bioihbjkbjnl/mcl2 huggingface dataset:
An Investigational Immuno-therapy Trial of Pomalidomide and Low-dose Dexamethasone With or Without Elotuzumab to Treat Refractory and Relapsed and Refractory Multiple Myeloma (ELOQUENT-3)
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Elotuzumab; Pomalidomide; Dexamethasone
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Pomalidomide; Elotuzumab; BB 1101
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 117.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if adding Elotuzumab to Pomalidomide and low-dose
      dexamethasone is a more effective treatment of relapsed and refractory multiple myeloma
      compared to pomalidomide and low-dose dexamethasone by itself.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  ≥ 2 prior lines of therapy which must have included at least 2 consecutive cycles of
             lenalidomide and a proteosome inhibitor alone or in combination

          -  Documented refractory or relapsed and refractory multiple myeloma

          -  Refractory to proteosome inhibitor and lenalidomide, and to last treatment

          -  Relapsed and refractory patients must have achieved at least a partial response to
             previous treatment with proteosome inhibitor or lenalidomide, or both, but progressed
             within 6 months, and were refractory to their last treatment

          -  Measurable disease at screening

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

        Exclusion Criteria:

          -  Active plasma cell leukemia

          -  Prior treatment with pomalidomide

          -  Unable to tolerate thromboembolic prophylaxis while on the study

          -  Prior autologous stem cell transplant within 12 weeks

          -  Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C
PRM-151 in the Prevention of Scarring Following Trabeculectomy
Condition: Glaucoma
MeSH terms: Glaucoma
Intervention: PRM-151; Placebo
Intervention description: PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9; Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 124.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: glaucoma, trabeculectomy

Summary:

      This study will assess the safety and tolerability of PRM-151 administered as a
      subconjunctival injection and explore the effect of PRM-151 on various correlates of the
      wound healing process that occurs in the eye after glaucoma filtration surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women of nonchildbearing potential (WONCBP) aged 18 years and older at
             screening.

          -  Diagnosis of chronic angle-closure glaucoma or open-angle glaucoma, phakic or
             pseudophakic, with visual field or optic disc changes characteristic of glaucoma. For
             pseudophakic glaucoma patients, the cataract surgery performed was with
             phacoemulsification and through a corneal incision.

          -  Suitable candidate for trabeculectomy in the study eye which the physician deems as
             medically necessary.

        Exclusion Criteria:

          -  Diagnosis of glaucoma other than chronic angle-closure glaucoma or open-angle glaucoma
             (ie., uveitic, traumatic or neovascular glaucoma).

          -  Any previous ocular surgeries in the study eye involving the upper conjunctiva and
             sclera.

          -  History of laser surgeries in the study eye within 90 days before day 1.

          -  Presence or history of any disease that could affect wound healing.

          -  Any asymmetric abnormality of the anterior segment which requires additional
             intervention (surgery or medication).

          -  Any abnormality other than glaucoma in the study eye that could affect tonometry.

          -  Presence or history of uveitis within 10 years or any other ocular infection or
             inflammation within 14 days before day 1.

          -  Clear corneal phacoemulsification performed within 90 days before day 1.
A Study of the Combination of Pemetrexed and Irinotecan Every Two Weeks in Metastatic Colorectal Cancer
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: pemetrexed; irinotecan
Intervention description: 400 mg/m^2, intravenous (IV), every 14 days x 12 cycles; 180 mg/m^2, intravenous (IV), every 14 days x 12 cycles
Intervention MeSH terms: Irinotecan; Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A non-randomized phase II study to determine the efficacy and safety of the combination of
      Pemetrexed and Irinotecan every two weeks in metastatic colorectal cancer patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of metastatic colorectal adenocarcinoma that is not amenable to curative
             therapy.

          -  Patient must have at least one unidimensionally measurable lesion.

          -  Prior radiation therapy to less than 25% of bone marrow. Radiation must be completed
             at least 4 weeks prior to study enrollment.

          -  Performance status 0 to 2

          -  Patient must have received 1 prior course of chemotherapy (Folfox regimen) for
             metastatic disease

        Exclusion Criteria:

          -  Treatment with any drug within the last 30 days that has not received regulatory
             approval.

          -  Serious systemic disorder (cardiac or pulmonary disease, active infection)

          -  Documented brain metastases not amenable to surgery or unstable after radiation

          -  Inability or unwillingness to take folic acid or Vitamin B12 supplementation.

          -  Presence of fluid retention that can not be controlled by drainage.
A Clinical Study of SHP674 (Pegaspargase) in Participants With Newly Diagnosed, Untreated Acute Lymphoblastic Leukemia
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: SHP674
Intervention description: SHP674: powder for solution for injection, IV (administered by 1 to 2 hours of drip infusion), dose determination : if BSA ≥0.6 m^2: 2500 IU/m^2 every 14 days if BSA <0.6 m^2: 82.5 IU/kg every 14 days
Intervention MeSH terms: Pegaspargase
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: The intervention study model is sequential in results section of record.
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 1 Year
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Acute Lymphoblastic Leukemia

Summary:

      The objectives of the study are to assess the safety and tolerability of a single dose of
      SHP674 in Japanese participants (dose confirmation) in the tolerability assessment period of
      Part 1 and to assess the safety, pharmacokinetics and efficacy of SHP674 dose in Part 2
      (found to be tolerated in Part 1) in the treatment of newly diagnosed untreated acute
      lymphoblastic leukemia (ALL) in Japanese participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 1 to ≤21 years at the time of informed consent;

          -  Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 2;

          -  Newly diagnosed, untreated precursor B-cell ALL

          -  No prior therapy for malignant tumor such as chemotherapy and radiation therapy before
             signing the informed consent;

          -  Life expectancy of at least 6 months from the date of enrollment;

        Exclusion Criteria:

          -  Mature B-cell ALL ; Philadelphia chromosome-positive (Ph+) or BCR-ABL1-positive ALL

          -  Preexisting known coagulopathy ;

          -  History of pancreatitis;

          -  Continuous use of corticosteroids;

          -  Prior treatment or possible prior treatment with an L-asparaginase preparation;

          -  History of sensitivity to polyethylene glycol (PEG) or PEG-based drugs;

          -  Pregnant
Fixed Versus Weight-Based Enoxaparin Dosing in Thoracic Surgery Patients
Condition: Venous Thromboembolism; Deep Venous Thrombosis; Surgery
MeSH terms: Thrombosis; Thromboembolism; Venous Thromboembolism; Venous Thrombosis
Intervention: Fixed Dose Enoxaparin; Variable Dose Enoxaparin
Intervention description: Eligible patients will be administered 40 mg enoxaparin daily and will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose.; Eligible patients will be administered 0.5 mg/kg enoxaparin daily and will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose.
Intervention MeSH terms: Enoxaparin; Enoxaparin sodium
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants enrolled in months 1-6 of the study will all receive a fixed dose of enoxaparin. Patients enrolled in months 7-12 of the study will all receive a variable dose of enoxaparin.
Masking: None (Open Label)
Enrollment: 131.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The aim of this research is to better understand how patient-level factors can be used to
      predict the appropriate enoxaparin dose to maximize venous thromboembolism (VTE) risk
      reduction and minimize bleeding.
    

Eligibility criteria:

        Inclusion Criteria:

          -  receiving Video-Assisted Thoracoscopic Surgery

          -  able to have Enoxaparin initiated within 8 hours after procedure

        Exclusion Criteria:

          -  Contraindication to use of enoxaparin

          -  Intracranial bleeding/stroke

          -  Hematoma or bleeding disorder

          -  Heparin-induced thrombocytopenia positive

          -  Creatinine clearance less than or equal to 30 mL/min

          -  Serum creatinine greater than 1.6 mg/dL

          -  Epidural catheter
Chemotherapy With Monoclonal Antibody and Radioimmunotherapy for High-Risk B-Cell Non-Hodgkins Lymphoma
Condition: Lymphoma, B-Cell
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell
Intervention: cyclophosphamide; etoposide; rituximab; cytarabine; doxorubicin; tositumomab
Intervention description: 1.5g/m2 IV over 1 hour on days 1-4 of induction for a total dose of 6.0g/m2; 300mg/m2 IV over 1 hour every 12 on days 1-3 of induction for a total dose of 1.8 g/m2.; 375mg/m2 each week x 4 weeks of induction, beginning on day 1; 3g/m2 IV over 1 hour every 12 during consolidation for a total of 8 doses; 45mg/m2/day IV over 30 minutes on days 1, 2, 3 during consolidation; 450mg unlabeled tositumomab over 1 hour, followed by 5 millicurie (mCi) Iodine I-131 labeled tositumomab over 20 minutes on day 0. Therapeutic dose of labeled tositumomab will be administered on day 15.
Intervention MeSH terms: Cytarabine; Cyclophosphamide; Rituximab; Doxorubicin; Etoposide
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
Keywords: high risk non-hodgkins lymphoma; NHL; Bexxar; high dose chemotherapy

Summary:

      The purpose of this study is to determine whether using high-dose chemotherapy, monoclonal
      antibodies, and targeted radioimmunotherapy will slow the progression of disease in patients
      with high-risk Non-Hodgkin's Lymphoma (NHL).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Untreated, biopsy proven B-cell non-Hodgkin's lymphoma

          -  Age >/= 18 years

          -  No other prior malignancy except for adequately treated basal cell or squamous cell
             skin cancer, in situ cervical cancer, or other cancer for which the patient has been
             disease-free for one year. The patient cannot have been exposed to chemotherapy to
             treat any of these diseases for at least 3 years prior to study entry.

          -  Meet staging studies and laboratory tests prior to induction, consolidation and
             radioimmunotherapy.

        Exclusion Criteria:

          -  Significant medical and/or psychiatric illness which may compromise planned treatment;

          -  Pregnant or lactating;

          -  HIV-infection.

          -  Patients with follicular lymphoma grade 1, 2 or 3A are not eligible for this trial.
Gemcitabine, Docetaxel, and Cetuximab in Patients With Unresectable Advanced Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: Gemcitabine; Docetaxel; Cetuximab
Intervention description: 1000mg/m2 30min IV, Day 1 & 8; 30mg/m2, 30min IV, day 1 & 8; 100mg/m2 IV, Cycle 1 Day 1, 250mg/m2 IV day 8 & 15, all subsequent cycles 250mg/m2 IV day 1, 8, & 15
Intervention MeSH terms: Gemcitabine; Docetaxel; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 69.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lung Cancer

Summary:

      This purpose of this study is to evaluate the role of gemcitabine and docetaxel, a well
      tolerated chemotherapy regimen in the treatment of advanced non-small cell lung cancer
      (NSCLC), in combination with a novel agent cetuximab.
    

Eligibility criteria:

        Inclusion Criteria:

        To be included in the study, you must meet the following criteria:

          -  18 years of age or older

          -  Non-small cell lung cancer confirmed by biopsy

          -  Unresectable stage III or IV disease

          -  Measurable disease

          -  Must not have received any prior chemotherapy for lung cancer

          -  Able to perform activities of daily living without considerable assistance

          -  Adequate bone marrow, kidney, and liver function

          -  Signed informed consent

        Exclusion Criteria:

        You cannot participate in the study if any of the following apply to you:

          -  History of serious heart disease within six months prior to study entry

          -  Prior treatment with agents that target the EGFR pathway

          -  History of any other uncontrolled or significant disease

        Please note: There are additional inclusion/exclusion criteria. The study center will
        determine if you meet all of the criteria. If you do not qualify for the trial, study
        personnel will explain the reasons. If you do qualify, study personnel will explain the
        trial in detail and answer any questions you may have. You can then decide if you wish to
        participate.
Study to Assess the Efficacy and Safety of Umbralisib in Participants With Non-Follicular Indolent Non-Hodgkin's Lymphoma
Condition: Marginal Zone Lymphoma; Waldenstrom Macroglobulinemia; Non Follicular Indolent Non-Hodgkin Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell, Marginal Zone; Waldenstrom Macroglobulinemia
Intervention: Umbralisib
Intervention description: Oral Daily Dose
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This research study will evaluate the safety and efficacy of a study drug called Umbralisib
      (also known as TGR-1202) alone as a possible treatment for Waldenstrom's Macroglobulinemia
      that has come back or that has not responded to standard treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of Waldenstroms Macroglobulinemia

          -  Relapsed or refractory after at least one prior treatment regimen

          -  Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

        Exclusion Criteria:

          -  Any major surgery, chemotherapy or immunotherapy within the last 21 days

          -  Evidence of hepatitis B virus, hepatitis C virus or known HIV infection

          -  Prior autologous stem cell transplant within 6 months of study entry
Study of the Effect of Ivacaftor on Lung Clearance Index in Subjects With Cystic Fibrosis and the G551D Mutation
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Ivacaftor; Placebo
Intervention description: 150 mg tablet, oral use, twice daily every 12 hours (q12h); Tablet, oral use, twice daily every 12 hours (q12h)
Intervention MeSH terms: Ivacaftor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 21.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the effect of ivacaftor (VX-770) on lung clearance
      index (LCI) in subjects aged 6 years and older with cystic fibrosis (CF) who have the
      G551D-CFTR mutation on at least 1 allele.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects with confirmed diagnosis of CF

          -  Must have the G551D-CFTR mutation in at least 1 allele

          -  FEV1 >90% of predicted normal for age, gender, and height

        Exclusion Criteria:

          -  Ongoing participation in another therapeutic clinical study or prior participation in
             an investigational drug study within the 30 days prior to screening

          -  Use of inhaled hypertonic saline treatment within 2 weeks of the Period 1, Day 1 visit
A Peer-Oriented HIV Prevention Outreach Program for Individuals at High Risk for HIV and Other STIs
Condition: HIV Infections; Sexually Transmitted Diseases
MeSH terms: Sexually Transmitted Diseases
Intervention: Peer-oriented intervention; Group cognitive behavioral therapy (CBT)
Intervention description: The peer-oriented intervention program emphasized social identity and the goals of protecting family and community. The peer program also trained participants to provide HIV/STD education to their peers.; Group CBT will focus on teaching ways to modify thoughts and behaviors associated with risky sexual behaviors.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 746.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Sex Education; Peer Group; Social Identity Theory; HIV Seronegativity; Intervention; women; Social Networks; Peer Education

Summary:

      This study will determine the effectiveness of a peer outreach intervention in preventing HIV
      infection in adults at high risk for contracting HIV and other sexually transmitted diseases
      (STDs).
    

Eligibility criteria:

        Inclusion Criteria for CBT or Peer Intervention Participants:

          1. Female

          2. Age 18-55

          3. Did not inject drugs in the past 6 months

          4. Self-reported sex with at least 1 male partner in the past 6 months

          5. Had at least 1 of the following sexual risk factors:

               1. More than 2 sex partners in the past 6 months

               2. STI diagnosis in the past 6 months

               3. Had a high risk sex partner in the past 90 days (i.e. a sex partner that injected
                  drugs, smoked crack, was HIV+, or MSM)

        Inclusion Criteria for Peer Network Participants:

          1. 18 years old or older

          2. One of the following:

               1. Injected drugs

               2. Sex partner of index

               3. Social network member that the index felt comfortable talking to about HIV/STIs

        Exclusion Criteria for All Participants:

          -  Currently enrolled in another HIV prevention intervention