bioihbjkbjnl/mcl2 huggingface dataset:
A Study Comparing Eribulin Mesylate and Ixabepilone in Causing or Exacerbating Neuropathy in Participants With Advanced Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Eribulin Mesylate; Ixabepilone
Intervention description: E7389 (eribulin mesylate) given at a dose of 1.4 mg/m^2 as a 2 to 5 minute intravenous (IV) bolus on Days 1 and 8 of a 21-day cycle.
The Treatment Phase will include six cycles. Patients may enter the Extension Phase for additional cycles following the sixth cycle of treatment.; Ixabepilone given at a starting dose of 32 or 40 mg/m^2 (as per approved labeling) as a 3-hour IV infusion on Day 1 of a 21-day cycle.
The Treatment Phase will include six cycles. Patients may enter the Extension Phase for additional cycles following the sixth cycle of treatment.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 104.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast Cancer; Oncology

Summary:

      The purpose of this study in patients with advanced breast cancer is to compare the incidence
      and severity of neuropathy adverse events for the two treatment groups (eribulin versus
      ixabepilone) using National Cancer Institute Common Terminology Criteria for Adverse Events
      (NCI CTCAE version 3.0) grading.
    

Eligibility criteria:

        Inclusion criteria:

        1. Female subjects with confirmed locally recurrent or metastatic carcinoma of the breast
        who have received prior taxane therapy and at least one prior cytotoxic chemotherapy
        regimen for advanced disease.

        Exclusion criteria:

          1. Subjects who have received prior ixabepilone therapy.

          2. Subjects with prior participation in an eribulin clinical study, even if not assigned
             to eribulin treatment.

          3. Subjects with pre-existing neuropathy Grade greater than or equal to 2.

          4. Subjects with a history of diabetes mellitus Type 1 or 2.

          5. Subjects with bilateral mastectomy which included bilateral axillary lymph node
             dissection.

          6. Subjects with missing digits required for vibration assessment.

          7. Subjects with any other concurrent diseases or conditions that would be expected to
             interfere with neuropathy assessments, which may include vitamin deficiency, sequelae
             of cerebrovascular disease, thyroid insufficiency, lumbar or cervical radiculopathy,
             or alcoholic or inflammatory neuropathy.
A Study to Evaluate Long Term Safety, Tolerability, and Effectiveness of Olesoxime in Patients With Spinal Muscular Atrophy (SMA)
Condition: Muscular Atrophy, Spinal
MeSH terms: Muscular Atrophy; Muscular Atrophy, Spinal; Atrophy
Intervention: Olesoxime
Intervention description: Participants will receive homogeneous suspension of olesoxime.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 131.0
Sex: All
Healthy volunteers: No

Summary:

      The purpose of this open-label, single arm study is to further evaluate long-term
      tolerability, safety and efficacy outcomes of olesoxime in participants with Spinal Muscular
      Atrophy (SMA) who previously participated in one of the following two clinical studies:
      TRO19622 CL E Q 1115-1 (open-label Phase Ib, multicenter, single- and multiple- dose study)
      or TRO19622 CL E Q 1275-1 (NCT01302600, Phase II/III, adaptive, parallel-group, double blind,
      randomized, placebo-controlled, multicenter, multinational study).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participation in the previous studies (TRO19622 CL E Q 1115-1 or TRO19622 CL E Q
             1275-1)

          -  For women of childbearing potential: agreement to use an acceptable birth control
             method during the treatment period and for at least 28 days after the last dose of
             olesoxime

        Exclusion Criteria:

          -  Female participants who are pregnant or lactating, or intending to become pregnant
             during the study

          -  Participants who, in the opinion of the investigator, are not suitable to participate
             in this open-label study

          -  Participants who have developed study drug hypersensitivity to olesoxime or one of the
             formulation excipients, including sesame oil

          -  Concomitant or previous participation in any investigational drug or device study
             within 90 days prior to screening

          -  Concomitant or previous participation in a survival motor neuron 2 (SMN2) targeting
             antisense oligonucleotide study within 6 months prior to screening

          -  History of human immunodeficiency virus infection, history of Hepatitis B infection
             within the past year, history of Hepatitis C infection which has not been adequately
             treated

          -  History of illicit drug or alcohol abuse within 12 months prior to screening, in the
             investigator's judgment

          -  Any serious medical condition or abnormality in clinical laboratory tests that, in the
             investigator's judgment, precludes the participant's safe participation in and
             completion of the study

          -  History or presence of an abnormal electrocardiogram (ECG) that is clinically
             significant in the investigator's opinion
Dasatinib in Imatinib Resistant/Intolerant Chinese CML (Chronic and Advanced Phase) Subjects
Condition: Leukemia
MeSH terms: Leukemia
Intervention: Dasatinib
Intervention description: Tablets, Oral, 70 mg BID (AD CML) or 100 mg QD (Chronic CML), once or twice daily dependent on disease stage, until subjects meet discontinuation (DC) criteria for study
Intervention MeSH terms: Dasatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 121.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Phase, Advanced Phase chronic myeloid leukemia; Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Summary:

      The primary objective of this study is to estimate the major cytogenetic response (MCyR) rate
      to Dasatinib in subjects with CP CML, complete and overall hematologic response (CHR and OHR)
      rate in subjects with AD CML or Ph+ ALL who have primary or acquired resistance to imatinib,
      or are intolerant of imatinib, when administered at 100 mg QD (Chronic CML) or 70mg BID (AP
      CML and Ph+ALL).
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Signed Written Informed Consent

          -  Men and women, ages 18 years of age or older

          -  Subjects with Chronic Phase (CP) or Advanced Disease (AD) chronic myeloid leukemia
             (CML)/Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)

          -  Subjects resistant/intolerant to imatinib

          -  Subjects presenting:

               1. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0-2

               2. Adequate hepatic function

               3. Adequate renal function

               4. Sodium, Potassium, Magnesium, Phosphorus, Calcium higher or equal than the lower
                  limit of normal range

        Exclusion Criteria:

          -  Women of child bearing potential who are not using adequate birth control

          -  Women who are pregnant or breastfeeding

          -  Subjects eligible for stem cell transplantation

          -  Serious uncontrolled medical disorder or active infection

          -  Uncontrolled or significant cardiovascular disease

          -  Concurrent incurable malignancy other than CML

          -  Subjects who received imatinib, interferon, cytarabine within 7 days or other
             antineoplastic agents other than hydroxyurea within 14 days before dasatinib,
             Dasatinib in the past

          -  History of significant bleeding unrelated to CML
A Randomized Phase II/Genomic Trial of Two Chemotherapy Regimens in Patients With Resected Pancreatic Adenocarcinoma
Condition: Pancreatic Adenocarcinoma
MeSH terms: Adenocarcinoma
Intervention: Gemcitabine; Abraxane; FOLFIRINOX; Chemoradiation
Intervention description: 1000mg/m2 IV over 30 to 100 minutes, day 1, 8, 15; 125 mg/m2 IV over 30 minutes, day 1, 8, 15; Irinotecan 180 mg/m2 Day 1 Oxaliplatin 85 mg/m2 Day 1 5-FU 400 mg/m2 bolus with Leucovorin 200 mg/m2 over 2h, Day 1, then 5-FU 2400 mg/m2 over 46h. Four cycles, if tolerated
Intervention MeSH terms: Paclitaxel; Gemcitabine; Albumin-Bound Paclitaxel; Folfirinox
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Patients; with; resected

Summary:

      Determine the relapse-free survival of resected pancreatic cancer patients following two
      novel regimens with activity in advanced disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed evidence of pancreatic
             carcinoma.

          -  Patients must have had all gross disease resected (R0 or R1 resection, patients who
             underwent an R2 resection are not eligible).

          -  Patients must have had no prior chemotherapy or radiation therapy for pancreatic
             cancer.

          -  Age > 18 years.

          -  Patient must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

          -  Patients must have normal organ and marrow function measured within 2 weeks, prior to
             registration as follows:

        Absolute Neutrophil Count (ANC) > 1,500/µL Platelets > 100,000/µL Total bilirubin less than
        2-fold upper limit of normal (ULN) Aspartate Aminotransferase (AST)/alanine
        aminotransferase (ALT)<2.5X institutional upper limit of normal Creatinine clearance >
        60mL/min for patients with creatinine levels above institutional normal.

          -  Patients must be > 4 weeks and < 12 weeks post-surgery at time of study registration.

          -  Women of childbearing potential and sexually active males are strongly advised to use
             appropriate contraceptive measures.

          -  Women must not be pregnant or breast-feeding.

        Exclusion Criteria:

          -  Patients receiving any other investigational agents.

          -  Patients with known metastases.

          -  Patients with wounds that have not fully healed.
A Study of LY900014 in a Medtronic Pump
Condition: Type1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Intervention: LY900014; Insulin Lispro
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Insulin Lispro
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the study drug LY900014 to insulin lispro (Humalog)
      when both are delivered by the Medtronic MiniMed 670G System in adults with type 1 diabetes
      (T1D). The study will consist of two treatment periods of 4 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must have been diagnosed with type 1 diabetes and have been using insulin
             continuously for at least 12 months

          -  Participants must be using an insulin pump with "rapid-acting insulin" for at least 6
             months and the same "rapid acting insulin" for at least the past 30 days

          -  Participants must have hemoglobin A1c (HbA1c) values ≥6.0% and ≤8.0%

          -  Participants must have been using the MiniMed 670G insulin pump for at least the past
             90 days

          -  Participants must use their Guardian (3) sensor at least an average of 75% of the time
             and remain in Auto Mode an average of 70% of the time

        Exclusion Criteria:

          -  Participants must not have had more than 1 emergency treatment for very low blood
             glucose or any hospitalizations for poor glucose control (very high blood sugar or
             diabetic ketoacidosis) in the last 6 months

          -  Participants must not have significant abnormal accumulation of fat, loss of fat
             tissue, or scars just under the skin in areas of infusion or have a history of an
             infection at an infusion site within 90 days prior to screening

          -  Participants must not have a total daily insulin dose >100 units

          -  Participants must not be receiving any oral or injectable medication intended for the
             treatment of diabetes other than rapid-acting analog insulin via CSII in the 30 days
             prior to screening

          -  Participants must not have major problems with their heart, kidneys, liver, or have a
             blood disorder
Vicriviroc (SCH 417690) Treatment Protocol in Human Immunodeficiency Virus (HIV)-Infected Participants: A Rollover Study for ACTG Protocol A5211 (P04100)
Condition: HIV; HIV Infections
MeSH terms: HIV Infections
Intervention: Vicriviroc maleate
Intervention description: VCV 30 mg tablet once daily by mouth.
Intervention MeSH terms: Maleic acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 79.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Treatment Experienced

Summary:

      The purpose of this study is to provide open-label vicriviroc (VCV) to human immunodeficiency
      virus (HIV) treatment-experienced participants who successfully completed 48 weeks of
      treatment on Acquired Immunodeficiency Syndrome (AIDS) Clinical Trial Group (ACTG) protocol
      A5211 (or who responded favorably to treatment but discontinued participation due to viral
      tropism shifts), and participants who screened for ACTG A5211 and met all inclusion/exclusion
      criteria, but were unable to enroll due to protocol closure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Successful completion of ACTG Protocol A5211, or favorable response in A5211 but
             discontinued due to tropism shift, or screened for A5211 and met inclusion/exclusion
             criteria but unable to enroll due to protocol closure.

          -  Participants must also be on a ritonavir-containing antiretroviral regimen at entry,
             and have acceptable hematologic and laboratory parameters.

          -  Female participants of reproductive potential must agree to use 2 reliable methods of
             contraception, including a barrier method, and must have a negative urine pregnancy
             test prior to dosing.

        Exclusion Criteria:

          -  History of seizure or drug use that increases risk of seizure, current use of CYP3A4
             inducers, prior history of malignancy, active drug or alcohol use or dependence that
             would interfere with study requirements

          -  Female participants who are breast-feeding, pregnant, or plan to become pregnant

          -  Participation in a clinical trial with another investigational drug.

          -  Participants with serious illness requiring systemic therapy and/or hospitalization
             must not begin VCV (if not already on VCV) until participant completes therapy or is
             clinically stable on therapy for at least 14 days prior to enrollment.
Phase 2a, Dose-ranging Study With PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)
Condition: Nonalcoholic Fatty Liver Disease; Nonalcoholic Steatohepatitis
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: Placebo; PF-05221304
Intervention description: Placebo; PF-05221304, Experimental Drug
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: C1171002 is a randomized, double blind, placebo controlled, 5 arm (placebo, plus 4 active doses of PF 05221304), parallel group study.
Masking: Double (Participant, Investigator)
Masking description: Double-Blind
Enrollment: 305.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: PF-05221304; NAFLD; NASH; features of metabolic syndrome; Dose-Ranging Study

Summary:

      Phase 2a, dose-ranging Study with PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body Mass Index >= 25 kg/m2

          -  Body Weight > 50 kg

          -  Liver fat (assessed via MRI-PDFF) >= 8%

          -  Biopsy-proven NASH - diagnosed in previous 24-months

          -  Presumed NASH - per Sponsor's definition

          -  NAFLD with minimal inflammation/fibrosis

          -  Features of Metabolic Syndrome

        Exclusion Criteria:

          -  Alcohol-induced steatohepatitis or other forms of chronic liver disease

          -  Positive for Hepatitis B, Hepatitis C, or Human Deficiency Virus

          -  Severe Renal Impairment

          -  Contraindications for MRI
A Study of Sublingual Immunotherapy in Peanut-allergic Children
Condition: Food Hypersensitivity
MeSH terms: Hypersensitivity; Food Hypersensitivity
Intervention: Peanut SLIT; Placebo SLIT
Intervention description: Liquid peanut protein drops diluted in glycerin which are dosed under the tongue.; Liquid glycerin without peanut which are dosed under the tongue.
Intervention MeSH terms: Glycerol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: For the initial 12 months of the study, subjects were blinded to receive either peanut SLIT or placebo. After unblinding, subjects on placebo are crossed over to receive open-label peanut SLIT. They underwent an identical dosing protocol as those that were initially randomized to active treatment.
After 12 months of peanut SLIT dosing, whether initially randomized to active or crossed over from placebo, all subjects remained part of an open-label extended maintenance phase for the duration of the study (total peanut SLIT dosing 36-60 months)
2 additional cohorts were included in the protocol. One cohort, called the Early Unblinded Peanut SLIT cohort, was unblinded prior to the scheduled 12 month time point for pharmacy safety concerns. The second cohort, called the Pilot Peanut SLIT Rollover cohort involved subjects from the prior pilot study (NCT00429429) who were added to the study through an amendment and received open-label peanut SLIT.
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 1 Year
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Peanut Allergy; Sublingual immunotherapy

Summary:

      The specific aim of this study is to determine if peanut allergen-specific SLIT will cause
      clinical desensitization and tolerance to develop in peanut-allergic young children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Peanut IgE > 7kU/L (> 2kU/L for children aged 2 years and under) AND

          -  History of significant clinical symptoms within 60 minutes after the ingestion of
             peanuts.

        Exclusion Criteria:

          -  History of severe life-threatening anaphylaxis to peanut, OR

          -  Medical history that would prevent a DBPCFC to peanut, OR

          -  Subjects with wheat or oat allergy (which are used in the placebo), OR

          -  Unable to cooperate with challenge procedures, OR

          -  Unable to be reached by telephone for follow-up
LEE011 for Patients With CDK4/6 Pathway Activated Tumors (SIGNATURE)
Condition: Tumors With CDK4/6 Pathway Activation
MeSH terms: Neoplasms
Intervention: LEE011
Intervention description: Study drug was provided in 200 mg and 50 mg hard gelatin capsules to be taken orally
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 106.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Solid malignancy; Hematologic malignancy; Mutations; Amplifications; Signature; CDK4; CDK6; CDK4/6; Cyclin D1; CCND,; Cyclin D3; p16 mutation; CDKN2A; LEE011; Breast cancer; Ovarian cancer; Lymphoma; Mesothelioma; Pancreatic neuroendocrine; Leukemia; Tumor

Summary:

      The purpose of this signal seeking study was to determine whether treatment with LEE011
      demonstrates sufficient efficacy in CDK4/6 pathway activated solid tumors and/or hematologic
      malignancies to warrant further study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient had a confirmed diagnosis of a select solid tumor (except breast cancer
             (however, triple negative was included), liposarcoma, CRPC, melanoma and teratoma) or
             hematological malignancy (except mantle cell lymphoma).

          -  Patient must have been pre-identified as having a tumor with CDK4 amplification or
             mutation, CDK6 amplification or mutation, Cyclin D1 (CCND1) amplification, Cyclin D3
             (CCND3) amplification, or p16 (CDKN2A) mutation

          -  Patient had received at least one prior treatment for recurrent, metastatic and /or
             locally advanced disease and for whom no standard therapy options are anticipated to
             result in a durable remission.

          -  Patient had progressive and measurable disease as per RECIST 1.1. or other appropriate
             hematological guidelines.

          -  Patient had an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

        Exclusion Criteria:

          -  Patients had received prior treatment with LEE011.

          -  Patient had clinically significant resting bradycardia (heart rate < 50 at rest),
             tachycardia (heart rate > 90 at rest), PR interval > 220 msec, QRS interval > 109
             msec, or QTcF > 450 msec.

          -  Patients had primary CNS tumor or CNS tumor involvement

          -  Patient had received chemotherapy or anticancer therapy ≤ 4 weeks prior to starting
             study drug