5 x the upper limit of normal (ULN) and/or the
             presence of a known C5 mutation conferring resistance to eculizumab

        Exclusion Criteria:

          -  History of meningococcal disease

          -  Current systemic infection or suspicion of active bacterial infection
Role of Intravitreal Aflibercept Injection for the Treatment of Radiation Maculopathy
Condition: Adverse Effect of Radiation Therapy
MeSH terms: Macular Degeneration
Intervention: aflibercept
Intervention description: This study will consist of 2 simultaneous treatment arms of aflibercept: A six week dosing regimen arm and a treat and extend (TAE) dosing regimen arm, total duration 54 weeks. In the TAE arm the patients will receive an intravitreal aflibercept injection first visit, again at the second visit at 6 weeks, and then begin treat and extend from second injection forward.
Intervention MeSH terms: Aflibercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Radiation Retinopathy; aflibercept

Summary:

      The primary objective of the study is to assess the safety of intravitreal aflibercept
      injection in treating visually compromising radiation maculopathy secondary to treatment of
      uveal melanoma by iodione-125 brachytherapy. The study will consist of two arms of 25
      patients each (totaling 50 patients). Subjects in arm 1 will undergo treatment every 6 weeks.
      Subjects in arm 2 will undergo treatment and if improvement is documented at the following
      evaluation the next treatment will be extended by two weeks. Secondary objectives of the
      study include evaluation and analysis of visual acuity, number of injections, macular edema,
      and vascular activity between both arms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A Patient must meet the following criteria to be eligible for inclusion in the study:

               1. 21 years of age and over

               2. 20/800 or better visual acuity

               3. Must have received previous treatment for radiation maculopathy within the last
                  4-26 weeks

               4. Any presence of macular edema (evaluated by SD-OCT) caused by radiation
                  retinopathy

               5. Willing and able to comply with clinic visits and study-related procedures

               6. Provide signed informed consent

        Exclusion Criteria:

          -  A patient who meets any of the following criteria will be excluded from the study:

               1. Patients less than 21 years of age.

               2. Patients with mental disability or any other condition that precludes the
                  acquisition of an sdOCT image such as (nystagmus, neck disease, etc.)

               3. Patients who have previously been treated with intravitreal triamcinolone
                  acetonide for macular edema (signs of recalcitrant disease)