bioihbjkbjnl/mcl2 huggingface dataset:
Trial of Dasatinib in Patients With Advanced Cancers Harboring DDR2 Mutation or Inactivating B-RAF Mutation
Condition: Carcinoma, Non-small Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: Dasatinib
Intervention description: Tablet, oral, 140 mg, once daily until unacceptable toxicity or disease progression
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: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to establish whether patients with malignancy harboring a
      discoidin domain receptor 2 mutation or an inactivating B-RAF mutation will respond to
      dasatinib.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com.

        Inclusion Criteria

          -  Diagnosis of advanced malignancy, nonsmall-cell lung cancer (NSCLC) only during stage
             1 of accrual.

          -  Nonsynonymous mutation of B-RAF or DDR2, defined as follows:.

             i) NSCLC with inactivating B-RAF mutation.

        ii) NSCLC with discoidin domain receptor 2 (DDR2) mutation.

        iii) Malignancy of other histology with DDR2 mutation or inactivating B-RAF mutation, or
        NSCLC having a B-RAF mutation that is not functionally characterized.

          -  At least 1 target lesion per Response Evaluation Criteria in Solid Tumors, vol 1.1, on
             baseline staging evaluation.

          -  Disease progression after ≥ 1 prior treatment regimen.

        Exclusion Criteria

          -  Pleural or pericardial effusion, Grade >1.

          -  QTcF >470 msec (Grade ≥2) or diagnosed congenital long QT syndrome.

          -  Absolute granulocyte count <1500/mm^3.

          -  Hemoglobin level <10 g/dL.

          -  Platelet count < 75,000/mm^3.

          -  Serum calcium level <institutional lower limit of normal.

          -  Hypokalemia, hypophosphatemia, or hypomagnesemia, Grade >1, despite supplementation.

          -  Creatinine >3*institutional upper limit of normal (ULN).

          -  Total bilirubin level >1.5*ULN.

          -  Alanine transaminase level >3*ULN.

          -  Other protocol-defined Inclusion/Exclusion criteria apply.
Intravaneous Iron(1000 mg Low Molecular Weight Iron Dextran Over 60 Minutes) for Pregnant Women
Condition: Pregnancy
Intervention: Intravaneous iron(low molecular weight iron dextran)
Intervention description: 1000 mg of Iron dextran administered over one hour
Intervention MeSH terms: Iron; Dextrans; Iron-Dextran Complex
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Iv iron in pregnant women; second and third trimester

Summary:

      To determine the percentage of women who achieve anemia correction after a single dose of
      1000mg of low molecular weight iron dextran(infed).
    

Eligibility criteria:

        Inclusion Criteria:

          -  pregnant women intolerable to oral iron. hbg <10.9 g/dl during second or third
             trimester.

        Exclusion Criteria:

          -  known sensitivity to IV iron. hemoglobinopathies. hemolytic anemia. women who have
             received or will receive blood transfusions. women with significant vaginal
             bleeding(>200 cc blood loss)prior to delivery. women with documented history of
             allergy to more than one class of drug clinically significant anemia requiring therapy
             in the opinion of the obstetrician, in the first trimester.
A Study to Evaluate SAGE-217 in Participants With Moderate to Severe Major Depressive Disorder
Condition: Major Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Intervention: SAGE-217; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Depression

Summary:

      This is a two-part (open-label followed by double-blind) study evaluating the safety,
      tolerability, pharmacokinetics, and efficacy of SAGE-217 in 102 participants diagnosed with
      moderate to severe Major Depressive Disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has a diagnosis of Major Depressive Disorder that has been present for at
             least a 4-week period as diagnosed by Structured Clinical Interview for DSM-IV Axis I
             Disorders (SCID-I)

        Exclusion Criteria:

          -  Participant has a history of suicide attempt

          -  Participant has a history of treatment-resistant depression, defined as persistent
             depressive symptoms despite treatment with adequate doses of antidepressants from two
             different classes for an adequate amount of time

          -  Participant has active psychosis

          -  Participant has a medical history of seizures

          -  Participant has a medical history of bipolar disorder, schizophrenia, and/or
             schizoaffective disorder
A Proof-of-Concept Study of Faricimab (RO6867461) in Participants With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)
Condition: Choroidal Neovascularization
MeSH terms: Macular Degeneration; Choroidal Neovascularization; Neovascularization, Pathologic
Intervention: Faricimab; Ranibizumab; Sham Procedure
Intervention description: Faricimab will be administered as per the regimen specified in the individual arm.; Ranibizumab will be administered as per the regimen specified in the individual arm.; The sham is a procedure that mimics an intravitreal injection, but involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It will be administered to participants in treatment arm D at applicable visits to maintain masking.
Intervention MeSH terms: Ranibizumab; Faricimab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 273.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This multiple-center, multiple-dose and regimen, randomized, double-masked active
      comparator-controlled, double-masked, five parallel group, 36-week study will evaluate the
      efficacy, safety, tolerability, and pharmacokinetics of faricimab (RO6867461) in participants
      with choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).

      The study was designed to allow the evaluation of RO6867461 in a treatment-naive population
      (comparison of Arms A, B, C, and D) and an anti-VEGF-incomplete responder population that met
      a predefined criterion at Week 12 (comparison between Arms A and E). Only one eye per
      participant was chosen as the study eye.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Treatment-naive with CNV secondary to AMD, with subfoveal CNV or juxtafoveal CNV with
             a subfoveal component related to the CNV activity by FFA or SD-OCT

          -  Active CNV

        Exclusion Criteria:

          -  CNV due to causes other than AMD

          -  Subretinal hemorrhage, fibrosis, or atrophy involving either the fovea or more than
             50% of the total lesion area

          -  Cataract surgery within 3 months of baseline, or any other previous intraocular
             surgery

          -  Major illness or surgery within 1 month prior to Screening

          -  Glycosylated hemoglobin (HbA1c) above 7.5%

          -  Uncontrolled blood pressure
Single-arm Trial to Evaluate the Biodistribution and Shedding of Talimogene Laherparepvec
Condition: Melanoma
MeSH terms: Melanoma
Intervention: Talimogene laherparepvec
Intervention description: Talimogene laherparepvec will be administered by intralesion injection at an initial dose of up to 4.0 mL of 10^6 PFU/mL. The second and subsequent doses will will be up to 4.0 mL 10^8 PFU/mL. The second dose should be administered 21 days from the initial dose. All subsequent doses should be given every 14 days.
Intervention MeSH terms: Talimogene laherparepvec
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      The primary objective was to estimate the proportion of participants with detectable
      talimogene laherparepvec deoxyribonucleic acid (DNA) in the blood and urine at any time after
      administration of talimogene laherparepvec within the first 3 cycles.
    

Eligibility criteria:

        Key Inclusion Criteria:

        Male or female age ≥ 18 years with histologically confirmed diagnosis of melanoma and
        unresected stage IIIB, IIIC, IVM1a, IVM1b, or IVM1c regardless of prior line of therapy.
        Subject is candidate for intralesional therapy administration into cutaneous, subcutaneous,
        or nodal disease and must also have measurable disease, serum lactate dehydrogenase ≤ 1.5 x
        upper limit of normal, and Eastern Cooperative Oncology Group (ECOG) performance status of
        0 or 1, and adequate hematologic, hepatic, and renal organ function.

        Key Exclusion Criteria:

        Subject must not have clinically active cerebral metastases, greater than 3 visceral
        metastases (this does not include lung metastases or any nodal metastases associated with
        visceral organs) or any bone metastases melanoma, primary ocular or mucosal melanoma,
        history or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis,
        or symptomatic autoimmune disease, or evidence of immunosuppression for any reason. Subject
        known to have acute or chronic active hepatitis B or hepatitis C infection, or human
        immunodeficiency virus infection will also be excluded. Subject who has active herpetic
        skin lesions or prior complications of herpes simplex virus type 1 ( HSV-1) infection (eg,
        herpetic keratitis or encephalitis), and/or requires intermittent or chronic systemic
        (intravenous or oral) treatment with an antiherpetic drug (eg, acyclovir), other than
        intermittent topical use will also be excuded. Subject must not have received previous
        treatment with talimogene laherparepvec.
A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (TRIGGER)
Condition: Non-Squamous Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: erlotinib
Intervention description: 150 mg orally once a day for 12 months
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single-arm, open-label study evaluated the efficacy and safety of Tarceva (erlotinib) in
      participants with locally advanced or metastatic non-small cell lung cancer. Participants
      received daily oral doses of 150 mg Tarceva. The anticipated time on study treatment was 12
      months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, >/=18 years of age

          -  Locally advanced or metastatic non-small cell lung cancer

          -  Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  Life expectancy over >/=12 weeks

          -  Adequate hematological, liver, or kidney function

        Exclusion Criteria:

          -  Previous therapy against epidermal growth factor receptor for metastatic disease

          -  Treatment with investigational drug during the 3 weeks before enrollment

          -  History of neoplasm

          -  Patients with symptomatic cerebral metastases

          -  Unstable systemic disease
Study to Evaluate the Effect of XmAb®5871 on Disease Activity in Patients With IgG4-Related Disease (RD)
Condition: IgG4-RD
MeSH terms: Immunoglobulin G4-Related Disease
Intervention: XmAb5871
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this Phase 2 study is to investigate the effect of XmAb5871 on IgG4-Related
      Disease (RD) activity
    

Eligibility criteria:

        Inclusion Criteria:

          -  Active IgG4-RD

          -  Compatible pattern of organ involvement consistent with IgG4-RD that cannot be
             attributed to other causes

          -  Histopathologically-proven diagnosis of IgG4-RD

          -  Peripheral blood plasmablast count >900 cells/mL and/or elevated IgG4-RD levels during
             screening

          -  Able and willing to complete the entire study according to the study schedule

          -  Able and willing to provide written informed consent

        Exclusion Criteria:

          -  History or evidence of a clinically unstable/uncontrolled disorder, condition or
             disease other than IgG4-RD that, in the opinion of the Investigator would pose a risk
             to the patient safety or interfere with the study evaluation, procedures or completion

          -  Malignancy within 5 years (except successfully treated in situ cervical cancer,
             resected squamous cell or basal cell carcinoma of the skin, or prostate cancer with no
             recurrence ≥3 years following prostatectomy)

          -  Presence of recurrent or chronic infections, defined as ≥3 infections requiring
             antimicrobials over the past 6 months prior to screening

          -  Active infection requiring hospitalization or treatment with parenteral antimicrobials
             within the 60 days prior to randomization or oral antimicrobials within the 21 days
             prior to enrollment

          -  Patient is taking >40 mg of prednisone QD

          -  Prior use of rituximab (or other B cell depleting agents) within 6 months of
             enrollment. Prior use of any B cell depleting agent greater than 6 months from
             enrollment is allowed if the CD19+ B cell count is within the normal reference range
             during screening

          -  Use of any investigational agent within 5 half-lives of the agent (or 6 months if the
             half-life is unknown) prior to enrollment

          -  Immunosuppressive agent use within the three months prior to enrollment

          -  Has received live vaccines within 2 months of enrollment

          -  Patient is pregnant or breast feeding, or planning to become pregnant while enrolled
             in the study, up to end-of-study visit

          -  Unable or unwilling to partake in the follow-up assessments or required protocol
             procedures
A Phase 2 Extension Study To Enroll Subjects Who Were Enrolled In B5301001 Study
Condition: Hypertrophic Scars Resulting From Prior Breast Scar Revision Surgery
MeSH terms: Hypertrophy; Cicatrix, Hypertrophic
Intervention: PF-06473871; PF-06473871
Intervention description: Subjects who previously were randomized in B5301001 study will go under a second revision surgery followed by 4 administration of PF-06473871.; Subjects who previously were randomized in B5301001 study will go under a second revision surgery followed by 3 administration of PF-06473871.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 57 Years
Healthy volunteers: No
Keywords: Phase 2; open-label; safety; hypertrophic scar revision surgery

Summary:

      Study is a multicenter, two-part, open-label phase II study in adults, evaluating the safety
      and long-term efficacy of PF-06473871 one year after surgical revision and treatment with
      PF-06473871.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects previously randomized to Pfizer clinical study B5301001.

          -  Subjects must be able to tolerate up to a 3 hour scar revision surgery under sedation
             and local anesthesia.

        Exclusion Criteria:

          -  Pregnant female subject; breastfeeding female subjects; male subjects with partners
             currently pregnant.

          -  Any previous history of intolerable adverse reactions to PF-06473871, such as serious
             adverse events attributed to study drug or having been withdrawn due to AE in
             prerequisite study B5301001.
Testing Crizotinib as a Potential Targeted Treatment in Cancers With ALK Genetic Changes (MATCH-Subprotocol F)
Condition: Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Hematopoietic and Lymphoid Cell Neoplasm; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Plasma Cell Myeloma
MeSH terms: Lymphoma; Neoplasms; Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Crizotinib
Intervention description: Given PO
Intervention MeSH terms: Crizotinib; Tyrosine Protein Kinase Inhibitors
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Crizotinib; ALK; NCI-MATCH; Tyrosine Kinase Inhibitor

Summary:

      This phase II MATCH treatment trial identifies the effects of crizotinib in patients whose
      cancer has a genetic change called ALK rearrangement. Crizotinib may stop the growth of
      cancer cells by blocking the ALK protein which may be needed for cell growth. Researchers
      hope to learn if crizotinib will shrink this type of cancer or stop its growth.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have met applicable eligibility criteria in the Master MATCH Protocol
             prior to registration to treatment subprotocol

          -  Patients must have an ALK rearrangement as defined via the MATCH Master Protocol

          -  Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment
             assignment and must have no clinically important abnormalities in rhythm, conduction
             or morphology of resting ECG (e.g. complete left bundle branch block, third degree
             heart block)

        Exclusion Criteria:

          -  Patients must not have non small cell lung cancer or anaplastic large cell lymphoma
             (ALCL)

          -  Patients with a history of interstitial lung disease or pneumonitis are excluded

          -  Patients must not have known hypersensitivity to crizotinib or compounds of similar
             chemical or biologic composition

          -  Patients must not have had prior ALK-targeted inhibitors, including crizotinib,
             ceritinib, alectinib, AP26113, TSR-011, X-396, RXDX-101, CEP-37440, PF-06463922

          -  Patients must not have had brain metastases unless 1) treated and neurologically
             stable for at least 2 weeks, or 2) untreated, asymptomatic, and treatment is not
             indicated. Steroids are permitted if doses are stable (or tapering) for 2 weeks prior
             to study enrollment

          -  Patients using drugs or foods that are known potent CYP3A4 inhibitors or inducers will
             be excluded
The Efficacy and Safety of FE 200486 in Treatment of Patients Suffering From Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Degarelix
Intervention description: Given as a subcutaneous injection.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 129.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this trial was to select a dose of degarelix (FE 200486). Three groups of
      patients were treated for six months on different doses. The patients had blood samples taken
      and measured for Testosterone in order to determine the most efficient dose to provide fast
      and sustained castration. The patients came to the clinic for 16 visits and dependent on the
      blood sample results they were invited to return for additional blood samples on a two weekly
      basis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent before any trial related activity

          -  Proven prostate cancer with a need for endocrine treatment

          -  Testosterone level within the normal range for the age

        Exclusion Criteria:

          -  Previous or current hormonal treatment of prostate cancer

          -  Candidate for prostatectomy or radiotherapy

          -  History of severe asthma, anaphylactic reactions or Quincke's Oedema

          -  Hypersensitivity towards any component of FE200486

          -  Cancer disease within the last ten years except for prostate cancer and some skin
             cancers

          -  Presenting with significant neurological, gastrointestinal, renal, hepatic,
             cardiovascular, psychological, pulmonary, metabolic, endocrine, haematological,
             dermatological or infectious disorder. In addition any other condition such as
             excessive alcohol or drug abuse that may interfere with trial participation or
             influence the conclusion of the trial as judged by the investigator

          -  Mental incapacity or language barrier

          -  Having received an investigational product within the last 12 weeks preceding the
             trial

          -  Previous participation in this trial