bioihbjkbjnl/mcl2 huggingface dataset:
Oral Immunotherapy for Peanut Allergy (PMIT)
Condition: Food Hypersensitivity
MeSH terms: Hypersensitivity; Peanut Hypersensitivity; Food Hypersensitivity
Intervention: Peanut OIT; Placebo
Intervention description: Defatted peanut flour ingested daily as oral mucosal immunotherapy; Oat flour matched by weight and consistency that is ingested daily as a placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 10.0
Sex: All
Minimum age: 1 Year
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Peanut allergy

Summary:

      The purpose of this study is to determine if mucosal peanut immunotherapy will make subjects
      who have peanut allergy less allergic and induce changes in their immune system.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject between 1 and 18 years of age

          -  EITHER history of significant clinical symptoms occurring within 60 minutes after
             ingesting peanuts greater than 6 months ago AND peanut specific IgE >15 kU/L

          -  OR history of significant clinical symptoms occurring within 60 minutes after
             ingesting peanuts within the past 6 months AND peanut specific IgE > 7 kU/L

          -  A family that will be able to be compliant with all study visits

          -  All females of child bearing age must be using appropriate birth control

        Exclusion Criteria:

          -  Subjects with a history of severe, anaphylaxis to peanut

          -  Medical history that would prevent a double blind placebo controlled oral food
             challenge (DBPCFC/OFC) to peanut

          -  Unable to cooperate with challenge procedures or unable to be reached by telephone for
             follow-up

          -  Diagnosed oat allergy

          -  Pregnancy or lactation
Open-Label Extension to Evaluate the Longer Term Efficacy and Safety of LIB003
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: LIB003
Intervention description: 300 mg SC Q4W
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: open-label
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To assess the longer term safety, tolerability, and LDL C lowering efficacy after 52 weeks of
      additional treatment with LIB003 with subcutaneous (SC) dosing every 4 weeks (Q4W)
    

Eligibility criteria:

        Inclusion Criteria:

          1. men and women 18 years or older

          2. Elevated LDL-C on current lipid lowering therapy and; prior atherosclerotic
             cardiovascular disease (CVD) event or evidence of CVD or without CVD but at high risk
             for CVD based on American Heart Association/American College of Cardiology (AHA/ACC)
             CVD risk calculator, or aged 40 years and older with diabetes and moderate- to
             high-intensity statin, or pre-treatment LDL-C 190 mg/dL or greater or heterozygous
             familial hypercholesterolemia (HeFH)

          3. patients who met original entry criteria in, and completed, the double-blind,
             placebo-controlled 16-week Phase 2 study (LIB003-002)

        Exclusion Criteria:

          1. patients who did not who complete the double-blind, placebo-controlled 16-week Phase 2
             study (LIB003-002)

          2. <18 years of age

          3. pregnant or women of childbearing potential not using acceptable birth control
Enzastaurin in Combination of Capecitabine to Treat Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: enzastaurin; placebo; capecitabine
Intervention description: 1125 milligrams (mg) loading dose then 500 mg, oral, daily, 21-day cycles until progressive disease; oral, daily, 21-day cycles until progressive disease; 1250 mg/m^2, BID, days 1-14 of each 21-day cycle until progressive disease
Intervention MeSH terms: Capecitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 86.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether the combination of enzastaurin and
      capecitabine is more effective than the combination of placebo and capecitabine in treating
      participants with breast cancer who were previously treated with an anthracycline and a
      taxane.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have been diagnosed with metastatic or recurrent breast cancer.

          -  Have been previously treated with both an anthracycline and a taxane.

          -  Have not received more than two prior chemotherapy treatment programs.

          -  Have stopped any antitumoral hormonal treatment before you enroll in this study.

          -  Have a negative pregnancy blood test if menstruating or capable of becoming pregnant.
             You must use an approved birth control method during the study and for 3 months after
             stopping study treatment.

        Exclusion Criteria:

          -  Cannot follow the study procedures (for example, you cannot swallow tablets).

          -  Are receiving another treatment for your cancer.

          -  Have received another experimental drug in the last 4 weeks.

          -  Have had serious heart disease within last 6 months.

          -  Are pregnant or breast-feeding.
Trial of Daily Pulse Interleukin-2 With Famotidine in Acute Myelogenous Leukemia
Condition: Acute Myelogenous Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: Interleukin-2
Intervention description: Famotine 20mg IV push daily just prior to the aldesleukin (IL-2) IL-2 18 million IU/m2 in 50 mL 5% D5 or NS IVPB over 15 - 30 minutes daily for 5 days
Intervention MeSH terms: Interleukin-2
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: acute myelogenous leukemia; interleukin-2

Summary:

      Assess the immunotherapy benefit of interleukin-2 in acute myelogenous leukemia treatment
      during lymphocyte recovery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed hematopathology diagnosis of AML receiving marrow suppressive treatment

          -  Total WBC recovery of 500 mm3 prior to IL-2 treatment

          -  Platelet count of at least 20,000 mm3 prior to starting IL-2 treatment

          -  Active infection controlled prior to starting IL-2 treatment

          -  Stable systolic blood pressure > 90mm Hg prior to starting IL-2 treatment

          -  O2 saturation >90% prior to starting treatment

          -  Stable cardiopulmonary status prior to starting IL-2 treatment

          -  Serum creatinine < or equal to 2.0 mg/dl

          -  Total bilirubin and AST <3x upper limits normal

        Exclusion Criteria:

          -  Acute Promyelocytic Leukemia

          -  Active thrombocytopenic bleeding

          -  Cardiac ejection fraction below 45%

          -  Pregnancy and/or lactation
Study of LY2181308 in Combination With Docetaxel Versus Docetaxel in Patients With Non-Small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Docetaxel; LY2181308
Intervention description: Administered intravenously; Administered intravenously
Intervention MeSH terms: Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 180.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the anti-tumor activity of LY2181308 in combination
      with docetaxel compared to docetaxel alone in participants with non-small cell lung cancer
      who were previously treated with first line chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with non-small cell lung cancer with locally or advanced metastatic
             disease(Stage IIIB or IV at entry) not amenable to curative therapy and who have
             progressed after 1 line of chemotherapy

          -  Measureable disease as defined by response evaluation criteria in solid tumors
             (RECIST) version 1.1

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

          -  Must make available any existing tumor tissue from the primary biopsy

          -  Participants with prior radiation may be eligible if they meet certain criteria

          -  Adequate bone marrow reserve and organ functioning

          -  Women must have a negative pregnancy test and must comply with a highly reliable
             contraceptive method during and for 6 months after the treatment period and must not
             be breastfeeding

          -  Men must comply with a contraceptive regimen during and for 6 months after the
             treatment period

        Exclusion Criteria:

          -  Currently enrolled in or discontinued a clinical trial involving an investigational
             drug/device within the last 30 days. Participants may be permitted to enter treatment
             before the 30 day waiting period in special circumstances

          -  Pregnant or breastfeeding

          -  Serious concomitant systemic disorders that would compromise the safety of the
             participant or the participant's ability to complete the study

          -  Second primary malignancy that could affect compliance with the protocol or
             interpretation of the study results

          -  Known allergy or hypersensitivity to docetaxel, taxanes, LY2181308, oligonucleotides,
             or any component of the formulations

          -  Participants with documented central nervous system or brain metastasis at the time of
             study entry

          -  Pre-existing neuropathy equivalent to a common terminology criteria for adverse
             events(CTCAE)code greater than or equal to 2
Velcade Consolidation Bone Study
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: bortezomib
Intervention description: Each cycle will consist of 5 weeks treatment. Subjects in the treatment group will receive: Velcade® 1.6 mg/m2 as an intravenous bolus injection on Days 1, 8, 15, and 22 of each cycle followed by a 13-day rest period (Days 23 to 35) Cycle will be repeated on Day 36. Subjects in the treatment group will receive up to 4 treatment cycles, unless they experience either unacceptable toxicity or if the subject requests to withdraw from the study.
Intervention MeSH terms: Bortezomib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 106.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multiple Myeloma; bortezomib; hematology; bone marrow cancer; Myeloma-related bone disease; bone mineral density; bone markers

Summary:

      The purpose of this study is to assess the effect of bortezomib on myeloma-related bone
      disease, analyzing bone mineral density (BMD) in patients with Multiple Myeloma (MMY) who
      have received high dose chemotherapy and autologous stem cell transplantation for primary
      treatment of MMY (single- or double-transplant). Eligible patients will be randomized (study
      treatment assigned by chance like flipping a coin) to either bortezomib or observation alone.
      Patients in the bortezomib arm will receive treatment of bortezomib for a total of 4 cycles.
      All subjects will be followed for a total of 24 months after randomization.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult Multiple Myeloma patients in partial response or better after high dose
             chemotherapy and autologous stem cell transplantation

          -  Patient fulfills defined laboratory requirements within 14 days before enrolment

          -  If female, is either postmenopausal for more than 24 consecutive months or surgically
             sterilized or willing to use an acceptable method of birth control for defined period

          -  If male, agree to use an acceptable barrier method of contraception and to not donate
             sperm up to 3 months following treatment

        Exclusion Criteria:

          -  Patient received another antimyeloma or experimental therapy following autologous stem
             cell transplantation

          -  Patient has a peripheral neuropathy or neuropathic pain of grade 2 or greater
             intensity as defined by the NCI common terminology criteria of adverse event (NCI
             CTCAE) version 3.0

          -  Patient has an uncontrolled or severe cardiovascular disease within 6 months of
             enrolment

          -  Patient has any conditions that would compromise his/her well-being or the completion
             of the study requirements
Study Evaluating the Safety and Tolerability of NCX 4251 for the Treatment of Acute Exacerbations of Blepharitis
Condition: Blepharitis
MeSH terms: Blepharitis
Intervention: Fluticasone Propionate; Placebo
Intervention description: NCX 4251 Ophthalmic Suspension, 0.1%; NCX 4251 Ophthalmic Suspension, 0%
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: sequential dose-escalating cohorts -- Cohort 1 (2 parallel groups) and Cohort 2 (2 parallel groups)
Masking: Double (Participant, Investigator)
Masking description: double-masked
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a multi-center, randomized, double-masked, placebo-controlled, Phase 2 study
      evaluating the safety and tolerability of NCX 4251 (fluticasone propionate nanocrystal)
      Ophthalmic Suspension 0.1% QD and BID for the treatment of acute exacerbations of
      blepharitis. The study will be performed in two sequential dose escalating cohorts.

      The study is designed to select the dose(s) of NCX 4251 to advance into the next stage of
      development, and to assess the safety and tolerability of NCX 4251 Ophthalmic Suspension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  history of blepharitis and meet qualifying criteria for an acute exacerbation of
             blepharitis in both eyes at Screening and Baseline/Day 1 Visits

          -  have a qualifying best-corrected visual acuity

        Exclusion Criteria:

          -  abnormality of the eyelids or lashes (other than blepharitis), or previous eyelid
             surgery

          -  IOP > 21 mmHg at Screening or Baseline/Day 1 Visits

          -  use of steroids in the past 30 days or retinoids in the past 12 months

          -  uncontrolled systemic disease
SU011248 In The Treatment Of Patients With Bevacizumab (Avastin)-Refractory Metastatic Renal Cell Carcinoma
Condition: Carcinoma, Renal Cell
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: Sunitinib
Intervention description: 50 mg orally daily for 4 weeks followed by 2 weeks off treatment for approximately 1 year or until disease progression/unacceptable toxicity; after completion of 1 year, pts with clinical benefit can continue the study treatment in a separate continuation protocol
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: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to test whether sunitinib (SU011248) has activity and is safe in
      patients with renal cell carcinoma (RCC) who have failed prior therapy with bevacizumab
      (Avastin) -based treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically proven renal cell carcinoma of clear cell histology with metastases

          -  Evidence of measurable disease

          -  Radiographic evidence of disease progression during or within 3 months of completion
             of bevacizumab-based treatment

          -  Prior radical or partial nephrectomy

        Exclusion Criteria:

          -  Prior treatment with any other anti-angiogenic therapy other than bevacizumab

          -  Prior systemic treatment for RCC > 2 regimens

          -  History of or known brain metastases

          -  Serious acute or chronic illness or recent history of significant cardiac abnormality
Combination Drug Study of Bexarotene and Rosiglitazone to Treat CTCL
Condition: Cutaneous T-cell Lymphoma; Mycosis Fungoides; Sezary Syndrome
MeSH terms: Mycoses; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Mycosis Fungoides; Sezary Syndrome; Lymphoma, T-Cell, Cutaneous
Intervention: Rosiglitazone and Bexarotene
Intervention description: rosiglitazone added to bexarotene capsules
Intervention MeSH terms: Rosiglitazone; Bexarotene
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cutaneous T-cell Lymphoma; CTCL; Mycosis Fungoides; Sezary Syndrome; Bexarotene; Targretin; Rosiglitazone; Avandia

Summary:

      The purpose of this trial is to determine if combination therapy with rosiglitazone and
      bexarotene might have a synergistic effect in the treatment of patients with CTCL.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with biopsy proven persistent or recurrent cutaneous cell lymphoma (CTCL)
             Stage IA-IVA

          -  Patients with a pathologic proven diagnosis of CTCL that is documented in the patient
             history.

          -  Patient has preserved organ function.

          -  Patient has an ECOG performance status between 0 - 2.

          -  Women of childbearing potential should be screened for pregnancy prior to treatment
             and utilize effective contraceptive methods (e.g. barrier) during treatment period.

          -  Patients over the age of 18 who are willing and able to provide Informed Consent

          -  The patient has been taking Targretin capsules for at least the last 4 months and the
             dose has remained relatively stable.

          -  The patient has had stable or progressive disease over the past 4 months.

          -  Patient has adequate laboratory parameters for liver and kidney function.

        Exclusion Criteria:

          -  Patients with CD30+ Anaplastic Large Cell Lymphoma

          -  Patients with pathology consistent with peripheral T-cell lymphoma.

          -  Patients with Stage IVB (visceral involvement with CTCL).

          -  Patients with history of Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis
             C infection.

          -  Patients with a diagnosis of congestive heart failure.

          -  Patients exhibiting significant edema or unstable cardiovascular disease.

          -  Patients with a fasting triglyceride level greater then 500mg/dl.

          -  Patients that have started any new treatment for CTCL in the past 4 months.

          -  Pregnant women will be excluded from the study.
Ezetimibe-Ursodiol Combination Therapy on Biomarkers of Liver Function and Sterol Balance in Subjects With NAFLD
Condition: Nonalcoholic Fatty Liver Disease (NAFLD)
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: EZ-Urso combination therapy
Intervention description: Ursodiol 13-15 mg per kg per day combined with Ezetimibe (Zetia) 10 mg per day
Intervention MeSH terms: Ezetimibe
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: 75 Years
Healthy volunteers: No
Keywords: nonalcoholic fatty liver disease; NAFLD

Summary:

      The purpose of this research is to gather information on the combination Zetia® (Ezetimibe)
      and Urso Forte® with respect to sterol balance and their effects on biomarkers of liver
      function in subjects with nonalcoholic fatty liver disease (NAFLD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Steatosis

          -  ALT >1.5 times normal

          -  ALT/AST ratio >1.0

          -  Normal Kidney Function

        Exclusion Criteria:

          -  Normal ALT within last 6 months

          -  Advanced fibrosis based on 1) biopsy, if available (Stage 3 or 4 NAFLD), 2) imaging,
             or 3) lab (platelet count <150,000)

          -  Daily alcohol use above 20 g/day for women and 30 g/day for men

          -  Prescription use of ursodiol, ezetimibe, vitamin E, fish oils, thiazolidinediones,
             insulin, sulfonylureas, HMG-CoA reductase inhibitors

          -  Weight loss greater than 15% in past 12 months

          -  Pregnant or breastfeeding

          -  Body Mass index greater than 50

          -  Largest body circumference greater than 160 cm

          -  Claustrophobia

          -  Allergy to ezetimibe or ursodiol
STOP-CA (Statins TO Prevent the Cardiotoxicity From Anthracyclines)
Condition: Heart Failure
MeSH terms: Heart Failure; Cardiotoxicity
Intervention: Placebo; Atorvastatin
Intervention description: A pill taken once a day; A pill taken once a day
Intervention MeSH terms: Atorvastatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 300.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cancer Treatment Related to Heart Failure

Summary:

      This research study will test whether atorvastatin, a drug commonly prescribed for reducing
      cholesterol levels, can protect the heart during chemotherapy with doxorubicin. Atorvastatin
      is from a family of medications that are commonly called "statins"
    

Eligibility criteria:

        Inclusion Criteria:

          -  > 18 years of age

          -  All patients with newly diagnosed NHL and HL

          -  Scheduled to receive anthracycline-based therapy

        Exclusion Criteria:

          -  Statin use or Statin use is indicated based on guidelines

          -  Pregnancy or breastfeeding

          -  Unable to provide informed consent

          -  Unexplained persistent elevation of transaminases (>3 times upper limits of normal)

          -  Concomitant use of cyclosporine

          -  Renal failure: estimated glomerular filtration <45 mL/min/1.73 m2

          -  Contraindication to a CMR (metallic object, severe claustrophobia, pacemaker, vascular
             clip

          -  LVEF of <50% at baseline