bioihbjkbjnl/mcl2 huggingface dataset:
Preoperative Fulvestrant With or Without Enzalutamide in ER+/Her2- Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Enzalutamide; Fulvestrant
Intervention description: 160mg of Enzalutamide will be given daily in conjunction with Fulvestrant.; 500mg Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC)
Intervention MeSH terms: Fulvestrant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: Female
Minimum age: 18 Years
Maximum age: 101 Years
Healthy volunteers: No
Keywords: ER+/Her2 - breast cancer; Preoperative Fulvestrant; Enzalutamide

Summary:

      This is a randomized two arm phase II study to further evaluate the efficacy of fulvestrant
      plus enza compared to single agent fulvestrant in postmenopausal women with locally advanced
      AR+/ER+/Her2- BC who will have local surgery after ~4 months on treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ER+ Her2- breast cancer

          -  Stage at least T2 or greater

          -  Planned to get local surgery

          -  Postmenopausal, or if pre- or peri- menopausal, then will need to have concurrent
             ovarian suppression.

          -  At least 18 years of age

          -  Not on anticoagulants

          -  PS 0-2

          -  Able to swallow study drug and comply with study requirements

          -  ANC >1000/uL, platelets >75,000/uL at screening visit

          -  Total bilirubin < 1.5 times upper limit of normal (ULN) at the screening visit unless
             an alternate nonmalignant etiology exists (eg, Gilbert's disease)

          -  Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 times ULN or <
             5 times ULN if patient has documented liver metastases

          -  Creatinine < 1.5 times ULN

          -  INR < 1.5 times ULN, or if on warfarin, can safely transition off for biopsy

          -  Willing to donate blood for research at 4 time points

          -  Willing to undergo core biopsies for research at study entry and at ~4 weeks.

          -  Willing to donate tissue to research from the surgical specimen

          -  Written informed consent obtained prior to biopsies and blood samples

        Exclusion Criteria:

          -  Current or previously treated brain or leptomeningeal metastases

          -  History of seizures

          -  Prior treatment with an anti-androgen (abiraterone, ARN-509, bicalutamide,
             enzalutamide, ODM-201, TAK-448, TAK-683, TAK-700, VT-464).

          -  Systemic estrogens or androgens within 14 days before initiating therapy. Vaginal
             estrogens are allowed if necessary for patient comfort.
Bendamustine as Second-Line Therapy in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Intervention: bendamustine hydrochloride
Intervention description: Bendamustine 120 mg/m2 IV on days 1 and 2 of a 21-day treatment cycle
Intervention MeSH terms: Bendamustine 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
Keywords: recurrent small cell lung cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as bendamustine, work in different ways to stop
      the growth of tumor cells, either by killing the cells or by stopping them from dividing.

      PURPOSE: This phase II trial is studying how well bendamustine works as second- or third-line
      therapy in treating patients with relapsed or refractory small cell lung cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed small cell lung cancer

          -  Relapsed or refractory disease after 1-2 prior chemotherapy regimens

          -  Measurable disease

          -  ECOG - Eastern Cooperative Oncology Group performance status 0-2

          -  ANC ≥ 1,500/mm³: ANC = Absolute neutrophil count

          -  Platelet count ≥ 100,000/mm³

          -  Hemoglobin ≥ 9 g/dL

          -  Bilirubin normal

          -  AST/ALT ≤ 2 times upper limit of normal (ULN) (≤ 5 times ULN in patients with hepatic
             metastases; AST/ALT = alanine transaminase (ALT) and aspartate aminotransferase (AST)

          -  Creatinine clearance > 40 mL/min

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception before, during, and for ≥ 3 months
             after completion of study therapy

          -  No known hypersensitivity to bendamustine

          -  No other malignancy for which the patient has been treated within the past year except
             for nonmelanoma skin cancer or carcinoma in situ of the cervix

          -  No cardiac disease, including any of the following:

               -  Unstable angina pectoris

               -  Life-threatening cardiac arrhythmia

               -  Symptomatic congestive heart failure

          -  No uncontrolled infection

          -  No other concurrent chemotherapy, immunotherapy, or anti-tumor hormonal therapy
Detection of High Grade Prostate Cancer With Subharmonic Ultrasound Imaging, A Pilot Study
Condition: Prostatic Neoplasm
MeSH terms: Prostatic Neoplasms
Intervention: Perflutren Lipid Microsphere Intravenous Suspension
Intervention description: The intravenous administration of Perflutren Lipid Microsphere will provide enhancement of vascular tissue when performing subharmonic prostate ultrasound imaging. This enhancement will be used to guide targeted biopsy of the prostate to vascular areas which are more likely to contain aggressive prostate cancer.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: prostate cancer; prostate ultrasound; subharmonic imaging; prostate biopsy

Summary:

      This is a phase II single center study using contrast-enhanced ultrasound to identify
      aggressive forms of prostate cancer with subharmonic imaging.

      The following are the study objectives:

        1. To implement subharmonic imaging technology on a transrectal probe suitable for prostate
           imaging and biopsy

        2. To demonstrate visualization of prostatic vascularity using subharmonic
           contrast-enhanced imaging.

        3. To provide a preliminary estimate of the diagnostic accuracy of contrast-enhanced
           subharmonic imaging for detection of clinically significant PCa.

      The study will include 50 subjects who are scheduled for prostate biopsy. Each subject will
      receive an intravenous infusion of microbubble contrast material immediately prior to a
      prostate biopsy procedure. The study will demonstrate whether subharmonic imaging with a
      microbubble contrast agent allows for detection of clinically significant prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject must be scheduled for a clinically indicated needle biopsy of the prostate
             based upon an elevated PSA, abnormal digital rectal examination, or based upon active
             surveillance of prostate cancer.

          2. Subject must be able and willing to give written informed consent for a contrast
             enhanced ultrasound study of the prostate.

          3. Subject must be a male at least 18 years of age when informed consent is obtained.

          4. Subject must have a life expectancy that exceeds the duration of the clinical trial.

        Exclusion Criteria:

          1. Participant in a clinical trial involving an investigational drug within the past 30
             days.

          2. Prior allergic reaction to the ultrasound contrast agent Definity™

          3. Previous treatment for PCa.

          4. Clinically unstable, severely ill, or moribund.
A Study of LY573636-sodium in Patients With Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: LY573636-sodium
Intervention description: Dose is adjusted to target a specific maximum concentration (Cmax) based on patient laboratory parameters, administered intravenously every 28 days until disease progression or other criteria for patient discontinuation are met
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastatic

Summary:

      The primary purpose of this study is to determine the objective response rate (complete and
      partial response) for patients who receive LY573636-sodium for metastatic breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Received at least 2 or more prior chemotherapy regimens for metastatic breast cancer.

          -  Have discontinued all previous therapies for cancer, including chemotherapy,
             radiotherapy, cancer-related hormonal therapy, or other investigational therapy for at
             least 4 weeks. Patients who have received whole-brain radiation must wait 90 days.

        Exclusion Criteria:

          -  Serious pre-existing medical condition.

          -  Have active central nervous system or leptomeningeal metastasis.

          -  Current hematologic malignancies, acute or chronic leukemia.

          -  Receiving Warfarin (Coumadin).

          -  Have a history of radiation therapy involving more than 25% of the bone marrow.
Colesevelam Versus Placebo in the Treatment of Nonalcoholic Steatohepatitis
Condition: Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: Colesevelam Hcl
Intervention description: 3.75 gm/day (six 675 mg tablets)
Intervention MeSH terms: Colesevelam Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: NASH; NAFLD; Steatohepatitis; Nonalcoholic; Fatty Liver Disease

Summary:

      The purpose of the study is to see if the drug colesevelam is a potential treatment for
      Nonalcoholic Steatohepatitis(NASH).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age at entry at least 18 years.

          2. Serum alanine (ALT) or aspartate (AST) aminotransferase activities that are above the
             upper limits of normal. 19 or more in women and 30 or more in men.

          3. Evidence of hepatic steatosis or liver fat (>5%) by MRI.

          4. Evidence of definite or suspected NASH

          5. Written informed consent.

        Exclusion criteria:

          1. Evidence of another form of liver disease.

          2. History of excess alcohol ingestion.

          3. Contraindications to liver biopsy.

          4. Decompensated liver disease.

          5. History of gastrointestinal bypass surgery or ingestion of drugs known to produce
             hepatic steatosis.

          6. Recent initiation or change of anti-diabetic drugs.

          7. Use of colesevelam or other agents in the same class.

          8. Significant systemic or major illnesses other than liver disease that, in the opinion
             of the investigator would preclude treatment with colesevelam and adequate follow up.

          9. Positive test for anti-HIV.

         10. Active substance abuse, such as alcohol, inhaled or injection drugs within the
             previous one year.

         11. Pregnancy or inability to practice adequate contraception in women of childbearing
             potential.

         12. Evidence of hepatocellular carcinoma
A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma
Condition: Advanced Cholangiocarcinoma; FGFR2 Gene Mutation
MeSH terms: Cholangiocarcinoma
Intervention: BGJ398 (infigratinib)
Intervention description: Capsule for oral use
Intervention MeSH terms: Infigratinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 143.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cholangiocarcinoma,; FGFR2 gene fusion,; FGFR genetic alteration

Summary:

      This is a multi-center, open label, single arm phase II study evaluating BGJ398
      (infigratinib) anti-tumor activity in advanced or metastatic cholangiocarcinoma patients with
      fibroblast growth factor receptor (FGFR) genetic alterations.
    

Eligibility criteria:

        Inclusion criteria:

        - Adult patients with histologically or cytologically confirmed cholangiocarcinoma at the
        time of diagnosis.

        Patients with cancers of the gallbladder or ampulla of Vater are not eligible.

        - Patients must have received at least one prior regimen containing gemcitabine with or
        without cisplatin for advanced/ metastatic disease. Patient should have evidence of
        progressive disease following prior regimen, or if prior treatment discontinued due to
        toxicity must have continued evidence of measurable or evaluable disease.

        Exclusion criteria:

          -  Prior or current treatment with a MEK inhibitor (all Cohorts), BGJ398 (infigratinib)
             (all Cohorts), or selective FGFR inhibitor (Cohorts 1 and 2 only).

          -  insufficient organ function

               -  Absolute Neutrophil Count (ANC) < 1,000/mm3 [1.0 x 10^9/L]

               -  Platelets < 75,000/mm3 [75 x 10^9/L]

               -  Hemoglobin < 109.0 g/dL

               -  Total bilirubin > 1.5x upper limit of normal (ULN)

               -  Aspartate aminotransferase/glutamic oxaloacetic transaminase (AST/SGOT) and
                  alanine aminotransferase/glutamic pyruvic transaminase (ALT/SGPT) > 2.5x ULN (AST
                  and ALT > 5x ULN in the presence of liver metastases)

               -  Serum creatinine > 1.5x ULN and a calculated or measured creatinine clearance <
                  45 mL/min

               -  Inorganic phosphorus outside of normal limits

               -  Total and ionized serum calcium outside of normal limits

        Other protocol-defined inclusion/exclusion criteria may apply.
Efficacy And Safety Of Sunitinib In Women With Advanced Breast Cancer
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Intervention: sunitinib
Intervention description: sunitinib (Sutent), 37.5 mg, daily dosing
Intervention MeSH terms: Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 83.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastatic Breast Cancer

Summary:

      Patients with advanced breast cancer to receive sunitinib (Sutent) once daily until disease
      progression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically proven diagnosis of breast cancer

          -  Metastatic or locally recurrent disease that is, in the opinion of the investigator,
             not amenable to resection or radiation therapy

          -  Patients with at least one measurable lesion as per RECIST

        Exclusion Criteria:

          -  Inflammatory breast cancer

          -  Prior treatment with VEGF inhibitors (unless in adjuvant setting at least 12 months
             ago)
Radioactive Iodine Implants for Pan-invasive Pituitary Macroadenomas
Condition: Pituitary Macroadenoma
MeSH terms: Pituitary Diseases
Intervention: Iodine Implants
Intervention description: Interstitial Radioactive Iodine Implants
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: pituitary gland

Summary:

      This study is a single arm Phase II pilot trial. Patients enrolled on the trial will undergo
      implantation of high activity iodine-125 seeds into their pituitary adenoma. The tumor
      response to treatment will be monitored as well as change in visual fields, associated
      adverse effects, progression free survival and patient reported outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathological or radiographic diagnosis of a pan-invasive pituitary macroadenoma

          -  Pan-invasive for the purposes of the protocol will be defined as meeting each of the
             following 2 major criteria: (1). tumor volume greater than 20 cc at enrollment, and
             (2). suprasellar extension. In addition, a pan-invasive tumor must meet any one of the
             following 3 minor criteria, a) unresectable tumor invasion into a cavernous sinus, b)
             bone or bone marrow invasion into the clivus or temporal bones, or c) tumor extension
             in any direction unlikely to be completely removed by specifically a transphenoidal
             surgical approach.

          -  Patients who meet the two major criteria above (1 and 2) and are medically inoperable
             for tumor resection (due to confounding co-existing medical problems) are eligible
             without meeting any of the three minor criteria (a, b, or c).

          -  Patients should be immediately threatened for vision loss or other significant
             neurological impairment directly related to tumor mass effect. As such, all patients
             enrolled would likely benefit from tumor response (shrinkage).

          -  Patients must have visible tumor on imaging studies (MRI or CT)

          -  The patient's Zubrod performance status must be 0-3.

          -  Patients must be at least 18 years of age.

          -  Mandatory Imaging Studies: Must be done 45 or fewer days prior to :

        MRI or CT scan of the brain including the entire skull base and all areas of tumor
        extension

        Exclusion Criteria:

          -  Patients who are unable to undergo general anesthesia

          -  Patients who are unable to undergo placement of a stereotactic head frame

          -  Patients who are unable to provide informed consent

          -  Patients who are pregnant or nursing

          -  Patients with severe kidney dysfunction

          -  Patients who have contraindications to MRI, such as implanted pacemaker device

          -  Patients with diagnosis of pituitary carcinoma
Study to Evaluate Efficacy & Safety of Tralokinumab in Subjects With Asthma Inadequately Controlled on Corticosteroids
Condition: Asthma
MeSH terms: Asthma
Intervention: Tralokinumab; Placebo
Intervention description: Subcutaneous Injection; Subcutaneous Injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 79.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Asthma; Reactive Airways; Respiratory Tract Disease; Obstructive Tract Disease; Lung Diseases

Summary:

      A Multicentre, Randomized, Double-blind, Parallel Group, Placebo Controlled, 12-Week, Phase 2
      Study to Evaluate the Effect of Tralokinumab on Airway Inflammation in Adults with Asthma
      Inadequately Controlled on Inhaled Corticosteroid.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18 to 75 years

          2. Documented physician-diagnosed asthma for at least 12 months prior to enrolment (v1)

          3. Documented treatment with an asthma controller regimen requiring treatment with ICS
             (minimum dose of ≥ 250 ug fluticasone propionate via dry powder inhaler equivalents
             total daily dose) alone or in combination ≥ 6 months and that has been taken at a
             stable dose for at least 1 month prior to enrolment (v1)

          4. Additional maintenance asthma controller medications must be given at a stable dose
             for at least 1 month prior to v1.

          5. At enrolment (v1) the subject must have a predicted normal value (PNV) for the
             pre-bronchodilator (BD) FEV1>50% and more than 1L.

          6. Post-BD reversibility in FEV1 of ≥12% and ≥200 mL at enrolment (v1).

        Exclusion Criteria:

          1. History of interstitial lung disease, chronic obstructive pulmonary disease (COPD), or
             other clinically significant lung disease other than asthma.

          2. History of anaphylaxis following any biologic therapy.

          3. Hepatitis B, C or HIV

          4. Pregnant or breastfeeding

          5. History of cancer

          6. Current tobacco smoking or a history of tobacco smoking for >10 pack-years.

          7. Previous receipt of tralokinumab