bioihbjkbjnl/mcl2 huggingface dataset:
JUNIPER: A Phase 2 Study to Evaluate the Safety, Biological Activity, and PK of ND-L02-s0201 in Subjects With IPF
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Intervention: ND-L02-s0201 (Low Dose); ND-L02-s0201 (High Dose); Other: Placebo
Intervention description: Intravenous administration every 2 weeks; Intravenous administration every 2 weeks; Saline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 123.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      A phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the
      safety, tolerability, biological activity, and pharmacokinetics (PK) of ND-L02-s0201 for
      Injection in subjects with IPF.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Forced vital capacity (FVC) ≥ 45% of predicted.

          -  Diffusion capacity of the lung for carbon monoxide (DLco) corrected for hemoglobin ≥
             30% of predicted value

          -  Ratio of forced expiratory volume in 1 second (FEV1) to FVC ≥ 0.70.

        Exclusion Criteria:

          -  Best, acceptable FVC from separate screening spirometry that differ by ≥ 200 mL.

          -  Respiratory exacerbation(s) or hospitalization for IPF exacerbation within 3 months
             before screening.

          -  Anticipated to receive a lung transplant during the subject's participation in the
             study.

          -  Active smoker or smoking cessation within 12 weeks before screening.

          -  Malignancy within the last 5 years, with the exception of curable cancer that has
             received adequate treatment.

          -  Evidence of any unstable or untreated, clinically significant disease or condition
             that, in the opinion of the Investigator, might confound the interpretation of the
             study or place the subject at increased risk.

          -  Treatment with high dose corticosteroids, cytotoxic agents, unapproved IPF targeted
             therapy, and cytokine modulating agents within 8 weeks or 5 half-lives (whichever is
             longer) before screening

          -  Participation in an investigational study with the last dose of investigational
             product occurring within 8 weeks or 5 half-lives (whichever is longer) before
             screening.

          -  Pregnant or breastfeeding.

          -  Medical history of infection with HIV, hepatitis B, or hepatitis C.

          -  History of alcohol abuse and/or dependence within the last 2 years.

          -  History within the last 2 years of significant mental illness, or physical dependence
             on any opioid or illicit drugs.

        Other protocol defined inclusion/exclusion criteria could apply.
Effects of Intravenous GC4419 on the Incidence and Severity of Esophagitis Due to Chemoradiotherapy for Lung Cancer
Condition: Esophagitis
MeSH terms: Esophagitis
Intervention: GC4419 (avasopasem manganese)
Intervention description: 90 mg, by 60-minute IV infusion, prior to each fraction of RT
Intervention MeSH terms: Manganese; Avasopasem manganese
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      GTI-4419-203 will be an open-label, multi-center study to evaluate GC4419 (avasopasem
      manganese) administered intravenous (IV) for the reduction of radiation induced esophagitis
      in subjects receiving chemoradiotherapy for unresectable Stage 3A/3B or post-operative Stage
      2B Non-Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC) treatable with
      chemoradiotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects scheduled to be treated with (definitive or adjuvant) radiation therapy in
             combination with chemotherapy once daily for Stage 3A/3B or post-operative Stage 2B
             NSCLC or limited stage SCLC

          2. Treatment plan for subjects show that 5 cm of the esophagus for at least one surface,
             is included in the 60 Gy isodose volume. Dose volume histograms show esophagus dose
             exposure meet V38>30% and/or V60>20%

          3. Age 18 years or older

          4. ECOG performance status ≤ 2

          5. Adequate hematologic, renal and liver function

          6. Use of highly effective contraception

        Exclusion Criteria:

          1. Metastatic disease

          2. Prior radiation therapy to the region of the study cancer

          3. Subjects not receiving chemotherapy

          4. Grade 2 or greater esophagitis at baseline

          5. Inability to provide information in the electronic symptom-reporting device

          6. Receiving any approved or investigational immunotherapy, targeted therapy, hormone
             therapy, or biologic therapy

          7. Participation in another clinical trial or use of another investigational agent within
             30 days of first does of GC4419

          8. Malignant tumors other than the current lung cancer within the last 5 years

          9. Previous diagnosis of pneumonitis

         10. Untreated, active infectious disease requiring systemic anti-infective therapy

         11. Untreated HIV or active hepatitis B/C

         12. Females who are pregnant or breastfeeding

         13. Known allergies or intolerance to chemotherapy and similar platinum-containing
             compounds

         14. Requirement for concurrent treatment with nitrates or other drugs that may create a
             risk for a precipitous decrease in blood pressure

         15. Clinically significant heart disease
Treadmill Cardiovascular Safety Study of Erenumab (AMG 334)
Condition: Stable Angina
MeSH terms: Angina Pectoris; Angina, Stable
Intervention: Erenumab; Placebo
Intervention description: A single dose of erenumab 140 mg infused over approximately 60 minutes.; A single dose of a matching volume of placebo infused over approximately 60 minutes.
Intervention MeSH terms: Erenumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 89.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Angina; Stable Angina; Cardiovascular Disease; Exercise-induced Angina

Summary:

      A phase 2a, multicenter, randomized, double-blind, placebo-controlled study in adults with
      stable angina to evaluate the effect of erenumab (AMG 334) compared to placebo on exercise
      time during an exercise treadmill test.
    

Eligibility criteria:

        Inclusion Criteria

          -  History of chronic stable angina or at least 3 months prior to screening, with at
             least 1 angina episode per month

          -  Ischemic heart disease documented by myocardial infarction, coronary angiography or a
             revascularization procedure

          -  Receiving stable doses of cardiac medication

          -  Completes 2 exercise treadmill tests during screening meeting protocol requirements

        Exclusion Criteria:

          -  Participating in another investigational study

          -  Current or prior malignancy within 5 years of randomization

          -  Known sensitivity to any components of the investigational product

          -  Not able to complete all protocol required study visits

          -  Having the following within 3 months prior to or during screening: Unstable angina or
             acute coronary syndrome, transient Ischemic attack (TIA) or stroke, revascularization
             procedure, or instability in ST-segment depression between screening exercise
             treadmill tests, as assessed by the core electrocardiograph (ECG) laboratory
A Study Being Conducted at Multiple Locations to Compare Safety and Efficacy of Three Different Regimens; (1) High-Dose Lenalidomide; (2) Lenalidomide + Azacitidine; or (3) Azacitidine in Subjects ≥ 65 Years With Newly-Diagnosed Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia; Acute Myelogenous Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: Azacitidine; Lenalidomide; Best Supportive Care (BSC)
Intervention description: Azacitidine at 75 mg/m^2/day subcutaneous on Days 1-7; Lenalidomide 50 mg PO daily x 28 days for the first 2 cycles then 25 mg PO daily x 28 days for the next 2 cycles followed by continuous 28-day cycles of lenalidomide 10 mg PO daily; The use of BSC was considered as concomitant treatment and must be documented as concomitant medication.
BSC includes, but is not limited to, treatment with Red Blood Celll (RBC) or whole blood transfusions, fresh frozen plasma transfusions, platelet transfusions, antibiotic or antifungal therapy, and nutritional support
Intervention MeSH terms: Lenalidomide; Azacitidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 88.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: AML; elderly; acute myelogenous leukemia; vidaza; azacitidine; elderly AML; revlimid; lenalidomide

Summary:

      The study aim is to compare safety and efficacy of high-dose lenalidomide regimen, sequential
      azacitidine and lenalidomide and an azacitidine in persons ≥65 years with newly-diagnosed
      acute myeloid leukemia (AML).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Newly diagnosed acute myeloid leukemia (AML), AML with antecedent hematologic disorder
             or therapy-related AML

          -  Male or female subjects aged ≥ 65

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

          -  White blood cell (WBC) count ≤ 10 x 10⁹/L at screening

        Exclusion Criteria:

          -  Previous treatment with azacitidine, decitabine, cytarabine or lenalidomide

          -  Previous cytotoxic or biologic treatment of any kind for AML or prior use of targeted
             therapy agents.

          -  Suspected or proven acute promyelocytic leukemia

          -  Prior bone marrow or stem cell transplantation

          -  Candidate for allogeneic bone marrow or stem cell transplantation

          -  AML antecedent hematologic disorder such as chronic myelogenous leukemia or
             myeloproliferative neoplasms

          -  Presence of malignant disease within the previous 12 months with exceptions
Dose Ranging Study of OTO-201 in AOMT
Condition: Acute Otitis Media; AOMT
MeSH terms: Otitis; Otitis Media
Intervention: 6 mg ciprofloxacin; 12 mg ciprofloxacin; Sham
Intervention description: Single administration of OTO-201; Single administration of OTO-201
Intervention MeSH terms: Ciprofloxacin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Enrollment: 95.0
Sex: All
Minimum age: 6 Months
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Acute otitis media with tympanostomy tubes; OTIPRIO

Summary:

      Dose Ranging Study of OTO-201 in AOMT
    

Eligibility criteria:

        Inclusion Criteria includes, but is not limited to:

          -  Subject is a male or female aged 6 months to 17 years, inclusive

          -  Subject has a clinical diagnosis of acute otitis media with tympanostomy tubes (AOMT)

          -  Subject's caregiver is willing to comply with the protocol an attend all study visits

        Exclusion Criteria includes, but is not limited to:

          -  Subject has a history of sensorineural hearing loss

          -  Subject has tympanic membrane perforation other than the surgical tympanostomy tube
             perforation

          -  Subject has a history of known immunodeficiency disease
Efficacy and Tolerability of ZD6474 in Patients With Thyroid Cancer
Condition: Thyroid Cancer
MeSH terms: Thyroid Neoplasms; Thyroid Diseases
Intervention: ZD6474 (vandetanib)
Intervention description: oral once daily tablet
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Caprelsa (vandetanib); ZD6474

Summary:

      The purpose of this open label, two stage, phase II study is to evaluate the efficacy and
      tolerability of ZD6474 in patients with locally advanced or metastatic hereditary medullary
      thyroid carcinoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Locally advanced or hereditary medullary thyroid cancer

          -  Signed informed consent

          -  One or more measurable lesions

        Exclusion Criteria:

          -  Brain metastases or spinal cord compression

          -  Specific laboratory ranges

          -  Specific heart problems

          -  Prior chemotherapy and/or radiation therapy

          -  Participation in other trials within 30 days
Ahmed Glaucoma Valve Surgery With Mitomycin-C
Condition: Glaucoma; Primary Open Angle Glaucoma; Secondary Glaucoma; Neovascular Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Glaucoma, Neovascular
Intervention: Mitomycin-C; Balanced Salt Solution; Ahmed Glaucoma Valve Implant
Intervention description: Intraoperative and postoperative injections of mitomycin-c/Mitosol; Intraoperative and postoperative injections of BSS; Implantation of Ahmed Valve in study eye
Intervention MeSH terms: Mitomycins; Mitomycin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 119.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will determine the effectiveness of Mitomycin-C use in the glaucoma surgery Ahmed
      valve implantation. Approximately 100 patients will be enrolled, with half receiving the
      Mitomycin-C treatment and the other half receiving placebo treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Inadequately controlled glaucoma on maximum tolerated medical therapy with intraocular
             pressure (IOP) greater than or equal to 18 mm Hg.

          -  Ahmed Glaucoma Valve (AGV) implantation as the planned surgical procedure.

          -  For patients in whom 2 eyes are eligible for enrollment, only the first eligible eye
             to be implanted is enrolled.

        Exclusion Criteria:

          -  Unwilling or unable to give consent, unwilling to accept randomization, or unable to
             return for scheduled protocol visits.

          -  Pregnant or nursing women.

          -  Previous cyclodestruction or glaucoma drainage device (GDD) surgery.

          -  Patients with nanophthalmos.

          -  Patients with Sturge-Weber syndrome or other conditions associated with elevated
             episcleral venous pressure.

          -  No light perception vision.

          -  VA <20/200 in non-study eye.

          -  Need for glaucoma surgery combined with other ocular procedures (i.e. cataract
             extraction, penetrating keratoplasty, or retinal surgery) or anticipated need for
             additional ocular surgery.

          -  Previous scleral buckling procedure or silicone oil present.

          -  Uveitic glaucoma.
Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202)
Condition: Cholangiocarcinoma
MeSH terms: Cholangiocarcinoma
Intervention: Pemigatinib
Intervention description: Pemigatinibonce a day by mouth for 2 consecutive weeks and 1 week off therapy
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 147.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cholangiocarcinoma; fibroblast growth factor (FGF); fibroblast growth factor receptor (FGFR); FGF/FGFR alterations

Summary:

      The purpose of this study is evaluate the efficacy of pemigatinib in subjects with
      advanced/metastatic or surgically unresectable cholangiocarcinoma with FGFR2 translocation
      who have failed at least 1 previous treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed cholangiocarcinoma.

          -  Radiographically measurable or evaluable disease per RECIST v1.1.

          -  Tumor assessment for FGF/FGFR gene alteration status.

          -  Documented disease progression after at least 1 line of prior systemic therapy.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

          -  Life expectancy ≥ 12 weeks.

        Exclusion Criteria:

          -  Prior receipt of a selective FGFR inhibitor.

          -  History of and/or current evidence of ectopic mineralization/calcification, including
             but not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting
             calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcifications.

          -  Current evidence of clinically significant corneal or retinal disorder confirmed by
             ophthalmologic examination.

          -  Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half-lives,
             whichever is shorter, before the first dose of study drug. Topical ketoconazole will
             be allowed.
Safety and Efficacy of KPI-121 in Subjects With Inflammatory Meibomian Gland Disease
Condition: Blepharitis
MeSH terms: Blepharitis; Meibomian Gland Dysfunction
Intervention: KPI-121; Vehicle
Intervention description: KPI-121 drug product will be supplied in 0.25% strength as a suspension in opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate. Subjects randomized to placebo control arm will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.; The vehicle control has the same composition as KPI-121 0.25% ophthalmic suspension except it does not contain loteprednol etabonate. The vehicle is essentially isotonic and is buffered to maintain pH 5.0 - 7.0. It is a sterile, aqueous solution supplied in the same white, low-density polyethylene plastic dropper bottle with the same white, controlled-drop polyethylene tip and white polypropylene closure as KPI-121 0.25% ophthalmic suspension.
Intervention MeSH terms: Loteprednol Etabonate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 206.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pain; Corticosteroid; Meibomian Gland Disease; Blepharitis; Eyelid; Ocular Discomfort

Summary:

      The primary purpose of this study is to determine the efficacy and safety of KPI-121
      ophthalmic suspension compared to vehicle (placebo) in subjects with signs and symptoms of
      inflammatory meibomian gland disease.
    

Eligibility criteria:

        Inclusion Criteria:

        Have a documented clinical diagnosis of inflammatory meibomian gland disease in both eyes.

        Exclusion Criteria:

          -  Known hypersensitivity/contraindication to study product(s) or components.

          -  Be currently receiving treatment for glaucoma, have history of or current glaucoma, or
             an IOP (intraocular pressure) over 21mmHg at Visit 1 (Screening) or Visit 2
             (Randomization).

          -  Be unwilling to discontinue warm compress therapy, lid expression, or lid massage 14
             days prior to Day 1 and for the duration of the study.

          -  Diagnosis of: ongoing ocular infection; severe/serious ocular condition that in
             judgment of Investigator could confound study assessments or limit compliance;
             severe/serious systemic disease or uncontrolled medical condition that in judgment of
             Investigator could confound study assessments or limit compliance; or have been
             exposed to an investigational drug within the 30 days prior to screening.

          -  Have had ocular surgery in the past 90 days or require ocular surgery during the
             study.

          -  In the opinion of Investigator or study coordinator, be unwilling or unable to comply
             with study protocol or unable to successfully instill eye drops.