bioihbjkbjnl/mcl2 huggingface dataset:
Pilot Study of the Effect of Duavee® on Benign Breast Tissue Proliferation
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Duavee
Intervention description: Once daily tablet of Duavee (Bazedoxifene (20 mg) plus conjugated estrogen (0.45 mg))
Intervention MeSH terms: Bazedoxifene; Estrogens; Estrogens, Conjugated (USP)
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: Female
Maximum age: 61 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to learn whether daily use of Duavee® is accepted and tolerated
      by peri- and post-menopausal women at moderate risk for development of breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women with vasomotor symptoms with a uterus who are postmenopausal or in late
             menopause transition

          -  Body Mass Index (BMI) <36 kg/m2

          -  Class I-III mammogram within 6 months of Random Periareolar Fine Needle Aspiration
             (RPFNA); If Class 0 or 4, must be resolved with additional procedures

          -  If previously on oral contraceptives or hormone replacement, off for 8 weeks or more
             prior to baseline RPFNA; the exception is low dose vaginal hormones

          -  Confirmed moderate risk of developing breast cancer

          -  RPFNA results within study defined range

          -  Kidney and liver function within study defined range

          -  Willing and able to comply with study related procedures

        Exclusion Criteria:

          -  Previous biopsy showing evidence of breast cancer

          -  Have a predisposition to or prior history of thromboembolism, deep venous thrombosis,
             pulmonary embolism, or stroke

          -  History of renal or liver disease

          -  Prior ovarian or endometrial cancer

          -  Stopped or started hormone replacement within 8 weeks

          -  Any other condition or intercurrent illness that in the opinion of the investigator
             makes the woman a poor candidate for RPFNA

          -  Currently taking or have taken specific medications in the past 6 months

          -  Participation on any chemoprevention trial within 6 months

          -  Current illness which would make potential participant unsuitable for enrollment
Therapy for Pediatric Hodgkin Lymphoma
Condition: Hodgkin Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Intervention: 12 Week Stanford V Chemotherapy; 4 cycles of VAMP chemotherapy; 2 alternating cycles of VAMP/COP chemotherapy; 3 alternating cycles of VAMP/COP chemotherapy
Intervention description: 12 weeks of Stanford V chemotherapy plus low-dose, involved-field RT in children; 4 cycles of VAMP chemotherapy alone in patients who achieve a complete response after 2 cycles of VAMP chemotherapy. For patients that do not achieve a complete response after 2 cycles of VAMP, they will receive low low-dose involved field radiotherapy at the end of all chemotherapy.; 2 alternating cycles of VAMP/COP chemotherapy (total 4 cycles of chemotherapy) plus low-dose, involved-field RT.; 3 alternating cycles of VAMP/COP chemotherapy (total 6 cycles of chemotherapy) plus low-dose, involved-field RT
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 296.0
Sex: All
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Lymphoma; Hodgkin Disease

Summary:

      With the success of current chemotherapy for Hodgkin's disease, the goal of this protocol is
      to maintain the currently successful cure rate and reduce treatment related side effects and
      long term toxicity. The main purpose of this study is to estimate the event free survival of
      patients treated with risk-adapted therapy compared to historical controls.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eligible patients must have histologically confirmed previously untreated Hodgkin's
             disease (Patients receiving limited emergent RT or steroid therapy because of
             cardiopulmonary decompensation or spinal cord compression will be eligible for
             protocol enrollment).

          -  Patients must be 21 years of age or younger

          -  Ann Arbor stages IIB-IV

          -  No prior treatment.

          -  No pregnant or lactating women.

          -  Signed informed consent

          -  If re-evaluation of a patient's disease shows favorable risk features or intermediate
             risk features, the patient will be removed from the HOD99 study and consented to the
             respective HOD08 or HOD05 study.

        Inclusion: treatment of favorable risk features:

          -  Ann Arbor IA or IIA with:

               1. Non-bulky mediastinal disease (<33% mediastinal to thoracic ratio on chest x ray)

               2. Ann Arbor stage IA or IIA with any of the following features: (1) "E" lesions
                  (s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy
                  (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph)

                  Inclusion: unfavorable risk features:

          -  Stage must be classified as one of the following:

               1. Ann Arbor stage IIB, IIIB, or any IV
A Study of Plazomicin Compared With Levofloxacin for the Treatment of Complicated Urinary Tract Infection (cUTI) and Acute Pyelonephritis (AP)
Condition: Complicated Urinary Tract Infection; Acute Pyelonephritis
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Pyelonephritis
Intervention: levofloxacin; plazomicin; placebo
Intervention MeSH terms: Levofloxacin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 145.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: urinary tract infection; UTI; cUTI; pyelonephritis; AP; ACHN-490

Summary:

      This was a multi-center, multi-national, double-blind, randomized, comparator-controlled
      study of plazomicin administered intravenously compared with levofloxacin, a standard
      approved intravenous therapy for complicated urinary tract infection (cUTI) and acute
      pyelonephritis (AP).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Documented or suspected cUTI/AP with clinical signs and symptoms

          -  Normal kidney function defined as creatinine clearance (CLcr) of ≥60mL/min using
             Cockcroft-Gault formula

        Key Exclusion Criteria:

          -  Acute bacterial prostatis, orchitis, epididymitis, or chronic bacterial prostatis

          -  Gross heanaturia requiring intervention other than study drug

          -  Urinary tract surgery within 7 days of randomization or during the study period

          -  A known nonrenal source of infection diagnosed within 7 days of randomization

          -  A corrected QT interval > 440 msec

          -  History of hearing loss with onset before the age of 40 years, sensorineural hearing
             loss, or family history of hearing loss

          -  Pregnant or breastfeeding women
A Study of LY2189265 in Japanese Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: LY2189265; Placebo
Intervention description: Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.; Administered by SC injection, QW for 12 weeks.
Intervention MeSH terms: Dulaglutide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 145.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Metabolic Diseases; Glucose Metabolism Disorders; Diabetes; GLP-1; Lilly

Summary:

      The main purpose of this study is to assess dose-response characteristics in Japanese
      patients with Type 2 Diabetes taking LY2189265 monotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese patients with type 2 diabetes with a body mass index (BMI)≥18.5 kilograms per
             square meter (kg/m^2) but <40.0 kg/m^2.

          -  Patients who are oral antidiabetic drug (OAD) naïve or are taking OAD monotherapy
             except for a dipeptidyl peptidase-4 inhibitor (DPP-IV) and are willing to discontinue
             their OAD.

          -  Patients who are OAD naïve with screening glycosylated hemoglobin (HbA1c) value of
             7.0% to 9.5% and randomization HbA1c value of 7.0% to 9.5%, or who are taking OAD
             monotherapy with screening HbA1c value of 6.0% to 8.5% and randomization HbA1c value
             of 7.0% to 9.5%.

          -  Patients who have, in the opinion of the investigator, a stable weight during the 12
             weeks prior to screening.

        Exclusion Criteria:

          -  Patients who are currently taking prescription medications to promote weight loss

          -  Patients who are receiving chronic systemic glucocorticoid therapy, or have received
             such therapy within 4 weeks immediately prior to screening.

          -  Patients who have a known clinically significant gastrointestinal disorder, have
             undergone excision of all or any part of the gastrointestinal tract, have undergone
             gastric bypass surgery for treatment of obesity, or chronically take drugs that
             directly influence gastrointestinal motility.

          -  Patients who have poorly controlled hypertension, renal artery stenosis, or evidence
             of labile blood pressure including symptomatic postural hypotension.

          -  Patients who have obvious clinical signs or symptoms of pancreatitis, a history of
             chronic pancreatitis or acute pancreatitis. Patients who have amylase and/or lipase of
             1.5 times or more the upper limit of the reference range.

          -  Have a family history, obvious clinical signs, or symptoms of medullary carcinoma of
             thyroid.
Study of Dasatinib (BMS-354825) in Patients With Advanced Estrogen/Progesterone Receptor-positive (ER+/PR+) or Her2/Neu-positive (Her2/Neu+)Breast Cancer
Condition: Breast Cancer; Metastasis
MeSH terms: Breast Neoplasms
Intervention: Dasatinib; Dasatinib 100 mg
Intervention description: Tablets, Oral, 70 mg, twice daily, as long as the participant benefits (average <6 months); Tablets, Oral, 100mg, twice daily, as long as the participant benefits (average <6 months)
Intervention MeSH terms: Dasatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 92.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Recurrent, locally-advanced, or metastatic breast cancer

Summary:

      This study will determine whether the investigational drug dasatinib is effective in
      treatment of women with progressive advanced ER+/PR+ or Her2/neu+ breast cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  females, 18 or older

          -  recurrent, locally advanced, or metastatic breast cancer with expression of ER/PR
             receptor and/or overexpression of Her2/neu

          -  paraffin-embedded tissue block must be available

          -  measurable disease

          -  prior chemotherapy with an anthracycline and/or a taxane (neoadjuvant, adjuvant, or
             metastatic setting)

          -  0, 1 or 2 chemotherapies in the metastatic setting

          -  adequate organ function

        Exclusion Criteria:

          -  Metastatic disease confined to bone only

          -  Symptomatic central nervous system (CNS) metastasis

          -  Concurrent medical condition which may increase the risk of toxicity

          -  Unable to take oral medication
PASS Study To Evaluate The Potential Of Zithromax To Cause Ocular Problems In Pediatric Patients
Condition: Pharyngitis; Tonsillitis
MeSH terms: Pharyngitis; Tonsillitis
Intervention: Azithromycin
Intervention description: Azithromycin oral suspension (immediate release) 12 mg/kg/day x 5 days
Intervention MeSH terms: Azithromycin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Ocular safety; azithromycin; pharyngitis; tonsillitis

Summary:

      This Post-Authorization Safety Study (PASS) is intended to fulfill a regulatory
      post-marketing requirement to provide data regarding visual abilities in children taking
      azithromycin (immediate-release formulation) for acute pharyngitis/tonsillitis. The primary
      objective of the study is to examine the incidence of clinically significant worsening in any
      of the following ophthalmic exams: best corrected visual acuity (distance), color vision,
      Amsler grid testing, anterior segment biomicroscopy, and fundus examination, in a group of
      approximately 30 pediatric patients taking azithromycin oral solution for treatment of an
      authorized indication of use (pharyngitis/ tonsillitis).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patient, aged 12 to 17 years.

          -  Requires outpatient treatment for acute pharyngitis/tonsillitis infection.

          -  Appropriate to treat with oral azithromycin as an alternative to intramuscular
             penicillin, in the opinion of the investigator.

          -  Positive rapid antigen detection test.

        Exclusion Criteria:

          -  History of clinically significant eye disorder that would interfere with protocol test
             procedures.

          -  Hypersensitivity to azithromycin, erythromycin, any macrolide, or ketolide antibiotic.

          -  Increased risk of QT prolongation.

          -  Pregnant or breastfeeding.
The Impact of Adjuvant Liquid Alginate on Endoscopic Ablation Therapy of Complicated Barrett's Esophagus
Condition: Barretts Esophagus With Dysplasia
MeSH terms: Barrett Esophagus
Intervention: Alginates
Intervention description: Liquid Alginate therapy will be added to twice daily PPI regimen. Patients will be asked to take the alginate solution four times daily (following meals and at bedtime) at 10ml/dose.
Intervention MeSH terms: Alginate, aluminium hydroxide, magnesium trisilicate, sodium bicarbonate drug combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: This is a pilot prospective cohort study at a single tertiary center who will be compared to historical controls.
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Barrett's; GERD; reflux; alginate solution; proton pump inhibitor

Summary:

      This study evaluates the addition of an alginate based solution to twice daily proton pump
      inhibitor therapy (PPI) in patients undergoing ablative therapy for dysplastic Barrett's
      esophagus. The investigators hypothesize that the addition of this medication will help to
      achieve complete remission of Barrett's over a shorter period of time.
    

Eligibility criteria:

        Inclusion Criteria:

          -  (1) Age 18 (2) Biopsy-proven complicated BE (low/high grade grade dysplasia or IMC,
             confirmed by our institution's GI pathologist) As part of standard of care, all
             patients' biopsies will be confirmed with the institutions' GI pathologist and, either
             with outside biopsies or from biopsies completed at the primary institution.

        Exclusion Criteria:

          -  1) Moderate to severe renal impairment, as defined by eGFR< 60 for 2 consecutive
             readings (2) Lack of capacity for decision-making (3) Allergy to hydroxybenzoates (4)
             Patients with uncontrolled hypertension or decompensated heart failure (5) Pregnancy-
             patients of child-bearing potential will be tested. (6) Patients with elevated calcium
             or potassium on screening laboratory testing (labs completed within the last month)
MGTA-145 + Plerixafor in the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: MGTA-145; Plerixafor
Intervention description: A chemokine receptor type 2 (CXCR2) agonist protein, administered via intravenous (IV) infusion over 3 to 10 minutes.; An azamacrocycle CXCR4 chemokine receptor antagonist, administered at 0.24 mg/kg subcutaneously, reduced to 0.16 mg/kg in patients with renal dysfunction (per package insert).
Intervention MeSH terms: Plerixafor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This study evaluates a new drug MGTA-145 in combination with plerixafor (Mozobil) to mobilize
      stem cells into the peripheral blood for collection by apheresis. The stem cells will be used
      for autologous stem cell transplant for treatment of multiple myeloma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of multiple myeloma (MM) per the International Myeloma Working Group (IMWG)
             criteria

          -  Eligible for autologous stem cell transplantation (ASCT) per institutional guidelines

          -  Within 1 year of start of therapy for multiple myeloma

          -  Cardiac and pulmonary status sufficient to undergo apheresis and transplantation per
             institutional transplant guidelines

          -  Calculated creatinine clearance > 30 mL/min, according to the Modification of Diet in
             Renal Disease (MDRD) formula.

          -  Absolute neutrophil count (ANC) > 1500 x 10e6/L

          -  Platelet count > 100,000 x 10e6/L

          -  Ability to understand and the willingness to sign a written informed consent document.

          -  Agreement to use an approved form of contraception for male patients or female
             patients of childbearing potential.

        Exclusion Criteria:

          -  History of prior stem cell transplant for multiple myeloma or other indications

          -  Planned tandem stem cell transplant

          -  Prior history of failure to collect HSCs.

          -  Total bilirubin > 1.5x upper limit of normal (ULN) in the absence of a documented
             history of Gilbert's syndrome

          -  Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 3x ULN

          -  Known allergy to MGTA-145 or plerixafor.

          -  Lifetime exposure to lenalidomide or another immunomodulatory drug greater than 6
             cumulative months of treatment, ie, > 6 cycles of 28 days or > 8cycles of 21 days

          -  Pregnant or lactating
Efficacy and Safety of Pemigatinib in Participants With Solid Tumors With FGFR Mutations or Translocations (FIGHT-208)
Condition: Advanced or Metastatic Solid Tumors; FGFR Mutations; FGFR Translocations
MeSH terms: Neoplasms
Intervention: Pemigatinib
Intervention description: Pemigatinib administered orally once daily.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Participants will be assigned to 1 of 2 cohorts (Cohort A: FGFR1-3 in-frame fusions or FGFR2 intron 17 rearrangements; Cohort B: Known/predicted activating point mutations in FGFR1-3 [excluding kinase domain]) but there is no difference in the treatment regimen between the cohorts.
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced solid tumor; metastatic solid tumor; FGFR inhibitor; FGFR mutation; FGFR translocation

Summary:

      The purpose of this study is to evaluate the efficacy and safety of pemigatinib in
      participants with previously treated locally advanced/metastatic or surgically unresectable
      solid tumors harboring activating FGFR mutations or translocations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed solid tumor malignancy that is advanced or
             metastatic (Stage IIIB or IV) or is surgically unresectable.

          -  Radiographically measurable disease (per RECIST v1.1 or RANO for primary brain
             tumors).

          -  Documentation of an FGFR1-3 gene mutation or translocation.

          -  Objective disease progression after at least 1 prior therapy.

          -  Not eligible or able to participate in any other Incyte-sponsored clinical trial.

        Exclusion Criteria:

          -  Advanced/metastatic bladder cancer or advanced/metastatic cholangiocarcinoma.

          -  Prior receipt of a selective FGFR inhibitor.

          -  Current evidence of clinically significant corneal or retinal disorder.

          -  History of calcium and phosphate hemostasis disorder or systemic mineral imbalance
             with ectopic calcification of soft tissues.
A Study to Evaluate the Safety and Efficacy of an Investigational Drug in HIV Infected Patients (0518-004)(COMPLETED)
Condition: HIV Infections; Acquired Immunodeficiency Syndrome
MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes
Intervention: Comparator: MK0518 monotherapy; Comparator: MK0518 combination therapy; Comparator: efavirenz; Comparator: tenofovir; Comparator: lamivudine; Placebo monotherapy
Intervention description: MK0518 twice daily for 10 days; MK0518 twice daily for 48 weeks; efavirenz 600 mg every night at bedtime for 48 weeks; tenofovir 300 mg daily for 48 weeks; lamivudine 300 mg daily for 48 weeks; Placebo to MK0518 twice daily
Intervention MeSH terms: Tenofovir; Lamivudine; Efavirenz; Raltegravir Potassium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 206.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a study that will investigate the safety and efficacy of an investigational drug in
      Human immunodeficiency virus (HIV) infected patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient must be HIV positive who must have received less than 7 days total of any
             antiretroviral therapy (HIV related therapy)

        Extension Studies:

          -  First extension: Patient completed the 48-week base study

          -  Second extension: Patient completed the first 144-week extension study

        Exclusion Criteria:

          -  Less than 18 years of age

          -  Individuals who currently do not test positive for HIV