bioihbjkbjnl/mcl2 huggingface dataset:
Study Evaluating Inotuzumab Ozogamicin (CMC-544) In Indolent Non-Hodgkins Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: Inotuzumab Ozogamicin (CMC-544)
Intervention description: Administered intravenously at 1.8 mg/m2 every 4 weeks for a planned 4 - 8 cycles
Intervention MeSH terms: Inotuzumab Ozogamicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Masking: None (Open Label)
Enrollment: 81.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Refractory Indolent NHL; lymphoma

Summary:

      The purpose of this study is to evaluate the efficacy of inotuzumab ozogamicin (CMC-544) in
      subjects with indolent Non-Hodgkins lymphoma (NHL) that is refractory or has relapsed after
      multiple therapies including rituximab or radioimmunotherapy. The investigational drug will
      be given to subjects with indolent NHL by intravenous infusion at a dose of 1.8 mg/m2, every
      4 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who have been previously diagnosed with CD22-positive, indolent NHL (defined
             as follicular, marginal zone, or small lymphocytic lymphoma) that has progressed after
             2 or more prior systemic therapies.

          -  Previous anticancer treatment given must have contained rituximab and chemotherapy, or
             anti CD20 Radio Immuno Therapy. Subjects must have exhibited no response or have
             progressed within 6 months from the completion of the most recent rituximab or
             rituximab containing therapy or within 12 months of the completion of Radio Immuno
             Therapy.

          -  Measurable disease with adequate bone marrow function, renal and hepatic function

        Exclusion Criteria:

          -  History of, or suggestive of, veno-occlusive disease (VOD) or sinusoidal obstruction
             syndrome (SOS) or history of chronic liver disease (eg, cirrhosis) or suspected
             alcohol abuse.

          -  Prior allogeneic hematopoietic stem cell transplant (HSCT).

          -  Clinical evidence of transformation to a more aggressive subtype of lymphoma or grade
             3b follicular lymphoma.
An Efficacy and Safety Study of APX001 in Non-Neutropenic Patients With Candidemia
Condition: Candidemia
MeSH terms: Candidemia
Intervention: APX001
Intervention description: APX001
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 is a multicenter, open-label, non-comparative, single-arm study to evaluate the efficacy
      and safety of APX001 for the first-line treatment for candidemia including suspected or
      confirmed antifungal-resistant candidemia in non-neutropenic patients 18 yeas of age and
      older.

      Suspicion of antifungal-resistant candidemia is sufficient (documented resistance is not
      required for enrollment). The Study Drug Treatment Period of APX001 will be a maximum of 14
      days. After completion of 14 days study drug therapy, if further antifungal treatment is
      indicated to complete treatment of candidemia in accordance with standard practice
      guidelines, fluconazole (unless susceptibility results warrant alternative antifungal
      therapy) may commence for up to a further 7 days. There will be a Follow up Period of 4 weeks
      (+4 days) after EOT. The total duration of participation in the study is up to approximately
      7.5 weeks.

      This study will be conducted at approximately 20 sites in the United States and globally.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Provision of written consent

          -  Adults ages 18 and above male or female

          -  New diagnosis of candidemia

          -  Able to have pre-existing intravascular catheters removed and replaced (as necessary)

        Key Exclusion Criteria:

          -  neutropenia

          -  deep-seated Candida-related infections

          -  hepatosplenic candidiasis

          -  received more than 2 days of prior systemic antifungal treatment for current
             candidemia episode

          -  severe hepatic impairment
Effect of Desipramine on Upper Airway Collapsibility and Genioglossus Muscle Activity in Patients With Obstructive Sleep Apnea - Study B
Condition: Sleep Apnea, Obstructive
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Intervention: Desipramine; Placebo
Intervention description: 200 mg administered 2 hours before normal sleep time; Placebo-matching desipramine administered 2 hours before normal sleep time
Intervention MeSH terms: Desipramine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Obstructive sleep apnea (OSA) is common and has major health implications but treatment
      options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle
      activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared
      to normal participants. Until recently, the search for medicines to activate pharyngeal
      muscles in sleeping humans has been discouraging. However, exciting new animal research has
      shown that drugs with noradrenergic and antimuscarinic effects can restore pharyngeal muscle
      activity to waking levels. In this protocol the investigators will test the effect of
      desipramine (a tricyclic antidepressant with strong noradrenergic and antimuscarinic effects)
      on upper airway collapsibility and genioglossus muscle activity (EMG GG) during sleep in OSA
      patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed OSA (moderate-to-severe; apnea hypopnea index >15 events/hr)

        Exclusion Criteria:

          -  Cardiovascular disease other than well controlled hypertension

          -  Depression
A Study Evaluating STA-9090 in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor (GIST)
Condition: Gastrointestinal Stromal Tumor
MeSH terms: Gastrointestinal Stromal Tumors
Intervention: Ganetespib
Intervention description: Ganetespib 200 mg/m^2 during an approximately 1-hour infusion once weekly for three consecutive weeks followed by a treatment-free week. Participants who demonstrate acceptable tolerability and objective clinical benefit (defined by at least stable disease or objective response per RECIST) can continue to receive ganetespib until disease progression or appearance of unacceptable toxicity.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: G.I. Stromal Tumor; GIST

Summary:

      The purpose of this study is to determine if STA-9090 is effective in the treatment of
      patients with metastatic and/or unresectable GIST.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be at least 18 years of age at the time of study entry

          -  Must have histologically confirmed metastatic and/or unresectable GIST

          -  Must have measurable disease on computed tomography or magnetic resonance imaging as
             defined by Response Evaluation Criteria in Solid Tumors (RECIST)

          -  Must have documented failure (due to either progression or intolerance)of at least
             prior imatinib and sunitinib. Previous administration of other known heat shock
             protein 90 (Hsp90) inhibitors is permitted

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

          -  Must have acceptable laboratory values as defined in the protocol

        Exclusion Criteria:

          -  Known central nervous system metastases

          -  Major surgery within 4 weeks prior to receiving STA-9090

          -  Use of any investigational agents within 2 weeks or 6 half-lives of the agent,
             whichever is shorter prior to receiving STA-9090

          -  No treatment with chronic immunosuppressants

          -  Must have otherwise adequate health status as defined in the protocol

          -  Left ventricular ejection fraction (LVEF) < than or = 50% at baseline

          -  Baseline corrected QT interval (QTc) > 470 msec

          -  Pregnant or lactating females
Photodynamic Therapy in Treating Patients With Resectable Non-Small Cell Lung Cancer That Has Spread to the Pleura
Condition: Lung Cancer; Metastatic Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: chemotherapy; porfimer sodium; immunohistochemistry staining method; laboratory biomarker analysis; spectroscopy; therapeutic conventional surgery
Intervention MeSH terms: Dihematoporphyrin Ether; Trioxsalen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; malignant pleural effusion

Summary:

      RATIONALE: Photodynamic therapy uses a drug, such as porfimer sodium, that is absorbed by
      tumor cells. The drug becomes active when it is exposed to light. When the drug is active,
      tumor cells are killed. Giving photodynamic therapy during surgery may kill any tumor cells
      that remain after surgery.

      PURPOSE: This phase II trial is studying the side effects and how well photodynamic therapy
      given during surgery works in treating patients with resectable non-small cell lung cancer
      that has spread to the pleura.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed non-small cell lung cancer (NSCLC)

               -  Must have clinical and/or pathological evidence of pleural spread

               -  Primary tumor must be resectable as assessed by the attending thoracic surgeon

          -  Patients who have received or are currently receiving two-to-four courses of standard
             front-line chemotherapy are eligible

        PATIENT CHARACTERISTICS:

          -  Must be medically fit to tolerate surgery

          -  No CTCAE v3.0 grade III-IV elevations in liver transaminases

          -  Bilirubin ≤ 1.5 mg/dL

          -  No known HIV infection

          -  Not pregnant or nursing

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No prior treatment for NSCLC except pleurodesis or standard front-line chemotherapy

          -  No prior pemetrexed disodium chemotherapy

          -  No prior mantle radiotherapy

          -  No concurrent chemotherapy or radiotherapy during the active study treatment period

               -  Post-operative radiotherapy will be administered as clinically indicated
A Safety and Efficacy Study of E10030 (Anti-PDGF Pegylated Aptamer) Plus Lucentis for Neovascular Age-Related Macular Degeneration
Condition: Age-Related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: E10030 plus Lucentis; Lucentis
Intervention description: once a month intravitreal injection; 10 mg/mL intravitreal injection monthly
Intervention MeSH terms: Ranibizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 449.0
Sex: All
Minimum age: 50 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      The objectives of this study are to evaluate the safety and efficacy of E10030 intravitreous
      injection when administered in combination with Lucentis® against a control of Lucentis®
      alone in subjects with subfoveal choroidal neovascularization secondary to age-related
      macular degeneration (AMD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subfoveal choroidal neovascularization (CNV) due to AMD

        Exclusion Criteria:

        Any of the following underlying diseases including:

          -  Diabetes mellitus

          -  History or evidence of severe cardiac disease (e.g., NYHA Functional Class III or IV -
             see Appendix 19.6), history or clinical evidence of unstable angina, acute coronary
             syndrome, myocardial infarction or coronary artery revascularization within 6 months,
             or ventricular tachyarrhythmias requiring ongoing treatment.

          -  Clinically significant impaired renal or hepatic function.

          -  Stroke (within 12 months of trial entry).

          -  Any major surgical procedure within one month of trial entry.

          -  Known serious allergies to the fluorescein dye used in angiography (mild allergy
             amenable to treatment is allowable), to the components of the ranibizumab (Lucentis)
             formulation, or to the components of the E10030 formulation
Preoperative Window of Endocrine Therapy Provides Information to Increase Compliance
Condition: Newly Diagnosed Hormone Positive Clinical Stage 1 or 2 Breast Cancer
Intervention: Tamoxifen; Breast cancer surgery
Intervention description: All patients will take tamoxifen 20 mg po daily for 7 days prior to surgery and for 14 days after surgery.; Breast cancer surgery
Intervention MeSH terms: Tamoxifen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to see if tumors respond to endocrine therapy by taking a total
      of 21 doses of Tamoxifen before and after surgery. Tamoxifen is currently approved by the FDA
      (Food and Drug Administration) for use in the treatment of hormone positive breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 18 years old

          -  Diagnosed with hormone receptor positive invasive breast cancer (estrogen receptor
             (ER) or progesterone receptor (PR) or both >1%) by core needle biopsy

          -  Clinical American Joint Committee on Cancer (AJCC) 7th edition Stage 1 or 2

          -  Candidate for surgical therapy

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0,1, or 2

          -  No chemotherapy or endocrine therapy for breast cancer in last 5 years

          -  Paraffin fixed core needle tissue block, or biopsy punch available for central
             analysis for proliferative markers

          -  Not pregnant or lactating and practicing adequate birth control if premenopausal

          -  Able and willing to provide informed consent

        Exclusion Criteria:

          -  Prior personal history of uterine cancer

          -  Prior personal history of stroke or deep vein thrombosis (DVT)

          -  Current therapy with strong CYP2D6 inhibitors The following medications should not be
             administered with tamoxifen (21 day treatment period) and will need to be stopped for
             the designated period of time prior to starting the study tamoxifen.

        No other prior malignancy is allowed except for the following: adequately treated basal
        cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage 0, I
        or II cancer from which the patient is currently in complete remission, or any other cancer
        from which the patient has been disease-free for 5 years

        Fluoxetine - should be discontinued 30 days prior to starting tamoxifen Paroxetine - should
        be discontinued 5 days prior to starting tamoxifen Sertraline - should be discontinued 5
        days prior to starting tamoxifen Bupropion - should be discontinued 5 days prior to
        starting tamoxifen

          -  Concurrent coumarin-type anticoagulation therapy

          -  Any other contraindications to tamoxifen therapy
Study of Bevacizumab Combined With Capecitabine and Either Oxaliplatin or Irinotecan as First Course of Treatment for Patients With Colorectal Cancer That Has Spread Beyond the Colon
Condition: Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms
Intervention: Bevacizumab; Oxaliplatin; Capecitabine; Irinotecan
Intervention description: 7.5 mg/kg IV Day 1 every 21 days for eight cycles*
*For patients with stable or responding disease after 8 cycles, continue bevacizumab at the same dose levels until disease progression.; 130 mg/m2 IV Day 1 every 21 days for eight cycles; 850 mg/m2 po BID Days 1-14 every 21 days for eight cycles*#
*For patients with stable or responding disease after 8 cycles, continue capecitabine at the same dose levels until disease progression.
#For patients with baseline calculated creatinine clearance of 30-50 mL/min, the starting dose will be reduced to 650 mg/m2 BID; 200 mg/m2 IV Day 1 every 21 days for eight cycles
Intervention MeSH terms: Bevacizumab; Capecitabine; Oxaliplatin; Irinotecan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: NSABP; bevacizumab; capecitabine; oxaliplatin; irinotecan; rectal cancer; colon cancer; colorectal cancer

Summary:

      Bevacizumab is an angiogenesis inhibitor which means it works to stop blood vessel formation
      in tumors. Without new blood vessels, the growth of a tumor is slowed. Chemotherapy works to
      kill cancer cells directly. This study is being done to see how colorectal cancer responds to
      treatment with the combination of bevacizumab and chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathological diagnosis of colon or rectal cancer from either the colon or rectum or a
             metastatic site (beyond the colon or rectum)

          -  Evidence of adequate organ function (such as liver, kidneys, etc.)

        Exclusion Criteria:

          -  Diagnosis of anal cancer

          -  Patients who are candidates for surgery

          -  Patients who have received previous treatments

          -  Pregnant or lactating women

          -  History of chronic disease(s) or other serious medical conditions
Evaluation of Tc 99m Tilmanocept Localization in Primary Cutaneous Kaposi's Sarcoma and Lymphatic Drainage by SPECT/CT
Condition: Kaposi's Sarcoma
MeSH terms: Sarcoma, Kaposi; Sarcoma
Intervention: Tc 99m tilmanocept
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study (NAV3-12) is to determine the dissemination and localization of Tc
      99m tilmanocept by SPECT and SPECT/CT imaging in subjects with confirmed cutaneous KS. This
      is a single center, open-label, within-subject study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The subject has provided written informed consent with Health Insurance Portability
             and Accountability Act (HIPAA) authorization before the initiation of any
             study-related procedures.

          2. The subject is at least 18 years of age at the time of consent.

          3. The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of
             Grade 0 to 2.

          4. The subject has a KS stage of T(0), I(0), S(0).

          5. The subject has a marker lesion with a confirmed diagnosis of KS (CD 206-expressing
             cutaneous KS) via punch biopsy. The location of the marker KS lesion will be limited
             to locations on the extremities: from the shoulder to the metacarpal region or from
             the groin to the metatarsal region.

          6. The subject has a marker KS lesion that is ≥ 1cm in diameter.

        Exclusion Criteria:

          1. The subject is pregnant or lactating.

          2. The subject has had prior chemotherapy, immunotherapy, or radiation therapy to the
             local KS site or regional lymphatic system within one year of enrollment.

          3. The subject has undergone node basin surgery of any type or radiation to the nodal
             basin(s) potentially draining the marker KS lesion.

          4. The subject has known sensitivity to dextran.
Rheumatoid Arthritis Dose Ranging Study (0663-086)(COMPLETED)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: etoricoxib; etoricoxib; etoricoxib; etoricoxib; Comparator: placebo; etoricoxib; Comparator: diclofenac
Intervention description: Period I: Arm 1: etoricoxib 10 mg tablet once daily. 12 weeks of treatment.; Period I: Arm 2: etoricoxib 30 mg tablet once daily. 12 weeks of treatment.; Period I: Arm 3: etoricoxib 60 mg tablet once daily. 12 weeks of treatment.; Period I: Arm 4: etoricoxib 90 mg tablet once daily. 12 weeks of treatment.; Period I: Arm 5: Pbo tablet once daily. 12 weeks of treatment.; Period II: Arm 1: etoricoxib 90 mg tablet once daily. 12 weeks of treatment.; Period II: Arm 2: diclofenac 75 mg tablet twice daily. 12 weeks of treatment.
Intervention MeSH terms: Diclofenac; Etoricoxib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 761.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Arcoxia

Summary:

      To assess the clinically active dose range of study medication in the treatment of patients
      with rheumatoid arthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient with diagnosed rheumatoid arthritis (RA) for at least 6 months prior who is
             otherwise judged to be in general good health and who is currently taking nonsteroidal
             anti-inflammatory drugs (NSAIDS) to treat his/her RA symptoms

          -  Patient will need to stop taking these medications in order to participate, but can
             continue taking his/her other anti-rheumatic medications as long as they have been
             stable for certain periods of time

        Exclusion Criteria:

          -  Patients with a disease or medical condition(s) that could worsen or interfere with
             the evaluation of the effectiveness of study medication are not allowed to participate